RESEARCH GOVERNANCE TOOLKIT FOR VICTORIAN PUBLIC HOSPITALS AND VMIA INSURED MEDICAL RESEARCH INSTITUTES

Transcription

1 RESEARCH GOVERNANCE TOOLKIT FOR VICTORIAN PUBLIC HOSPITALS AND VMIA INSURED MEDICAL RESEARCH INSTITUTES

2 Contact The Victorian Managed Insurance Authority Phone: Acknowledgement The VMIA would like to acknowledge the contribution of its client base, who generously provided their time and their organisation s intellectual property, to develop this Research Governance Toolkit. The generous contribution, enthusiasm and commitment exhibited, has made the production of this toolkit possible. The information provided in this document is intended for general use only. It is not a definitive guide to the law, does not constitute formal advice and does not take into consideration the particular circumstances and needs of any individual organisation. Every effort has been made to ensure the accuracy and completeness of this document as of the date of publication. The VMIA, in addition to the contributors to this document, cannot be held responsible and extend no warranties as to the suitability of the information in this document for any particular purpose and for actions taken by third parties. The document is protected by VMIA copyright. The VMIA grants a non-exclusive right for this document on the condition that it is not distributed for profit. The VMIA encourages the free transfer and copying of the document if such activities support the purpose and intent for which this document was developed. April 2010.

3 Contents Introduction 3 Scope of the RGT Project 3 How to Use 4 Research Ethics 5 Induction, Training & Accreditation 73 Legal & Insurance 109 Research Finance Management 123 Data & Tissue Management 133 Intellectual Property & Publication 149 Research Risk Management 187

4 Glossary of Abbreviations ADE ADR AE ACHS AHEC ARC CIRA CPE CPMP CTRA CTN CTX DSMB DE DH EOR ERM EU FTIH GCP HEAG HREC ICH Adverse Device Event Adverse Drug Reaction Adverse Event Australian Council On Healthcare Standards Australian Health Ethics Committee Australian Research Council Clinical Investigation Research Agreement Clinical Pharmacology Expert Committee for Proprietary Medicinal Products Clinical Trial Research Agreement Clinical Trial Notification (Scheme) Clinical Trial Exemption (Scheme) Data and Safety Monitoring Board Device Expert Victorian Department of Health Executive Officer, Research Enterprise - Wide Risk Management European Union First Time In Human Good Clinical Practice Human Ethics Advisory Group Human Research Ethics Committee International Conference on Harmonisation of Technical Reuirements for Registration of Pharmaceuticals for Human Use ICH-GCP International Conference on Harmonisation-Good Clinical Practice ICSR IP KPI NDA NEAF NHMRC Individual Case Safety Reports Intellectual Property Key Performance Indicator Non Disclosure Agreements National Ethics Application Form National Health and Medical Research Council NPP NS PI QA REC RGO RGT RGU SAE SADE SOP SUSAR TGA VGRMF VMIA National Privacy Principle National Statement on Ethical Conduct in Human Research (also National Statement ) Principal Investigator Quality Assurance Research Ethics Committee Research Governance Office Research Governance Toolkit Research Governance Unit Serious Adverse Event Serious Adverse Device Effect Standard Operating Procedure Serious Unexpected Suspected Adverse Reaction Therapeutic Goods Administration Victorian Government Risk Management Framework Victorian Managed Insurance Authority 2

5 RESEARCH GOVERNANCE TOOLKIT Introduction The Research Governance Toolkit is intended to provide the appropriate guidance and provision of essential tools in the form of templates, proformas or SOPs that will facilitate good research governance practice. The various elements of the RGT should be used as a guide only and be adapted, adopted and version controlled by the Research Governance Unit or euivalent of the institute to ensure, where possible, standard application across your entire organisation. The RGT is underpinned and reliant on a number of Victorian Managed Insurance Authority (VMIA) documents which the institute and its researchers should be familiar with. The following VMIA documents are integral to facilitating the RGT objectives: VMIA CTN Guidelines VMIA FTIH Protocol VMIA Clinical Trial Research Agreements (CTRAs) VMIA Clinical Investigation Research Agreement (CIRA) VMIA 13 SOPs for minimum ICH GCP Compliance All the above documents can be downloaded from the VMIA website: and then proceed to Public Healthcare > Clinical Trials The institute and its researchers should be familiar with all relevant National and International standards, legislation or regulatory reuirements that need to be adhered to in the conduct of clinical research. It is not the intention of this document to define or reference all relevant standards, legislation or regulatory reuirements. The RGT has been developed with the input from Victorian public health services and medical research institutes who are insured by the VMIA. The RGT has been developed to be used by clients of the VMIA. 1. Introduction to the VMIA The VMIA is Victoria s state insurer. The VMIA insures all public hospitals across the state and a number of leading research institutes. The RGT project has been sponsored by the VMIA as part of its risk mitigation for clinical research activity at VMIA insured sites. The key deliverables of the project are the generation of guideline policies, generic SOPs, templates and proformas as tools available to assist with the regulatory reuirements under the National Statement on Ethical Conduct in Human Research (NH&MRC 2007), Australian Code for the Conduct of Research (NH&MRC 2007), The VMIA CTN Guidelines 2009, Therapeutic Goods Act 1989 and any other relevant legislative or statutory codes. Clinical research that is not conducted in accordance with Australian regulatory reuirements presents an exposure risk to the investigating institute and clinical trial subject. The VMIA supports the excellent work conducted by the Victorian (and Australian) clinical research industry aiming to facilitate and support continued growth of the clinical research industry. 1.1 Scope of the RGT Project and why it was developed The RGT project provides the basic tools for an institute engaged in the conduct of medical/clinical research to fulfil its basic reuirements in relation to good research governance and better align this aspect of its operations with your organisation s overarching governance imperatives. The RGT should not be viewed as all exhaustive and a complete package of all elements reuired to achieve good governance, but as a document that provides suitable guidance and points for consideration in this regard by the provision of guideline policies, SOPs, templates and proformas. It needs to be noted that this document is intended to complement and supplement, rather than replace, any existing policies, SOPs or templates that your institution may already have in place and which are suitable for your institute s operational reuirements.

6 RESEARCH GOVERNANCE TOOLKIT Introduction continued The various elements within the RGT document are intended to be adapted to suit local site and ethics committee reuirements while still complying with the regulated clinical research industry. Once implemented at the site, the RGT elements will provide a basic operational documentation system that should be version controlled and reviewed at regular intervals for current applicability. Clinical research that is conducted on behalf of the pharmaceutical industry or other entity may have reuirements in addition to those outlined in this RGT project. The additional reuirements are usually due to commitments or regulations reuired to be followed by other regulatory jurisdictions. The VMIA RGT project does not aim to satisfy additional international reuirements. 1.2 How to use this document The RGT gives due consideration to the following elements: 1. Research Ethics. 2. Induction, Training and Accreditation. 3. Legal and Insurance. 4. Research Finance Management. 5. Data & Tissue Management. 6. Intellectual Property and Publication. 7. Research Risk Management. All elements of the RGT will be provided to the VMIA insured entities engaged in clinical research in a word document to allow for institute specific adaptation of the materials provided. It is appreciated that an institute may already have in place adeuate processes to satisfy good research governance. It is not expected that such institutes would replace their existing documentation with that provided in the RGT, if their current documentation adeuately meets the institute s governance reuirements. The RGT is intended to supplement and augment the institute s research governance imperatives and assist with the provision of background materials to address any areas of identified deficiencies. Each organisation will need to adeuately manage the dissemination, implementation and version control of the RGT across its research departments. Each organisation at all times will be responsible for ensuring its own legislative compliance. Each of the above elements may comprise of policies, procedures, SOPs, templates and proformas that can be used by the institute to address an identified weakness or gap in a particular area.

7 Research Ethics RESEARCH ETHICS Introduction 5 Recommended Recruitment Strategies for HREC Members 6 Monitoring Human Research Policy 7 Key Performance Indicators for HRECs and Research Governance Units 13 Allocation of Research to Different Levels of Review 18 Models of Ethics Review 21 Handling Research Related Complaints Policy 24 Conflict of Interest Research Related Activities Policy 28 Template for HREC Report to Institution 30 Template for Reporting HREC Review Waiver of Reuirement for Consent 31 APPENDIX 1: HREC Terms of Reference Template 32 APPENDIX 2: CTA HREC Mutual Acceptance Submissions 36 APPENDIX 3: Recognised Prior Review Guidelines - Peter MacCallum Cancer Institute 38 APPENDIX 4: Low Risk Research Review Procedures - Melbourne Health 41 APPENDIX 5: Human Ethics Advisory Groups (HEAGs) - University of Melbourne 42 APPENDIX 6: Low Risk Research Application Form - Alfred Health 44 APPENDIX 7: Melbourne Health QA Guidelines 52 APPENDIX 8: Approval of a Quality Assurance Project Application Form 54 APPENDIX 9: Criteria for Allocation of Research to Different Levels of Review Checklist 63 APPENDIX A: HREC Spokesperson Project Review 64 APPENDIX B: Project Summary Report For Ethics Committee 67 APPENDIX C: Template for HREC Report to Institution 69 APPENDIX D: Waiver of the Reuirement for Consent 72

8 Preamble Research proposals involving human participants must be reviewed and approved by a Human Research Ethics Committee (HREC) that is established by and provides advice to an institution regarding ethical approval for research projects. The National Statement on Ethical Conduct in Human Research (2007) sets out reuirements for the establishment of HRECs, their reviewing practices, the monitoring of such decision-making and the conduct of the approved research itself. When establishing an HREC, institutions must set out its terms of reference, including the scope of its responsibilities, relationship to non-affiliated researchers, accountability, mechanisms of reporting and remuneration for members. Parties involved in monitoring research projects must be familiar with the NHMRC Australian Ethics Committee (AHEC) Position Statement 2009.

9 RESEARCH ETHICS Introduction While the primary role of an HREC is to protect the welfare and the rights of participants in research, the decisions an HREC makes have implications for the researchers and the institution it acts on behalf of. The institution must accept legal responsibility for decisions and advice received from the HREC, and indemnify its members. Accordingly, it is strongly recommended that procedures for addressing conflict of interest and complaint resolution be put in place. Materials provided as part of the VMIA Research Governance Framework to provide assistance in this area include the following: 1. HREC construction Guidelines for HREC member recruitment Monitoring Human Research policy Sample HREC Terms of Reference (Appendix 1, HREC Terms of Reference Template ) Other important sources of information relating to the operation of HRECs: The National Statement on Ethical Conduct in Human Research (NHMRC 2007) e72syn.htm NHMRC - When does uality assurance in healthcare reuire independent ethical review? (2003) e46syn.htm Health Records Act 2001 (Victoria) Privacy Act 1988 (Cwlth) Information Privacy Act (Vic) HREC Operation research proposal review Key Performance Indicators for HREC members, Administrative personnel Allocation of research to different levels of review Existing models of scientific/research and ethical review 3. HREC - Accessory operations Complaints resolution policy - template Conflict of interest policy - template HREC report to institution - template Guidelines for reporting HREC review waiver of reuirement for consent

10 RESEARCH ETHICS Recommended Recruitment Strategies for HREC Members 1. Purpose The National Statement on Ethical Conduct Human Research (2007), Section , states that members should be appointed to an HREC using open and transparent processes. The following procedures are designed to enable these stipulations to be adhered to. 2. Scope Section 5 of the National Statement on Ethical Conduct in Human Research (National Statement) describes the wide range of activities associated with research governance and ethical review and sets out the processes by which institutions establish, conduct and oversee different levels of ethical review, including the operations of HRECs. This document supplements this section of the National Statement and provides additional guidance to institutions in the area of recruitment of members for HREC duty. 3. Applicability This procedure applies to all staff who are responsible for facilitating and regulating HREC activity on the campuses of [NAME OF INSTITUTION/ ORGANISATION] and the individual research institutes and groups for whom the [NAME OF INSTITUTION/ ORGANISATION] HREC provides research governance and services. 4. Procedure It is recommended that the following recruitment strategies are adopted for the categories of membership: 4.1 Chair: May be a Board appointment made according to local policy. 4.2 Lay people: Open advertisement in daily media (local or statewide) depending on the location of the institution. 4.3 Person with knowledge of and current experience in professional care, counselling or treatment of people: Within the health service, through advertisement via staff bulletins, research newsletters, notice boards. External to the health service, through advertisement in the daily media or in other healthcare services. 4.4 Person who performs a pastoral care role in a community, for example, an Aboriginal elder, a minister of religion: Aboriginal elder Seek advice through aboriginal liaison officer or organisation representing indigenous people in the health service catchment area. Minister of religion: Seek advice from health service chaplaincy or pastoral care coordinator or euivalent in regard to appropriate local religious organisations to approach seeking expressions of interest. An open advertisement in the daily media may also be appropriate. HRECs at health services auspiced by religious organisations may have their own policy or processes for recruitment of members in this category. 4.5 Lawyer: Open advertisement in local media and through appropriate professional organisations eg. Law Society of Victoria. 4.6 People with current research experience that is relevant to research proposals to be considered: Within the health service, through advertisement via staff bulletins, research newsletters, notice boards. External to the health service, through advertisement in the daily media, in other healthcare services or relevant academic institutions or research organisations. References The National Statement on Ethical Conduct Human Research (2007) Section lists the minimum membership for a Human Research and Ethics Committee (HREC).

11 RESEARCH ETHICS Monitoring Human Research Policy 1. Purpose This policy has been developed to provide a framework for monitoring human research projects across the campuses of [NAME OF INSTITUTION/ ORGANISATION] and the individual research institutes and groups for whom the [NAME OF INSTITUTION/ ORGANISATION] HREC provides research governance and services. The policy details responsibilities for the various parties involved in monitoring research projects and the procedures to be followed. Parties involved in monitoring research projects must be familiar with the NHMRC Australian Health Ethics Committee (AHEC) Position Statement Scope This policy encapsulates all research undertaken by [NAME OF INSTITUTION/ORGANISATION] that is governed by the National Statement on Ethical Conduct in Human Research (2007) 3. Glossary Adverse device event (ADE): A clinical sign, symptom or condition that is causally related to the device implantation procedure, the presence of the device, or the performance of the device system. Adverse drug reaction (ADR): Any noxious and unintended response to an unapproved medicinal product, related to any dose. The phrase response to an unapproved medicinal product means that a causal relationship between the product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. ( Unapproved medicinal product here includes approved products used at levels or in ways that are unapproved by a Regulatory Authority). or A noxious and unintended response to a drug that occurs at doses of marketed medical products normally used in humans for prophylaxis, diagnosis or therapy of diseases or for modification of physiological function. Adverse event: The meaning given in the TGA document Access to Unapproved Therapeutic Goods - Clinical Trials in Australia Oct 2004 or replacement. Clinical trial: A form of research designed to find out the effects of an intervention, including a treatment or diagnostic procedure. Data and Safety Monitoring Board (DSMB): Is a multidisciplinary group comprised of experts who review data and conduct safety monitoring to assure the safety of participants in a clinical trial. The DSMB is expected to review the study at predetermined intervals to review adverse event reports and to determine whether the study should continue or be suspended or terminated. Investigational Product: Investigational Product is the medicine or device being trialled or tested in the study and includes where relevant any placebo. Monitoring: Process of verifying that the conduct of the research conforms to the approved proposal. Principal investigator: The person responsible for the conduct of the clinical trial at a trial site. In the case of a trial being conducted by a team of individuals at the site, the principal investigator is the responsible leader of the team Risk: The function of the magnitude of harm and the probability that it will occur. Serious adverse event (SAE): Any untoward medical occurrence that: results in death; is life threatening (NOTE: The term life-threatening refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/reaction which hypothetically might have caused death if it were more severe); reuires inpatient hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability/ incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. Serious unexpected suspected adverse reaction (SUSAR): A SAE (see definition above) for which there is some degree of probability that the event is an adverse reaction to the administered drug, and the adverse reaction is unexpected. Sponsor: An individual, company, institution or organisation that takes responsibility for the initiation, management, and/or financing of research. Unexpected adverse drug reaction: An adverse reaction, the nature or severity of which is not consistent with the applicable scientific information (eg. Investigator s Brochure for an unapproved investigational product or Product Information document or similar for an approved, marketed product).

12 RESEARCH ETHICS Monitoring Human Research Policy continued 4. Applicability This policy applies to all staff and students conducting human research on the campuses of [NAME OF INSTITUTION/ORGANISATION] and the individual research institutes and groups for whom [NAME OF INSTITUTION/ORGANISATION] provides research governance and services. 5. Policy 5.1 Individuals conducting human research must comply with the [NAME OF INSTITUTION/ ORGANISATION] research policy and associated procedures. [NAME OF INSTITUTION/ORGANISATION] has ultimate responsibility for ensuring, via its research governance arrangements, that all its approved research is monitored 1.The types of monitoring that [NAME OF INSTITUTION/ORGANISATION] employs are: a. Reports from researchers of unforeseen events that may affect the continuing acceptability of the project. b. Reports from researchers, at least on an annual basis and at the completion of the project. c. Reports from sponsors and independent agencies (such as data and safety monitoring boards). d. Review of adverse event reports. e. Random inspections of research sites, data and consent documentation. c. ADRs, SUSARs, SADEs from any site for which the institution is responsible are reported according to the Adverse Event reporting procedures ; d. where the project is a large multi-centre trial, a DSMB is used and there is a mechanism for informing the HREC of any relevant emerging data from the DSMB 4 ; e. where the project is a local trial, there is an identified person/s or committee with suitable expertise to assist and advise the HREC about reports of serious adverse events Responsibilities The responsibilities described below are specific, but not limited to, this policy and associated procedures: Principal Investigator (PI) Researchers have a significant responsibility in monitoring, as they are in the best position to observe any adverse events or unexpected outcomes. They should report such events or outcomes promptly to the relevant institution/s and ethical review body/ies, and take prompt steps to deal with any unexpected risks 6. The granting and continuation of ethical approval of clinical research is on the condition that, for any trial site under the HREC s responsibility, researchers 7 are responsible for the following: 5.2 Monitoring arrangements will be commensurate with the risk, size and complexity of the study 2. For each project, each institute must ensure that: a. SAEs at any site for which the institution is responsible are reported according to the Adverse Event reporting procedures ; b. there are mechanisms for reporting and reviewing 3 ; 1 National Statement on Ethical Conduct in Human Research (NHMRC; 2007) paragraph and National Statement on Ethical Conduct in Human Research (NHMRC; 2007) paragraph and Ibid. paragraph Ibid. 5 Ibid. 6 Ibid. paragraph Ibid. paragraph and

13 RESEARCH ETHICS Monitoring Human Research Policy continued a. Notifying the HREC that mechanisms for monitoring are in place, and for satisfying the HREC that the mechanisms are appropriate to the research. b. Conducting the trial in compliance with the approved protocol. c. Providing reports of the progress of the trial to the HREC, at a freuency directed by the HREC in the initial approval notification (but at least annually), and related to the degree of risk to participants. d. Informing the HREC, and seeking its approval, of amendments to the protocol including amendments that: are proposed or undertaken in order to eliminate immediate risks to participants; may increase the risks to participants; or significantly affect the conduct of the trial. e. Notifying the relevant HREC of any SAEs at any trial sites according to the HREC procedures. f. Informing the HREC as soon as possible of any new safety information from other published or unpublished studies that may have an impact on the continued ethical acceptability of the trial or may indicate the need for amendments to the trial protocol. g. Informing the HREC, giving reasons, if the trial is discontinued before the expected date of completion. h. For trials with implantable medical devices, confirming the existence of, or establishing a system for: tracking the participant, with consent, for the lifetime of the device; and reporting any device incidents to the TGA. i. Reporting SAEs or reactions to trial sponsors to meet the reuirements of regulatory agencies, such as the TGA 8. j. Meeting the monitoring responsibilities of the Principal Researcher or research team under any Clinical Trial Research Agreements. k. Ensuring that [NAME OF INSTITUTION/ ORGANISATION], as an institution, meets its monitoring responsibilities under any Clinical Trial Research Agreement Sponsor Where a sponsor is designated to a study, the sponsor is responsible for: a. Monitoring responsibilities as detailed in the following documents: Note for Guidance on Good Clinical Practice (CPMP/ICH/135/99). Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95). b. Meeting the monitoring responsibilities under any CTRA and CIRA. c. The ongoing safety evaluation of the investigational product(s). d. Reporting SAEs or SUSARs to: regulatory agencies (such as, TGA) to meet the conditions of approval to conduct a trial; investigators to enable them to fulfil the conditions of ethical approval by an HREC; and DSMB or similar entity. 8 NHMRC HREC Alert Number 1 dated 18 April 2007.

14 RESEARCH ETHICS Monitoring Human Research Policy continued Human Research Ethics Committees The responsibility of HRECs and of the institutions they advise, is to protect the safety of participants in clinical trials. In order to discharge this responsibility, HRECs need to receive sufficient reliable information about the implications of adverse events or reactions. HRECs should note items related to annual reporting, AE reports and institutional audit reports. HREC members can reuest additional information or investigation Member Expertise HREC membership should incorporate the inclusion of or access to individuals who have expertise in the relevant disciplines involved in research projects for which the HREC is responsible for reviewing. For example, clinical pharmacologists, or experimental device experts The responsibilities of the Research Governance Unit include: a. The RGU s primary responsibility is to facilitate communication between all parties in a timely and professional manner. b. The RGU will provide advice and assistance to the Principal Researcher and the HREC as reuired. 5.4 Annual Progress Reporting A condition of approval for studies approved by the [NAME OF INSTITUTION/ORGANISATION] HREC is that a report of project progress is submitted annually. The letter of approval will identify if more freuent progress reports are reuired. All forms should be available from the RGU website. On the anniversary of HREC approval of a project, the researcher should submit a report of project progress for the preceding year. If a researcher fails to complete and return an annual report, approval for the study may be suspended by the HREC. A final report is also due on completion of the study, or if the research is discontinued before the expected date of completion. Completion of the study means: For commercially sponsored clinical trials - the study is considered complete once the closeout visit has been completed. For investigator initiated clinical trials - the study is considered complete once the last patient has completed follow up and the data has been analysed. For other research projects - the study is considered complete once data collection is complete and there is no further contact with patients or access to medical records or other sources of personal or health information. The Annual or Final Report will be reviewed and acknowledged by the Executive Officer, Research or the Secretary of the relevant HREC. Where concerns are raised, the matter will be referred to the Chair or delegate of the relevant HREC. c. The RGU staff will review annual reports, Adverse Event reports and institutional audit reports and will report any issues of significance to the relevant Chair or HREC member and/or place the item on the relevant HREC agenda. 10

15 RESEARCH ETHICS Monitoring Human Research Policy continued 5.5 Reporting Adverse Events Researcher Responsibilities a. The researcher must note and report Adverse Events, including SAEs, which occur at their site to the sponsor in accordance with the study protocol. b. The researcher must report all SAEs to the sponsor immediately (within 24 hours) in accordance with GCP guidelines. c. If the researcher is also the study sponsor, as is the case in investigatorinitiated clinical trials, see also section 5.5.3, Sponsor Responsibilities for additional responsibilities HREC Reporting Reuirements For each clinical trial for which an HREC is responsible, the HREC reuires: a. Researchers to report to the HREC all SAEs (within 1 working day) or unexpected AE s (within 30 working days) involving participants for which the HREC is responsible and which are possibly, probably or definitely related to participation in a clinical trial. b. Researchers to report to the HREC promptly, within 3 working days: Information which materially impacts the continued ethical acceptability of the trial; or Information that reuires, or indicates the need for, a change to the trial protocol, including changed safety monitoring in the view of the investigator or sponsor. c. Researchers to report to the HREC, on a six-monthly basis: Listing of all SUSARS, Australian and international, occurring with an investigational product, including sponsor and researcher comments as to whether action is planned for the trial on the basis of the reports. European Union format for these reports is acceptable. d. Researchers to report to the HREC, on an annual basis: an updated Investigator Brochure; or an EU Annual Safety Report (or similar format report); or a current, approved Product Information, if appropriate (eg. in a study for a product approved in Australia or where an Investigator Brochure is no longer maintained); or other reports consistent with section of the NHMRC National Statement and GCP as adopted by the TGA. e. Researchers to forward reports from clinical trial DSMB to the HREC as they are received, in a timely manner Sponsor Responsibilities Sponsors have a significant role in supporting researchers to meet their obligations for safety reporting to their institutions. Sponsors must communicate to researchers, in a prompt manner (within 3 working days), information which could adversely affect the safety of research participants, materially impact the continued ethical acceptability of a trial or that reuires (or indicates the need for) a change to the trial protocol, including changed safety monitoring. Sponsors are NOT reuired to routinely send individual SUSARs from other Australian or international sites to researchers or the HREC UNLESS the researcher concerned or the responsible HREC, or the sponsor considers this necessary because of the risk, size or complexity of the proposed research Reporting to Insurer Trials conducted in Victorian public health services are reuired to comply with the Guidelines for Clinical Trials for Victorian Public Hospitals 2009 issued by the VMIA, insurer of all public health services in Victoria. 11

16 RESEARCH ETHICS Monitoring Human Research Policy continued Reports of SAEs [or which relate to a claim made against the hospital (or a member of its staff) and/or the occurrence of circumstances which may subseuently give rise to a claim against a hospital], must be reported to the VMIA in accordance with the provisions of the VMIA Public Liability and Medical Indemnity policies. Failure to give proper notification of any circumstance likely to give rise to a claim or the making of a claim may compromise insurance coverage for both the hospital and/or a member of its staff. For these reasons, all SAEs or unexpected Adverse Events involving a research participant for which the HREC is responsible, and which are possibly, probably or definitely related to participation in a clinical trial, must be reported in writing to the VMIA. Researchers should forward such reports to the HREC as prescribed above and the HREC administration/rgu will forward all relevant documentation and correspondence to the VMIA in accordance with the VMIA guidelines. 5.6 Institutional Audits A number of studies should be selected at random and audited on a monthly basis. The audit should be conducted by the RGU and review: Consent documentation is complete for all participants enrolled in the study. The PI is responsible for keeping a record of consent (written consent form or note of verbal consent) for every participant recruited into a study. Consent documentation is the version most recently approved by the HREC. Each participant should be consented on the Participant Information and Consent Form approved by the HREC at the time. Study documentation is stored as reuired. Study documentation should be stored in a secure location. Audit reports should be sent to the PI if reuired. The report will include recommendations if reuired. Reports should be tabled at HREC meetings Reporting to the TGA Sponsors are responsible for reporting individual case safety reports to the TGA in accordance with expedited reporting guidelines. In investigator initiated or collaborative group sponsored studies, responsibility for reporting adverse reactions to the TGA rests with the investigator or collaborative group. References: The National Statement on Ethical Conduct in Human Research (NHMRC 2007) ( Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - annotated with TGA comments. DSEB. July ( Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95). Annotated with TGA comments, August 2001 ( The Australian Clinical Trials Handbook (TGA; March 2006) ( Access to Unapproved Therapeutic Goods clinical trials in Australia. Australian Government Department of Health and Ageing. Therapeutic Goods Administration. Oct 2004 ( NHMRC HREC Alert Number 1 dated 18 April 2007 (NHMRC; 2007) VMIA Guidelines for Clinical Trials for Victorian public hospitals (VMIA; July 2009) ( Therapeutic Goods Act 1989 (Cwlth) ( 67A98FD37A0824C8CA256F710006F162?OpenDocument&mostrecent=1) 12

17 RESEARCH ETHICS Key Performance Indicators for HRECs and Research Governance Units 1. Purpose To define Key Performance Indicators (KPIs) which will allow institutional management, the HREC members and administrative staff to better understand how the HREC and RGU are performing. Such KPIs will also allow comparisons of uality and efficiency of RGUs and HRECs across institutions and against national and international benchmarks. 2. Scope This process encapsulates all research undertaken by [NAME OF INSTITUTION/ORGANISATION] that is governed by the National Statement on Ethical Conduct in Human Research (2007). These KPIs have been established with an emphasis on uality, as in the medical arena this is of upmost importance. However time and cost have also been considered as these are both essential considerations for any RGU. 3. Applicability Parameters have been chosen based on the experience of three different research organisations. The majority of the KPIs should be able to be implemented by most RGUs, and be used to ensure standards of performance for HREC operation and the administrative units that support HREC operation are maintained at acceptable levels. 13

18 RESEARCH ETHICS Key Performance Indicators for HRECs and Research Governance Units continued 4. Procedure HREC Administrators Key Performance Indicators Core business Goal Detail KPI Source (if reuired) Report to government agencies on behalf of the institution Reports submitted accurately and on time AHEC Annual Report Victorian Health Services Commissioner Annual Report Annual Report submitted accurately and by the deadline as determined by AHEC Annual Report submitted accurately and by the deadline as determined by the Office of the Victorian Health Services Commissioner AHEC s of the Health Records Act 2001 (Victoria) Statutory Guidelines on Research issued for the purposes of Health Privacy Principles 1.1(e)(iii) and 2.2(g)(iii) Report to institution Reports submitted accurately and on time Internal report, for example to Board or Research Committee As reuired by organisation i.e. monthly or annually Institutional policies and guidelines May be specified in HREC Terms of Reference Provide secretarial support to HREC Distribute committee agendas and minutes on time Agenda Agendas prepared and distributed no less than 3 business days prior to meeting Section (d) of the National Statement on Ethical Conduct of Human Research 2007 Minutes Minutes prepared no more than 7 business days after the meeting Correspondence to and from HREC actioned in a timely manner Receipt of applications Receipt/Notice of receipt of application sent to Principal Researcher no more than 5 business days after receipt of application by the RGU Section (l) of the National Statement on Ethical Conduct of Human Research 2007 Correspondence to research team Correspondence sent to Principal Researcher (and others as reuired) within 5 business days following completion of meeting minutes or receipt of researcher correspondence by the RGU. Section (l) of the National Statement on Ethical Conduct of Human Research 2007 For urgent applications (as advised to committee) letter could be produced within 1 business day and signed by administrative staff on behalf of the Chair in case the Chair is not available or signature not reuired. 14

19 RESEARCH ETHICS Key Performance Indicators for HRECs and Research Governance Units continued Core business Goal Detail KPI Source (if reuired) Letters/certificates of final approval Letters/certificates of approval sent to Principal Researcher within 5 business days following final project HREC approval or amendment approval by the RGU. For urgent applications (as advised to committee) letter could be produced within 1 business day and signed by administrative staff on behalf of the Chair in case the Chair is not available or signature not reuired. Section (l) of the National Statement on Ethical Conduct of Human Research 2007 Business arising from the meetings is actioned in a timely manner Business arising from the minutes is actioned no more than 10 business days after the meeting for general issues. For urgent issues (as advised to the committee) items to be actioned no more than 5 business days after the meeting. Section (l) of the National Statement on Ethical Conduct of Human Research 2007 Manage complaints Complaints responded to and managed in a timely manner Acknowledgement of complaint to be sent to the complainant within 1 business day of receipt. Response to complainant to be sent within 3 business days. Follow up and correspondence actioned in a timely manner. Institutional Complaints policy Record keeping: Maintain statistics of applications Ensure that KPIs are being met Annually review the KPIs mentioned above to ensure they are being met. 15

20 RESEARCH ETHICS Key Performance Indicators for HRECs and Research Governance Units continued Core business Goal Detail KPI Source (if reuired) Research Governance Ensure all site specific research governance matters have been addressed as reuired by relevant parties Research activity complies with the reuirements of commonwealth and state legislation 100% of research projects comply with the reuirements of commonwealth and state legislation. 10% of all projects should undergo a RGU audit each year. CTRAs CTRAs are reviewed within [10 business days] of receipt and meet the reuirements of the institution. The reuirements of the institution may include reuirements of the institution s insurer - the VMIA. Indemnity and insurance TGA CTN / CTX forms Indemnity and respective insurance arrangements comply with the reuirements of the institution and the VMIA. TGA CTN / CTX forms accurately reflect the study protocol, are signed by all parties and are sent to the TGA by the appropriate party. Maintain Human Research / HREC website Maintain a comprehensive, up-to-date and accurate website Ensure that all relevant policies and other information is up-to-date and available on the website at all times. Every change to a document or form is placed onto the website within two weeks. [Recommendation] It is recommended that the website is reviewed on a 6 monthly basis to ensure currency. Facilitate Institutional Research Enuiries answered in a timely manner. Conduct regular educational and training sessions for or make appropriate material available to researchers and other research support staff. Create a culture of cooperation between RGUs/HRECs and researchers. Enuiries answered within 5 business days. [Recommendation] It is recommended that staff and customers are surveyed on a regular basis to determine level of satisfaction and to determine where improvements can be made. Survey results should be actioned in a timely manner and ensure that they are used to influence staff and customer educational opportunities. 16

21 RESEARCH ETHICS Key Performance Indicators for HRECs and Research Governance Units continued Core business Goal Detail KPI Source (if reuired) Maintain high level of research ethics knowledge To be able to appropriately refer to pertinent sections and be familiar with the National Statement. Attend continuing education or training programs in research ethics. Complete a self audit tool to measure level of knowledge. Attend continuing education or training programs in research ethics at least every three years, or as available. Review agenda and applications in a timely manner and in a consistently high standard Achieve comprehensive ethical project reviews in a timely manner. Review 100% of projects in a timely manner. Contribute to discussion at the respective HREC meeting. Attend and participate in HREC meetings Prepare for and attend scheduled meetings, or, if unavailable, fulfil HREC absence procedures. 100% attendance or fulfilment of absence procedures. Contribute to discussion of agenda items at HREC meetings. Institutional reuirements. May be specified in HREC Terms of Reference and/or Working Procedures. References: The National Statement on Ethical Conduct in Human Research NHMRC 2007 Australian Code for the Responsible Conduct of Research NHMRC/ARC/ Australian Universities 2007 Health Records Act 2001 (Victoria) 17

22 RESEARCH ETHICS Allocation of Research to Different Levels of Review 1. Purpose To facilitate compliance with the NHMRC National Statement on Ethical Conduct in Human Research 2007 (NS), sections , Oversight and review of ethical review procedures, by providing an auditing process which allows institutions to confirm: that research projects in their institution are being reviewed at a level commensurate with the risk involved; that research is being exempted from review only in accordance with the criteria set out in NS and ; and the uality of the actual scientific and ethical review at each level. Compliance with these procedures will assist institutions in meeting their responsibilities in terms of research governance and ethical review as outlined in Section 5.1 of the NS. 2. Scope This process encapsulates all research undertaken by [NAME OF INSTITUTION/ORGANISATION] that is governed by the National Statement on Ethical Conduct in Human Research (2007) Institutions that establish different levels of ethical review, including review other than by an HREC, must establish criteria for allocating research to those different levels of review (including exemption from review) taking into account the principles of risk and benefit (as discussed in NS section 2.1). These criteria must be readily accessible to all those involved in the conduct and review of research (NS ). 3. Applicability Although primary responsibility for establishing criteria for allocation of research to different levels of review and auditing the appropriateness of that process rests with the institution responsible for the research, the NS (5.1.10) reuires that these criteria be made readily accessible to all those involved in the conduct and review of that research. Accordingly, these procedures are applicable to: a. any researcher conducting human research; b. any member of an ethical review body reviewing that research; c. those involved in research governance; and/or d. potential research participants. 4. Procedure 4.1 Define and establish different levels of ethical review as appropriate. Descriptions/definitions of these different levels of review must be readily accessible as indicated above, to researchers, members of ethical review bodies, research participants, and those involved in research governance. For example, this information could be posted on an institution s website. Examples of different levels of ethical review: Victorian central streamlined scientific and ethical review of multi-site research. streamlining.htm Full review by an HREC (Appendix 1 - HREC Terms of Reference Template). Mutual recognition/mutual acceptance of the HREC review undertaken by another institution (Appendix 2 - Cancer Trials Australian HREC Mutual Acceptance Submission). Recognised prior review (Appendix 3 Recognised Prior Review Guidelines Peter MacCallum Cancer Centre). Low risk research review, eg. review by a subcommittee of an HREC or review/ assessment at departmental level by either the head of department or a departmental committee of peers (Appendices 4-6 Melbourne Health Low Risk research review procedures/terms of reference, University of Melbourne Human Ethics Advisory Group Terms of Reference and Alfred Health Low Risk Application Form). Research exempt from review, eg. QA/clinical audit, negligible risk research and research involving only non-identifiable data, other research eg. non-medical surveys (Appendix 7 Melbourne Health QA Guidelines). 18

23 RESEARCH ETHICS Allocation of Research to Different Levels of Review continued 4.2 Use clear criteria to allocate research to different levels of review (Appendix 9). assess harm; gauge risk; and determine level of review reuired. 4.3 Assessment of research review processes. Audit, monitor and regularly assess all research review processes, including: adeuacy of the criteria for allocating research to different levels of review; assessing the uality of the reviews themselves; to ensure that those processes enable the institution to meet its responsibilities under the NS. 4.4 Key Performance Indicators (KPIs) Institutions are reuired to develop KPIs to assess the level of review reuired: percentage of projects allocated to non-hrec review (eg. exempt, low risk, QA) that should have had full HREC review; and percentage of projects allocated to full HREC review that would have sufficed with a lesser (non-hrec ) level of review Assessing the uality of the actual HREC and non-hrec reviews. It is difficult to establish KPIs for assessment of the levels and the actual uality of review of research. This is because institutions employ different processes for the spectrum of research projects reviewed. Nevertheless, institutions have a responsibility to ensure that the bodies conducting the different levels of research review operating under their auspices are functioning in accordance with the reuirements of the NS. Assessment of the uality of actual scientific and ethical reviews can take a number of different forms. Some examples are given below: Assessing adeuacy of non-hrec review (eg. by QA or Low Risk Committee or Departmental Group) review of randomly selected projects to be referred to the full HREC for comparison RGU (or euivalent) to coordinate. Assessing adeuacy of full HREC review comparison with the review of the same project undertaken by another HREC or reuesting another HREC to review randomly selected projects - RGU (or euivalent) to coordinate. 19

24 RESEARCH ETHICS Allocation of Research to Different Levels of Review continued The procedures discussed previously are illustrated schematically in the flowchart below: 1. Set up review bodies (HREC, Low Risk and QA Committees, etc). 2. Establish criteria for assessing level of review reuired. Allocation of research to different levels of review 3. Assess: appropriateness of review level selection; uality of actual ethical review. References: NHMRC - National Statement on Ethical Conduct in Human Research (2007) NHMRC - When does uality assurance in healthcare reuire independent ethical review? (2003) Health Records Act 2001 (Victoria) Privacy Act 1988 (Cwlth) 20

25 RESEARCH ETHICS Models of Ethics Review 1. Purpose To outline mechanisms that can be employed to perform ethical review (including scientific review) of research projects and manage associated research governance functions. These mechanisms include those that facilitate the streamlined review of multicentre research (with the conseuent minimisation of duplication of review) and those that can be employed to perform reviews of low risk research, negligible risk research and other investigative activities such as uality improvement and audit. 2. Scope Section 5 of the NS describes the wide range of activities associated with research governance and ethical review and sets out the processes by which institutions establish, conduct and oversee different levels of ethical review, including the operations of HRECs. This document supplements section 5 of the NS and provides additional guidance to institutions regarding the alternatives available to them for establishing structures, mechanisms and processes that comply with the NS, meet the reuirements of regulatory authorities, satisfy organisational imperatives, and are consistent with the interests of the Victorian research community and research participants. 3. Applicability The mechanisms outlined in this document are broadly applicable to institutions throughout Victoria and should be applied with due consideration for the degree of risk presented by a particular research project or other investigative activity. 4. Policy/Procedure 4.1 HREC Review An HREC must be constituted and must operate in accordance with the National Statement, section 5. Additional mechanisms that may assist an HREC in dealing with review of applications could include: a. spokespersons allocated to speak to particular research proposals; c. use of a facilitator (HREC member or not) to liaise between the HREC and the PI; and d. the reuirement for Chairs of sub-committees to be on the HREC. A proforma may be used by HREC members and/or spokespersons to assist their assessment of a research application. (Appendix 1) 4.2 Scientific Review Alternative mechanisms that could be employed to undertake scientific review of applications include: a. integrating scientific review with ethics review at the same HREC meeting (single committee process); b. use of a scientific sub-committee that meets before the ethics committee meeting and of whose discussions and advice the HREC is informed; c. internal review by a small number of experts that are independent of the HREC; and or d. external review by an independent expert reviewer. This method is most commonly used for early phase drug/device trials. 4.3 Review of low risk research/uality and audit activities The NS section outlines reuirements and suggestions for institutions when review of low risk research is conducted at a non-hrec level. Many institutions employ mechanisms apart from full HREC review for this sort of investigative activity. Some alternatives are: a. Review by an HREC sub-committee. b. Review by delegates of the HREC, eg. the HREC Chair. c. Review by a low risk review panel. The NS section describes the option given to institutions to exempt from review, research that is negligible risk research and involves existing data sets or records that contain non-identifiable data. b. appointment of lead discussants for a research proposal; 21

26 RESEARCH ETHICS Models of Ethics Review continued 4.4 Minimising duplication of review The NS section 5.3 addresses the review of research projects that may generate duplication of ethical review and states that each institution has the responsibility to adopt a review process that eliminates any unnecessary duplication of ethical review. There are multiple existing review models that facilitate compliance with this reuirement. It can be anticipated that additional models will be introduced in Victoria and nationally to enhance the ability of institutions to meet state or national standards. Existing models are described below: The Mutual Acceptance Program (MAP) is managed by Cancer Trials Australia (CTA) and is open to all CTA affiliates. This program facilitates acceptance by one or more member institution/s of the review conducted by another of its members and also streamlines aspects of research governance. MAP is currently limited to cancer clinical trials or associated clinical research. (Appendix 2) Recognised Prior Review (RPR) is a scheme developed by Peter MacCallum Cancer Centre that permits unilateral acceptance by an HREC of a review conducted in any Australian jurisdiction by a competent HREC. RPR is currently limited to clinical trials of drugs or other interventional treatment for cancer. (Appendix 3) Forms of mutual recognition, unilateral recognition or other models of reciprocal approval by one institution of another s review are in place between public and private hospitals (generally those that share facilities, staff and/or patient care), between teaching hospitals and universities and within health services consisting of multiple institutions. The Victorian Department of Health (DH) has developed a Central System for ethical and scientific review of multi-site research that is available to all Victorian hospitals for use in facilitating recognition of reviews conducted by selected institutions. The first stage of this program is limited to commercially sponsored clinical trials and clinical trials run by collaborative groups to be conducted within a select group of Victorian public hospitals. Further information can be obtained from: The Commonwealth, via the NHMRC, is developing the Harmonisation of Multi-centre Ethical Review (HoMER) project to facilitate cross-jurisdictional recognition of single ethical reviews conducted by an HREC, which has had its HREC processes accredited under HoMER. Further information on this initiative can be obtained from: ethics/homer/homer_news.htm Review of amendments A significant proportion of approved research projects will reuire amendment during the conduct of the project. Mechanisms to deal with significant amendments could include: a. review by delegates of the HREC followed by HREC ratification; b. review by an HREC sub-committee followed by HREC ratification; or c. review by a full HREC. Administrative amendments could be processed by: review and approval by the HREC secretariat only; review by Department Managers followed by approval by the HREC Secretariat, the HREC Chair or the full HREC; review and approval by delegates of the HREC; review by a sub-committee of the HREC; or review by the full HREC. Expedited review/interim approval Research or other investigative activities may be eligible for approval via expedited or interim processes when the safety or other critical interests of research participants or other matters of urgency are implicated. Matters that may be eligible for expedited review/interim approval include new applications, amendments, protocol waivers or other matters reuiring review. In such circumstances, institutions may choose to use one or more of the following HREC-related processes, followed by HREC ratification: a. review by delegates of the HREC; b. review by the Chair of the HREC or HREC sub-committee. 22

27 RESEARCH ETHICS Models of Ethics Review continued Safety monitoring Reports of SAEs and SUSARs and other safety reports may be managed by: a. review by the HREC secretariat; b. review by an internal or external pharmacologist/expert; c. review by the HREC Chair; d. review by HREC delegates; e. review by an HREC sub-committee; or f. review by the full HREC. Many organisations employ more than one of these mechanisms to manage SAE/SUSAR reports. Whichever mechanisms are used, the process for receiving and reviewing (if appropriate) internally and externally generated safety reports must be clearly articulated for researchers, external sponsors and regulators. Institutions are also expected to comply with standards for managing safety reports promulgated by advisory bodies (eg. the AHEC) and both national and international regulatory agencies (eg. the TGA). These standards generally reuire that reports submitted to an HREC, or other institutionally authorised entity or individual, only be submitted with an indication of whether action is recommended in response to the report. Institutions and their HRECs are within their rights to reject reports not submitted with this indication. Ethics and research governance An institution may choose to delegate to its HREC secretariat the review or management of various components of research governance. Matters commonly delegated to an HREC secretariat may include: a. review of clinical trial agreements/research agreements; b. review of indemnity/insurance documents; c. assessment of the existing relevant resources within the organisation; d. review of project budgets; e. assessment of ualifications of researchers; f. developing and implementing SOPs, practice guidelines or policies; g. notification of institutional research projects to the Radiation Safety Section of DH and addition to the relevant institutional licence. Safety monitoring is covered in greater detail under Monitoring Human Research Policy of this document. References: The NHMRC/ARC/AVCC National Statement on Ethical Conduct in Human Research (2007) 23

28 RESEARCH ETHICS Handling Research Related Complaints Policy 1. Purpose This policy for handling research related complaints has been developed to clearly set out the roles and responsibilities of [NAME OF INSTITUTION/ ORGANISATION] and its research related committees and the processes in place in relation to managing any complaints that may be received about research undertaken at and/or by [NAME OF INSTITUTION/ ORGANISATION]. Complaints may be made about researchers or the conduct of research or about the conduct of a research related committee or other review body. Complaints may be made by research participants, researchers, staff or others. All complaints should be handled promptly and sensitively. [NAME OF INSTITUTION/ORGANISATION] Research Policy reuires that all research in which [NAME OF INSTITUTION/ORGANISATION] is involved complies with all relevant codes of practice, ethical guidelines and legislation including the National Statement on Ethical Conduct in Human Research 2007, the Code of Practice for the care and use of animals for scientific purposes 2007, the Gene Technology Act 2000 (Cwlth) and the Australian Code for the Responsible Conduct of Research Scope This process encapsulates all research undertaken by [NAME OF INSTITUTION/ORGANISATION] that is governed by the National Statement on Ethical Conduct in Human Research Definitions Informal Complaint: An informal complaint is a verbal expression of dissatisfaction that can be dealt with promptly and to the reporter s/complainant s satisfaction at the point of service. Informal complaints do not need to be recorded. Formal Complaint: A formal complaint includes all written incident reports or complaints and any verbal complaints that cannot be dealt with as informal incidents/complaints. Formal complaints should be recorded by the RGU in the Research Complaints Register and reported to the relevant committee. A written file note of the complaint should also be placed in the relevant file associated with the application. Formal complaints related to Human Research are also reported to the NHMRC s AHEC as part of the HREC Annual Report. Research Misconduct: The Australian Code for the Responsible Conduct of Research 2007 defines research misconduct as follows: A complaint or allegation relates to research misconduct if it involves all of the following: an alleged breach of this Code; intent and deliberation, recklessness or gross and persistent negligence; serious conseuences, such as false information on the public record; and adverse effects on research participants, animals or the environment. Research misconduct includes fabrication, falsification, plagiarism or deception in proposing, carrying out or reporting the results of research, and failure to declare or manage a serious conflict of interest. It includes avoidable failure to follow research proposals as approved by a research ethics committee, particularly where this failure may result in unreasonable risk or harm to humans, animals or the environment. It also includes the wilful concealment or facilitation of research misconduct by others. 4. Applicability This policy applies to all staff and students conducting research on the campuses of [NAME OF INSTITUTION/ORGANISATION] and the individual research institutes and groups for whom the [NAME OF INSTITUTION/ORGANISATION] HREC provides research governance and services. 5. Principles Complaint management must be sensitive towards the rights, needs and concerns of reporters, complainants, patients, research participants, researchers and administrative staff. Complaint management must comply with the Victorian Information Privacy Act 2000, the Health Records Act 2001 and the Health Services (Conciliation and Review) Act All reporters, complainants, patients, research participants and investigators have a right to report or complain either in person or through a representative. All complaints should be managed in a timely and sympathetic manner and be treated confidentially. 24

29 RESEARCH ETHICS Handling Research Related Complaints Policy continued It is the responsibility both of the RGU and the Chair of the relevant research related committee to ensure that the process is easily accessible to all concerned. The evaluation of complaints helps to inform the RGU and the relevant research related committee about areas where processes can be improved, particularly in relation to research governance and management. 6. Procedures Complaints will be recorded on the Research Complaints Register, held in the RGU. The register includes information to track the progress of the complaint and provide a history of all referrals and action taken, as well as dates of receipt and resolution of the complaint. The decision as to whether an incident/complaint is minor or serious will be made by the Executive Officer, Research (EOR) in consultation with the Chair of the relevant Committee and, where necessary, the Director of Research. For human research, information regarding the contact person for complaints should be included in Participant Information and Consent Forms. Examples are as follows: Complaints If you have any complaints about any aspect of the study or the way in which it is being conducted you may contact the Patient Representative at [NAME OF INSTITUTION/ORGANISATION] on Telephone: [telephone number]. You will need to tell the Patient Representative the name of the person who is noted above as PI. Under the heading Research Participant Rights insert the following paragraph VERBATIM: Research Participant Rights If you have any uestions about your rights as a research participant, then you may contact the EOR at [NAME OF INSTITUTION/ORGANISATION] on Telephone: [telephone number]. Formal Complaints from Research Participants and Researchers Where the research participant is a [NAME OF INSTITUTION/ORGANISATION] patient, the institution s patient complaint policy should be referred to. Complaints will be reported to the relevant committee and an update provided on each subseuent committee meeting agenda. Research participant is not a [NAME OF INSTITUTION/ORGANISATION] patient. At [NAME OF INSTITUTION/ORGANISATION], the first person designated to receive complaints from research participants is the EOR. It is expected that most complaints from research participants will be able to be dealt with by the EOR in conjunction with the relevant principal researcher. Serious complaints, which cannot be readily resolved, will be referred for consideration by the EOR, Chair or the relevant research related committee and, where necessary, the Director of Research. In circumstances where a complaint cannot be resolved using [NAME OF INSTITUTION/ ORGANISATION] internal complaint resolution processes, external, independent advice will be sought. This may include consultation with the Office of the Health Services Commissioner or with senior staff from other organisations. Complaints which highlight problems warranting amendments to the research protocol will be reviewed by the Chair of the relevant research related committee who will provide written advice to the principal researcher. Complaints will be reported to the relevant committee and an update provided on each subseuent committee meeting agenda. Complaints from researchers Complaints from researchers about any aspect of the management of their research project by the RGU or a research related committee should be directed in the first instance to the EOR. The EOR will liaise with the principal researcher and, where necessary, the Chair of the relevant research related committee and the committee itself to resolve the matter. 25

30 RESEARCH ETHICS Handling Research Related Complaints Policy continued Serious complaints which cannot be resolved using the process outlined above will be referred to the Director of Research and, if necessary, the [NAME OF INSTITUTION/ORGANISATION] Chief Medical Officer or Chief Executive Officer. In some circumstances, external independent advisors may be consulted to provide assistance and advice. Complaints from committee members and other interested persons Complaints from research related committee members or other interested persons should be directed in the first instance to the EOR. Other interested persons may include heads of departments whose services are reuired by researchers to support their research project and staff in wards or service departments whose assistance or support is reuired to facilitate the research. The EOR will endeavour to resolve the problem directly with the complainant and/or the principal researcher (as applicable) and, where necessary (and if appropriate), with the Chair of the relevant research related committee. Categories of complaints Complaints will be identified as relating to research activities or to review of research proposals by the relevant research related committee and will be categorised to allow analysis of trends. Categories may include: breaches of privacy/confidentiality; misappropriation/falsifying data/dubious authorship/plagiarism/misrepresentation; careless or inappropriate collection, analysis, use or disclosure of information; conflicts of interest; coercion/failure to appropriately obtain consent; departures from good research practice; animal welfare related matter; non-compliance with relevant legislation; unethical behaviour; other. Serious complaints (refer to section 7) will be referred to the Director of Research. Consultation with the [NAME OF INSTITUTION/ORGANISATION] Chief Medical Officer or Chief Executive Officer and external independent advisors, as outlined above, will be sought if reuired. In all cases, details of a complaint will be recorded in the Research Complaints Register held in the RGU. Hard copies of the details of the complaint, actions taken and outcomes will also be kept in the relevant project file and the RGU Research Complaints file. It is important to identify either the project number or project title when registering a complaint or enuiry related to a specific project. All research related complaints will be reported to the Chair of the relevant research related committee. All complaints involving human research will also be reported to the NHMRC s AHEC as part of the HREC Annual Report. 26

31 RESEARCH ETHICS Handling Research Related Complaints Policy continued Seriousness of complaints Complaints will be rated on a scale for seriousness when they are first received by the EOR and again, when they are closed, in order to help with more accurate assessment of seriousness. The level of seriousness does not reflect the amount of resources that may go into the management of a particular complaint. It is not uncommon for less serious complaints to consume large amounts of time and other resources and for more serious incidents to be resolved comparatively uickly. A complaint can often raise several issues with different levels of seriousness: Post-complaint enuiries Any enuiries regarding the handling of incidents or complaints related to research activities should be directed to: Executive Officer, Research or euivalent. [Insert contact details] Low Rated Complaints - are those that ought to be easily resolved by a telephone call or letter and an explanation. These may include misunderstandings or misconceptions where a detailed investigation is unwarranted. Medium Rated Complaints - are those involving incidents such as misunderstandings, access to records, disputes about costs, discourtesy, protocol violations, breaches of privacy without serious conseuences, and diagnostic or treatment errors without serious conseuences. High Rated complaints - are those involving significant uality assurance implications, practices that need changing to avoid recurrence of the event, such as amendments to the study protocol, or development of new policy or procedures. In addition, they include complaints about protocol violations, breaches of privacy, personal injury, professional misconduct, fraud, unlawful or unethical acts, lack of informed consent and diagnostic or treatment errors with serious adverse outcomes. References: These guidelines should be read in conjunction with: Institutions Research policy (if exists) Institutions Code of Conduct (if exists) Human Resources policies (if exist) Patient complaints policy (if exists) National Statement on Ethical Conduct in Human Research (NHMRC 2007) Australian Code for the Responsible Conduct of Research (NHMRC 2007) Note for Guidance on Good Clinical Practice (TGA 2000) Legislation Health Records Act (Vic) 2001 Information Privacy Act (Vic) 2000 Health Services (Conciliation and Review) Act (Vic) 1987 Privacy Act (Cwlth)

32 RESEARCH ETHICS Conflict of Interest Research Related Activities Policy 1. Purpose A conflict of interest, in the context of research, may exist where the interests or responsibilities of an individual or an institution have the potential to influence the way they carry out their institutional role or professional obligations in research. A conflict may relate to financial interests and/or private, professional or institutional benefits that depend significantly on the research outcome. In addition to affecting the integrity of a researcher, a conflict of interest may compromise the research process itself, as well as the institutional governance of research. In identifying and managing potential, perceived or actual conflicts of interest, the key principles which should guide individuals are: 2. Scope full disclosure; and avoidance of perceived or actual conflict of interest. This policy has been developed to provide a framework for advising individuals involved in research activities on matters related to potential, perceived or actual/real conflicts of interest. 3. Applicability This policy applies to all staff and students conducting human research on the campuses of [NAME OF INSTITUTION/ORGANISATION] and the individual research institutes and groups for whom the [NAME OF INSTITUTION/ORGANISATION] HREC or RGU provide HREC or RGU services. 4. Procedures Staff conducting research have a responsibility to disclose at the time of proposing and reporting research, any potential conflict of interest that may influence or be seen to influence any aspect of the conduct of the research. This responsibility extends to matters related to research including investigations, publication, media reports, ethics and compliance applications, grant applications and applications for appointment or promotion. 4.1 Staff shall disclose the potential conflict of interest to their head of department in the following instances: where a head of department may have/has a conflict of interest related to research activities, the Director of Research will be responsible for determining the appropriate management arrangements; where the Director of Research may have/ has a conflict of interest related to research activities, the Chief Executive Officer will be responsible for determining the appropriate management arrangements. 4.2 The head of department/director of Research/ Chief Executive Officer shall make a determination as to whether the multiple interests disclosed constitute a conflict of interest reuiring action. Disclosure of a conflict of interest shall be handled as follows: the officer in receipt of the disclosure referred to above must discuss the matter with the staff member concerned and agree on a conflict of interest management or elimination plan; the procedure must be documented and the staff member advised in writing and a copy of the agreement held in the department s or RGU s records; where relevant, conflicts of interest should be disclosed to research participants in the Participant Information and Consent Form; disclosure of affiliation with, or financial involvement in, any organisation with a direct commercial interest in the research of any staff must be forwarded in writing to the Director of Research, on an annual basis. Details of any benefits should be included. 28

33 RESEARCH ETHICS Conflict of Interest Research Related Activities Policy continued 4.3 Research related committee members Members of a research related committee shall declare any conflict of interest related to the activities being considered by that committee to the Chair of that committee. Members of a research related committee shall refrain from involvement in the decision making process in matters in which they have a conflict of interest. This may involve exclusion from the meeting or exclusion from some or all of the committee s activities. A record of a conflict of interest shall be made and shall include how the conflict was/is managed in the proceedings. References: National Statement on Ethical Conduct in Human Research; NHMRC 2007 Australian Code for the Responsible Conduct of Research; NHMRC 2007 Guidelines for Accreditation of Organisations v. 2.1; Office of the Gene Technology Regulator 2007 Australian Code of Practice for the Care and Use of Animals for Scientific Purposes; NHMRC

34 RESEARCH ETHICS HREC Report to Institution Template 1. Purpose To provide a template HREC annual report to institutions, in accordance with section 5.1 Institutional Responsibilities of the NS. Specifically paragraph states An institution that establishes an HREC should ensure that the HREC establishes, implements and documents working procedures to promote good ethical review, including procedures for reporting on its activities to the institution. (Appendix C) In order to avoid duplication of reporting for HRECs and over-reporting to institutions, the template has been developed to allow for HRECs to cut and paste from relevant sections of the AHEC report into the template. There are some sections of the template that are not contained in the AHEC report. However, these sections are within the scope of providing a succinct report on the HRECs activities. 2. Scope Institutions with an HREC are reuired to provide an annual report to the AHEC, which is a principal committee of the NHMRC, established under the NHMRC Act The Act sets out AHEC s functions, which are to advise the NHMRC on ethical issues relating to health and to develop guidelines for the conduct of research involving humans. The report that is submitted to AHEC is prepared by the HREC, on behalf of the institution and this report is submitted at the end of each calendar year. Question 21 of AHEC report asks has a reporting mechanism been established between the HREC and the organisation(s) responsible for it? If this uestion is answered yes, there is a follow on uestion asking the mechanism for reporting. 3. Applicability The template is applicable to all those institutions that have an HREC, in order to inform the executive/board of the following issues, for which the institution has responsibility for under section 5.1 of the NS: research governance; processes for ethical review; legal protection for those involved in ethical review of research; oversight and review of ethical review procedures; research involving no more than low risk; research that can be exempted from review; research involving more than low risk; establishment of HRECs; composition of HRECs; appointment of HREC members; HREC procedures. 4. Procedure The HREC annual report to the institution report may be completed at the same time that the AHEC report is completed. References: Australian Code for the Responsible Conduct of Research (NHMRC 2007) National Statement on Ethical Conduct in Human Research (NHMRC 2007) NHMRC Health Ethics Website viewed on 28 October Appendices HREC Report to Institution Template (Appendix C) 30

35 RESEARCH ETHICS Template for Reporting HREC Review Waiver of Reuirement for Consent 1. Purpose To provide guidance in the creation of a template that will facilitate compliance with the reuirements of sections to Waiver of the NHMRC NS, which reuires institutions to make publicly accessible summary descriptions of all their research projects for which the reuirement for consent has been waived under NS paragraphs and Scope This toolkit constitutes a template that can be used by research active institutions to record and publish summary descriptions of applicable research projects for which the reuirement for consent has been waived by an HREC. The summary descriptions can be published in a range of different media including hard copy or electronic annual reports or on an institution s website. (Appendix D) 4. Procedure The summary description of each project for which the reuirement for consent has been waived, should be added to the list of such projects using the enclosed Appendix D. At least annually, institutions should make this list publicly accessible, for example in an annual report, on a website, etc. It is suggested that after the end of each calendar year, institutions publish a list of such eligible projects reviewed in the past 12 months. 3. Applicability This template can be used to record summary descriptions of all research projects for which an HREC has waived the reuirement for consent for use of personal information in medical research, or personal health information, in accordance with the NS. References: NHMRC National Statement on Ethical Conduct in Human Research, Health Records Act 2001 (Vic). Privacy Act 1988 (Cwlth). Appendices Appendix D waiver of the reuirement for consent in accordance with sections Of the NHMRC National Statement on Ethical Conduct in Human Research template. 31

36 RESEARCH ETHICS APPENDIX 1: HREC Terms of Reference Template Introduction [NAME OF INSTITUTION/ORGANISATION] affirms its commitment to the highest standards of medical research including the strict observance of relevant ethical principles and practices. To this end, [NAME OF INSTITUTION/ORGANISATION] shall appoint and maintain a Human Research Ethics Committee, which shall function with autonomy appropriate to its role. The Human Research Ethics Committee shall report to the Board of [NAME OF INSTITUTION/ ORGANISATION] annually. The membership, functions, applications of functions and meeting procedures of the Human Research Ethics Committee, shall conform to the reuirements of the Commonwealth of Australia s National Statement on Ethical Conduct in Human Research 2007 and its successor. The Committee shall ensure that any other relevant reuirements of: The National Health and Medical Research Council Act 1992 (Cwlth); Therapeutic Goods Act 1989 (Cwlth); Human Tissue Act 1985 (Vic); Human Tissue Act 1983 (Cwlth); Infertility Treatment Act 1995 (Vic); Australian Code for the Responsible Conduct of Research 2007; Health Records Act 2001 (Vic); Privacy Act 1988 (Cwlth) s95; NHMRC Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Research 2003; Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA comments. (July 2000); Guardianship & Administration Act 1986 (Vic); Medical Treatment Act 1988 (Vic); and their successors and such other statutes that have relevance to ethical considerations, are not offended in the research practices and policies of [NAME OF INSTITUTION/ORGANISATION]. In accordance with the above determinations, all research projects carried out in, or under the auspices of [NAME OF INSTITUTION/ORGANISATION] involving human subjects, must have the prior approval of a Victorian Consultative Council for Human Research Ethics accredited HREC that has also been endorsed by the institution. Membership The membership of the Human Research Ethics Committee shall conform to the reuirements of the NHMRC NS and its successors and shall include as far as possible eual numbers of men and women, at least one-third of whom are from outside [NAME OF INSTITUTION/ORGANISATION]. The committee shall include: The Chair; at least two members who are lay people, one man, one woman, who have no affiliation with [NAME OF INSTITUTION/ORGANISATION] are not currently involved in medical, or legal work; at least two members with current research experience, that is relevant to the type of research to be considered at the meetings they attend; at least one member with knowledge of, and current experience in, the professional care, counselling or treatment of people, a nurse or allied health professional; 32

37 RESEARCH ETHICS APPENDIX 1: HREC Terms of Reference Template continued at least one member who performs a pastoral care role in a community, eg. a Minister of Religion, Aboriginal elder; at least one member who is a lawyer, where possible one who is not engaged to advise the institution; and where possible one or more of the members should be experienced in reflecting on and analysing ethical decision making. Additional members at [NAME OF INSTITUTION/ORGANISATION] may include: Chairs of all sub-committees, or nominees; and may also include one or more of : registered nurse medical practitioner epidemiologist other persons as considered appropriate for the type/s of research usually being considered. In attendance Manager, [NAME OF INSTITUTION/ORGANISATION] Research Governance Unit Minutes Secretary of Human Research Ethics Committee Further persons may be appointed to a maximum of [Y]. A uorum shall consist of the seven core positions and sufficient other members to make up half the total number of members of the HREC. If the seven core members are not present, the Chairperson must be satisfied that these members have received all the relevant papers and have had the opportunity to contribute their views and that these have been received and considered (as per Section of the National Statement). The Chairperson shall be appointed by [NAME OF INSTITUTION/ORGANISATION] [NAME OF INSTITUTION/ORGANISATION] shall appoint sufficient staff and provide sufficient facilities for a Secretariat (the Research Governance Unit) to act on behalf of the Committee. The Committee may seek advice or assistance from other person/s, with relevant expertise related to a particular project. Appointment of Members [NAME OF INSTITUTION/ORGANISATION] shall appoint Committee members in a fair and transparent manner. Members shall be appointed for a term of three years with the option of future terms. However, future terms are not mandated. Members absent for three consecutive meetings (without prior notification) will be disualified. Members are to submit their resignation from the Committee, in writing to the Chairperson, at least one meeting in advance unless the member is disualified for non-attendance. Members are reuested to give at least 4 weeks notice prior to non-attendance at a meeting. Should this not be possible, members should expect to receive all the relevant meeting papers and take the opportunity to contribute their views so that these can be recorded and considered (as per Section of the National Statement). 33

38 RESEARCH ETHICS APPENDIX 1: HREC Terms of Reference Template continued Conditions of Appointment Members shall receive a formal notice of appointment and an assurance that [NAME OF INSTITUTION/ ORGANISATION] will provide appropriate indemnity (under VMIA hospital insurance cover Public Healthcare Program). Members who are not staff members of [NAME OF INSTITUTION/ORGANISATION] shall be offered an honorarium for each attendance at a committee meeting. The value of the honorarium will be determined from time to time by [NAME OF INSTITUTION/ORGANISATION]. [paragraph optional]. Committee members will be reuired to sign a confidentiality agreement. Functions The Human Research Ethics Committee shall carry out the functions of an institutional ethics committee consistent with those set out in the NHMRC National Statement on Ethical Conduct in Human Research (2007) and its successor. Procedures The Human Research Ethics Committee (through its Secretariat) shall establish, implement and document its working procedures concerning: Freuency of meetings Attendance at meetings Conduct and structure of meetings and deliberations Preparation of agendas and minutes Timely distribution of papers prior to meetings Presentation of applications for ethical review Timely consideration and review of applications Managing conflicts of interest Communicating with researchers, including face to face, by telephone and in writing (including ) Reporting on its activities to the institution Methods of decision making Prompt notification of decisions Record keeping Monitoring of approved research Reporting and handling of adverse occurrences Appropriate monitoring Receiving and handling of complaints Advising institution(s) or organisation(s) of decisions to withdraw ethical approval of a research project Attendance, as observers, of people other than members or researchers Fees, if any, to be charged Confidentiality of the content of protocols and of committee proceedings 34

39 RESEARCH ETHICS APPENDIX 1: HREC Terms of Reference Template continued Sub-Committees To assist the Human Research Ethics Committee in its work, the following sub-committees may provide advice, recommendations and/or decisions: Drug Trial Scientific Review Committee Non Drug Study Review Sub-Committee Executive Review Sub-Committee Low Risk Research Sub-Committee Such other sub-committees as deemed necessary by the HREC The Human Research Ethics Committee Secretariat shall establish procedures for the workings of these sub-committees and submit their Terms of Reference to the HREC for approval. Review of Minimal Risk Research The Human Research Ethics Committee (through its Secretariat the Research Gevernance Unit or its euivalent) shall establish procedures for the review of Minimal Risk Research. Compliance Reports The Human Research Ethics Committee shall report at least annually to the NHMRC information relevant to its ethical review processes as reuired under section of the National Statement on Ethical Conduct in Human Research (2007). The Human Research Ethics Committee shall report annually to the Health Services Commissioner of Victoria studies involving reliance on Privacy Principles 35

40 RESEARCH ETHICS APPENDIX 2: Cancer Trials Australia (CTA) HREC Mutual Acceptance Submissions The HREC Mutual Acceptance Program (MAP) has been developed by Cancer Trials Australia (CTA) and the HRECs of its member sites. The process consists of mutual recognition of study review/approvals by the member HRECs. Conseuently, once the approval is issued by one of the HRECs, the process allows an expedited approval at the other participating CTA Sites. The primary objective of MAP is to streamline the ethics review process. MAP benefits the sponsor, investigators and HRECs, without losing any uality or rigour in the review process, through: One set of scientific and ethics ueries. Reduced approval times for multi-site trials. Reduced duplication of processes and effort. Reduced submission costs for the sponsor. CTA Submission Co-ordinators are involved in managing the seuence of submissions, timelines and compilation/submission of documentation for MAP studies. MAP Submission Process Allocation of Primary and Accepting Sites CTA first confirms which sites are participating. A Primary Site (for full submission) is usually the first site available to start the study (based on reconciliation of resources and timelines). The remaining CTA sites that will participate in the study will be nominated as Accepting Sites. CTA will inform the sponsor on the allocation and seuence of submissions to the Primary and Accepting HRECs. Submission to the Primary HREC CTA, on behalf of the Primary Member Site will submit a full application to its ethics committee at the next available submission deadline provided that the application is received by the reuired date. There is no difference in the way sponsors should prepare studies for submission for mutual acceptance projects compared to single site studies. The scientific and ethics review is conducted according to the Primary HREC s regulations. Additionally, documentation for legal review from the Accepting Site/s will also be submitted to the Primary HREC. The Primary Site Submission Co-ordinator, in conjunction with the Investigator and sponsor, will answer any ueries arising from the Primary HREC or its sub-committees and any ueries arising from the hospital lawyers and VMIA/DLA Phillips Fox review. Under the MAP, the PICF is identical at all sites except for site-specific reuirements (eg. Investigator s name and contact details, site details). The Accepting Sites will accept the version and date of the PICF that was approved at the Primary Site. Approval at the Primary Site Once the application meets the Primary HREC / Site reuirements, the Primary HREC will issue its approval as per its standard processes. The Primary HREC will also release all regulatory and legal documentation to enable the trial to commence at the Primary Site. As soon as the approval is issued, the Accepting Site submission person/delegate is notified and organises the Accepting Site approval. Submission to the Accepting HRECs The Accepting Site Submission Co-ordinator will receive all documentation from the Primary Site, but will also prepare site-specific documentation (eg. departmental approvals) in anticipation of Primary site approval. The parallel preparation of documentation streamlines any additional preparation time for Accepting Site submission. 36

41 RESEARCH ETHICS APPENDIX 2: Cancer Trials Australia (CTA) HREC Mutual Acceptance Submissions continued MAP documentation relevant to the Accepting HREC will be reviewed by representatives from the Accepting HREC in an expedited fashion. There is no deadline for submitting to an Accepting HREC. The process may also be utilised when a trial is approved and running at one CTA site, while another CTA site is chosen to participate at a later date. This is known as retrospective MAP. Approval at the Accepting Site If the documentation is sufficient and meets the Accepting HREC / Site reuirements, the Accepting HREC can approve the Primary HREC decision and provide an approval letter / certificate. In general, the Accepting HREC will provide approval documents within 5-10 working days after the reuired submission documentation has been submitted to them. The Accepting HREC will also release all relevant regulatory and legal documentation. 37

42 RESEARCH ETHICS APPENDIX 3: Recognised Prior Review Guidelines - Peter MacCallum Cancer Institute Introduction Recognised prior review (RPR) is an initiative intended to expedite the approval of research projects that have already been approved by an external HREC 1. Many of these projects will already have commenced at another Australian site before they are submitted to Peter MacCallum Cancer Centre (Peter Mac) for approval. By using the RPR approval process, Peter Mac will be recognising the prior approval by the external HREC while still ensuring that the Peter Mac HREC, via delegation to an executive group, broadly reviews the project and satisfies itself that the project is scientifically sound and ethically appropriate. The RPR scheme is an experiment and, as such, reuires testing and revision. Over time, RPR may be extended, modified, retracted or overridden by state or national developments. The RPR Scheme All projects submitted to the Ethics Committee Secretariat are screened by the process used for new project submissions. The Ethics Coordinator may then classify a project as eligible for the RPR review and approval process and, if so, would then send the project to the executive review group established for this purpose. As at September , this group includes the following individuals: Chair, Ethics Committee Chair, CRC/Medical Oncology CRC member/radiation Oncology CRC member/pharmacy CRC member/centre for Biostatistics and Clinical Trials CRC member/clinical Trials Research Nurse Ethics Coordinator RPR-eligible projects may be submitted at any time 3. The RPR executive review group members will then have 7 days to review the project and notify the Ethics Coordinator and each other of any significant concerns 4 that they have with the project. These concerns will then be communicated to the applicant. Once all of the reuirements for the project have been met 5, the project will be approved. The eligibility criteria for projects reviewed under the RPR scheme are as follows: 1. The project must be a Phase II or Phase III clinical trial 6 2. The project must have been properly reviewed by an HREC that is recognised by Peter Mac as having sufficient expertise in cancer clinical trials. These HRECs are based at the institutions/organisations/health networks listed below 7. 1 The external HREC approval may have been granted by a single institutional HREC or a recognised centralised review and approval process. 2 The executive review group will vary according to need, as determined by the Ethics Committee from time to time. A uorum shall consist of any 4 members of the executive review group. 3 That is, submission of RPR-eligible projects does not have to meet the deadlines used for submissions to the Ethics Committee and its sub-committees. 4 The executive review group will not endeavour to replicate the extensive review that a full sub-committee would conduct. 5 Reuirements include full documentation, compliant legal documents and satisfactory responses to any concerns of the executive review group. 6 If the RPR scheme is successful, it may be extended to Phase I clinical trials and/or other types of research in future. 7 This list is subject to modification. As sufficient expertise is a subjective judgment, the inclusion or exclusion of HRECs from this list is based on anecdotal information only. Victorian and inter-state professionals in the area of cancer research have been consulted in the development of this list. 8 Note that if changes were made to documents in order to obtain approval from the original site, the approved documents must be submitted, not the documents originally submitted. 38

43 RESEARCH ETHICS APPENDIX 3: Recognised Prior Review Guidelines - Peter MacCallum Cancer Institute continued 3. The project submission must include the following documentation Copies of all documents approved 8 by the HREC that originally granted approval (minus any documents specific to the other site) The approval certificate issued by the HREC that originally granted approval A Participant Information and Consent Form that has been modified to comply with Peter Mac guidelines for Participant Information and Consent Forms The Supplementary Peter Mac Submission Form Reuired Declaration by Head of Supporting Department forms Insurance/legal documents that comply with Victorian reuirements. Recognised HRECS Victoria Melbourne Health (Royal Melbourne Hospital/ Western Health) Austin Health Southern Health (Monash Medical Centre) Alfred Health (The Alfred Hospital) St. Vincent s Health Royal Children s Hospital Royal Women s Hospital NSW University of Sydney (NHMRC Clinical Trials Centre) Cancer Institute NSW Sydney Area Health Services (Northern/West/ Southwest/Southeastern) covering Royal North Shore Hospital Children s Hospital at Westmead Westmead Hospital Nepean Hospital Royal Prince Alfred Hospital Liverpool Hospital Concord Repatriation General Hospital Prince of Wales Hospital St. Vincent s Hospital Sydney Children s Hospital St George Hospital Wollongong Hospital Hunter/New England Area Health Service covering Newcastle Mater Misericordiae Hospital John Hunter Hospital Queensland Royal Brisbane Hospital Mater Health Services Princess Alexandra Hospital Queensland Institute of Medical Research South Australia Royal Adelaide Hospital Queen Elizabeth Hospital Flinders Medical Centre Western Australia Sir Charles Gairdner Hospital Royal Perth Hospital Fremantle Hospital 39

44 RESEARCH ETHICS APPENDIX 3: Recognised Prior Review Guidelines - Peter MacCallum Cancer Institute continued Projects reviewed under the RPR scheme will be reviewed with attention to the following factors: 1. Scientific merit, protocol design and statistical strength 2. Compatibility with Peter Mac clinical and research standards and administrative and patient care processes 3. Impact on Peter Mac patients 4. Impact on Peter Mac organisational resources The review will be focused on identifying any major flaws or incompatibilities related to the protocol and on the appropriateness of the Participant Information and Consent Form that has been proposed for use at Peter Mac. RPR Procedure All reuired documents should be submitted in hard copy (1 only) and electronically to the Ethics Committee Secretariat (details below). Note that applications to most HRECs in Victoria are made via a Common Application Form (CAF) promulgated by the Dept of Health (DH). If the submission to the HREC that originally approved this project was made using the CAF, then submit the approved modules in their approved form with appropriate Peter Mac sign-off from the following individuals: Principal Peter Mac Researcher Associate Peter Mac Researchers Head of Department of the Principal Peter Mac Researcher Head/s of Supporting Peter Mac Department/s (see attached Supplementary Peter Mac Submission Form) If you are not using the CAF in this project submission, then ensure that all appropriate sign-offs are submitted using analogous forms. Submit the versions of the application forms, information and consent forms (if applicable), project description/protocol (if applicable), Investigator Brochure/s (if applicable), and any other supporting documentation that were approved by the originally approving HREC. Submit the signed Supplementary Peter Mac Submission Form. Submit any Participant Information and Consent Form/s (PICF/s) for the project modified in accordance with the attached guidelines for PICFs. [Note that these guidelines will soon be replaced by a template available on the DH website as part of the Common Application Form < ethics/application/common_app_form.htm>]. When preparing the Peter Mac Participant Information and Consent Form, please ensure that you have allowed enough space for the Peter Mac letterhead (top and bottom of first page only), that you have included the date and version number of the PICF under the project title, and that you do not put anything in the footer of the 1st page; however version number, date and page numbering etc should appear in the footer from page 2 onward. If applicable, submit the reuired TGA, insurance and legal documents with Peter Mac properly named in accordance with the Victorian Managed Insurance Authority (VMIA) reuirements. [Note: electronic submission of these documents is not reuired.] Submit a copy of the approval certificate issued by the HREC that originally granted approval. [Note: electronic submission of this document is not reuired.] Submit a cover letter explaining that you are submitting this project via the RPR scheme and listing the documents that you are submitting for review. 40

45 RESEARCH ETHICS APPENDIX 4: Low Risk Research Review Procedures - Melbourne Health In accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007), the Melbourne Health HREC has established a process for the review of research involving no more than low risk review by the Low Risk Research Sub-Committee. The Low Risk Research Sub-Committee is an informal sub-committee of the HREC which meets in the week prior to the monthly meeting of the full HREC. The membership of the Low Risk Research Sub-Committee is fluid but is reuired to comprise at least 2 scientific spokespersons and 2 ethics spokespersons from amongst the membership of the HREC. The HREC Manager or Assistant Manager also attend these meetings. Each month, different members of the HREC attend the meeting of the Low Risk Research Sub-Committee. The minutes of the meetings of the Low Risk Research Sub-Committee are incorporated into the agenda and then the minutes of the next scheduled meeting of the HREC and the decisions of the Low Risk Research Sub-Committee must be endorsed and adopted by the HREC before any correspondence is forwarded to the researchers involved. The application procedures and submission deadlines for the Low Risk Research Sub-Committee are the same as those for the HREC. New projects are triaged as being suitable for review by the Low Risk Research Sub-Committee by the HREC Manager and Assistant Manager after each monthly new project submission deadline. Researchers are welcome to contact the Office for Research prior to submission deadlines to discuss whether their project would be suitable for review by the Low Risk Research Sub-Committee. Only twelve (x12) copies, including the original are reuired for projects to be reviewed by the Low Risk Research Sub-Committee. 41

46 RESEARCH ETHICS APPENDIX 5: Human Ethics Advisory Groups (HEAGS) - University of Melbourne The primary function of a department HEAG is to provide preliminary assessment of human research projects submitted by staff and students in a department, and to advise the HREC on issues pertaining to human research ethics in the department. 1. Membership A department Human Ethics Advisory Group (HEAG) should comprise at least three members of academic staff of a department or centre, including one senior member of staff (eg. Associate Professor). Where possible a post-graduate student should also be appointed to the HEAG. In the case of small departments or centres it may be helpful if two or more combine to form a multidepartment HEAG for review of research ethics proposals. Alternatively a faculty-based Human Ethics Advisory Group may also be formed. 2. Functions and responsibilities 2.1 To examine proposals which involve the use of humans as participants in the research of staff and students of the department, and to advise the HREC and its Sub-Committees on whether the proposals comply with the ethical guidelines adopted by the University and the Human Research Ethics Committee. 2.2 To make an assessment of the ethical implications and the academic value including methodology and technical aspects of proposals to be conducted by staff and students of the department prior to submission of the proposal to the appropriate Human Ethics Sub-Committee, in accordance with the policy and procedures adopted by the HREC. 2.3 To consider, approve and keep appropriate records of Project-within-Program proposals, which are derived from Program applications of research previously approved by the Human Ethics Sub-Committees. To report Project-within- Program approvals and forward a signed copy to the HREC. 2.4 To consider, approve and keep appropriate records of Minimal Risk proposals. To report Minimal Risk approvals and forward a signed copy to the HREC. 2.5 To assist and advise the HREC and its Sub-Committees as follows: a. to ensure that investigators are appropriately ualified to conduct the research including any specific procedures proposed by them in a project; b. to ensure that proper arrangements are made in accordance with University and HREC policy for security and disposal of confidential data collected in the course of research; c. to monitor research projects conducted by staff and students of the department in accordance with the National Statement on Ethical Conduct in Research Involving Humans and University procedures; 2.6 To keep appropriate records for audit and compliance purposes. 2.7 To provide ethics training for department researchers, supervisors, post-graduate students and HEAG members, including information on the policy and procedures of the University s ethics committees. 2.8 Representatives of HEAGs are to attend information sessions and other training seminars provided by the HREC. 3. Method of operation 3.1 The HEAG is to meet regularly during the year to review projects and to discuss general issues relating to the ethical review of research. Minutes, including decisions regarding project approvals made at the meetings, must be recorded, in particular those regarding Minimal Risk or Projectwithin-Program proposals. 3.2 Where projects are reviewed by circulation between meetings a cover sheet with some record for comments and signatures must be kept. Minimal risk projects which are submitted for approval by the department must be discussed at a meeting of the HEAG and cannot be approved by circulation. Details of discussions at the meeting are to be recorded. 3.3 Members of the HEAG may not review and approve their own research. In such cases another person must review the project and sign HEAG approval. 42

47 RESEARCH ETHICS APPENDIX 5: Human Ethics Advisory Groups (HEAGS) - University of Melbourne continued 3.4 Proposal types a. Individual research projects Proposals for research involving human participants forwarded by students or staff in the department should be assessed by the HEAG and forwarded to the appropriate Sub-Committee for consideration, together with the Advisory Group s recommendations or comments, where relevant. b. Program applications In the case of applications for ethics approval of a program of research, researchers are to complete the program application form and forward it to the HEAG for consideration. HEAG members are to make an assessment of the program with regard to academic merit and ethical implications and then forward to the Sub-Committee the Advisory Group s recommendations any other comments, where relevant. c. Project-within-program applications In the case of project-within-program applications HEAG members are to make an assessment of the project with regard to academic merit and ethical implications and then, if appropriate, approve the project. 3.5 The HEAG must provide an annual report to the HREC on its activities, including: current membership including name of Chair and contact details procedures for consideration of proposals, including details and freuency of meetings procedures for monitoring of projects, including projects being undertaken overseas security of data, conditions of storage, development of protocol for storage, access, disposal ethical problems which may have arisen in relation to conduct of projects, complaints list details of all Project-within-Program applications approved by the HEAG, list details of all Minimal Risk applications approved by the HEAG. 3.6 The Chair and/or other HEAG members are to attend at least one meeting of the relevant Human Ethics Sub-Committee to discuss the HEAG annual report and other issues of common interest. d. Minimal Risk projects In the case of Minimal Risk applications considered eligible for approval by the HEAG, Advisory Group members are to make an assessment of the project with regard to academic merit and ethical implications and then, if appropriate, approve the project. The HEAG may decide that a Minimal Risk application reuires a full review by the HREC. 43

48 RESEARCH ETHICS APPENDIX 6: Low Risk Research Application Form - Alfred Health Alfred Hospital Ethics Committee Application for Ethical Review of Low Risk Projects PLEASE NOTE before completing this form Nursing related activities, including those using nursing resources, should be presented to the Nursing Research and Access Committee prior to any submission to the Ethics committee: Researchers using discarded tissue should use the discarded tissue application form: Activities generated by external organisations, in particular those reuiring Alfred Health authorisation, and some internal applications involving multiple departments should contact the Clinical Governance Unit of the Alfred Hospital: A. General Information Project Title: Grant period: Applicant Details: Responsible Investigator: (Where a student is involved Senior Staff must be listed) Name & Title/Position: Telephone Number(s): Fax: Department: Monash University Status: Staff Member Honnorary Staff Member Address for correspondence: Student Investigator: Name: University: Contact: List the names of any additional investigators (Copy/paste) cells as reuired for additional investigators/assistants) Name & Title/Position: Department/University: Telephone Number(s): Name & Title/Position: Department/University: Telephone Number(s): Name & Title/Position: Department/University: Telephone Number(s): Proposed period of ethics approval reuired: 44

49 RESEARCH ETHICS APPENDIX 6: Low Risk Research Application Form - Alfred Health continued To assist in determining whether your research activity is Low or Negligible Risk, please select [X] any one or more boxes below applicable to your project: [Double-click on check box and select checked ] PLEASE NOTE: Selection of one or more boxes ordinarily reuires full ethical review. Items listed marked * must be submitted for full ethical review. Do not complete this form. Items listed marked # may need to go for full ethical review or may ualify for low risk review depending on the context. For all # or checked boxes please complete the expandable box below to justify why low risk review is applicable to your activity B: Activity Risk Classification Checklist Vulnerable participants, (children, those dependent on care, psychological/psychiatric condition, elderly, pregnant)# Genetic research* Externally funded research reuiring HREC-level clearance* Research conducted by a person not associated with the institution* Other sites reuiring HREC-level approval or multi-centre study with Alfred Health as coordinating centre# Data access/use subject to statutory guidelines &/or reporting* Data access/use without an individual s proper prior consent* (excludes retrospective record reviews/appropriate secondary use#) Identification of participant groups/individuals in research outcomes without full consent or there is unclear consent* Sensitive information/issues vis-à-vis context/impact (legal*, regulatory compliance*, commercial, professional, cultural, etc) Personally intrusive/confronting or uite inconvenient/embarrassing uestioning or other activity* Physically confining/invasive techniues or significant physical contact/stimulation TMS*, X-ray*, CT scan*, MRI*, clothing change Providing, or potential to provide, individual health/medical/psychiatric diagnosis* Screening for healthy participant inclusion/exclusion Providing individual health/medical/psychiatric therapy/treatment* Administration of other (non-medical) substances/treatments Non-minimal impact therapeutic or other devices* /activity* Withdrawal of treatment/services or use of placebo Conflicts of interest or dual researcher-professional roles Research conducted overseas Serious psychological profiling, investigation or exploration Deception or covert observation Human research activity commenced or completed without ethical approval# Limited or non-disclosure of research information/procedures including deception or concealment 45

50 RESEARCH ETHICS APPENDIX 6: Low Risk Research Application Form - Alfred Health continued Participant recruitment/selection via third party Qualitative research without experience Research involving family members of patient Participation incentives, prizes or significant payments Research placing researchers/assistants at risk 46

51 RESEARCH ETHICS APPENDIX 6: Low Risk Research Application Form - Alfred Health continued C: Project Details WHY? Why are you undertaking this project? Include the aims and intent of the project WHAT AND HOW? Brief description of project and procedures Please detail clearly and sufficiently the proposed research procedures and outcome measures. Attach uestionnaires, data collection sheets, cover letters, advertisements, flyers and brochures. Possible risks to participants or investigators? Please describe any risks you perceive and the measures to be taken to minimise these. Anticipated benefits Please describe the potential benefit/s to participants, profession, society etc Future use of data Will any of these data be used by yourself, your students or others for any purpose other than for this project? If so please describe. External involvement Is a body external to Alfred Health involved in the initiation or support of the project? If an external body is associated with the project you must provide the HREC with detail of Alfred Health authorisation., including details of any funding or other resources being provided Yes Name of body/organisation: Funding How is the project funded? 47

52 RESEARCH ETHICS APPENDIX 6: Low Risk Research Application Form - Alfred Health continued D: Ethical Issues Checklist Y N 1 Does the activity seek to gather information beyond that collected in routine care or service? 2 Does the proposal involve any significant alteration to the routine care or service provided to the individuals? 3 Does the data collection process involve access to confidential personal data (including access to data provided for a purpose other than this particular research project) without the prior consent of subjects? 4 Does the project pose any risks for participants beyond those of their routine care, treatment or activity? 5 Does the project impose a burden on participants beyond that experienced in their routine care, treatment or activity? 6 Is the proposed activity to be conducted by a person who may not normally have access to the patient s health or other records for care or a directly related secondary purpose? 7 Will information that can identify individuals be collected, used or disclosed? 8 Will participants have pictures taken of them, eg, photographs, video recordings? If Yes, please explain, in the space below, how you intend to maintain confidentiality and ultimately dispose of the material. 9 If interviews are to be conducted, will they be recorded by electronic device? If Yes, please explain, in the space below, how you intend to retain confidentiality and ultimately dispose of the material. 10 Might any aspect of your study reasonably be expected to place the participant at risk of criminal or civil liability (not just immediately or directly)? 11 Might any aspect of your project risk damage to the participant s professional/social/cultural/ financial standing or employability? 12 Will the research involve access to data banks or intend to access or establish a registry? 13 Is any aspect of the activity likely to breach the confidentiality of an individual s personal information, beyond that experienced in the provision of routine care or service? 14 Will any treatment be used with potentially unpleasant or harmful side effects? 15 Does the research involve any stimuli, tasks, investigations or procedures which may be experienced by participants as stressful, noxious, aversive or unpleasant during or after the research procedures? 16 Will the research involve the use of randomisation, placebo control or the withholding/substitution of treatment, programs or services (health, educational, commercial, other)? 17 Will any samples of body fluid or body tissue be reuired specifically for the research which would not be reuired in the case of ordinary treatment? 18 Does the proposed activity potentially infringe the rights, privacy or professional reputation of carers, health providers or institutions 19 Are there any other ethical issues involved in the research? PLEASE NOTE: If the answer to any of the above uestions is Yes, please explain and justify below in sufficiently clear detail. The box below will expand to fit your response. 48

53 RESEARCH ETHICS APPENDIX 6: Low Risk Research Application Form - Alfred Health continued E: Participant Details and Consent 1 Participant details: Grant period: Please include age, gender, diagnostic category, number of participants and the method of recruitment/ selection 2 Disclosure and informed consent: a. How will participants be informed about the project in order to give valid consent and what method of consent is to be used? Please check the box that applies and attach any information sheets and consent forms to application: Information Statement(s)/Letter(s) and Signed Consent Form(s) will be used Information Statement(s)/Letter(s) and consent implied by return of anonymous uestionnaire Verbal advice and verbal consent Please explain how and why: Consent as part of routine clinical care in projects where no additional procedures are performed No additional consent as project involves secondary use of previously collected data Previously provided consent for future use of data for research Other Please explain how and why: b. If a waiver of consent is reuired please explain and justify why: 3 Privacy and access to external data Does the research involve access to data which was collected by an organisation for its own purposes (ie. not specifically collected for this project) such as data banks or diagnostic specimens provided by an institution? 49

54 RESEARCH ETHICS APPENDIX 6: Low Risk Research Application Form - Alfred Health continued F: Data and Publication 1 Data collection and use a. Whowill access the data and how or in what form will data be accessed? (eg. Will you access medical records or a database?) In relation to data access, please acknowledge whether one or both of the following apply: An individual can be identified OR is potentially identifiable / re-identifiable / coded An individual is not identifiable b. In what form will data be collected / recorded? (eg, notes; verbatim, audio and/or video recordings; transcripts of recordings; recorded or signed consents; etc) In relation to any data collection or retention, please acknowledge whether one or both of the following apply: An individual can be identified OR is potentially identifiable / re-identifiable / coded An individual is not identifiable c. If a waiver of consent is reuired please explain and justify why: 2 Data Security Please indicate how data (all types of data, including, eg, signed consent forms, uestionnaires, electronic data) will be securely stored (eg, electronic form in password-protected disk drive, locked filing cabinet, etc). With more than one type of data, will the types be separately stored? 3 Publication / Outcomes Please explain in sufficient detail a. During the study: b. Following completion of study, including length of time data will be stored after completion of the study: a. What, if any, publication (conference, news media, academic journal, other journal, etc) is envisaged following on or in relation to this project, both in terms of data proper and/or analysis of data? b. Will participants be informed about any envisaged research publication/outcome? c. Would any participants be able to be identified through the publication of data proper or research findings? If so, explain why this is necessary. 50

55 RESEARCH ETHICS APPENDIX 6: Low Risk Research Application Form - Alfred Health continued G: Declarations I/We agree to undertake the research activity and handle data confidentially in accordance with the reuirements of Alfred Health, the National Statement on Ethical Conduct in Human Research 2007 and the Alfred Hospital Ethics Committee, including any special ethical conditions. Name: (block letters) Signature: Date: / / Name: (block letters) Signature: Date: / / Endorsement of Head of Unit (or Delegate) I declare that this project has been developed and will be conducted in accordance with relevant Alfred Health standards, policies and codes of practice, has research merit, adeuate resources and appropriate leadership/supervision. Name: (block letters) Signature: Date: / / (Please note: endorsement must be given by an authorised official who is not an investigator in this project ) Submitting Your Application: Please the completed form and any relevant documents to research@alfred.org.au In the subject field, type Project for low risk ethical review, followed by your last name. We will review your application and contact you by . 51

56 RESEARCH ETHICS APPENDIX 7: Melbourne Health QA Guidelines Quality Assurance Projects Approval Process and Management These guidelines have been developed using the document, When does uality assurance in healthcare reuire independent ethical review: Advice to Institutions, Human Research Ethics Committees and Healthcare Professionals Quality Assurance (QA) projects are an essential and integral part of healthcare delivery that is encouraged by Melbourne Health. It is the aim of the Office for Research to encourage and facilitate the approval and conduct of QA projects. Quality assurance projects are essentially an evaluation or monitoring of a current service or practice with the aim of improving that service or practice. They may also be audits to identify and/or uantify the extent of a problem, practice or behaviour to gain knowledge that may then be used to improve a service or practice. Projects that seek to gain knowledge from monitoring and evaluating the introduction of a new practice/procedure may also fit the criteria of uality assurance. The ethical principles of integrity, respect for persons, beneficence and justice apply to all QA and research projects as set out in the Australian Code for the Responsible Conduct of Research and the Melbourne Health Guidelines for Scientific Practice. The Quality Assurance Approval Process aims to expedite approval of low risk uality assurance projects. However those projects that fall into the high risk category will need to be submitted for review by the Melbourne Health Human Research Ethics Committee or the Mental Health Research and Ethics Committee as appropriate. Is My Project Quality Assurance? It is difficult to separate QA from research. For the purposes of simplicity you should answer the following uestions about your project: 1. Is this project undertaken for a valid purpose and does it aim to use the outcomes to improve delivery of healthcare? 2. Does this project seek to identify and or uantify problems within, or impediments to, good health care delivery and to identify ways of improving those problems? 3. Does this project seek to evaluate current health practices or to monitor the introduction of a new practice? 4. Could this project infringe on ethical principles that guide human research? If you answer yes to uestions 1 to 3 your project may fit the definition of a low risk QA project. If you answered yes to uestion 4 your project may fit the definition of a high risk QA project and may warrant ethical review. Such projects should be submitted by the Melbourne Health Human Research Ethics Committee or the Mental Health Research and Ethics Committee as appropriate. For further advice contact XXXXXXXXX by at: XXXXXXXXXXX or telephone XXXXXXXXXXXX Application for QA Project Approval To meet the standard reuired of QA at Melbourne Health, applications for approval of QA projects must contain information as follows: 1. A protocol or outline of the project. This outline should clearly state: Relevant background information. The aims of the project. The problem, procedure, or practice being assessed. An outline of the likely benefits of conducting the QA project. A literature review (where applicable). The method you will use to obtain data. Who, if any, the participants will be and how they will be recruited eg. patients, carers, staff. If consent will be sought and how. How information will be given to participants (where applicable). The nature of information to be collected, how it will be stored and destroyed. References: When does uality assurance in healthcare reuire independent ethical review: Advice to Institutions, Human Research Ethics Committees and Healthcare Professionals (February 2003) produced by NHMRC au/ethics/human/conduct/guidelines/_files/e46.pdf. 52

57 RESEARCH ETHICS APPENDIX 7: Melbourne Health QA Guidelines continued If a permanent database of information will be created that may subseuently be used in further QA projects. If access to information that already exists within the organisation will occur. eg. Medical records, homer, test results. How the data will be assessed and results validated. Quality assurance Projects should utilise valid methodology and tools. For assistance in statistical methods contact the Clinical Epidemiology and Health Service Unit RMH. 2. Evidence of support from your Department Manager and the Managers of any other department that will be involved in the research. This can be in the form of an from the appropriate individuals. 3. Evidence of support from any external organisation that is involved in the research. 4. Declaration of any financial benefit/loss that the Department will obtain for undertaking the research. eg. Income to cover the cost of employment of a researcher, etc. To apply for approval of a QA project, complete the QA Module and send all reuired documents, via to XXXXXXXXXXXXXX Notification of receipt of the project will be sent to you via . Your project will be given a uniue identifying number, which should be used on all further correspondence. Approval will be sent to you via , within two weeks of receipt of a complete application. Ongoing Management of QA Projects Investigators should inform the Office for Research of when they commence and complete the project via to XXXXXXX A final report should be sent to the Office for Research upon completion of the project. The Office for Research will audit all open QA projects annually. 5. A copy of the patient information and consent form or patient information sheet, if one is going to be used. 6. A copy of any letters, transcripts of telephone calls, surveys etc. that will be used in the project. 7. A copy of the data collection forms. 8. If the project involves accessing medical records, please submit a Health Information Service QA Approval Form, signed by the Director, Health Information Services, XXXXXXXXXX. Fax this form to: To XXXXXXXXX, Management Accountant Research (ph. XXXXXXXX) Approval of the project cannot occur until this form is received. 53

58 RESEARCH ETHICS APPENDIX 8: Approval of a Quality Assurance Project Application Form Before you begin This Application Form is for use by researchers proposing to conduct a low risk uality assurance (QA) project. Please read the guidelines document: Quality Assurance Projects Approval Process and Ongoing Management, prior to completion of this form. Also refer to the documents: When does uality assurance in healthcare reuire independent ethical review? Advice to institutions, Human Research Ethics Committees and Healthcare Professionals Feb 2003 published by the NHMRC The Australian Code for the Responsible Conduct of Research The National Statement on Ethical Conduct in Human Research The Melbourne Health Guidelines for Scientific Practice The process to obtain approval to conduct a QA project at Melbourne Health is conducted via . Please complete this form and it along with all other reuired documentation to XXXXXXX, Assistant Manager Research Directorate: XXXXXXXXXXXX. Office Use Only: QA Ref. No. Date of Approval: / / A: Project Overview 1. Project Title 1.1 Name, appointment and contact details of the Principal Researcher 1.2 Names, appointments and contact details of the Co-Researchers 54

59 RESEARCH ETHICS APPENDIX 8: Approval of a Quality Assurance Project Application Form continued 2. NHMRC Reuirements: When does uality assurance in healthcare reuire independent ethical review? Complete the NHMRC When does uality assurance in healthcare reuire independent ethical review? Questions to be Considered. If you answer no to all of the following uestions, the project does not need consideration by the full HREC and can be submitted for review as a QA project. If you answer yes to any of the uestions, your project may still fit within the boundaries of a QA project and you should contact the Research Directorate for advice. Please explain your responses. Consent 2.1 Is the consent from participants inadeuate or is the activity inconsistent with National Privacy Principle (NPP) 2.1 (a)? NPP 2.1 (a) An organisation must not use or disclose personal information about an individual for a purpose (the secondary purpose) other than the primary purpose of collection unless both of the following apply: i. The secondary purpose is related to the primary purpose of collection and, if the personal information is sensitive information, directly related to the primary purpose of collection. ii. The individual would reasonably expect the organisation to use or disclose the information for the secondary purpose. Risks and Burdens 2.2 Does the proposed QA activity pose any risk for patients beyond those of their routine care? Note: Risks include not only physical risks but also psychological, spiritual and social harm or distress. (eg. stigmatisation or discrimination) 2.3 Does the proposed QA activity impose a burden on patients beyond that experienced in their routine care? Note: Burdens may include intrusiveness, discomfort, inconvenience or embarrassment eg. persistent telephone calls, additional hospital visits or lengthy uestionnaires. 55

60 RESEARCH ETHICS APPENDIX 8: Approval of a Quality Assurance Project Application Form continued Privacy and Confidentiality 2.4 Is the proposed uality assurance activity to be conducted by a person who does not normally have access to the patient s records for clinical care or a directly related secondary purpose? eg. Practitioners or Health Information Staff. Yes No Note: Please state the position of the person who will have access to the records. (eg. AMS student, ward pharmacists, etc). The involvement of a clinical student who is a member of the team in any clinical setting or involvement of an authorised uality assurance officer would be acceptable. However, the involvement of a student external to the clinical team would need further consideration. Review of medical records by anyone who would not normally have access to information contained therein, unavoidably compromises the privacy of individuals. However, authorised audit of records is an extremely valuable uality assurance activity. Provided the individual reviewing the records is bound by legislation or a professional code of ethics, the use can be considered as directly related secondary purpose and is within the expectations of the patient, this uestion can be answered in the negative. 2.5 Does the proposed QA activity risk breaching the confidentiality of any individual s personal information, beyond that experienced in the provision of routine care? Note: A QA activity that reuires a letter, fax or to a patient that includes sensitive health information could lead to a breach of confidentiality, if the communication is read by someone other than the proposed recipient. Overlap with Research 2.6 Does the proposed QA activity involve any clinically significant departure from the routine care provided to the patients? Note: Application and evaluation of new technology not previously used in the health service may need further consideration. 56

61 RESEARCH ETHICS APPENDIX 8: Approval of a Quality Assurance Project Application Form continued 2.7 Does the proposed QA activity involve randomisation, the use of a control group, or a placebo? Note: Proposals involving comparison with published or prior treatment results with other groups are acceptable if the proposals do not involve randomisation. 2.8 Does the proposed QA activity seek to gather information about the patient beyond that collected in routine clinical care? Note: Information may include observations, blood samples, additional investigations, etc. Genetic or other studies that seek information about family members, relatives or contacts as well as the individual patient, reuire further consideration. Broader Implications 2.9 Does the proposed QA activity potentially infringe the rights, privacy or professional reputations of carers, healthcare providers or institutions? Note: These issues should be considered by management and may have legal implications. Consideration may need to be given to the relevant State or Territory legislation with respect to legal privilege for uality assurance body. 3. Project Protocol / Outline 3.1 Have you included a protocol or project outline as per the guidelines? Yes No If Yes, complete any uestions that are not covered in the protocol/outline. If No, complete uestions 3.2 to

62 RESEARCH ETHICS APPENDIX 8: Approval of a Quality Assurance Project Application Form continued 3.2 What is/are the aim/s of the project? 3.3 What is the problem, procedure or practice that will be assessed/uantified? 3.4 What is/are the likely benefit/s of conducting this QA project? 3.5 Method: What activities will you undertake to gather the reuired information to meet the aims of the project? 3.6 Will participants be involved in the project? Yes No If yes provide details 58

63 RESEARCH ETHICS APPENDIX 8: Approval of a Quality Assurance Project Application Form continued 3.7 Will consent from participants be sought? Yes No Note: Participants may include patients, carers, healthcare providers and the institution involved. If Yes, refer to Guidelines for Consent and Information sheets for QA projects and Patient Information and Consent for QA Template or Patient Information Sheet Template Will consent be verbal or written? Verbal Written Implied Provide details 3.8 What information will be collected? Provide details. 3.9 Will information that already exists within the organisation be accessed? (eg. Medical Records, Department Databases, Test Results) Yes No If yes please detail 3.10 How will the data be collected, kept and subseuently destroyed? Attach a copy of surveys, data collection tools, etc. 59

64 RESEARCH ETHICS APPENDIX 8: Approval of a Quality Assurance Project Application Form continued 3.11 How will the data be labelled on the data collection tool and in any electronic storage? (Note: data should be collected in non-identifiable manner, i.e. anonymous (no label or a label that is not linked to the participant) or a re-identifiable manner, i.e. coded (with a uniue code project number, not the UR number) if it is necessary to be able to re-identify the data) How will the data collected be assessed and results validated? (i.e. statistical consideration) 3.13 Will a permanent database of information be created and kept that may be used for further QA or research projects? Yes No If Yes, provide details and complete a Melbourne Health Databank Registration Form (available on the Office for Research website). 4. External Organisations 4.1 Name any external organisations involved in this project and explain the nature of their involvement. 60

65 RESEARCH ETHICS APPENDIX 8: Approval of a Quality Assurance Project Application Form continued 4.2 Will any data or results be provided to an external organisation? Yes No If yes, explain: 4.3 Is this research being conducted at other sites? Yes No If yes, name other sites: 5. Budget 5.1 Has or will the department conducting the research receive any income for this project? (eg. Grant, fee for services) Yes No If yes, provide details of the budget and the funding source and how this income will be used: 5.2 Will Melbourne Health incur any expenses in undertaking this QA project? Yes No If yes, give details. These can be included in the budget provided for Q

66 RESEARCH ETHICS APPENDIX 8: Approval of a Quality Assurance Project Application Form continued 5.3 Does this project involve access to Medical Records via Health Information Services? Yes No If yes, obtain a signed Health Information Services Approval Form from the Director of Health Information Services. (Available on the Office for Research website). Fax this form to the Management Accountant Research, XXXXXXXXXXXXX. Attach the following documents: 1. Protocol/Outline 2. Evidence of support from the Department Manager and the Managers of any other departments that will be involved in the project. (An from the Manager to the Investigator should be forwarded with this application.) 3. A copy of the Patient Information and Consent Form or Patient Information Sheet, if one is going to be used. 4. A copy of any letters, telephone scripts, surveys etc. that will be used in the project. 5. A copy of the data collection form. NB These documents must be sent with this form via . 62

67 RESEARCH ETHICS APPENDIX 9: Criteria for Allocation of Research to Different Levels of Review Checklist Allocation to Different Levels of Review Checklist Ticks in the High Risk column > Full HREC Review is reuired. Ticks in the low risk column but not in the high risk column > project reuires Low Risk Ethical Review at a minimum. Ticks in the negligible risk column only (which can only relate to inconvenience ) > project may be exempt from Ethical Review. Project Number: Project Title: Type of Risk 1 Level of Risk Negligible 2 Low Risk 3 Hisk Risk 4 Physical harm Psychological harm Devaluation of personal worth Social harm Economic harm Legal harm Discomfort Inconvenience Level of Review Allocated: 1 Risk a potential for harm, discomfort or inconvenience. It involves (a) the likelihood that a harm (or discomfort or inconvenience) will occur; and (b) the severity of the harm, including its conseuences. 2 Negligible Risk research - where there is no foreseeable risk of harm or discomfort and any foreseeable risk is no more than inconvenience. 3 Low Risk research - where the only foreseeable risk is one of discomfort. 4 High Risk research - where the risk is more serious than discomfort. 63

68 RESEARCH ETHICS APPENDIX A: HREC Spokesperson Project Review HREC Project No: Spokesperson Name: Scientific/ Ethics (please indicate): Date of Review: 1. General Comments Please consider and, where applicable, include references to/ comments about: Compliance with NHMRC National Statement Compliance with Health Records Act, Privacy and the Privacy Principles Compliance with Guardianship Act (participants lacking capacity) Research uestion(s) and experimental design (including statistics) Is the research worthwhile? Concerns about the investigational product Literature review Primary Pharmacology and Toxicology Safety Issues Oversight/monitoring of the study Informed Consent Participant Information and Consent Form (PICF) Questionnaires Risks v Benefits Ethical issues Qualifications/competence/experience of the researchers Cost and resource implications / Budget / Funding source(s) Insert comments here 64

69 RESEARCH ETHICS APPENDIX A: HREC Spokesperson Project Review continued 2. Specific Questions for Researcher(s) Please clearly list any specific uestions you would like the researcher(s) to address. 65

70 RESEARCH ETHICS APPENDIX A: HREC Spokesperson Project Review continued 3. Amendments Reuired: Please list any documents that you consider need to be amended and provide marked up copies (by hand is fine) if you can (eg. a marked up PICF). 66

71 RESEARCH ETHICS APPENDIX B: Project Summary Report For Ethics Committee Project Number: Principal Researcher: Type of Project: Clinical Trial Phase: Laboratory Research Supportive Care Research Other Clinical Research Retrospective Study Mutual Acceptance Recognised Prior Review (RPR) Other: Prior Sub-committee Review: CRC TRMC Executive Expedited Sub-committee Meeting Date: Review Track: Track 1 Track 2 N/A Privacy Review Reuired: Yes No Sites / Sponsorship / Funding: Internal Commercial Sponsor Multi-Centre Collaborative Group Commercial Support Granting Agency Fee: No Yes $5000 (+GST) Other: Trial Registration: Yes No N/A Major Concerns: Minor Concerns: Study Design or Drug/Treatment regime Statistical Considerations Impact on Patients/Participants Participant Information and Consent Form Privacy Resource Issues Conflict of Interest Other: Protocol/Project description-related Participant Information and Consent Form (content/editorial) Resource Issues Incomplete submission Other: Comments: 67

72 RESEARCH ETHICS APPENDIX B: Project Summary Report For Ethics Committee continued Notes for minutes 68

73 RESEARCH ETHICS APPENDIX C: HREC Report to Institution Template The purpose of this report is to provide the executive/board of this institution with a succinct summary of the HREC activities for the previous calendar year. Please contact the HREC secretariat or euivalent if you reuire further details on any aspect of this report. This report has been prepared, in order to comply with section 5.1 Institutional Responsibilities of the National Statement on Ethical Conduct in Human Research (National Health and Medical Research Council [NHMRC] 2007). Section 1 - Identification Information Name of HREC/s Report Period: Name of HREC/s Chair Name of HREC Secretariat/s and contact details List of Institutions that this Institution offers an HREC Review Only service (If any) List of Institutions with which this Institution has an established Mutual Recognition Program (If any) List the Institutions where this Institution is either the primary reviewing institution or the accepting institution. Section 2 - Reuirements of the National Statement on Ethical Conduct in Human Research Composition of the HREC/s List the name of the members and their position Ie. Ms. Jane Smith, Lay Woman. It is suggested that a note be put in this section stating that the membership list is located in Appendix 1. The membership composition is in accordance with section of the National Statement on Ethical Conduct in Human Research (NHMRC 2007) Yes No A member from each category was present at each meeting Yes No If no, indicate if the absent member/s were provided with an opportunity to read and comment on the agenda papers prior to the meeting. Training undertaken by HREC members during the year and the members that undertook this training Number of HREC meetings held during the year and freuency Record Keeping State how the records of the HREC meetings and files have been maintained. Ie. All agendas and minutes from the meetings are available in hard copy form (in the Research Governance Unit) and electronic form, on a shared drive. Hard copies files for each current research application are maintained by the Research Governance Unit. The files of projects that are no longer active are filed at a secure off-site archiving facility. Areas of research reviewed by the HREC/s 69

74 RESEARCH ETHICS APPENDIX C: HREC Report to Institution Template continued Number of proposals that were reviewed by the full HREC/s Number of proposals that were approved by the full HREC/s This Institution has a mechanism for review of projects that are negligible risk or low risk (Ie. Quality Assurance or Low Risk projects) Note: Approval may be interpreted as approval was granted subject to amendments. Yes No If there is such a mechanism, provide brief details on who oversees this process and how many proposals were reviewed and approved under this process. Researchers are reuired to submit to the HREC/ secretariat the following for approved projects: annual report; immediate serious or unexpected adverse events involving participants at this institution; proposed changes to the protocol; any information which may affect the continued ethical acceptability of the project continuing; notification if the project is to discontinue, prior to the original anticipated completion date. Yes No Were there any complaints raised by a research participant during the reporting period? Were there any complaints raised by a researcher participant during the reporting period? Yes No If yes, provide brief details on the nature of the complaint and how it was resolved. Yes No If yes, provide brief details on the nature of the complaint and how it was resolved. Section 3 - Privacy Guidelines Did the HREC need to apply the s95 Guidelines in assessing research proposals? Did the HREC did need to apply the s95a Guidelines in assessing research proposals? Yes No If yes, provide brief details on the project and the circumstances and the outcome. Yes No If yes, provide brief details on the project and the circumstances and the outcome. 70

75 RESEARCH ETHICS APPENDIX C: HREC Report to Institution Template continued Section 4 - Analysis of Research Projects Number of: Clinical Drug/Device Trials Clinical Research Projects; Public Health Research Projects; Psychological Research Projects; Social Science Research Projects; Other Research Projects; submitted to the HREC. Number of: Phase I; Phase II; Phase III; Phase IV; trials submitted to the HREC. Indicate the breakdown of projects submitted and if any of the submissions were not approved by the HREC. Indicate the breakdown of trials submitted and if any of the submissions were not approved by the HREC. Number of research projects that were: commercially sponsored; funded through a competitive research grant; funded through a higher degrees scholarship; funded through a philanthropic source funded through this institution; investigator s research funds; departmental research funds; investigator-initiated (self-funded); and total amount of funding received from each funding source. List of projects where an audit was carried out and the brief outcome of the audit. List of any projects that were suspended by the HREC (if any). Appendix 1 Attach a list of the HREC membership Appendix 2 Attach a list of the projects submitted to the HREC (including the name of the principal researcher) 71

76 RESEARCH ETHICS APPENDIX D: Waiver of the Reuirement for Consent Waiver of the Reuirement for Consent in Accordance with Sections of the NHMRC National Statement on Ethical Conduct in Human Research 2007 Reporting Period: DD/MM/YYYY to DD/MM/YYYY In accordance with the reuirements of the NHMRC National Statement on Ethical Conduct in Human Research 2007 (National Statement), sections , the Institution s Human Research Ethics Committee (HREC) waived the reuirement for consent for research involving the collection, use and/or disclosure of personal information in medical research or personal health information for the research projects listed below. In reaching the decision to waive the reuirement for consent, the HREC considered and applied sections and of the National Statement and one or more of the (a) Statutory Guidelines on Research issued under section 22 of the Health Records Act 2001 (Vic) (b) Guidelines approved under section 95A of the Privacy Act 1988 (Cwlth) or (c) Guidelines approved under section 95 of the Privacy Act 1988 (Cwlth) as applicable. Project Title: Brief Plain English Summary: (maximum 250 words) Repeat Title and Brief Plain English Summary boxes for each project as reuired. 72

77 Induction, Training and Accreditation Clinical Research Stakeholders 73 Introduction 74 KPIs for Induction, Training and Accreditation of Research Governance Offices, Departments/Teams and Researchers 75 INDUCTION, TRAINING & ACCREDITATION Research Governance Office New Starter Checklist 77 Research Governance Office Accreditation Checklist 79 Research Governance Office Checklist ACHS Accreditation 83 Research Governance Office Audit Checklist Researcher 91 Research Team - New Team Checklist 93 New Researcher Checklist 95 Researcher Self-Accreditation Checklist 97 Investigator Self-Accreditation Checklist for Clinical Trials 99 VMIA Reuirements for Drug and Device Trials Under CTN Scheme 102 APPENDIX 1: Checklist for Induction, Training and Accreditation Research Governance Office 104 APPENDIX 2: Checklist for Induction, Training and Accreditation Department/Team 105 APPENDIX 3: Checklist for Induction, Training and Accreditation Researcher 106 APPENDIX 4: KPI Chart 107 Training Modules Training Module 1 - National Statement of Ethical Conduct in Human Research Training Module 2 - Clinical Research Site SOPs Training Module 3 - VMIA CTN Guidelines Training Module 4 - ACHS Standards Training Module 5 - To describe the process to access TGA unapproved therapeutic goods (drugs and devices) Training Module 6 - Privacy - Overview of Privacy Law reuirements for governance of research programs Training Module 7 - Radiation Available on the VMIA website Go to: Public Healthcare > Clinical Trials

78 Preamble In order to perform good uality research, you must have access to appropriate training and guidelines. This set of materials provides guidance to new and experienced researchers, research teams and research governance staff. The materials cover the areas of induction for new staff; training materials in areas related to research governance; accreditation tools for the Research Governance Office (RGO), research teams and individual researchers. How to use these materials The self-assessment checklist tools have been developed based on the relevant guidelines and they should be used in an un-altered format to ensure that all elements of the guidelines are being followed. The new starter, new research team and new researcher checklists are provided as a starting point and may need to be adapted to cover any additional reuirements of a particular institution. Similarly the audit tools are also provided as starting points and may need to be adapted to suit an individual institution. The training materials provide a high level overview of a number of guideline documents that have not previously had any training materials associated with them. The intent of the training modules is to provide awareness and orientation to the guidelines, however they do not substitute for reading and referencing the relevant guidelines.

79 INDUCTION, TRAINING & ACCREDITATION Clinical Research Stakeholders Medical Technologies Association Australia REGULATORY Medicines Australia TGA / FDA / EU VMIA NH & MRC HREC / RGO Trial Monitor Researchers Medical Director SPONSOR Laboratory INSTITUTE Participant Local Sponsor 73

80 INDUCTION, TRAINING & ACCREDITATION Introduction Induction Materials prepared under the induction topic include the following: 1. Research Governance Office new starter checklist This checklist provides some basic new RGO employee pre-start date tasks, first day tasks and guidance on what documentation they should be given as initial reading. This checklist may need to be adapted for local institutional needs. 2. Research Team new team checklist This checklist provides guidance to new research teams in order to ensure that the team is adeuately euipped to commence conducting research projects. It is focused towards clinical trials but may be adapted by departments or institutions towards other types of research. 3. New researcher checklist This checklist provides some basic new researcher pre-start date tasks, first day tasks and guidance on what documentation they should be given as initial reading. This checklist may need to be adapted for local department or institutional needs. Training Training modules have been prepared for a number of sets of guidelines to provide awareness, overview and orientation to these documents. A copy of the full guidelines should be readily available to all researchers to which they apply. The training modules cover the following topics: 1. The National Statement 2. VMIA SOPs for GCP 3. VMIA Clinical Trial Guidelines 4. ACHS research standards 5. TGA Guidelines on access to unapproved therapeutic goods 6. Privacy 7. Radiation (ARPANZA guidelines). Accreditation The accreditation to conduct research for institutions, research teams and researchers is currently a self governed process. The Research Governance Toolkit project that has been sponsored by the VMIA aims to provide tools to assist institutions in undertaking good research governance and research risk management. The RGO should self-assess its own compliance against the following checklists: 1. RGO self-assessment checklist NS/ACRCR (The National Statement, Australian Code for Responsible Conduct of Research) 2. RGO self-assessment checklist ACHS (The Australian Council on Healthcare Standards) 3. VMIA Clinical Trials Guidelines self-assessment checklist Although this self-assessment is not mandated by the VMIA, it does provide supporting evidence for good research risk management as part of a clinical risk plan and supports ACHS accreditation. The next level in the hierarchy of accreditation can be determined by the institution. An individual institution may reuire its researchers to undertake self-assessment and provide evidence of that self-assessment to the RGO, or alternatively each research team may be asked to undertake self-assessment, with the RGO only checking that it is completed in the event that they audit a study. An individual research team may self-assess using the following documents: 1. The NS/ACRCR checklist 2. VMIA Clinical Trials Guidelines self-assessment checklist 3. Research Team new team checklist. The team may also reuire its team members to conduct their own self-assessments using the following templates: 1. Researcher self-accreditation checklist 2. Investigator self-accreditation checklist for clinical trials. To support the RGO in undertaking research audits two auditing tools have been developed: 1. Research Governance Office Audit Checklist Researcher A high level researcher audit tool to assess the researcher 2. VMIA Clinical Trial Auditing Tool short audit A more detailed audit tool to assist in conducting a study specific audit. Each audit tool can be updated to suit the relevant institution and may be enforced via institutional research policies. This project therefore recommends that each institution creates a hierarchy of self-accreditation using the tools developed in this project. 74

81 INDUCTION, TRAINING & ACCREDITATION Key Performance Indicators for Induction, Training and Accreditation of Research Governance Offices, Departments/Teams and Researchers 1. Aim To create a set of Key Performance Indicators (KPI) covering the induction, training and accreditation of research offices, researchers and research departments or teams so it can be known to what extent these activities take place in the Victorian public hospitals that conduct research. 2. Scope A set of KPIs for all applicable Victorian public hospitals conducting research. 4. Procedure KPIs are to be kept by each of the Research Governance Office, research departments and researchers at defined intervals. A set of KPI checklists is available for each in Appendices 1, 2 and 3. A summary chart of KPIs is to be prepared annually by the RGO and presented to the relevant research directorate and others as reuired (Appendix 4). Information to be gathered is listed as follows: 3. Applicability The KPIs may be used by senior management, Research Governance Offices, department/team heads and researchers to aid the proper governance of research in their institutions. Research Governance Office Checklist Activity KPI Freuency of recording of KPI Induction % staff attended induction Once Training Selfaccreditation Other accreditation % staff attended training How many courses/training sessions attended per staff Type of training (eg. on-line, face-to-face) Freuency of training/courses on offer % staff performed self-accreditation Accreditation rating achieved % staff accredited Accreditation rating achieved Annually or as decided by RGO or senior management Annually Whenever accreditation occurs 75

82 INDUCTION, TRAINING & ACCREDITATION Key Performance Indicators for Induction, Training and Accreditation of Research Governance Offices, Departments/Teams and Researchers Research department/team Checklist Activity KPI Freuency of recording of KPI Induction % researchers attended induction Once Training Accreditation % researchers attended training Which courses/training sessions available to researcher How many courses/training sessions attended per researcher Type of training (eg. on-line, face-to-face) % researchers accredited Accreditation rating achieved Annually or as decided by senior management, RGO or department Whenever accreditation occurs Researcher Checklist Activity KPI Freuency of recording of KPI Induction Whether they attended induction Once Training Accreditation Which courses/training sessions available to researcher Which courses/training sessions attended by researcher Type of training (eg. on-line, face-to-face) Whether the course was completed % researchers accredited Accreditation rating achieved Annually or as decided by department or RGO Whenever accreditation occurs Appendices: Appendix 1 RGO Checklist for training and accreditation Appendix 2 Department Checklist for induction, training and accreditation Appendix 3 Researcher Checklist for induction, training and accreditation Appendix 4 Summary KPI chart 76

83 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office New Starter Checklist Section 1 Employee (New Starter) Details Full Name: Position / Title: Manager to complete all sections Type of Position: Existing New Proposed Start Date: Classification: Permanent Full Time Permanent Part-Time Casual Generic Job Description: Yes Reuires Updating To be created Primary Site: Manager s Full Name: Position / Title: Section 2 Pre-Start Date Reuirements The following actions should be completed prior to the new employee starting date No. Description Reuired Completed 2.1 Reuest employee contract by completing [institution s hiring form]and ensure employment pack has been sent to employee 2.2 Prepare job description, ready for sign-off on day Create training file 2.4 Determine training reuirements for position and review reuirements are correct for the position 2.5 Complete new IT account creation form 2.6 Organise/assign desk and/or working space 2.7 Organise for new telephone extension and update telephone list (if reuired) 2.8 Assign mentor/buddy 2.9 Book employee into next scheduled [institute] Induction 2.10 Prepare schedule for first week (eg. meetings with different departments) Section 3 First Day Reuirements No. Description Reuired Completed 3.1 Ensure new employee returns completed employment pack 3.2 Introduce new employee to as many staff members as possible 3.3 Provide a tour of the [department / facility / site] 3.4 The notification process for advising of absence (sickness) has been explained 3.5 Reuest an updated employee CV including details of new position. 3.6 Develop training plan 3.7 Mentor/buddy Introduction 3.8 Obtain security pass 3.9 Notify when [institution] Induction is to occur Sign-off job description 77

84 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office New Starter Checklist continued 3.11 Sign-off IT Policy prior to obtaining IT Network Access 3.12 Quick Tour of our Intranet 3.13 Complete Facility Orienation Checklist for Primary Site 3.14 If employee is to work at multiple sites, organise a Facility Orientation for other sites Section 4 Access to Key Information No. Description Reuired Completed 4.1 Ensure new employee has access to National Statement on Ethical Conduct in Human Research Ensure new employee has access to Research Governance Office & HREC SOPs 4.3 Ensure new employee has access to [institute] policies and SOPs 4.4 Ensure new employee has access to Australian Clinical Trial Handbook TGA Ensure new employee has access to VMIA Guidelines for Clinical Trials for Victorian Public Hospitals Ensure new employee has access to Access to Unapproved Therapeutic Goods Clinical trials in Australia TGA Ensure new employee has access to Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) annotated with TGA comments TGA Ensure new employee has access to Australian Code for the Responsible Conduct of Research NHMRC Ensure new employee has access to Privacy Act 1988 Section 5 Qualifications/Registration No. Description Reuired Completed 5.1 Identification Check (Passport, Driver s License / Photo Identification) 5.2 Copies of Qualifications (Degrees etc.) reuested 5.3 Medical Board Registration # 5.4 Hospital Honorary Appointment reuested 5.5 Nursing Board Registration # 5.6 Pharmacy Board Registration # 5.7 Visa reuirements met Visa Type Comments: Name / Signature of Manager: Date: / / File completed form in employee training file 78

85 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office Accreditation Checklist Section 1 Research Governance Office (RGO) Details RGO Name: Responsible Manager s Name: Auditor s Name: Position / Title: Date of audit: Section 2 General Principles No. Description Reuired Completed 2.1 Guidelines are in place to monitor processes for assessing uality, safety, privacy, risk management, financial management and ethical acceptability of research. 2.2 Guidelines are in place that demand compliance with relevant laws and regulations. 2.3 The above guidelines are readily available. 2.4 A policy is in place on collaboration with other institutions and organisations. This policy covers financial management, intellectual property, authorship and publication, consultancies, secondments, ethics approval and ownership of euipment and data covering. 2.5 Training and mentoring processes for all research staff are in place. 2.6 The institution provides a safe working environment. Section 3 All human research conducted in this institution is designed and conducted in accordance with ACRCR and with the NS No. Description Reuired Completed 3.1 The human research meets relevant scholarly or scientific standards. 3.2 Processes are in place to ensure that all staff conducting research in this institution are adeuately experienced and ualified, or supervised. 3.3 Each human research project is assessed for risks to the researcher and participants. 3.4 Staff conducting human research in this institution are free to withdraw from any research project based on conscientious grounds. Research data and primary materials No. Description Reuired Completed 3.5 A policy is in place on the retention of materials and research data. 3.6 There are facilities for safe and secure storage of research data and for maintaining records of where research data is stored. 3.7 A policy is in place on the research data ownership, access to data, and storage including arrangements for storage in other locations. 3.8 Processes must be in place to ensure that computing systems are be secure and all IT personnel understand the responsibilities for network security and access control. 79

86 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office Accreditation Checklist continued Research trainees No. Description Reuired Completed 3.9 Processes are in place to ensure research trainees have appropriately ualified and trained supervisors Induction training is provided covering research ethics, occupational health and safety, environmental protection and appropriate technical training. Conflicts of interest No. Description Reuired Completed 3.11 For conflicts of interest involving the institution, processes are in place to inform the ethical review body Processes are in place to manage researcher conflict of interest including any personal, financial conflicts of interest or competing research Processes are in place for members of the ethics review body to disclose conflict of interest including any personal, financial conflicts or competing research. Monitoring research No. Description Reuired Completed 3.14 Processes are in place to ensure all approved research is monitored relevant to degree of risk Relevant reporting processes are in place to observe unexpected outcomes or adverse events Regular reporting of research progress is provided to the relevant review body. This includes information on progress to date, outcome of completed research, maintenance and security of records, compliance with approved proposal and any conditions of approval Any suspension or cessation of research is adeuately reported within appropriate timeframes. Handling complaints No. Description Reuired Completed 3.18 Specific guidelines on research misconduct are in place as described in the Australian Code for the Responsible Conduct of Research Institutional processes are in place to deal with others forms of misconduct such as harassment or bullying The institution has identified a person or agency external to the institution to whom a person can take a complaint Well publicised procedures are in place to resolve complaints about the conduct of review bodies in reviewing research, including access to a person external to the review body Well publicised procedures are in place to handle complaints about researchers or conduct of research. 80

87 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office Accreditation Checklist continued Publication No. Description Reuired Completed 3.23 Policy is in place to promote responsible publication and dissemination of research findings Policies are in place to protect confidentiality and manage intellectual property Policy is in place to support communication of research findings to the wider public Policy is in place on the criteria for authorship, including details on minimising disputes and resolving conflicts that may arise. Peer review No. Description Reuired Completed 3.27 Policies are in place that recognise the importance of peer review and encourage participation. Research misconduct framework No. Description Reuired Completed 3.28 A policy is in place to progressively incorporate research misconduct policy into the institution s job descriptions. These are to be reviewed with each employee when next negotiated A designated person has been appointed to advise the Chief Executive Officer or their delegated officer whether allegations of misconduct appear to be justified. All staff members are aware of this appointment One or more senior staff members have been appointed as advisers in research integrity. This appointment is to advise other staff members if they are unsure about a research conduct issue and whether to make an allegation. All staff members are aware of this appointment. Section 4 Access to Key information No. Description Reuired Completed 4.1 Ensure employees have access to National Statement on Ethical Conduct in Human Research Ensure employees have access to Research Governance Office and HREC SOPs. 4.3 Ensure employees have access to [institute] policies and SOPs. 4.4 Ensure employees have access to Australian Clinical Trial Handbook TGA Ensure employees have access to VMIA Guidelines for Clinical Trials for Victorian Public Hospitals Ensure employees have access to Unapproved Therapeutic Goods Clinical Trials in Australia TGA

88 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office Accreditation Checklist continued 4.7 Ensure employees have access to Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) annotated with TGA comments TGA Ensure employees have access to Australian Code for the Responsible Conduct of Research NHMRC Ensure employees have access to Privacy Act Comments: Name / Signature of Manager: Date: / / 82

89 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office Checklist ACHS Accreditation EQuIP 4 Standard 2.5 Criterion The organisation encourages and adeuately governs the conduct of health and medical research to improve the safety and uality of healthcare. The organisation s research program promotes the development of knowledge and its application in the healthcare setting, protects consumers/patients and manages organisational risks associated with research. Rating Elements Reuired LA a. The organisation fosters and encourages clinical and health services research. Examples of evidence: Strategic Directions Executive Management Team Terms of Reference Executive Director Research Position Description Research Directorate Positions Flowchart Research Directorate Activities Flowchart Example acknowledgement by VIDs for the assistance of the RD. Yes / NA Evidence Documentation Location Rating Elements Reuired LA b. The governing body demonstrates its responsibility for the governance of research. Examples of evidence: Research Policy with all policies and guidelines listed within Monthly Performance and Activity Report to CEO Data Management in Research documentation Use of Human Tissue Samples in Research documentation Research Publications and Authorship documentation Clinical Trials Costing Financial Process and Related Matters Guidelines for Clinical Trials Payments Financial Process and Related Matters Handling Complaints in Research Policy Guidelines for Research Practice Misconduct Section Executive Management Team Terms of Reference Board Reports Research Advisory Council. Yes / NA Evidence Documentation Location 83

90 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office Checklist ACHS Accreditation continued Rating Elements Reuired LA c. A policy exists and is publicly available for governing the uality of research in the organisation. Examples of evidence: Policy Guidelines for Research Practice Evidence of availability to staff. Yes / NA Evidence Documentation Location Rating Elements Reuired LA d. The research policy is consistent with: i. key NHMRC statements ii. state/territory legislation iii. codes of conduct. Examples of evidence: Government Acts and Guidelines List and files National Statement and Australian Codes for Human and Animal Research are referenced throughout the GRP VMIA -Guidelines for Clinical Trials for Victorian Public Hospitals HREC Submission Modules are used which are based on NS, Australian Code and Health Records and Privacy Laws. Yes / NA Evidence Documentation Location Rating Elements Reuired LA e. Staff are aware of the research policy. Examples of evidence: Website pages Distribution lists Researchers, Registrars, Research Nurses, Research Coordinators. Yes / NA Evidence Documentation Location 84

91 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office Checklist ACHS Accreditation continued Rating Elements Reuired SA a. The research policy is implemented. Examples of evidence: Minutes of HREC meeting Example letter re: committees comments and changes reuired Excel spreadsheet of all projects Annual Audit Form Database Registration Form or similar Tissue Bank Registration Form or similar Publication and Authorship Form or similar Investigator Curriculum Vitae Form Financial Disclosure in Research Form or similar. Yes / NA Evidence Documentation Location Rating Elements Reuired SA b. Ethics approval processes are timely, transparent and effective. Examples of evidence: How the Process Works for HREC on website Meeting dates are displayed on the website Time to Approval spreadsheet to demonstrate turn around KPI Copy of letter to researchers to demonstrate comments are fed back to researcher HREC meetings 20XX guest list and sample invitation. Yes / NA Evidence Documentation Location 85

92 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office Checklist ACHS Accreditation continued Rating Elements Reuired SA c. Scientific review standards of research are timely, transparent and effective. Examples of evidence: How the Process Works for REC and HREC on website Meeting dates are displayed on the website Time to Approval spreadsheet to demonstrate turn around KPI Copy of letter to researchers to demonstrate comments are fed back to researcher HREC meetings 20XX guests list and sample invitation. Yes / NA Evidence Documentation Location Rating Elements Reuired SA d. Researchers are appropriately trained and ualified for the roles they are undertaking. Examples of evidence: Training Records GRP Researchers responsibilities are explained Researcher Curriculum Vitae. Yes / NA Evidence Documentation Location Rating Elements Reuired SA e. The respective responsibilities of all parties involved in research are identified and documented. Examples of evidence: GRP How the HREC process works document (get from SA c) HREC Membership and Terms of Reference. Yes / NA Evidence Documentation Location 86

93 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office Checklist ACHS Accreditation continued Rating Elements Reuired SA f. The role and reporting line of the organisational HREC are clearly defined. Examples of evidence: HREC Membership and Terms of Reference (get from SA e) Example HREC appointment letter Institutional Biosafety Committee (IBC) Membership and Terms of Reference. Yes / NA Evidence Documentation Location Rating Elements Reuired SA g. The HREC is adeuately resourced. Examples of evidence: Research Directorate cost centre budget Position Description Clinical Trials Research Management Accountant Livelink front page demonstrating livelink system for HREC processing QA database Research Directorate Flowchart HREC distribution list Journal of bioethics to all members VMIA Health Alert to all members Copy of the National Statement given to all members. Yes / NA Evidence Documentation Location 87

94 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office Checklist ACHS Accreditation continued Rating Elements Reuired SA h. Consumers and researchers work in partnership to make decisions about research priorities, policies and practices. Examples of evidence: Lay members on the HREC committee Examples of consumer involvement in research decision making Evidence of consumer forums and/or activities in research week List of grants from funding bodies with consumer representatives. Yes / NA Evidence Documentation Location Rating Elements Reuired SA Evidence i. Formal agreements exist with collaborating agencies. Examples of evidence: Deed of Agreement with NHMRC Documents to be made available of all trial agreements. Yes / NA Documentation Location 88

95 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office Checklist ACHS Accreditation continued Rating Elements Reuired MA a. Performance indicators are used to evaluate the effectiveness of the governance of research. Examples of evidence: Monthly Performance and Activity Report to CEO (get from LA b) Annual Audit of all projects Annual Audits database - example of study reports Random Medical Audit - example letter Audit of translational research HREC Report to Health Services Commissioner HREC Report under the Heatlh Records Act 2001 SAE register Complaints Register. Yes / NA Evidence Documentation Location Rating Elements Reuired MA b. The system for ensuring effective research governance is evaluated and is improved as reuired. Examples of evidence: Annual Audit Form New policies written Feedback surveys Quality Assurance System formalised Database, Application Form, Process Guidelines Quality improvement projects undertaken with outcomes available Quality and Business Plan Checklist for new project submission NEAF. Yes / NA Evidence Documentation Location 89

96 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office Checklist ACHS Accreditation continued Rating Elements Reuired EA a. Research outcomes are implemented in the organisation and are used to demonstrate improvements in healthcare, and/or Examples of evidence: Translation of Research into Practice Reports Annual Reports showing outcome and relevance to patient outcomes. Yes / NA Evidence Documentation Location Rating Elements Reuired EA b. The organisation participates voluntarily in a regular external evaluation of research governance. Examples of evidence: Documentation showing involvement in Study Days/Forums/Focus Groups/ Working Parties. Yes / NA Evidence Documentation Location Rating Elements Reuired OA a. The organisation demonstrates that its research program and the governance thereof is outstanding. Examples of evidence: Research Director is part of the Executive Management Team List of publications in high impact journals International visitors Staff that have been invited to speak Nationally and Internationally Awards Financially Scorecard and tracking expenses (get from MA b) Annual Research and Clinical Services Report List of Grants from competitive review. Yes / NA Evidence Documentation Location 90

97 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office Audit Checklist Researcher Section 1 Team Details Research Team Name: Primary Site: Responsible Manager s Name: Position / Title: Date of audit: Manager to complete all sections Auditor s name: Section 2 Administrative Information No. Description Reuired Completed 2.1 Is there a membership list of the research team? 2.2 Has the research team completed a self-acceditation form? 2.3 Have all relevant departmental approvals been obtained? 2.4 Does the team have a separate research account? 2.5 Does the team have a team charter or contract? 2.6 Does the team have adeuate working space? Section 3 Site Qualification, Adeuacy of Resources and Training No. Description Reuired Completed 3.1 Do team members have skills and experience to conduct the research being undertaken? 3.2 Do the staff meet all the ualifications specified by the applicable regulatory reuirement(s) eg. Current medical practitioner registration? 3.3 Are the team able to demonstrate a potential for recruiting the reuired number of suitable subjects within the agreed recruitment period? 3.4 Are all persons assisting with the trial adeuately informed about the protocols, the investigational product(s), and their trial-related duties and functions? 3.5 Are records kept relating to delegation of tasks and are the tasks delegated to appropriately skilled and experienced staff? 3.6 Is all documentation of trial related training kept current and available for review? 3.7 Are all essential documents maintained according to ICH-GCP? Section 4 Access to Key Information No. Description Reuired Completed 4.1 Does the team have access to National Statement on Ethical Conduct in Human Research 2007? 4.2 Does the team have access to Research Governance Office and HREC SOPs? 4.3 Does the team have access to [institute] policies and SOPs? 4.4 Does the team have access to Australian Clinical Trial Handbook TGA 2006? 91

98 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Governance Office Audit Checklist Researcher continued 4.5 Does the team have access to VMIA Guidelines for Clinical Trials for Victorian Public Hospitals 2009 or as updated from time to time? 4.6 Does the team have access to Access to Unapproved Therapeutic Goods Clinical trials in Australia TGA 2004? 4.7 Does the team have access to Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) annotated with TGA comments TGA 2000? 4.8 Does the team have access to Australian Code for the Responsible Conduct of Research NHMRC 2007? 4.9 Does the team have access to Privacy Act 1988? Comments: Name / Signature of Manager: Date: / / 92

99 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Team - New Team Checklist Section 1 Team Details Research Team Name: Manager to complete all sections Primary Site: Responsible Manager s Name: Position / Title: Section 2 Adminsitrative Information No. Description Reuired Completed 2.1 Prepare membership list of research team 2.2 Prepare contact list 2.3 Obtain any relevant departmental approvals 2.4 Create research accounts (where applicable) 2.5 Prepare team charter or contract (where applicable) 2.6 Organise/assign desk and/or working space. Section 3 Team start-up No. Description Reuired Completed 3.1 Assess team skills and experience to conduct the research to be undertaken 3.2 Introduce new team members to as many staff members as possible 3.3 Provide a tour of the [department/facility/site] 3.4 Reuest an updated Employee CV including details of new position (if reuired) 3.5 Develop Training Plan (if reuired) 3.6 If members are to work at multiple sites, organise a Facility Orientation for other sites. Section 4 Access to Key Information No. Description Reuired Completed 4.1 Ensure team has access to National Statement on Ethical Conduct in Human Research Ensure team has access to Research Governance Office and HREC SOPs 4.3 Ensure team has access to [institute] policies and SOPs 4.4 Ensure team has access to Australian Clinical Trial Handbook TGA Ensure team has access to VMIA Guidelines for Clinical Trials for Victorian Public Hospitals Ensure team has access to Access to Unapproved Therapeutic Goods Clinical Trials in Australia TGA Ensure team has access to Note for Guidance on Good Clinical Practice (CPMP/ ICH/135/95) annotated with TGA comments TGA

100 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Team - New Team Checklist continued 4.8 Ensure team has access to Australian Code for the Responsible Conduct of Research NHMRC Ensure team has access to Privacy Act Name / Signature of Manager: Date: / / File completed form in employee training file 94

101 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy New Researcher Checklist Section 1 Employee (New Starter) Details Full Name: Position / Title: Manager to complete all sections Type of Position: Existing New Proposed Start Date: Classification: Permament Full Time Permanent Part-Time Casual Generic Job Description: Yes Reuires Updating To be created Primary Site: Manager s Full Name: Position / Title: Section 2 Pre-Start Date Reuirements The following actions should be completed prior to the new employee starting date No. Description Reuired Completed 2.1 Reuest employee contract by completing [institution s hiring form]and ensure employment pack has been sent to employee 2.2 Prepare job description, ready for sign-off on day Create training file 2.4 Assess relevance of skills and experience to undertake the role they are to be appointed to. Determine training reuirements for position and review reuirements are correct for the position. 2.5 Complete new IT account creation form 2.6 Organise/assign desk and/or working space 2.7 Organise for new telephone extension and update telephone list (if reuired) 2.8 Assign mentor/buddy 2.9 Book employee into next scheduled [institute] Induction 2.10 Prepare schedule for first week (eg. meetings with different departments). Section 3 First Day Reuirements No. Description Reuired Completed 3.1 Ensure new employee returns completed employment pack 3.2 Introduce new employee to as many staff members as possible 3.3 Provide a tour of the [department/facility/site] 3.4 The notification process for advising of absence (sickness) has been explained 3.5 Reuest an updated employee CV including details of new position 3.6 Develop training plan 3.7 Mentor/buddy introduction 3.8 Obtain security pass 3.9 Notify when [institution] Induction is to occur. 95

102 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy New Researcher Checklist continued 3.10 Sign-off Job Description 3.11 Sign-off IT Policy prior to obtaining IT Network Access 3.12 Quick Tour of our Intranet 3.13 Complete Facility Orientation Checklist for Primary Site 3.14 If employee is to work at multiple sites, organise a Facility Orientation for other sites. Section 4 Access to Key information No. Description Reuired Completed 4.1 Ensure new employee has access to National Statement on Ethical Conduct in Human Research Ensure new employee has access to research protocol(s) and investigational brochure(s) relevant to their work 4.3 Ensure new employee has access to [institute] policies and SOPs 4.4 Ensure new employee has access to Australian Clinical Trial Handbook TGA Ensure new employee has access to Access to Unapproved Therapeutic Goods Clinical trials in Australia TGA Ensure new employee has access to Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) annotated with TGA comments TGA Ensure new employee has access to Australian Code for the Responsible Conduct of Research NHMRC Ensure new employee has access to Privacy Act Section 5 Qualifications/Registration No. Description Reuired Completed 5.1 Identification Check (Passport, Driver s License / Photo Identification) 5.2 Copies of Qualifications (Degrees etc.) reuested 5.3 Medical Board Registration # 5.4 Hospital Honorary Appointment reuested 5.5 Nursing Board Registration # 5.6 Pharmacy Board Registration # 5.7 Visa reuirements met Visa Type Comments: Name / Signature of Manager: Date: / / File completed form in employee training file 96

103 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Researcher Self-Accreditation Checklist Section 1 Researcher Details Researcher s Full Name: Position / Title: Researcher to complete all sections Primary Site: Section 2 Compliance with guidelines for responsible research conduct (completed by researcher about themselves) No. Description Reuired Completed 2.1 If I left suddenly, my project could be completed or replicated because the documentation for my projects is up-to-date, accessible, clearly ordered and comprehensible. The Principal Researcher knows where to find all relevant documentation and has been provided with the passwords to the databases. 2.2 I am conducting the study in accordance with the protocol approved by the Ethics Committee. Any modifications have been reported to the committee and the relevant documents updated. 2.3 I am appropriately ualified to conduct the trial. 2.4 I have obtained signed consent forms from all participants (where applicable) and stored these securely. They are available for audit. 2.5 I have reported all serious and unexpected adverse incidents to the Ethics Office 2.6 I have provided all study participants with a copy of the Participant Information sheet approved by the Ethics Committee. 2.7 I have provided a translator and/or a translated copy of the Participant Information sheet in his/her own language to all non-english speaking participants. 2.8 I have received Ethics Committee approval for all public advertising material that seeks volunteers to participate in the study. 2.9 Approaches to potential participants have been made only by the individuals with full knowledge of the study protocol and of the risks and inconveniences associated with participation (and approved by the Ethics Committee) All paper-based uestionnaires have the identifying information removed immediately after processing and are then identifiable only by a code. The code-key is stored separately under lock and key at all times All principal computer files containing study data are stored on a secure network drive where they are regularly backed up All computer files containing study data are protected by passwords No personal identifying information has been transferred to portable drives including USB sticks or portable computers Participants know who to contact if they have a uestion, complaint or an emergency There is a regular meeting of the study team including the Principal Researcher/s to discuss the progress of the study and a record of these meetings is maintained. 97

104 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Researcher Self-Accreditation Checklist continued Comments (refer to those items marked N/A or no): Name / Signature of Manager: Date: / / Principal Researcher: Date: / / File completed form in employee training file 98

105 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Investigator Self-Accreditation Checklist for Clinical Trials Section 1 Researcher Details Investigator s Full Name: Position / Title: Researcher to complete all sections Primary Site: Section 2 Compliance with Investigator responsibilities under ICH-GCP (completed by investigator about themselves) No. Description Reuired Completed 2.1 I ensure that clinical studies are carried out according to International Conference on Harmonisation (ICH), regulatory authorities reuirements and any other local reuirements. 2.2 I understand that when a trial is sponsored by an agency/pharmaceutical company, I may be reuested to follow their procedures in order to comply with company obligations. Agreement between all parties should be discussed before initiating the trial. 2.3 I am appropriately ualified to conduct the trial. 2.4 I inform the participant's primary physician about the participant's participation in the trial if the participant has a primary physician and if the participant agrees to the primary physician being informed. 2.5 I declare any conflicts of interest, payments etc. from other parties. 2.6 I maintain a list of any delegated duties with respect to the trial, and the persons and ualifications of those persons to whom the duties are assigned. 2.7 I am able to demonstrate that adeuate participant recruitment is likely to be possible, with necessary time available to conduct the study to GCP (Good Clinical Practice) reuirements, and with adeuate facilities and trial staff. 2.8 I am able to provide medical care to trial participants that is necessary as a result of any adverse events experienced during or following the trial that are related to the trial, and must be responsible for all trial-related medical decisions. 2.9 I possess, prior to trial commencement, a favourable HREC endorsement of trial protocol, patient information and consent documents, recruitment procedures, consent form updates and any other information given to participants I present all trial related documents to the HREC for review including the Investigator s Brochure as well as updates I ensure that the trial is conducted according to the approved protocol I document any deviation from the protocol for later review I ensure that no deviation from the protocol occurs without HREC endorsement, unless it is reuired to prevent imminent harm to participants. If the protocol deviation results in the creation of a separate and distinct therapeutic good as defined in section 16 of the Therapeutic Goods Act 1989, a new notification is reuired for CTN or CTX trials I ensure a new CTN form is completed, or in the case of CTX a new notification of intent to conduct clinical trial form, for any new trial site subseuently added to a study. 99

106 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Investigator Self-Accreditation Checklist for Clinical Trials continued 2.15 I ensure accountability of the investigational product at the trial site(s) I ensure that, prior to the commencement of the research, participants have made fully informed, written consent, with all trial procedures and risks adeuately explained and that the principles and essential elements of informed consent are upheld and included in the information document I am thoroughly familiar with the appropriate use of the investigational product(s), as described in the protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor I ensure that all persons assisting with the trial are adeuately informed about the protocol, the investigational product(s), and their trial-related duties and functions I submit written summaries of the trial status to the HREC annually, or more freuently, if reuested by the HREC I provide written reports to the sponsor, the HREC and, where applicable, the institution promptly on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants I comply with the applicable regulatory reuirement(s) related to the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) and the HREC I promptly inform the trial participants if the trial is prematurely terminated or suspended for any reason as well as the institution and should assure appropriate therapy and follow-up for the participants, and where reuired by the applicable regulatory reuirement(s), inform the regulatory authority(ies) If I terminate a trial without prior agreement of the sponsor, I will inform the institution where applicable, and I will promptly inform the sponsor and the HREC, and provide the sponsor and the HREC a detailed written explanation of the termination or suspension I, upon completion of the trial, where applicable, inform the institution; the investigator/institution should provide the HREC with a summary of the trial s outcome, and the regulatory authority(ies) with any reports reuired. Section 3 Compliance with site ualifications, adeuacy of resources and training under ICH-GCP (completed by investigator or delegate about the site and team) No. Description Reuired Completed 3.1 We maintain an up-to-date Curriculum Vitae of all staff and review on a yearly basis. 3.2 We ensure all staff are ualified by education, training, and experience to assume responsibility for the proper conduct of the trial. This should be evident in the CV. 3.3 We meet all the ualifications specified by the applicable regulatory reuirement(s). Current medical practitioner registration details and similar documentation should be referenced in the CV. 3.4 We are able to demonstrate (if possible based on retrospective data) a potential for recruiting the reuired number of suitable participants within the agreed recruitment period. 100

107 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Investigator Self-Accreditation Checklist for Clinical Trials continued 3.5 We have sufficient time to properly conduct and complete the trial within the agreed trial period and have available an adeuate number of ualified staff and adeuate facilities for the foreseen duration of the trial to conduct the trial properly and safely. 3.6 We ensure that all persons assisting with the trial are adeuately informed about the protocol, the investigational product(s), and their trial-related duties and functions. 3.7 We ensure that documentation of this training be kept current and available for review on reuest throughout the entire trial period. 3.8 We ensure that tasks delegated to study staff are documented appropriately. 3.9 We ensure that all persons assisting with the trial are adeuately informed about the protocol, the investigational product(s), and their trial-related duties and functions. We ensure that all research documents are securely stored during the conduct of the study and are retained for at least 5 years after publication and in the case of an adult clinical trial for 15 years and for a clinical trial involving a child for 25 years. Comments: Name / Signature of Investigator: Date: / / File completed form in employee training file 101

108 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy VMIA Reuirements for Drug & Device Trials Under CTN Scheme Important Note : Failure to adhere to the following reuirements of the VMIA may invalidate your policy coverage Section 1 General Reuirements No. Description Reuired Completed 1.1 Has the Therapeutic Goods Administration (TGA) been notified in accordance with all statutory and regulatory reuirements? 1.2 If the trial is included in the following list, has the trial been approved by the VMIA s assigned lawyers, DLA Phillips Fox? Clinical drug or device trial with no commercial sponsorship Commercially sponsored Phase I and Phase II clinical drug trial Commercially sponsored device trial Commercially sponsored Phase III and IV clinical drug trial not complying with the minimum reuirements outlined in the VMIA CTN guidelines. Section 2 VMIA Notification Reuirements Prior to Commencing Phase I / II or Investigator Initiated Trials No. Description Reuired Completed 2.1 Has a copy of the following documents been provided to DLA Phillips Fox Lawyers : cover letter, registration proforma, lay summary, scientific summary, patient information sheet and patient consent form? 2.2 For commercially sponsored trials, has an indemnity from the commercial sponsor and a Certificate of Insurance evidencing the commercial sponsor's insurance arrangements in respect of the trial been supplied to DLA Phillips Fox Lawyers? 2.3 Has the VMIA been provided with a copy of the cover letter? NOTE : A hospital/institution is not reuired to submit for approval any commercially sponsored Phase III and IV drug trial, provided the trial complies with the reuirements for Phase III and IV drug trials guidelines set out in VMIA CTN guidelines. If it complies, the trial will be automatically covered by the Public Liability and Medical Indemnity Policies. If not, the reuirements set out in apply. Section 3 HREC No. Description Reuired Completed 3.1 If the clinical trial involves a medical procedure and the recruitment of participants aged 18 years or over who are incapable of giving consent, has the responsible HREC ensured that the reuirements of the Guardianship and Administration Act 1986 (Vic) (GAA) are met? 3.2 Where a trial is being conducted outside the HREC s institution, has the HREC determined that supervision and reporting arrangements are satisfactory? Section 4 Indemnity and Insurance Reuirements (Commercially Sponsored Trials) No. Description Reuired Completed 4.1 Is the indemnity provided by the commercial sponsor in a form no less favourable than the current version Medicines Australia Form of Indemnity for Clinical Trials? 102

109 INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy VMIA Reuirements for Drug & Device Trials Under CTN Scheme continued 4.2 Is the commercial sponsorship and the indemnity provided by an Australian corporate entity? 4.3 Where the trial is being conducted by private hospitals or practitioners in private practice,and the trial is reviewed by a public hospital s HREC, has the commercial sponsor s indemnity named and fully indemnified the public hospital and its agents and servants for their participation? 4.4 Where a third party such as a researcher or other body or organisation involved in a clinical trial wishes to be indemnified by the commercial sponsor, has a separate Form of Indemnity been arranged? 4.5 Has a Certicificate of Insurance been received from the commercial sponsor that satisfy the following conditions: names the Australian corporate entity acting as commercial sponsor as a named insured under the relevant insurance policy; evidences the existence of an insurance policy which covers the conduct of the relevant clinical trial in Australia; is through an insurer either approved by the Australian Prudential Regulation Authority or an overseas insurer; evidences that the policy will be current throughout the entire period in which the clinical trial is conducted; contains insurance coverage for a minimum amount AUD$10 million for any one occurrence and in the annual aggregate; does not contain an excess/deductible or self-insured retention amount greater than AUD$25,000 for each and every claim or series of claims arising out of one originating cause. Comments: Name / Signature of Manager: Date: / / 103

110 INDUCTION, TRAINING & ACCREDITATION APPENDIX 1: Checklist for Induction, Training and Accreditation Research Governance Office Institution: Department: Research Governance Office Name of Manager: Signature: Date: / / Name Induction Date (dd/mm/yy) Course(s) available Month(s) available Attended (dd/mm/yy) Type of training (on-line, face to face) Accreditation Date (dd/mm/yy) Rating Action /Comments Person 1 Person 2 Person 3 104

111 INDUCTION, TRAINING & ACCREDITATION APPENDIX 2: Checklist for Induction, Training and Accreditation Department/Team Institution: Department Team: Head of Department/Team: Signature: Date: / / Name Induction Date (dd/mm/yy) Course(s) available Month(s) available Attended (dd/mm/yy) Type of training (on-line, face to face) Accreditation Date (dd/mm/yy) Rating Action /Comments Researcher 1 Researcher 2 Researcher 3 105

112 INDUCTION, TRAINING & ACCREDITATION APPENDIX 3: Checklist for Induction, Training and Accreditation Researcher Institution: Department Team: Researcher: Signature: Date: / / Induction Date (dd/mm/yy) Course(s) available Month(s) available Attended (dd/mm/yy) Completed (Y/N) Type of training (on-line, face to face) Accreditation Date (dd/mm/yy) Rating Action /Comments 106

113 INDUCTION, TRAINING & ACCREDITATION APPENDIX 4: KPI Chart Institution: Manager of RGO: Director of Research: Signature: Signature: Date: / / Group Induction Attended (%) Training Courses available (n) Training Courses offered (n) Number from group Attended (%) Number undergoing accreditation (%) Accredited (%) Action /Comments RGO Department Researcher 107

114 108

115 Legal and Insurance Introduction 109 Version Control Coversheet 110 Contract Creation, Approval and Execution SOP 111 Clinical Trial Preparation Agreement 114 Deed of Variation 117 Checklist for Participant Information & Informed Consent 118 Standard Wording for Research Involving Collection of Drug Use Information 119 Register of Research Ethics and Compliance 120 APPENDIX 1: Flowchart 122 LEGAL & INSURANCE

116 Preamble To ensure that hospitals/institutions participating in the conduct of research protect their rights and entitlements when conducting research, and to not jeopardise their entitlements under the VMIA s policies, it is essential that the institute puts in place and implements appropriate processes. An awareness of matters having implications for the legal and insurance arrangements of institutes involved in human research are an integral component of responsible research governance. An institution should have in place appropriate tools to regulate the manner in which matters that could expose the institution to greater liability than is necessary are adeuately identified, and that appropriate tools and processes are instigated to mitigate any potential exposures or deficiencies. Documents provided within this chapter are intended to assist the hospital/institute in this regard. This chapter focuses predominantly on the legal and insurance considerations in the conduct of clinical research and is supplementary to other chapters within the RGT that may contain materials of relevance. This chapter addresses matters of informed consent, contracts/indemnification and compliance with relevant government regulations.

117 LEGAL & INSURANCE Introduction The legal and insurance chapter should also be reviewed in conjunction with other VMIA related initiatives that will assist with the imperatives as indicated below: VMIA CTN Guidelines. The standard Clinical Trial Research Agreements. The standard Clinical Investigation Research Agreement First Time in Human Protocol. 13 SOPs for Minimum ICH GCP compliance. To aid institutions in protecting their entitlements emanating from the conduct of clinical research and also facilitating greater compliance with policies arranged by the VMIA, the RGT provides the following documents: 1. Management of Research Agreements Version control coversheet for template authorisation. Agreement for preparation of clinical trial (Pre-Clinical Trial Agreement). Deed of variation for amendments to agreements. SOP for review of provisions within Research Agreements. 2. Guidance on specific risks Checklist for informed consent procedure. Standard wording for reference to illegal activity research. 3. Compliance with legislation and guidelines Register of relevant insurance and legal guidelines. 109

118 LEGAL & INSURANCE Version Control Coversheet Title: Document ID: Version: [insert version as per your local site uality management system] Author: [insert name of local author or approver] Author Signature: Date: / / Effective Date: [insert date that this procedure is effective from, in your institution/department] Review Before: [insert date of when this procedure should be reviewed] Department/Institution name: [insert department/institution name] Reviewed and approved by: [insert name] [insert title/position] Signature: Date: / / Departmental Head: [insert name] Signature: Date: / / 110

119 LEGAL & INSURANCE Contract Creation, Approval and Execution SOP 1. Purpose To document the procedure for the creation and management of contracts. 2. Scope This applies to all contracts whether it be a new contract or an existing contract. (Please note that for the purposes of this process the terms contracts and agreements are interchangeable). 3. Applicability All staff that the contract s activities relate to and those responsible for approving and/or executing the contract. 4. Procedure 4.1 Flowchart See Appendix 1 for complete chart. In summary: Recognition of need to contract Process for creating a draft document Internal and other party approval Execution of contract Management of contract Variation and/or renewal of contract Closing out contract 4.2 Initiating the creation of a new contract or renewing or variation to an existing contract All staff relevant to a study may: identify the need for a new contract or a deficiency in an existing contract; notify the Research Directorate [or euivalent] or the PI and discuss the need with them. The PI will: raise the potential need for a new contract or renewal or variation with the hospital s Legal department, Contracts unit and/or Research Directorate (or euivalent) and follow their instructions; liaise with the other party as directed by the department[s] above. The Research Directorate Manager [or euivalent] will: assess and verify the identified need and if reuired liaise with the hospital s Legal department and/or Contracts unit; liaise with the other party as directed by the department[s] above; facilitate the exchange of documentation with the relevant stakeholders to achieve settlement of a draft agreement; primarily consider the contractual terms and conditions against prescribed contract templates (namely the VMIA approved Clinical Trial Research Agreements and any other DH, and/or hospital specific templates); ensure the settled version of the contract follows the hospital s delegation and/or approval process for contracts; ensure copies of the executed contract are maintained on the project file in accordance with the relevant SOP[s] and that the relevant hospital staff are aware of the contracts existence; maintain a register of contracts and or contracts variations and/or renewals; ensure contractual performance is monitored for contracts that relate to studies it has approved, and performance is recorded and filed in accordance with the relevant study SOPs. 4.3 Drafting, settling and signing a new contract All staff relevant to a study may: upon direction from the PI and/or Research Directorate reuest contract documentation from the other party. The PI will: reuest contract documentation from the other party; familiarise themselves with the draft contract; consider the practical issues within any draft contract documentation and advise the Research Directorate of any concerns; ensure the Research Directorate becomes the primary point of contact for all contractual discussions on behalf of the hospital; liaise with the other party regarding the draft contract as directed by the Research Directorate. 111

120 LEGAL & INSURANCE Contract Creation, Approval and Execution SOP continued The Research Directorate Manager [or euivalent] will: review the draft contract documentation and liaise with the hospital s Legal department and/or Contracts unit; liaise with the other party as directed by the department[s] above; facilitate the exchange of documentation with the relevant stakeholders to achieve settlement of a draft agreement; primarily consider the contractual terms and conditions against prescribed contract templates (namely the VMIA approved Clinical Trial Research Agreements and any other DH, and/or hospital specific templates); ensure the settled version of the contract follows the hospital s delegation and/or approval process for contracts; ensure copies of the executed contract are maintained on the project file in accordance with the relevant SOP[s] and that the relevant hospital staff are aware of the contract s existence; maintain a register of contracts and/or contracts variations and/or renewals; ensure contractual performance is monitored for contracts that relate to studies it has approved, and performance is recorded and filed in accordance with the relevant study SOPs. The Legal and/or Contracts unit will: for a new study contract, one of the VMIA and DH approved templates are to be utilised. for a new study that does not relate to the templates, a contract should be drafted that includes: i. a clear separation of responsibilities in accordance with GCP and ICH, VMIA and DH directives and/or guidelines, and the relevant hospital SOP[s]; ii. jurisdiction being the State of Victoria; iii. indemnities; iv. reference to the protocol; v. the contract prevailing over the protocol; vi. payment terms and amounts; vii. patient information process; viii. confidentiality; ix. acknowledgement [only] by the PI; x. warranties relating to study products [drug or device] as reuired by TGA and Trades Practices Act; xi. publication; xii. intellectual Property; xiii. dispute resolution; xiv. study termination process. ensure the settled version of the contract is approved and executed in accordance with the hospital s policies maintain a copy of the final contract 4.4 Approval and execution of contracts The hospital s Research Directorate must ensure it is aware of the hospital s contract approval and execution policy/process and ensure it is communicated to PI[s] and study staff and followed. No study contract should be settled or signed without the Research Directorate managing the contract process. 4.5 Termination and archiving of contracts If a study is terminated by the Research Directorate, the PI or the other party [including if it is not extended], the contract is to be terminated in writing by the Research Directorate and archived in accordance with the hospital s contract policy/process and study SOP[s]. 112

121 LEGAL & INSURANCE Contract Creation, Approval and Execution SOP continued 5. Glossary Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected. International Conference on Harmonisation (ICH) International Conference on Harmonisation of Technical Reuirements for Registration of Pharmaceuticals for Human Use is a joint initiative involving both regulators and research-based industry focusing on the technical reuirements for medicinal products containing new drugs. Investigator or PI An individual responsible for the conduct of a clinical trial at a trial site and ensures that it complies with GCP guidelines. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the PI. In this instance they may delegate tasks to other team members. Standard Operating Procedure (SOP) Detailed, written instructions to achieve uniformity of the performance of a specific function. References Note for guidance on Good Clinical Practice (CPMP/ICH/135/96) annotated with TGA comments DSEB, July 2000, sections 1 and 5 Appendices Appendix 1: Flowchart 113

122 LEGAL & INSURANCE Clinical Trial Preparation Agreement This agreement is made on the day of 20 Parties [NAME OF INSTITUTION/ORGANISATION] of [ADDRESS OF INSTITUTION/ORGANISATION] (Institution) The party named in Item 1 of the Schedule to this agreement (Company). Recitals a. Institution intends to conduct the study referred to in Item 2 of the Schedule (Study). In order to evaluate various aspects of the Study and to assess the feasibility of the Institution performing the Study, the Institution must perform certain activities (Activities). The company will pay the Organisation for the Activities. b. This agreement concerns the performance of the Activities by the Institution. If the parties decide to proceed with the Study, the parties will enter into a separate document (Clinical Trial Research Agreement) concerning the conduct of the Study. Term and Termination 1. This agreement commences on the date set out on page 1 and, subject to clause 2, ends immediately when the parties enter into a Clinical Trial Research Agreement in relation to the Study. 2. The Company may terminate this Agreement with 30 days prior written notice to the Institution. In the event of such early termination, the Company must pay the Institution in accordance with Item 3 of the Schedule for any Activities performed until the date of termination. Activities 3. The Institution must perform the Activities as set out in Item 4 of the Schedule. Principal Investigator 4. The Institution has authorised the person specified as the PI in Item 5 of the Schedule as the person responsible for the day to day conduct of the Activities. Payment 5. In consideration of the Institution performing the Activities, the Company must pay the Institution the amounts, and in the manner set out in Item 3 of the Schedule. 6. The amounts set out in Item 3 of the Schedule do not include GST. At the time of payment, the Company must pay to the Institution any amount of GST that the Institution is reuired to pay in addition to the prices set out in Item 3 of the Schedule. 7. Any obligation on the Company to pay the Institution under this agreement: 7.1 arises whether or not the Company and the Institution subseuently enter into a Clinical Trial Research Agreement; and 7.2 survives termination of this agreement. Company s Products 8. Neither this agreement nor any consideration paid under this agreement is contingent upon the Institution s use or purchase of any of the Company s products. 114

123 LEGAL & INSURANCE Clinical Trial Preparation Agreement continued Intellectual Property 9. This agreement does not affect any party s right to its respective intellectual property. Neither party acuires any rights concerning the intellectual property of the other party. In this clause, intellectual property means all and any patients, patent applications, trademarks, service marks, trade names, registered designs, unregistered design rights, copyrights, knowhow, trade secrets, domain names, internet addresses, rights in confidential information, and any other intellectual property, whether registered or unregistered and including all applications and rights to apply for any of the same. Confidential Information 10. A party must not use or disclose any confidential information of the other party, other than where and only to the extent such use or disclosure is necessary for the performance of the Activities except in the following circumstances: 10.1 where the use or disclosure is necessary for the performance of the Activities; 10.2 where the use or disclosure relates to an application to the Institution s HREC for approval of the Study; 10.3 where the confidential information has entered the public domain other than as a result of a breach of this agreement; 10.4 where release of the confidential information is reuired by law, with notice as soon as reasonably practical to the other party; 10.5 for the purposes of legal advice; or 10.6 for the purposes of disclosure to a party s insurer. 11. In this agreement, confidential information means information in relation to a party s: 11.1 business, operations or strategies; 11.2 information designated as confidential by a party; 11.3 information acuired by the other party solely by virtue of the provisions of this agreement; 11.4 intellectual property or other property; or 11.5 actual or prospective customers, clients or competitors. Governing Law and Jurisdiction 12. This agreement is governed by and will be construed in accordance with the laws of the State of Victoria, Commonwealth of Australia. The parties submit to the non-exclusive jurisdiction of the courts of Victoria and courts entitled to hear appeals from those courts. Miscellaneous 13. Variation of any of the terms of this agreement must be in writing and signed by both parties. 14. For the purposes of this agreement, GST, taxable supply and tax invoice have the meanings attributed to those terms in A New Tax System (Goods and Services Tax) Act 1999 (Cwlth). If GST is imposed on any supply made under or in accordance with this agreement, the recipient of the taxable supply must pay to the supplier an amount eual to the GST payable on or for the supply subject to the recipient receiving a valid tax invoice in respect of the supply at or before the time of payment. 15. This agreement contains the entire understanding between the parties concerning the subject matter of the agreement and supersedes all prior communications between the parties. 16. Any provision of this agreement which is invalid must: 16.1 be read down to the minimum extent necessary to achieve its validity, if applicable; and 115

124 LEGAL & INSURANCE Clinical Trial Preparation Agreement continued 16.2 be severed from this agreement in any other case, without invalidating or affecting the remaining provisions of this agreement or the validity of that provision. 17. The relationship between the parties is that of principal and independent contractor. No party is an agent, representative or partner of any other party by virtue of this document. 18. This document is properly executed if each party executes either this document or an identical document. 19. In the event of any inconsistency, this agreement must be interpreted in accordance with the following in order of priority: 19.1 the special conditions set out in item 6 of the Schedule (if any); and then 19.2 the terms and conditions set out in the body of this agreement. Execution Executed as an agreement Signed for and on behalf of [insert name of Institution] by an authorised officer Signature of authorised officer Signed for and on behalf of [insert name of Company] by an authorised officer Signature of authorised officer Acknowledged by the Principal Investigator Signature of Principal Investigator Schedule Item 1 Item 2 Company Study Item 3 Payment Manner of payment: Amounts: Time of payment: Item 4 Item 5 Item 6 Work Activities Principal Investigator Special conditions 116

125 LEGAL & INSURANCE Deed of Variation Clinical Trial Research Agreement Parties [Name of institution] ABN [ ] of [insert address] (Institution) [Name of Local Sponsor (or CRG)] ABN [ ] of [insert address] (Local Sponsor (or CRG)) Background a. The parties have entered into a Clinical Trial Research Agreement dated [insert date] (CTRA). b. The parties wish to amend the CTRA in the manner set out in this deed. Operative provisions 1. Amendments to CTRA Amendments 1.1 The parties agree that with effect from the date of this deed the CTRA is amended as follows: [Insert reuired amendment] [Insert reuired amendment] 2. Confirmation of the CTRA CTRA reconfirmed 2.1 Subject to the terms of this deed, the parties reconfirm the terms and conditions of the CTRA. Execution and date Executed as a deed. Date: Signed on behalf of the Local Sponsor [or CRG] Signed on behalf of the Institution Signed: Signed: Name: Name: Position: Position: Date: Date: 117

126 LEGAL & INSURANCE Checklist for Participant Information & Informed Consent The purpose for seeking informed consent Before research is undertaken, whether involving individuals or collectives, the consent of the participants must be obtained, except in specific circumstances defined elsewhere in this statement. The ethical and legal reuirements of consent have two aspects: the provision of information and the capacity to make a voluntary choice. So as to conform with ethical and legal reuirements, obtaining consent should involve: a. provision to participants, at their level of comprehension, of information about the purpose, methods, demands, risks, inconveniences, discomforts, and possible outcomes of the research (including the likelihood and form of publication of research results); and b. the exercise of a voluntary choice to participate. Where a participant lacks competence to consent, a person with lawful authority to decide for that participant must be provided with the reuired information to exercise that choice. for research involving more than minimal risk: an explanation as to whether any compensation or medical treatments are available if injury occurs; information on who the participant may contact if they have uestions about the research study or about their rights as a participant; a statement that participation is voluntary and that refusal to participate or discontinuing to participate will not effect the benefits to which the participant is otherwise entitled; a statement that a participant may be discontinued from the study without their consent; the procedure for withdrawing from the study and any outcomes that may result from withdrawing; a statement to say that participants will be notified of any significant new findings which develop during the course of the research; written consent from the participant/or responsible person. The essential components of seeking informed consent are: a statement that the study involves research: saying what the purpose is, what would be expected of the participant (time commitment etc), the procedures involved in participating and if the study is experimenting a new drug/device; the appropriate number of participants; potential risks of participating; potential risks of participating to a person of childbearing age; possible benefit to the participant or others that may be reasonably expected from the research; alternative procedures (if any) that may be beneficial to the participant; any additional costs involved in participating in the study; how records identifying the participant and data collected from the participant will be stored; References: MDAV Checklist for Informed Consent 2006, MDAV Outlook NHMRC Human Research Ethics Handbook: Commentary on the National Statement on Ethical Conduct in Research Involving Humans 118

127 LEGAL & INSURANCE Standard Wording for Research Involving Collection of Drug Use Information For research projects that involve collection of information relating to the use of illicit drugs, and therefore may involve the identification of illegal substance use by participants, the use of the following wording in public research documents (such as participant information and consent forms) is recommended: Preferred Language The research project involves the collection of information about your use of drugs, including illegal drugs. Participation in the research project includes [blood and/ or urine analysis] to determine the presence of [name of substances]. The test may reveal evidence that you have previously used illegal drugs. That information will be stored in a de-identifiable (or coded) format. [Name of site] will generally not disclose that information without your consent but there may be circumstances where it is reuired by law to do so. In that case, the information may be used against you by the party to whom it is disclosed. 119

128 LEGAL & INSURANCE Register of Research Ethics and Compliance Ethics Legal compliance Other Research Conduct Catholic Health Australia, Code of Ethical Standards for Catholic Health and Aged Care Services in Australia, 2001 Australian Code for the Responsible Conduct of Research (NHMRC) 2007 Human Research National Statement on Ethical Conduct in Human Research (NHMRC) 2007 Human Research Ethics Handbook (NHMRC) 2001 Epidemiology Studies (Confidentiality) Act 1981 (Cwlth) Epidemiology Studies (Confidentiality) Regulations (Cwlth) Codes or Practice Code of Practice for the Exposure of Humans to Ionising Radiation for Research Purposes 2005 Ethical Guidelines on the use of assisted reproductive technology in clinical practice and research (NHMRC) 2004 Values and Ethics: Guidelines for ethical conduct in Aboriginal and Torres Strait Islander Health Research (NHMRC) 2003 Guardianship and Administration Act 1986 (Vic) Human Tissue Act 1982 (Vic) Human Tissue Regulations (Vic) Privacy legislation Privacy Act 1988 (Cwlth) Other Victorian Managed Insurance Authority, Guidelines for Clinical Trials for Department of Human Services Victorian Public Hospitals (VMIA) 2009 or as updated from time to time Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies (NHMRC) 1999 NHMRC, Guidelines for Genetic Registers and Associated Genetic Material, January 2000 Ethical aspects of genetic testing: an information paper (NHMRC) 2000 Guidelines approved under section 95 of the Privacy Act 1988 (NHMRC) 2000 Guidelines approved under section 95A of the Privacy Act 1988 (NHMRC) 2001 Information Privacy Act 2000 (Vic) Health Records Act 2001 (Vic) Health Services Commissioner, Health Records Act 2001 (Vic) Statutory Guidelines on Research, February 2002 Therapeutic Goods Act 1989 (Cwlth) TGA, Human Research Ethics Committees and the Therapeutic Goods Legislation, May 2001 ICH/CPMP Note for Guidance on Good Clinical Practice Therapeutic Goods Administration (TGA) Access to Unapproved Therapeutic Goods Clinical Trials in Australia, May 2001 Therapeutic Goods Administration (TGA) Special Access Scheme Therapeutic Goods Administration (TGA) Authorised Prescriber Human Embryo research National Statement on Ethical Conduct in Research Involving Humans (NHMRC) 2007 Ethical Guidelines on the use of assisted reproductive technology in clinical practice and research NHMRC) 2004 Research Involving Embryos Act 2000 (Cwlth) Prohibition of Human Cloning Act 2002 (Cwlth) Infertility Treatment Act 1995 (Vic) 120

129 LEGAL & INSURANCE Register of Research Ethics and Compliance continued Ethics Legal compliance Other Animal research Prevention of Cruelty to Animals Act 1986 (Vic) Codes Australian Code of Practice for the care and use of animals for scientific purposes (NHMRC; 7th edition) 2004 Code of Practice for the Housing and Care of Laboratory Mice, Rats, Guinea Pigs and Rabbits (Victorian Government Department of Primary industries) 2004 Guidelines for the generation, breeding, care and use of genetically modified and cloned animals for scientific purposes (NHMRC) 2006 NHMRC policy on the care and use of non-human primates for scientific purposes (NHMRC) 2003 Many other codes see BAW website Gene Technology National Framework for Ethical Principals in Gene Technology (OGTR) Statement on ethical principals in biotechnology in Victoria (DHS, Victoria) 2006 Gene Technology Act 2001 (Cwlth) and Regulations (Cwlth) Gene Technology Act 2001 (Vic) and Regulations (Vic) Many guidelines and policy see OGTR website Quarantine Quarantine Act 1908 (Cwlth) Environment Environment Protection and Biodiversity Conservation Act 1999 (Cwlth) Narcotics Narcotic Drugs Act 1967 (Cwlth) Funded research NHMRC Act 1992 (Cwlth) ARC Act 2001 (Cwlth) 121

130 LEGAL & INSURANCE APPENDIX 1: Flowchart Contract Reuired Research Directorate and Legal/Contracts create a draft from templates where possible Research Directorate and/legal/contracts liaise with internal stakeholders to settle hospital s preferred draft Research Directorate and/legal/contracts liaise with other party to settle contract Execution of contract x 2+ copies by other party and then hospital as per process Management of contract by Research Directorate and/or PI Variation and/or renewal of contract Management of contract by Research Directorate and/or PI Terminate and archive contract 122

131 Research Finance Management Introduction 123 Recommended Clauses for Clinical Trial/Research Agreement 125 Research Grant Financial Management 126 Summary of Financial Position 129 Hospital Foundation Review of Research Funding Applications Checklist 130 RESEARCH FINANCE MANAGEMENT

132 Preamble Good finance management practices are an integral component of an institute s Corporate Governance. Having in place the appropriate tools to administer financial transactions intended for research purposes should facilitate better financial administration, better provision of accountability and assist with the institute s annual reporting reuirements. In principle, costs of research studies, especially those that are externally sponsored, should be covered so that the public health system does not subsidise clinical research. Careful costing of a trial should be undertaken to ensure that the budget covers the costs of the various resource expectations reuired to be put in place by the institute in order to satisfactorily perform the clinical research, and that the research effort can be sustained to the point of satisfactory conclusion.

133 RESEARCH FINANCE MANAGEMENT Introduction Materials provided as part of the VMIA Research Governance Toolkit to provide assistance in this area include the following: 1. Research Finance Checklist 2. Budget spreadsheet 3. Recommended clauses for Clinical Trial/Research Agreement (invoicing and payment scheduling) 4. Hospital Foundation Funds Application Checklist 1. The Research Finance Checklist provides a stepby-step process by which research teams and/or research finance management staff may identify whether relevant reuirements relating to appropriate management of research funds are satisfied throughout the life of a research grant. The areas of assessment include: pre-grant processes; understanding grant conditions; establishment of a financial reporting process; budget planning and on-going budget review; annual review of financial statements; and annual acuittals. 2. Budget spreadsheet Every clinical trial protocol should contain a schedule of procedures that summarises the procedure and tests that will be conducted in the research program. It is recommended that an assessment of this list of procedures and tests in the schedule is undertaken, and the information is translated to the budget spreadsheet (item 2) to reflect the protocol s tables of procedures and tests. This has been provided to assist the efficient preparation of project budgets and to record budget detail in a standard format. Clinical Trial income to be considered includes, but is not limited to: payments made by the funding body on a per participant basis; expenses paid directly by the funding body eg. HREC submission fees; pathology and pharmacy costs; reimbursement of costs which will be made by the funding body; and upfront payments in addition to the above. Research groups and research administrators alike should be aware of the various types of costs associated with human research activity in public healthcare institutions. Clinical Trial expenditure to be considered includes, but is not limited to: medical record retrieval costs, archiving/storage costs; copies of scans: scanned copies may be reuired, and this cost should either be included in the per patient budget or noted as an additional cost in the clinical trial agreement; standard costs: Fees for standard radiology and pathology tests can be found in the Medicare Benefits Schedule Book (MBS) and the Australian Medical Association Book (AMA) which are both updated regularly; HREC submission fees; meal allowances; hospital department or administration fees: Some institutes reuire that hospital departmental costs must be listed in an application to and approved by that institute s HREC. Project Coordinators at these sites should retain copies of the departmental approval memos which should be reviewed prior to internal budget finalisation; fixed/variable costs charged by pharmacy or pathology: For example, if any of the drugs associated with the study are not covered by the PBS for the treatment indication, consultation with the hospital pharmacy should be undertaken to ensure that any additional drug costs are included in the research budget. Appropriate per patient dispensing charges should also be accounted for in the budget; patient transport reimbursement: An estimate of the cost of cab vouchers or reimbursement of parking fees that may be reuired should be undertaken; staff time: The cost of time spent on the research project by the Project Coordinator, Investigators, Research Nurses etc can be significant and as a result should be carefully estimated. 123

134 RESEARCH FINANCE MANAGEMENT Introduction continued 3. In the case of externally sponsored trials, approval from all relevant institutional parties is reuired before the budget can be sent to the sponsor for budget finalisation. Budget specifics can then be incorporated into the payment schedule of the study s clinical trial agreement. Recommended standard wording for such payment clauses is described in Recommended clauses for Clinical Trial/Research Agreement. 4. Hospital or research institute foundations receive many reuests from researchers for funding of their research projects. The foundation checklist developed and supplied here has been designed for use by such foundations to allow easy identification of research programs that have been designed and reviewed appropriately. 124

135 RESEARCH FINANCE MANAGEMENT Recommended Clauses for Clinical Trial/Research Agreement All [NAME OF INSTITUTION/ORGANISATION] Clinical Trial or Clinical Research Agreements must contain clause(s) regarding all invoicing and payment arrangements under the agreement (preferably in the payments section of the agreement). The following is a summary of the clause(s) reuired. Please select the applicable clause(s) to be inserted into the Clinical Trial/Research Agreement. Invoicing All reuests to raise an invoice from [insert Funding Body name] to [NAME OF INSTITUTION/ORGANISATION] under this agreement are to be sent to the attention of the Management Accountant Research at the following address: [Address] If the invoices are to be generated as Recipient Created Tax Invoices (RCTI) by [insert Funding Body name] under this agreement the RCTIs are to be sent to the attention of the Management Accountant Research at the address specified above. Payment by Cheue All payments by cheue under this agreement will be made as follows: Payee Name: Payee Address: Attention Management Accountant Research All cheues paid under this agreement will be accompanied with documentation of the calculation of each payment. The documentation from [insert Funding Body name] will specify: the Human Research Ethics Committee (HREC) project number; the Principal Investigator s name; what the payment is being made for; the number of participants who have completed particular milestones; and detail of any partial payments, or any other information relevant to the calculation of the payment by the [insert Funding Body name]. Payment by EFT/Direct Credit All payments by EFT/direct credit under this agreement will be made as follows: Notification of all payments by EFT/direct credit made under this agreement will be communicated to the Management Accountant Research at the following address: [xxxxxxxx] The notification of all payments made under this agreement will be accompanied with documentation of the calculation of each payment. The documentation from [insert Funding Body name] will specify: the Human Research Ethics Committee (HREC) project number; the PI s name; what the payment is being made for; the number of participants who have completed particular milestones; and detail of any partial payments, or any other information relevant to the calculation of the payment by the [insert Funding Body name]. 125

136 RESEARCH FINANCE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Grant Financial Management Research Grant details Manager to complete all sections Grant Holder name: Grant period: Start date: Research Project Title: Funding source: Grant value: Year 1 Year 2 Year 3 Total Grant Source contact: Details: Section 1 Pre grant processes (as they relate to Financial matters) The researcher should consider certain issues prior to applying for a grant so that they understand the extent of the project, have the support of service providers and most importantly know how much grant funding is reuired to successfully complete the project. Refer to example budget spreadhsheet in the VMIA Research Governance Toolkit as a guide to the type of costs you may need to consider. No. Description Reuired Completed 1.1 Have you fully planned the research process that you will undertake during the reseach? 1.2 If yes to 1.1 you can confirm your resource reuirements and cost staff, consumables, internal/external services, euipment availability and foreign exchange impact on overseas items. 1.3 Have you considered upfront fees/start up costs? 1.4 Have you considered post-research costs such as storage of samples etc., publication costs? 1.5 Has the draft budget been discussed with the relevant service providers and costs confirmed? 1.6 Have you considered a cash flow time line to ensure the funds will be available when you need them? 1.7 Have you sought assistance/clarification from your finance office at this preliminary phase? 1.8 Have you completed statistical power calculations where appropriate? 1.9 Has the budget and application been approved by the appropriate authority prior to making application? Section 2 Understanding Grant Conditions (as they relate to Financial matters) The granting body often places limitations on how the funds can be spent. The grant holder and finance officer need to have a clear understanding of the grant conditions relating to finances so that expenditure and acuittance obligations can be met. No. Description Reuired Completed 2.1 Have you reviewed the total value of the grant awarded together with the composition eg. salary, consumables, institutional overheads? The funds awarded may be less than what was reuested. 126

137 RESEARCH FINANCE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Grant Financial Management continued 2.2 Based on the composition of the grant (refer 2.1) have you determined salary levels of staff working on the project and the overall ability to do the research within the budgetary constraints. 2.3 Does the grant awarded enable you to complete the project or do you need additional funding support? 2.4 Has the the grantor been advised on how and where (bank details) to make payments? 2.5 Have you discussed the granting bodies standard acuittance form with the finance office to ensure that the internal cost reporting can provide the information reuired by the grantor. Section 3 Establish a financial reporting process. The researcher should be able to understand the reports so that the income and expenditure can be monitored and avoid overexpenditure. Financial reports are a helpful tool. No. Description Reuired Completed 3.1 Do you understand the implications of accrual accounting? While not expecting you to be an accountant, you need to be aware that the income you receive will be for a specific period so try to euate/manage your costs over the same income period. 3.2 Have you arranged for a cost centre to be established that will enable your income and costs to be recorded in a report specifically for your project? 3.3 Are expenditure approval processes in place and do they follow the internal guidelines of your organisation? Have you established good expenditure management with your staff who may have approval to order consumables etc? Section 4 Budget planning and on-going budget review. Organisations monitor their income and expenditure on a regular basis, at a macro and micro level. The research projects should be part of this process. No. Description Reuired Completed 4.1 Is the grant income being received and in a timely manner (refer 2.4)? 4.2 Is the expenditure proceeding according to budget? 4.3 Have any institutional overheads, that may be applicable, been transferred out of your cost centre so that you can focus on monitoring the on-going discretionary expenditure eg. services and consumables? 4.4 Are the financial reports for your cost centre being provided in a timely manner to enable you to properly manage your project? 4.5 Have you sought advice from the appropriate management in relation to any financial aspects of the project, post this review? 4.6 If there is a substantial change to circumstances, have you pursued the possibility of renegotiating the grant with the grantor? 127

138 RESEARCH FINANCE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Research Grant Financial Management continued Section 5 Annual Review of financial statements A year end review should focus on analysing positives and negatives of the financial year and more importantly use this experience to review the next year s work. No. Description Reuired Completed 5.1 Has the year end accounts been reviewed and any surplus or shortfall discussed with the finance office, in terms of how these funds will be treated? 5.2 Has planning for next year been impacted by what has happened this year and do you need to make adjustments? 5.3 Do the accounting records substantiate the acuittal (refer 2.5)? Section 6 Annual Acuittals The grantor generally reuires that acuittal and accounting records should be able to support the acuittal and held for future inuiries. No. Description Reuired Completed 6.1 Do the financial cost reports substantiate the acuittance? 6.2 Has the acuittance been approved by the appropriate officer (generally specified in the grant conditions)? 6.3 Has the acuittance been prepared and ready for submission by the due date? 6.4 Have the relevant papers been secured in case of future verification? Comments: Name / Signature of Manager: Date: / / 128

139 RESEARCH FINANCE MANAGEMENT Summary of Financial Position Receipts Notes 08/09 09/10 10/11 11/12 12/13 13/14 14/15 15/16 Total 1 CPI 5.00% GST Total Per Patient Receipts $0 $0 Ethics Fees $0 $0 $0 $0 $0 $0 $0 Meal Allowance $0 $0 $0 $0 $0 $0 $0 Pathology - Fixed $0 $0 $0 $0 $0 $0 $0 Pathology - Variable $0 $0 $0 $0 $0 $0 $0 Pharmacy - Fixed $0 $0 $0 $0 $0 $0 $0 Pharmacy - Variable $0 $0 $0 $0 $0 $0 $0 Salaries & Wages $0 $0 $0 $0 $0 $0 $0 Travel Allowance $0 $0 $0 $0 $0 $0 $0 Upfront Payment (in addition to per patient payment) $0 $0 $0 $0 $0 $0 $0 Total Receipts $0 $0 $0 $0 $0 $0 $0 Outlays Participants Total Per Patient Costs Bone & Mineral Density 0 $0 $0 $0 Cardiology 0 $0 $0 $0 Medical Record Retrieval 0 $0 $0 $0 Meal Allowances 0 $0 $0 $0 Medical Illustrations 0 $0 $0 $0 Nuclear Medicine 0 $0 $0 $0 Ophthalmology 0 $0 $0 $0 Pathology 0 $0 $0 $0 Pathology - Fixed 0 $0 $0 $0 Pharmacy 0 $0 $0 $0 Pharmacy - Fixed 0 $0 $0 $0 Radiology 0 $0 $0 $0 Respiratory 0 $0 $0 $0 Salaries & Wages 0 $0 $0 $0 Travel Allowances 0 $0 $0 $0 Archiving Costs $0 $0 $0 $0 $0 $0 Ethics Fees $0 $0 $0 $0 $0 $0 Health Information Services $0 $0 $0 $0 $0 $0 Meals Allowance $0 $0 $0 $0 $0 $0 Administration Fee $0 $0 $0 $0 $0 $0 Other Costs $0 $0 $0 $0 $0 $0 Postage $0 $0 $0 $0 $0 $0 Printing & Stationery $0 $0 $0 $0 $0 $0 Salaries & Wages $0 $0 $0 $0 $0 $0 Storage $0 $0 $0 $0 $0 $0 Telephone Expense $0 $0 $0 $0 $0 $0 Travel Expense $0 $0 $0 $0 $0 $0 Total Outlays Yearly Net Position Cumulative Yearly Net Position HREC:... CHECK: SHOULD EQUATE TO THE MARGIN ON THE per patient comparison WORKSHEET (for the same number of participants) Project Name:... Participants:... NOTES 1 CPI CPI increase of 5% pa. Principal investigator name:... Reviewed by:... Final:... Signature:... Signature:... Date:... Date:

140 RESEARCH FINANCE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Hospital Foundation Review of Research Funding Applications Checklist Research Grant details Manager to complete all sections Chief Investigator: Project ID: Grant period: Start Date: Research Project Title: Simplified Project Title: Funding source: Category: Reuested funding: Year 1 Year 2 Year 3 Total Grant Source contact: Details: Section 1 Grant Conditions and Eligibility Criteria No. Description Reuired Completed 1.1 Has the Chief Investigator eligibility criteria been met? 1.2 Has the Co-Investigator and associate investigator eligibility criteria been met? 1.3 Does the Foundation/Research office meet the criteria for administration of grants? 1.4 For internal projects and scholarships/fellowships funded by the Foundation, consider: applicant s track record, scientific merit, significance, novelty, whether project is co-funded and feasibility. Section 2 Budget Planning and Financial Management No. Description Reuired Completed 2.1 Refer to Research grant financial management checklist (Document: [XXXXXX]) Section 3 Time lines No. Description Reuired Completed 3.1 Internal submission dates verified 3.2 Sponsor submission dates verified Section 4 Administration No. Description Reuired Completed 4.1 Who is the administering institution? 4.2 Where is the location where research will be undertaken? 4.3 Agreement for multiple research centres 130

141 RESEARCH FINANCE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Hospital Foundation Review of Research Funding Applications Checklist continued 4.4 Ethics clearance: Research involving humans, research involving animals, biosafety committee clearance 4.5 Is internal ranking reuired? 4.6 Can the application be submitted to multiple agencies/sponsors? Section 5 Review of application No. Description Reuired Completed 5.1 All sections completed in reuired format (eg. font size, margins, spacing, file type) 5.2 Order of documents 5.3 Appropriate language ( eg. lay summary vs research protocol) 5.4 Reports (eg. Progress reports) 5.5 Publications 5.6 Certifications and signatures 5.7 Reuired copies for submission and additional research office copy 5.8 Project design (eg. methodology, statistics (power calculation)). Section 6 Intellectual Property and Confidentiality Agreements No. Description Reuired Completed 6.1 Protection of intellectual property (staff and student rights) 6.2 Confidentiality agreement. Section 7 Safety and Risk Management No. Description Reuired Completed 7.1 Is the project in line with organisation s research strategy and overall research policy? Consider sensitive research areas (eg. stem cell research, funding from tobacco companies). 7.2 Biological materials and uarantine 7.3 Conflict of interest. 131

142 RESEARCH FINANCE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Hospital Foundation Review of Research Funding Applications Checklist continued Section 8 Grant Conditions and Eligibility Criteria No. Description Reuired Completed 8.1 Are the appropriate facilities available to conduct research (eg. Clinical trial area)? 8.2 Endorsement by internal service providers where necessary (eg. pathology, health information services) Comments: Name / Signature of Manager: Date: / / 132

143 Data and Tissue Management Introduction 133 Use of Human Tissue in Research Policy 134 Establishment of Data/Biobank Checklist 138 Databank Access Reuest for Research Purposes 140 Use of Cadaveric Tissue for Research 142 APPENDIX 1: Acknowledgement and Authorship 147 DATA & TISSUE MANAGEMENT

144 Preamble Recent advances in research methods reuire that large repositories of normal and diseased human tissue be constructed and maintained. Research involving human tissue must observe the fundamental ethical principle of respect for the tissue donor, including the provision of full information, consent, professional removal of samples and secure storage of the tissue to maintain confidentiality and privacy. This is complicated by: the fact that the most valuable research often is made possible by the linking of the tissue to the donor; the cultural or religious sensitivities of the donor need to be considered when soliciting or accepting human tissue samples.

145 DATA & TISSUE MANAGEMENT Introduction Activities involving biobanks must be in accordance with the NHMRC National Statement on Ethical Conduct in Research Involving Humans The use of human tissue in research must be carried out in accordance with the HREC reuirements of your institute. Materials provided as part of the VMIA Research Governance Toolkit to provide assistance in this area include the following: 1. guidelines/policy template for data/tissue management and storage; 2. application template for establishment of data/biobank; It is recommended that the application procedures referred to within the policy document (item 1) relating to the assessment of research activities involving human tissue should either utilise or be informed by the templates provided within this section (items 2-5). In some places, this section refers to the control of tissue exchange between institutions through the use of Material Transfer Agreements (MTA). An example MTA that may serve as a template for such activity can be found in the section Intellectual Property and Publication of the VMIA Research Governance Toolkit. 3. application template to access established data/biobank; 4. application template to access cadaveric tissue for research; 5. guidelines for the Provision of Data from the Registry (Appendix 1). 133

146 DATA & TISSUE MANAGEMENT Use of Human Tissue in Research Policy 1. Purpose This document describes the [NAME OF INSTITUTION/ORGANISATION] reuirements for ethical approval of research studies involving the use of human tissue, including the reuirement for donor consent for the use of that tissue. 2. Scope HREC approval of the use of human tissue may relate to: tissue discarded after surgery; tissue removed at autopsy; tissue collected for one-off research projects; tissue stored in tissue banks ; or tissue donated or received. This policy is based on the principles described more fully in the following documents: Human Tissue Act National Statement on Ethical Conduct in Human Research The National Statement consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act National Code of Ethical Autopsy Practice 3 On 1 August 2001 Australian Health Ministers directed the Australian Health Ministers Advisory Council (AHMAC) to establish a subcommittee to continue the work recently completed by the Australian Health Ethics Committee (AHEC) on organs retained at autopsy. The Code will be a public document and will inform families and the community. Advice for informing and involving families has been developed. Victorian Government Policies and Practices in Relation to Post-Mortem Examinations Includes model Victorian Guidelines on reuesting consent for non-coronial post-mortem (PM) examination; a model reuest form for noncoronial PM examination; and information for next-of-kin regarding non-coronial PMs. 3. Glossary Tissue includes tumour biopsies (fresh or paraffinembedded blocks), samples of normal tissues, blood and serum samples, urine and other body fluids, and tissue derivatives including DNA, RNA and proteins obtained from human beings. Research includes activities other than diagnostic, biochemical, or pathological examinations performed as a component of patient care, audit type activities and calibration of euipment. It includes the evaluation of new diagnostic, prognostic or biological techniues in a series of patients. Unconsented tissue is tissue for which consent to its use in research was not obtained at the time of collection. 4. Policy Use of human tissue in research must be in accordance with the NS. Specifically, research involving human tissue must observe the fundamental ethical principle of respect for the tissue donor, including the provision of full information, consent, professional removal of samples and secure storage of the tissue to maintain confidentiality and privacy. The cultural or religious sensitivities of the donor should be considered when soliciting or accepting human tissue samples. The use of human tissue in research at [NAME OF INSTITUTION/ORGANISATION] must be carried out in accordance with the [NAME OF INSTITUTION/ ORGANISATION] HREC reuirements outlined in this document. Donor consent for the use of tissue is generally reuired, but the reuirement may be waived by the [NAME OF INSTITUTION/ORGANISATION] HREC in appropriate circumstances. Acuisition of tissue from an external source for research at the [NAME OF INSTITUTION/ ORGANISATION] and/or supply of tissue to an external source reuires review by the HREC through a formal application. Transfer of tissue between [NAME OF INSTITUTION/ ORGANISATION] tissue bank(s) and an external tissue repository is subject to a Materials Transfer Agreement (MTA) that complies with [NAME OF INSTITUTION/ ORGANISATION] specifications National Code of Ethical Autopsy Practice 134

147 DATA & TISSUE MANAGEMENT Use of Human Tissue in Research Policy continued 5. Procedure 5.1 Application to use human tissue in research (general) It is a reuirement of the National Health & Medical Research Council (NHMRC) 4 that all medical or scientific research done on humans or animals must be approved by a properly constituted HREC. Applicants seeking HREC approval to use human tissue in research must complete and forward to the HREC the application forms relevant to their particular research. Contact the [NAME OF INSTITUTION/ORGANISATION] RGU or euivalent for information relating to these reuirements. The specific reuirements for HREC approval for the use of discarded human tissue, whole human organs and tissue obtained at autopsy, museum specimens, tissue banks or genetic testing are described in separate sections below Consent Documentation of consent by the donor for the use of tissue in research is also reuired, unless one of the exceptions below applies. a. Applications for approval of research projects in which unconsented tissue held at the [NAME OF INSTITUTION/ ORGANISATION] will be used must include a reuest for waiver of the consent reuirement addressing the factors identified in sections to of the NS. The Committee will then assess the merits of each reuest. as much information as possible regarding the source of the tissue, the consent policies of the facility where the tissue is stored/ archived, the nature of the consent obtained at collection, and if applicable, evidence of approval of the consent process provided by another HREC or, a statement as to why this information cannot be provided. c. The HREC may also reuest further information from researchers proposing to use unconsented tissue in order to comply with [NAME OF INSTITUTION/ ORGANISATION] or national standards. The Committee will then assess the merits of each application on a caseby-case basis Transfer of tissue Where tissue is to be obtained from an external source by a [NAME OF INSTITUTION/ORGANISATION] researcher for use in research at the [NAME OF INSTITUTION/ORGANISATION], whether or not as part of collaborative research, approval by the Ethics Committee is reuired. Evidence of application for approval of the proposed research project by the HREC at any other site(s) must be submitted to the [NAME OF INSTITUTION/ ORGANISATION] HREC before the research can proceed. b. Applications for approval of research projects in which unconsented tissue will be used where the tissue is held external to the [NAME OF INSTITUTION/ORGANISATION] must include a reuest for waiver of the consent reuirement addressing the factors identified in sections to of the National Statement. Such applications must also include: 4 The National Statement On Ethical Conduct in Human Research Section lists the minimum membership for a Human Research and Ethics Committee (HREC). 135

148 DATA & TISSUE MANAGEMENT Use of Human Tissue in Research Policy continued Where tissue is to be used in a [NAME OF INSTITUTION/ORGANISATION] research project and which has been obtained from an external tissue bank and is to be transferred to the control of [NAME OF INSTITUTION/ORGANISATION] tissue bank(s), the transfer of tissue shall be subject to a MTA. The MTA must be completed in accordance with the policies and procedures of the [NAME OF INSTITUTION/ORGANISATION] tissue bank(s) and must document the formal transfer of authority from the external institution to the [NAME OF INSTITUTION/ ORGANISATION] tissue bank(s) with respect to management of the tissue. Where tissue is to be provided by [NAME OF INSTITUTION/ORGANISATION] tissue bank(s) for use in research at another site(s), whether or not as part of collaborative research, approval by the [NAME OF INSTITUTION/ORGANISATION] HREC is reuired. Evidence of application for approval of the proposed research project by the HREC at the other site(s) must be included in the application to the HREC for approval of the arrangement. Any transfer of tissue from [NAME OF INSTITUTION/ORGANISATION] tissue bank(s) to the control of another site(s) shall be subject to a MTA completed in accordance with the policies and procedures of the [NAME OF INSTITUTION/ORGANISATION] tissue bank(s) and which documents the formal transfer of authority from the [NAME OF INSTITUTION/ORGANISATION] to the external institution with respect to management of the tissue. 5.2 Application to use discarded tissue in research Applicants applying for clearance to use discarded tissue must follow the direction given by the [NAME OF INSTITUTION/ORGANISATION] RGU. The review and approval of applications to utilise discarded tissue from surgical operations, when permission has been provided by the patient, may be delegated to an appointed senior medical officer. The appointed senior medical officer will assess the application to ensure compliance with HREC guidelines and if HREC criteria are met, approve the application. Approval is usually granted for a two-year period. Researchers are reuired to submit a progress report to the senior medical officer on the anniversary of their approval. Researchers can apply for an extension of approval if reuired. The appointed senior medical officer will report to the HREC every twelve months. 5.3 Application to use whole human organs and tissue obtained at autopsy Applicants should contact the [NAME OF INSTITUTION/ORGANISATION] RGU for information and follow the directions for submission. The review and approval of applications to utilise discarded tissue from autopsy, when permission has been provided by the next of kin, may be delegated to an appointed senior medical officer. The appointed senior medical officer will assess the application to ensure compliance with HREC guidelines and if HREC criteria are met, approve the application. The appointed senior medical officer will report to the HREC every twelve months. 136

149 DATA & TISSUE MANAGEMENT Use of Human Tissue in Research Policy continued 5.4 Applications to use tissue stored in tissue banks Applicants should follow the procedures outlined in the section Application to use human tissue in research (general) above. Specific issues to consider when applying for HREC approval include: the original reason for which the tissue is collected, that is, whether it is donated for the purpose of research or removed as part of a medical procedure performed for a therapeutic purpose; whether the proposed use of the samples is different from the original purpose of collection of the stored human tissue samples; 5.5 Applications to conduct genetic research Applicants should read Chapter 3.5: Human genetics of the NS. Applicants should follow the procedures outlined in the section Application to use human tissue in research (general) above. 5.6 Museum Specimens It is becoming increasingly rare to preserve and store human tissue or organs for teaching, training or as part of a museum or reference collection. Researchers who wish to use human tissue in this way must apply to the HREC directly. Applications will be considered on a case-by-case basis. whether consent was obtained at the time of collection and whether the current proposed use differs from the consented use; the research use to which the tissue will be put, that is, whether this will be epidemiological, non-identifying or identifying use, given that the results of such research may have conseuences for the donor or the donor s family; whether information of clinical importance to the health of the donor may be discovered; whether there may be potential commercial applications for research outcomes and whether the donor, or an authorised third party, understands and approves the research and its objectives. Issues of religious and cultural sensitivity to the collection, storage and use of particular human tissue samples should also be considered. References Human Tissue Act National Code of Ethical Autopsy Practice htm/$file/code.pdf National Statement on Ethical Conduct in Human Research Policies and Practices for Post-Mortem Examinations 137

150 DATA & TISSUE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Establishment of Data/Biobank Checklist Section 1 Applicant details (should be the Custodian of the Biobank) Full Name: Position / Title: Qualification: Classification: Permanent Full Time Permanent Part-Time Casual Summary Job Description: Organisation Department: Address (line 1) Address (line 2) Address (line 3) Name of Biobank: Proposed Start Date: Funding Body: Funding duration: Section 2 Prior to application to HREC The following actions should be completed prior to application to HREC No. Description Reuired Completed 2.1 Determine who will be the custodians of the Data/Biobank Determine if there are institutional policies for: the establishment of data/biobanks collection, use, storage and disposal of human tissue or data 2.2 Custodians of the Databank/Biobank need to establish: type of data fields and biospecimens to be collected whether data or biospecimens will be available for a specific research project or for future unspecified research conditions of release of information/biospecimens to researchers whether patients will be identifiable and how privacy will be respected 138

151 DATA & TISSUE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Establishment of Data/Biobank Checklist continued Section 3 Ethical considerations To be considered whilst writing the submission to HREC No. Description Reuired Completed 3.1 Review NH&MRC National Statement on Ethical Conduct in Human Research, Apply to relevant HREC to establish a Databank or Biobank Paying particular attention to: patient consent collection, storage and use of data or biospecimens patient privacy (Health Records Act 2001 (Vic); Information Privacy Act 2000 (Vic); Privacy Act 1988 (Cwlth)- Privacy Amendment 2000 (Private Sector) ) conflicts of interest Section 4 Once HREC approval is obtained As custodians of a Biobank, appropriate processes to collect, use, distribute and monitor data/biospecimens must be developed No. Description Reuired Completed 4.1 Ensure processes are in place to: obtain patient consent collect relevant information and/or biospecimens store data and/or biospecimens according to relevant guidelines allow researchers access to data or biospecimens (strongly suggest that researchers accessing data/specimens from a Biobank have their own independent ethically approved project) distribute data and/or biospecimens in line with what the patient has consented to and according to what has been ethically approved monitor the use of data/biospecimens and report to relevant bodies dispose of data/biospecimens in the event that a patient withdraws consent uality control of information and biospecimens so that researchers are reassured that what they receive is accurate deal with adverse events Comments: Name / Signature of Manager: Date: / / 139

152 DATA & TISSUE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Databank Access Reuest for Research Purposes Section 1 Applicant details Name: Department: Contact telephone number: address: Postal address: Project title: Application date: Application number: office use only Are you a student? Yes No If yes, what degree are you working towards? Name and contact details of your supervisor: Section 2 Details of proposed research Short title of data reuest: Brief description of proposed research: (1 3 paragraphs) Reason for data reuest: Section 3 Data reuirements Actual data reuested: Is this for a funded research project? If yes, who has funded the project? Was [registry] formally involved in the grant application? Yes Yes No No 140

153 DATA & TISSUE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Databank Access Reuest for Research Purposes continued Have you received Ethics Committee approval to access [registry] data? If YES, please attach copy What use do you expect to put this information to? Have you read the data access authorship and acknowledgements document (Appendix 1)? Do you agree to comply with this? Yes Yes Yes No No No Section 4 Handling of data Identification of data: Identified Re-identifiable (eg. coded) Non-identifiable (anonymous) Describe storage, security and destruction arrangements: Signature of Principal Researcher: Date: / / Signature of Head of Department: Date: / / Office Use Only Application approved: Yes No (please provide details in the Notes section below) Approved by: Signature: Date: Notifications Letter of notification forwarded to applicant: Report forwarded to Ethics Committee: Yes Yes Date: Date: Notes (attach additional pages if reuired) File completed form in XXXX 141

154 DATA & TISSUE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Use of Cadaveric Tissue for Research Section 1 Applicant details Name: Department: Contact telephone number: address: Postal address: Project title: Application date: Application number: office use only Section 2 Details of proposed research Brief description of proposed research: (up to 1,000 words in total - attach additional pages if reuired) Aims: Describe the broad aims of the project Background: Brief review of previous research Project summary: Include hypothesis, specific uestions to be asked, research design Significance: Relevance/value to current health or social issues,potential to contribute to existing knowledge and/or practices 142

155 DATA & TISSUE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Use of Cadaveric Tissue for Research continued Section 3 Tissue reuirements Type of tissue: Fresh tissue Stored tissue On-premises use/access (not retention) Fresh Tissue Nature of sample: Volume: Number of samples: Freuency: Special reuirements for retrieval, exclusions or storage: as freuently as available other (specify, eg. fortnightly, for duration of project) No Yes (please specify) Information reuired about deceased person: (eg. age, sex, cause of death) Stored Tissue Nature of sample: Volume: Number of samples: Freuency: Special reuirements for retrieval, exclusions or storage: as freuently as available other (specify, eg. fortnightly, for duration of project) No Yes (please specify) Information reuired about deceased person: (eg. age, sex, cause of death) On-Premises Use/Access (Not Retention) Nature of tissue: Information reuired about deceased person: (eg. age, sex, cause of death) 143

156 DATA & TISSUE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Use of Cadaveric Tissue for Research continued Section 4 Handling of samples and related data Describe how samples will be removed/collected: Describe storage, security and destruction arrangements: Identification of samples: Identified Re-identifiable (eg. coded) Non-identifiable (anonymous) Identification of data: Identified Re-identifiable (eg. coded) Non-identifiable (anonymous) Description of security measures for confidential recording, storage and release of data: Section 5 Consent Consent: (If applicable, please attach next-of-kin information and consent form) written consent obtained as part of routine consent for surgery (or tissue obtained in accordance with donor s expressed wishes) written consent obtained as part of routine consent for post-mortem examination (or tissue obtained with consent of the senior available next-of-kin) written consent obtained independent of surgical or post-mortem consent (give details) application for consent to be waived (give details and justification) Details: Religious/cultural considerations: Section 6 Post-project Will the tissue be destroyed on completion of the project? Yes* No If No, explain why it will be retained, how it will be stored, who will have access to it in the future: Might the research produce health information of relevance to family members of the deceased donor? If Yes, describe the type of information: Yes No *Note that researchers should try to accommodate any reasonable wishes of the next-of-kin regarding the disposal of tissue [NS 3.4.9] 144

157 DATA & TISSUE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Use of Cadaveric Tissue for Research continued Do you intend to communicate this information to the donor s family? If Yes, describe how this communication would happen: Yes No If No, explain why the information should not be communicated: Will the findings of your research be made publicly available? Yes No If Yes, explain how: If No, explain why: Do you envisage that there will be commercial applications arising from this research project? If Yes, describe: Yes No Section 7 Other considerations Have any applications been made to other sources for tissue? Yes No If Yes, state the source(s) applied to, the application process(es) and why you are unable to obtain/use the reuired tissue from the source(s): If No, state why you have not applied to any other source: 145

158 DATA & TISSUE MANAGEMENT Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Use of Cadaveric Tissue for Research continued Is there any potential conflict of interest for researchers, departments or the institution? If Yes, please describe the issue and how it will be managed: Yes No Signature of Principal Researcher: Date: / / Signature of Head of Department: Date: / / Office Use Only Application approved: Yes No (please provide details in the Notes section below) Approved by: Signature: Date: Notifications Letter of notification forwarded to applicant: Report forwarded to Ethics Committee: Yes Yes Date: Date: Notes (attach additional pages if reuired) File completed form in XXXX 146

159 DATA & TISSUE MANAGEMENT APPENDIX 1: Acknowledgement and Authorship Guidelines For Provision of Data From The [Registry] The [registry] is a valuable source of data about [insert subject title]. Access to the data, and reuests for data from the database are subject to strict access guidelines (see Guidelines for Access to Data). Any data provided to you is on the condition that the [registry] is acknowledged as the source of the data. The suggested citation is: Where the interpretation of [registry] data is central to the data reuest, it is expected that at least one member of the [registry] team is named as a co-author on any publication arising from use of data from this project. The actual contributor/s to be named would depend on the actual input to the particular data exercise. The [registry] would appreciate it if you could provide us with a copy of any document or presentation in which you uote these figures. Please sign and this form to [ ] I agree to acknowledge the [registry] for the provision of data for reports, presentations, publications and documents as appropriate. Signed: Date: / / Name: Position / Organisation: Tel number: 147

160 148

161 Intellectual Property and Publication Introduction 149 Intellectual Property Policy 150 Review of Material Transfer Agreements 157 Material Transfer Deed 159 Non-Disclosure Agreement (NDA) Creation, Review and Execution 167 Guidelines for Determining Authorship 170 Evidencing Inventorship 172 Invention Disclosure Template 175 APPENDIX 1: Standard Terms and Conditions on Intellectual Property 178 APPENDIX 2: NDA Flowchart 184 APPENDIX 3: Standard NDA Template Non-Disclosure Agreement 185 INTELLECTUAL PROPERTY & PUBLICATION

162 Preamble Effective administration, protection and utilisation of an organisation s Intellectual Property can provide important financial benefits to that organisation and thus can offset the substantial costs of an organisation s investment in its research activity and contribute enormously towards its financial viability, reputation and ongoing success. Likewise, ensuring that due recognition for discoveries and the work that was undertaken to achieve them is appropriately afforded may protect the institute from possible future disputes on matters of authorship and inventorship.

163 INTELLECTUAL PROPERTY & PUBLICATION Introduction Materials provided as part of the VMIA Research Governance Framework to provide assistance in this area include the following: 1. Management of the sharing of materials with external parties IP policy template Standard Operating Procedure for review of incoming Material Transfer Agreement Material Transfer Agreement template 2. Identification and management of Intellectual Property resulting from research activity IP policy template Invention Disclosure form template Non-disclosure agreement template Guidelines for evidencing inventorship 3. Appropriate authorship entitlements for publications, consistent and transparent dispute resolution Guidelines for determining authorship The use of Invention Disclosure forms is referred to within the Intellectual Property (IP) Policy. The VMIA recommends that users should either utilise the Invention Disclosure template presented in this chapter or develop a system informed by the templates provided within this chapter. Other important sources of information relating to the management of IP: Biotechnology Intellectual Property Management Manual: cfm?event=object.showcontent&objectid=fb6a4675- BCD6-81AC-17F3303EB6B2F33B Auditor-General report on Management of Intellectual Property in the Public Sector: Management_of_Intellectual_Property_in_the_Public_ Sector.pdf 149

164 INTELLECTUAL PROPERTY & PUBLICATION Intellectual Property Policy Summary This policy establishes the [NAME OF INSTITUTION/ ORGANISATION] s policy for the ownership, protection and commercialisation of IP created by [NAME OF INSTITUTION/ORGANISATION] employees and students in the course of their employment, engagement, studies, scholarship or research or with more than incidental use of the [NAME OF INSTITUTION/ORGANISATION] s funds or facilities. This policy is premised on the following principles and objectives and, in this context, the term employees and students encompasses all members of staff, students, research fellows, consultants, contractors and visiting scientists and any other person who carries out, or proposes to carry out, research using [NAME OF INSTITUTION/ORGANISATION s] funds or facilities. 150

165 INTELLECTUAL PROPERTY & PUBLICATION Intellectual Property Policy continued 1. Principles 1.1 {The [NAME OF INSTITUTION/ORGANISATION] can insert their principles / philosophies for IP management and commercialisation here } 1.2 {Etc} 1.3 {Etc} 1.4 Formal contracts or letters of engagement reuiring adherence to the Standard Terms and Conditions on Intellectual Property will form the basis of all research utilising the [NAME OF INSTITUTION/ORGANISATION] s resources. 1.5 Employees and students must use their best endeavours to assist in, and comply with, the reasonable directions of the staff of the Research Directorate / Commercialisation Office in relation to the management, protection and commercialisation of IP owned by the [NAME OF INSTITUTION/ORGANISATION] and will be expected, during the course of their work, to seek to identify and protect intellectual property and explore commercial opportunities to exploit their findings. 1.6 IP created and developed with the use of the [NAME OF INSTITUTION/ORGANISATION] s resources in the course of employment or engagement will be owned by the [NAME OF INSTITUTION/ORGANISATION]. 1.7 The [NAME OF INSTITUTION/ORGANISATION] will retain an overriding right of consent in respect of any publication by any employee or student. 1.8 In conjunction with other organisations or parties, there will be a mechanism for sharing the net income arising from the commercialisation of the IP jointly created by the [NAME OF INSTITUTION/ ORGANISATION] and its employees and students. 1.9 Any IP that belongs to an employee or student prior to their engagement with the [NAME OF INSTITUTION/ORGANISATION] must be identified prior to entry into their contract of engagement with the [NAME OF INSTITUTION/ ORGANISATION] or at the earliest time at which the employee or student becomes aware of the existence and relevance of such IP If the [NAME OF INSTITUTION/ORGANISATION] decides not to commercialise any IP that is assigned to it under this policy, the employee or student who developed the IP may seek approval from the [NAME OF INSTITUTION/ ORGANISATION] to pursue commercialisation opportunities in his or her own right. The [NAME OF INSTITUTION/ORGANISATION] will not withhold consent unreasonably Any net royalty income derived from commercial exploitation by the [NAME OF INSTITUTION/ ORGANISATION] of IP will be shared between stakeholders in accordance with this policy and the Standard Terms and Conditions. 2. Objectives 2.1 To protect the IP derived from work undertaken by the [NAME OF INSTITUTION/ORGANISATION] and its researchers when its researchers are working as detailed in their contract of engagement. 2.2 To enhance the reputation and attractiveness of the [NAME OF INSTITUTION/ORGANISATION] as a research facility. 2.3 To capitalise on research undertaken at the [NAME OF INSTITUTION/ORGANISATION] or involving the [NAME OF INSTITUTION/ ORGANISATION] s funds and resources (including research staff and students). 2.4 To accelerate research outcomes. 2.5 To add value to the public and private investment in the [NAME OF INSTITUTION/ ORGANISATION] s research. 2.6 To reward stakeholders. 3. Implementation 3.1 The Director of Research / Intellectual Property Officer is responsible for the overall implementation of this policy. 3.2 Individuals who wish to raise any matter relating to this policy or IP generally should contact the Director of Research / Intellectual Property Officer in the first instance. 151

166 INTELLECTUAL PROPERTY & PUBLICATION Intellectual Property Policy continued 3.3 <Where applicable to an individual organisation, the Board of the organisation will have the option to appoint an Intellectual Property and Commercialisation Committee to implement this policy. The makeup of the Committee is up to the Board of the organisation> 3.4 Head of Business Development / Executive General Manager: <This section where applicable to the individual organisation>: 3.5 The Board will delegate the following responsibilities arising from this policy to the Head of Business Development / Executive General Manager: a. consultation with the inventors of IP developed utilising the [NAME OF INSTITUTION/ ORGANISATION] s resources about the commercial exploitation of that IP; b. protection of IP owned by or licensed to the [NAME OF INSTITUTION/ORGANISATION] as reuired; c. commercial exploitation of IP owned by or licensed to the [NAME OF INSTITUTION/ ORGANISATION] under this policy in accordance with the Standard Terms and Conditions; d. distribution of any cumulative net royalty income of commercial exploitation of IP owned or licensed by the [NAME OF INSTITUTION/ ORGANISATION] in accordance with this policy; and e. identification of intellectual capital within the [NAME OF INSTITUTION/ORGANISATION] and education of employees and students on relevant aspects of IP protection. 4. Scope 4.1 This policy applies to all employees and students and any other person who carries out or proposes to carry out research during the term of their engagement with the [NAME OF INSTITUTION/ORGANISATION] using the [NAME OF INSTITUTION/ORGANISATION] s funds, resources or facilities and following the termination of their engagement to the extent that it relates to an employee s or student s activities whilst engaged by the [NAME OF INSTITUTION/ ORGANISATION]. 4.2 This document is intended to be a description of the [NAME OF INSTITUTION/ORGANISATION] policy on confidentiality and IP only. The legal obligations of the [NAME OF INSTITUTION/ ORGANISATION] and its employees and students are contained in the Standard Terms and Conditions. 4.3 In the event of any inconsistency arising between the policy and employment agreement, the contents of this policy shall prevail. 5. Ownership of IP 5.1 In this Policy, Intellectual Property means all statutory and other proprietary rights in respect of trade marks, patents, circuit layouts, plant varieties, copyright, confidential information, know-how and all other rights with respect to IP as defined in Article 2 of the Convention Establishing the World Intellectual Property Organisation of July 1967, and includes: a. any application, right to apply for registration, or registration of any of these rights (if applicable); b. all other rights derived from, or deriving title or priority from, these rights, including all divisionals, renewals, continuations (in part or whole) and extensions of these rights; c. the absolute right to do anything in relation to the ownership, protection, use, modification and adaptation of any of these rights; and d. the right to bring proceedings and recover damages (or any other remedies) in respect of infringement by a third party of these rights, regardless of whether such infringement occurred before or after the date of this policy. 152

167 INTELLECTUAL PROPERTY & PUBLICATION Intellectual Property Policy continued 5.2 Subject to clause 9, the [NAME OF INSTITUTION/ ORGANISATION] owns all worldwide rights, title and interest in any IP in any inventions, developments or works made or created: a. by the [NAME OF INSTITUTION/ ORGANISATION] s employees and students: i. in the course of their employment or engagement with the [NAME OF INSTITUTION/ORGANISATION]; or ii. in the course of using funding, facilities or resources of, or awarded or donated to the [NAME OF INSTITUTION/ORGANISATION]; or iii. in the course of any commissioned works; b. by students, visitors to the [NAME OF INSTITUTION/ORGANISATION] and others, with more than incidental use of funds, facilities or resources of, or awarded or donated to, the [NAME OF INSTITUTION/ORGANISATION]; or c. by a student in the course of his or her engagement, studies, scholarship or research at the [NAME OF INSTITUTION/ ORGANISATION]; or d. with the assistance of the [NAME OF INSTITUTION/ORGANISATION] (or by a third party on behalf of the [NAME OF INSTITUTION/ORGANISATION]) including by way of funding, resources, facilities, apparatus, supervision or other means; shall vest in the [NAME OF INSTITUTION/ORGANISATION] at the time of development. 5.3 The [NAME OF INSTITUTION/ORGANISATION] s employees and students must do all things and execute all documents necessary and must provide any assistance reasonably reuired by the [NAME OF INSTITUTION/ORGANISATION] in order to give full effect to the [NAME OF INSTITUTION/ORGANISATION] s ownership of IP and the terms of this policy. 6. Disclosure and confidentiality 6.1 All employees and students must keep all confidential information confidential. Any person who is in doubt as to whether information is confidential should seek clarification from the Head of Business Development or the Director of Research / Intellectual Property Officer of the [NAME OF INSTITUTION/ORGANISATION]. 6.2 The effective transfer of the [NAME OF INSTITUTION/ORGANISATION] s ideas and knowledge into clinical outcomes depends on the early identification of potentially patentable inventions. 6.3 Accordingly, the [NAME OF INSTITUTION/ ORGANISATION] reuires that an Invention Disclosure Form be prepared and submitted to the Research Directorate / Commercialisation Office for Intellectual Property that may have commercial potential, which is created by, or in collaboration with, the [NAME OF INSTITUTION/ ORGANISATION] s employees and students. 6.4 The Invention Disclosure Form must be submitted by the relevant employees and students as soon as reasonably practicable after the IP is created and before any information relating to the IP is made publicly available. 6.5 The [NAME OF INSTITUTION/ORGANISATION] s employees and students must submit new Invention Disclosure Forms for IP that is an improvement on a previous invention, regardless of whether an Invention Disclosure Form has been submitted previously. 6.6 The [NAME OF INSTITUTION/ORGANISATION] s employees and students are expected to apply reasonable judgment as to whether the research findings have potential for commercial application. If in doubt the Research Directorate / Commercialisation Office should be consulted prior to any public disclosure. 6.7 Creators of copyright works that have potential commercial value, and which are not assigned to the creator under clause 9 of this policy, must disclose the copyright works to the Research Directorate / Commercialisation Office by submitting an Invention Disclosure Form. 153

168 INTELLECTUAL PROPERTY & PUBLICATION Intellectual Property Policy continued 6.8 The [NAME OF INSTITUTION/ORGANISATION] s employees and students must comply with the terms of the confidential information Policy at all times. To avoid doubt, information regarding potentially patentable inventions or commercially valuable information is considered confidential information of the [NAME OF INSTITUTION/ORGANISATION] and the [NAME OF INSTITUTION/ORGANISATION] s employees and students must treat such information in accordance with the terms of the confidential information Policy, including by refraining from making any such information publicly available until after submitting an Invention Disclosure Form to the Research Directorate/Commercialisation Office. 7. Distribution on net royalty income 7.1 If the commercialisation of IP owned by the [NAME OF INSTITUTION/ORGANISATION] is successful, the [NAME OF INSTITUTION/ ORGANISATION] may receive cash in the form of royalty or other payments (monetary income). 7.2 Net royalty income derived by the [NAME OF INSTITUTION/ORGANISATION] from the commercialisation of a granted patent and/or the licensing of know-how and/or the commercial exploitation of a copyright work will be distributed annually by the [NAME OF INSTITUTION/ ORGANISATION] in the following way: <Here each organisation can insert their own royalty distribution agreement> 8. Multiple inventors 8.1 IP can be made or created solely or jointly with others as co-inventors or co-creators. 8.2 IP may be developed under agreements between the [NAME OF INSTITUTION/ORGANISATION] and third parties other than employees and students. These agreements should clearly identify: a. any background IP contributed to the relevant research or project by the [NAME OF INSTITUTION/ORGANISATION] and/or the third party; c. how the proceeds of any commercial exploitation of any IP developed in the course of the relevant research or project shall be distributed consistent with this policy. 8.3 If there is more than one relevant [NAME OF INSTITUTION/ORGANISATION] employee and student involved the net income or euity income to be distributed to those relevant [NAME OF INSTITUTION/ORGANISATION] employees and students under this policy it will be divided between them eually, unless the relevant [NAME OF INSTITUTION/ORGANISATION] employees and students advise [NAME OF INSTITUTION/ ORGANISATION], by written notice signed by each of them, of differing individual shares. 8.4 If the relevant [NAME OF INSTITUTION/ ORGANISATION] employees and students are unable to agree within a reasonable time, the Director of Research / Intellectual Property Officer will consult with the relevant the [NAME OF INSTITUTION/ORGANISATION] employees and students and determine the respective shares. 9. Assignment of Certain Copyright to the [NAME OF INSTITUTION/ORGANISATION] s employees and students 9.1 The [NAME OF INSTITUTION/ORGANISATION] assigns to the creating employees and students copyright in the following copyright works to which this policy applies: a. written works created solely for the purpose of publication in a professional or learned journal or other academic publication; b. theses created by the [NAME OF INSTITUTION/ORGANISATION] students in the course of their studies; and c. media opinion in the field of the author s expertise. 9.2 The assignment of copyright to the creating employees and students under this policy is subject to any obligations owed by the [NAME OF INSTITUTION/ORGANISATION] to third parties with respect to the relevant copyright works. b. the person or entity that will own any IP developed in the course of the relevant research or project; 154

169 INTELLECTUAL PROPERTY & PUBLICATION Intellectual Property Policy continued 9.3 Where a copyright work is created solely for the purpose of publication in an academic publication, the [NAME OF INSTITUTION/ ORGANISATION] shall assign copyright in that copyright work to the person who created that copyright work or to the publisher, as the case may be, but only subject to any conditions set out in the Standard Terms and Conditions. 10. Publications 10.1 Overriding consent It is recommended that the [NAME OF INSTITUTION/ORGANISATION]: a. reuire any publication (including any academic publication) to be submitted to the Head of Business Development or the Director of Research / Intellectual Property Officer for consent; and/or b. prevent or delay any publication where there is a reasonable likelihood of the publication disclosing a patentable invention, or if the publication may place at risk the commercial exploitation of any IP owned by the [NAME OF INSTITUTION/ORGANISATION] Theses a. The [NAME OF INSTITUTION/ORGANISATION] will not prevent the publication of a student s thesis within the time frame established by the student s tertiary institution. If a delay is reuired in order to protect IP, arrangements for examination under a confidentiality agreement should be arranged with the relevant tertiary institution. 11. Competing IP obligations 11.1 The [NAME OF INSTITUTION/ORGANISATION] carries out research in collaboration with industry members and other organisations. As a conseuence, The employees and students to whom this policy applies may also fall under the IP policies of others or have competing obligations with respect to IP to third parties It is the responsibility of the employees and students to advise the staff of the Research Directorate/Commercialisation Office of any other IP policy that may apply to them and any other IP obligations that are inconsistent with the obligations under this policy. This must be done prior to initiating any collaboration, sponsored research, IP protection or commercialisation activities. 12. Acknowledgement of moral rights 12.1 The [NAME OF INSTITUTION/ORGANISATION] acknowledges the moral right of the author(s) of any copyright work. 13. Rights of creators and inventors to patent and commercialise 13.1 Where the disclosure of an invention suggests patent protection or identifies commercial potential, the decision to file a patent will be based on the recommendation of the Research Directorate / Commercialisation Office and/or Commercialisation Committee where applicable If the [NAME OF INSTITUTION/ORGANISATION] decides to initiate patent protection for an invention, the inventor shall, if reuired, formally assign all rights in such an invention to the [NAME OF INSTITUTION/ORGANISATION]. The inventor must also assist the [NAME OF INSTITUTION/ORGANISATION] and its patent attorneys and legal advice to apply for, prosecute and maintain any patent negotiation or any other form of statutory protection including the signing of all necessary documents The costs of patenting, statutory protection and commercialisation expenses shall be negotiated between the Director of Research / Commercialisation Office and the inventor and his or her research department If the [NAME OF INSTITUTION/ORGANISATION] decides not to protect or commercialise IP owned by the [NAME OF INSTITUTION/ ORGANISATION] the relevant employees and students may apply to the Director of Research / Intellectual Property Officer for the [NAME OF INSTITUTION/ORGANISATION] to assign the relevant IP to the creator. 155

170 INTELLECTUAL PROPERTY & PUBLICATION Intellectual Property Policy continued 13.5 The Director of Research / Intellectual Property Officer may, in his or her sole and unfettered discretion, consent to the assignment. In considering a reuest, the Director of Research/Intellectual Property Officer may take into account the [NAME OF INSTITUTION/ ORGANISATION] s objectives, the most effective means of transferring the relevant IP to the public, the [NAME OF INSTITUTION/ ORGANISATION] s obligations to third parties, conflicts of interest and the reasonable career and personal interests of relevant the [NAME OF INSTITUTION/ORGANISATION] employees and students The Intellectual Property Officer s consent may be conditional, including a condition that the inventor or creator pay any costs incurred by the [NAME OF INSTITUTION/ORGANISATION] in protecting or commercialising the IP or that the inventor or creator share the proceeds of any commercialisation The assignment of IP and any conditions to that assignment must be in writing and, once given, cannot be revoked. 14. Dealing with the [NAME OF INSTITUTION/ ORGANISATION] s IP 14.1 Only the Director of Research / Intellectual Property Officer has the delegated authority to enter into agreements in respect to the [NAME OF INSTITUTION/ORGANISATION] s IP rights. The authority may be delegated by the Director of Research / Intellectual Property Officer for the [NAME OF INSTITUTION/ORGANISATION] All such agreements should be forwarded to the Director of Research or Commercialisation Officer (where applicable) for legal and commercial review prior to execution by the relevant authority. 15. Conflicts of interest 15.1 A conflict of interest may arise in the context of this policy where the interests of an individual conflict with the duties owed by the individual to the [NAME OF INSTITUTION/ORGANISATION] <The Organisation should have a Conflicts of Interest Policy in place. Please insert your C of I policy here>. 16. Dispute resolution 16.1 If a dispute arises in relation to this policy, the dispute shall be notified in writing to the Executive General Manager/ Business Development Manager <It is up to each organisation to have an internal process in place to resolve Disputes. Please insert relevant policy here>. 17. Waiver in exceptional circumstances The [NAME OF INSTITUTION/ORGANISATION] s Board of Directors may waive part or all of the provisions of this policy in circumstances that the Board deem to be exceptional Agreements which affect the [NAME OF INSTITUTION/ORGANISATION] s IP rights include (but are not limited to): a. confidentiality agreements; b. research and services agreements; c. clinical research agreements; d. license and option agreements; and e. material transfer and other agreements that deal with tangible research property (such as biological materials or devices). 156

171 INTELLECTUAL PROPERTY & PUBLICATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Review of Material Transfer Agreements Section 1 Academic Freedom No. Description Reuired Completed 1.1 Has the Permitted Purpose/Usage been appropriately defined? (check with researcher) 1.2 Are any restrictions imposed on type of use acceptable? (eg. research use only, modifications prohibited) 1.3 Are all researchers involved in the study covered by the MTA? 1.4 Does the MTA allow the right to publish freely? 1.5 Are the rights of students to submit their theses protected? 1.6 Where prior submission of a manuscript to provider is reuired, is this for the purposes of review/suggestions (vs. approval) only? 1.7 If a delay for review/ip protection is reuired, is the delay period specified, and acceptable? 1.8 Do the confidentiality provisions of the MTA allow the researcher to publish (eg. are materials themselves held to be confidential)? 1.9 If there is an expiry date, is the period of permitted use sufficient? (check with researcher) Section 2 Ownership Rights No. Description Reuired Completed 2.1 Have the materials been defined? 2.2 Is the definition limited to the materials, progeny, replicates and unmodified derivatives? 2.3 If derivative is used in the definition, is it clear that this refers to modified or unmodified derivatives? 2.4 Is ownership of research results and data retained by researcher? 2.5 Is ownership of background IP and any third party IP used in the research protected? 2.6 Has a means for determining inventorship been included? 2.7 Has ownership of any IP arising from the study been specified? 2.8 Are the terms of IP ownership acceptable? 2.9 Is the researcher free to apply for patents on inventions arising from the study? 2.10 Is it clear who is responsible for any commercialisation activities arising from the study? (including payment of patent costs) 2.11 In cases where results or IP may be jointly owned or Provider owned, is a research licence included to allow the researcher to continue with their research in the area? 2.12 Is a means of conflict resolution included? 157

172 INTELLECTUAL PROPERTY & PUBLICATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Review of Material Transfer Agreements continued Section 3 Risk No. Description Reuired Completed 3.1 Is the governing law acceptable? 3.2 Are indemnity terms fair and acceptable? (eg. limited to costs arising from actions of the recipient only and excluding the provider negligence/misconduct) 3.3 Has the researcher entered into any other correspondence with the provider that imposes additional obligations on use of the Material? 3.4 Is the agreement between the provider organisation and the recipient organisation? (vs naming the Recipient Scientist as a contracting Party) Section 4 Conflict of Obligations No. Description Reuired Completed 4.1 Is the research for which the material is to be used independent of any third party grant, contract or other MTA? 4.2 If third party contracts are involved, are the obligations of those contracts free of conflict with the provisions of the MTA? (particularly IP ownership rights) Comments: Name / Signature of Manager: Date: / / 158

173 INTELLECTUAL PROPERTY & PUBLICATION Material Transfer Deed Parties [Name of Provider] of [insert address] (Provider) [Name of Recipient] of [insert address] (Recipient) Background a. The Provider owns the Material. b. The Provider has agreed to transfer the Material to the Recipient for the purposes of the Research. c. The Recipient agrees to use the Material in accordance with the terms of this Deed. Operative provisions 1. Material Delivery 1.1 The Provider will deliver the Material to the Recipient at the Delivery Address on or before the Delivery Date, using any lawful and generally accepted method for the storage and transportation of the Material. Costs of delivery and insurance 1.2 The Recipient will pay the costs of delivery of the Material to the Delivery Address, including the cost of any insurance in connection with the delivery of the Material. Property in Material 1.3 The Material is owned by the Provider at all times. Property in Replicates and Derivates 1.4 Property in a Replicate or Derivative will vest in the Provider immediately upon its creation. Destruction of Material 1.5 The Recipient may, if reasonably reuired for the purposes of the Research, undertake procedures which result in the destruction of the Material, a Replicate or Derivative. Use of Material 1.6 The Recipient must not, without the prior written consent of the Provider, use the Material, or a Replicate or Derivative for any purpose other than the Research. Compliance with Law 1.7 The Recipient and, where relevant, the Provider must comply with all applicable laws in relation to the handling, storage, transport, disposal, destruction and use of the Material, a Replicate or Derivative. Risk 1.8 Once the Material is delivered to the Delivery Address, the Recipient assumes all risk and responsibility in connection with the Material including risks associated with on-delivery, handling, storage, transport, disposal and any use or misuse of the Material, a Replicate or Derivative. No Disposal of Material 1.9 The Recipient must not share, sell, transfer or otherwise dispose or destroy the Material, a Replicate or Derivative, without the prior written consent of the Provider, except as permitted in clause 1.5. Return of Material to Provider 1.10 When the Recipient has completed the Research, the Recipient must, at its own cost and at the option of the Provider, destroy or return all unused Material and all Replicates and Derivatives to the Provider, unless otherwise agreed in writing. 159

174 INTELLECTUAL PROPERTY & PUBLICATION Material Transfer Deed continued 2. Ownership of Intellectual Property No Transfer 2.1 Nothing in this deed operates to transfer any Intellectual Property Rights to the Recipient. All Intellectual Property Rights to be vested in Provider 2.2 All Intellectual Property Rights in the Material, Replicates and Derivatives vest in the Provider immediately upon their creation, and the Recipient hereby assigns to the Provider all existing and future IP rights. The Recipient agrees to execute or procure the execution by its personnel of any documents reasonably necessary to give effect to this assignment, at the Provider s expense. Restrictions 2.3 The Recipient must not do any act or anything to attempt to copy, reverse engineer or otherwise act contrary to the Provider s ownership of the Material, Replicates and Derivatives or IP rights. For avoidance of doubt, the Recipient must not commercialise the Material, or any Replicates or Derivatives. Notice 2.4 The Recipient must promptly notify the Provider in writing if it creates or acuires any IP Rights relating to the Material which, in its reasonable opinion, has the potential to be commercialised or otherwise exploited. 3. Confidential Information Obligation of confidence 3.1 A party (the Receiving Party) must not use, copy, disclose, reproduce or make public the other party s (the Disclosing Party) confidential information for any purpose except in accordance with this deed. Each party must ensure that its personnel does not do anything that would breach this clause. 3.2 If the Receiving Party becomes aware of a breach of this obligation, that party must immediately notify the Disclosing Party. Further permitted use and disclosure 3.3 The Receiving Party must not disclose any of the Disclosing Party s confidential information unless one of the following circumstances applies: The Disclosing Party has consented in writing to the disclosure. The consent may be subject to the condition that the third party to whom the disclosure is to be made, enters into a separate confidentiality agreement with the Disclosing Party The disclosure is specifically contemplated and permitted by this deed The disclosure is to personnel of the Receiving Party to the extent the personnel need to know the confidential information in order to perform a function in connection with this deed. The Receiving Party must ensure that its personnel comply with the terms of this clause The disclosure is to a Representative in order for it to provide advice in relation to matters arising under or in connection with this deed The disclosure is reuired by a court, a binding directive of a governmental or administrative authority or to comply with any applicable law. Confidentiality compliance and undertakings 3.4 The Disclosing Party may at any time reuire the personnel of the Receiving Party engaged in the performance of this deed to give written undertakings in a form prepared by the Disclosing Party relating to the non-disclosure of the Disclosing Party s confidential information and the Receiving Party will arrange for all such undertakings to be given promptly. 160

175 INTELLECTUAL PROPERTY & PUBLICATION Material Transfer Deed continued Obligations to continue after agreement ends 3.5 All obligations of confidence set out in this deed continue in full force and effect after this deed ends. 4. Publication and disclosure of results Publications 4.1 Each party has the right to publish the methods, results of, and conclusions from, the Research, and in relation to the Material, Derivative and Replicate subject to this clause and in accordance with copyright law. 4.2 The party wishing to publish material relating to the Research, the Material, Derivative or Replicate (the Publishing Party) must give notice of any proposed publication drafted by it or any of its personnel to the other party (the Other Party) at least 30 days before seeking to publish same. 4.3 The Other Party may, within that 30-day period do any of the following: Provide comments on the proposed publication to the Publishing Party, in which case the Publishing Party must consider such comments but will not be bound to follow them, except that if the Recipient is the Publishing Party, it must, if reuested, acknowledge the Provider as the source of the Material and cite the Provider as a co-author in any publication If the Other Party can reasonably demonstrate that it has proprietary rights that may be affected by the publication and which reuires protection, reuest delay of the publication for no more than 60 days to allow the Other Party to file patent applications or take other measures to preserve those proprietary rights, in which case the Publishing Party must abide by that reuest Reuest that the Publishing Party remove specified confidential information of the Other Party from the publication, in which case the Publishing Party must remove such specified confidential information as is reasonably reuired to protect the IP of the Other Party. 4.4 If the Publishing Party has not received any comments from the Other Party within 30 days of giving notice to the Other Party under clause 4.2, the Publishing Party may proceed to make the publication. 4.5 In this clause, a reference to publish or publications means to publish by way of a paper, article, manuscript, report, poster, internet posting, presentation, slides, abstract, outline, video, instruction material or other disclosure in printed, electronic, oral or other form. 4.6 Upon completion of the Research, the Recipient will provide a written report to the Provider setting out the results of the Research. 5. Disclaimer and limitation of liability Provider makes no representations or warranties 5.1 To the extent permitted by law and except as expressly provided in this Deed, the Provider makes no representations or warranties with respect to the Material, any Replicate or Derivative whether express or implied, including without limitation, any implied warranty of authenticity, merchantability, title or fitness for a particular purpose. 5.2 The Provider expressly excludes any representations or warranty that use of the Material or any Replicate or Derivative by the Recipient for the Research will not infringe any IP rights of any person. Exclusion of liability 5.3 To the extent permitted by law, the Provider will not be liable under or in relation to this deed, whether in contract, tort (including negligence or breach of statutory duty) or otherwise, to compensate the Recipient for: any indirect, special, incidental or conseuential loss or damage, including economic loss, loss of profit, revenue, opportunity, business, contracts or anticipated savings; 161

176 INTELLECTUAL PROPERTY & PUBLICATION Material Transfer Deed continued any liability arising from personal injury or death; and any liability arising from infringement of any third party s IP rights. [NOTE: The above clause 5.3 is recommended to be used when the Provider is a Victorian Public Healthcare Service and the Recipient is not. For all other arrangements the parties can determine if it is appropriate in the circumstances to keep the above clause.] 6. Insurance 6.1 Each party must maintain such insurances as are reasonably available and necessary to provide indemnity to it in relation to any liability which it may incur in performing its obligations under this agreement. 6.2 A party satisfies the reuirements of clause 6.2 if it is entitled to indemnity under a program or scheme of insurance or indemnity that is arranged by a State or Territory of the Commonwealth of Australia. 7. Term and termination Term 7.1 This deed commences from the date specified on the execution page of this deed, or if such date is not included, on the date this deed is last signed by either party. In the ordinary course of events this deed terminates when the Recipient has completed the Research. Termination 7.2 Either party may terminate this deed with 30 days prior written notice or such shorter time period as is reasonably reuired in the circumstances if the other party: is in breach of any obligations under the deed and fails to remedy such breach where it is capable of remedy within 30 days of a written notice from the terminating party specifying the breach and reuiring its remedy; or is declared insolvent or has an administrator or receiver appointed over all or any part of its assets or ceases or threatens to cease to carry on its business. 8. Goods and Services Tax (GST) Recovery of GST on supplies and adjustments under this deed 8.1 Any consideration provided under this deed is exclusive of GST, unless it is expressed to be GST-inclusive. 8.2 Where a party (Supplier) makes a taxable supply to another party (Recipient) under or in connection with this deed, the Recipient must pay to the Supplier an additional amount eual to the GST payable on the supply (unless the consideration for that taxable supply is expressed to include GST). The additional amount must be paid by the Recipient at the later of the following: the date when any consideration for the taxable supply is first paid or provided; the date when the Supplier issues a tax invoice to the Recipient. 8.3 If, under or in connection with this deed, the Supplier has an adjustment for a supply under the GST law which varies the amount of GST payable by the Supplier, the Supplier will adjust the amount payable by the Recipient to take account of the varied GST amount. The Supplier must issue an adjustment note to the Recipient within 28 days of becoming aware of the adjustment. Other GST matters 8.4 If a party is entitled to be reimbursed or indemnified under this deed, the amount to be reimbursed or indemnified is reduced by the amount of GST for which there is an entitlement to claim an input tax credit on an acuisition associated with the reimbursement or indemnity. The reduction is to be made before any increase under clause 8.2. An entity is assumed to be entitled to a full input tax credit on an acuisition associated with the reimbursement or indemnity unless it demonstrates otherwise before the date the reimbursement or indemnity is made. 162

177 INTELLECTUAL PROPERTY & PUBLICATION Material Transfer Deed continued 8.5 Any reference in this deed to cost, expense, liability or similar amount (Expense) is a reference to that Expense exclusive of GST (unless that Expense is expressed to be GST-inclusive). 8.6 This clause will not merge on completion and will survive the termination of this deed by any party. 8.7 Terms used in this clause that are not otherwise defined in this deed have the meanings given to them in the GST Act. 9. Notices Giving notices 9.1 Any notice or communication given to a party under this deed is only given if it is in writing and sent in one of the following ways: delivered or posted to that party at its address and marked for the attention of the relevant department or officer (if any) set out below; faxed to that party at its fax number and marked for the attention of the relevant department or officer (if any) set out below. Provider Name: [name] Address: [address] Fax number: [fax number] Attention: [attention] Recipient Name: [name] Address: [address] Fax number: [fax number] Attention: [attention] Change of address or fax number 9.2 If a party gives the other party three business days notice of a change of its address or fax number, any notice or communication is only given by that other party if it is delivered, posted or faxed to the latest address or fax number. Time notice is given 9.3 Any notice or communication is to be treated as given at the following time: if it is delivered, when it is left at the relevant address; if it is sent by post, two (or, in the case of a notice or communication posted to another country, nine) business days after it is posted; if it is sent by fax, as soon as the sender receives from the sender s fax machine a report of an error free transmission to the correct fax number. 9.4 However, if any notice or communication is given, on a day that is not a business day or after 5pm on a business day in the place of the party to whom it is sent, it is to be treated as having been given at the beginning of the next business day. 163

178 INTELLECTUAL PROPERTY & PUBLICATION Material Transfer Deed continued 10. Miscellaneous Approvals and consents 10.1 Unless this deed expressly provides otherwise, a party may give or withhold an approval or consent in that party s absolute discretion and subject to any conditions determined by the party. A party is not obliged to give its reasons for giving or withholding a consent or approval or for giving a consent or approval subject to conditions Where this deed refers to a matter being to the satisfaction of a party, this means to the satisfaction of that party in its absolute discretion. Assignments and transfers 10.3 A party must not assign or transfer any of its rights or obligations under this deed without the prior written consent of each of the other parties. Costs 10.4 Except as otherwise set out in this deed, each party must pay its own costs and expenses for preparing, negotiating, executing and completing this deed and any document related to this deed. Entire agreement 10.5 This deed contains everything the parties have agreed in relation to the subject matter it deals with. No party can rely on an earlier written document or anything said or done by or on behalf of another party before this deed was executed. Execution of separate documents 10.6 This deed is properly executed if each party executes either this document or an identical document. In the latter case, this deed takes effect when the separately executed documents are exchanged between the parties. Further acts 10.7 Each party must at its own expense promptly execute all documents and do or use reasonable endeavours to cause a third party to do all things that another party from time to time may reasonably reuest in order to give effect to, perfect or complete this deed and all transactions incidental to it. Governing law and jurisdiction 10.8 This deed is governed by the law of Victoria. The parties submit to the non-exclusive jurisdiction of its courts and courts of appeal from them. The parties will not object to the exercise of jurisdiction by those courts on any basis. Joint and individual liability and benefits 10.9 Except as otherwise set out in this deed, any covenant, agreement, representation or warranty under this deed by two or more persons binds them jointly and each of them individually, and any benefit in favour of two or more persons is for the benefit of them jointly and each of them individually. Severability Each provision of this deed is individually severable. If any provision is or becomes illegal, unenforceable or invalid in any jurisdiction it is to be treated as being severed from this deed in the relevant jurisdiction, but the rest of this deed will not be affected. The legality, validity and enforceability of the provision in any other jurisdiction will not be affected. Variation No variation of this deed will be of any force or affect unless it is in writing and signed by each party to this deed. Waivers A waiver of any right, power or remedy under this deed must be in writing signed by the party granting it. A waiver only affects the particular obligation or breach for which it is given. It is not an implied waiver of any other obligation or breach or an implied waiver of that obligation or breach on any other occasion. 164

179 INTELLECTUAL PROPERTY & PUBLICATION Material Transfer Deed continued The fact that a party fails to do, or delays in doing, something the party is entitled to do under this deed does not amount to a waiver. 11. Definitions and interpretation Definitions 11.1 In this deed the following definitions apply: Confidential Information means information, including any of the following information (whenever it was obtained) in relation to a party s: a. business, operations or strategies; b. the terms of this deed; c. information designated as confidential by a party; d. information acuired by the other party solely by virtue of provisions of this deed; e. IP or other property; f. actual or prospective customers, clients or competitors. Information is not confidential in any of the following circumstances: a. it is in the public domain, unless it came into the public domain by a breach of confidentiality; b. it is already known by the other party at the time this deed is entered into; c. it is obtained lawfully from a third party without any breach of confidentiality. Delivery Address means the address specified in the Schedule. Delivery Date means the date specified in the Schedule. Derivative means any material created from the Material or a Replicate that is modified to have new properties and includes any analogue of the Material or Replicate. GST Act means A New Tax System (Goods and Services Tax) Act 1999 (Cwth). Intellectual Property Rights means all and any patents, patent applications, trade marks, service marks, trade names, registered designs, unregistered design rights, copyrights, knowhow, trade secrets, domain names, internet addresses, rights in confidential information, and all and any other IP rights, whether registered or unregistered, and including all applications and rights to apply for any of the same created or acuired in the course of the Research as a result of, or in connection with, the use of the Material or a Replicate or Derivative. Material means the material specified in the Schedule. Replicate means any material that represents a substantially unmodified copy of the Material and includes any material produced by amplification, by whatever means, of the Material. Research means the research specified in the Schedule. Interpretation 11.2 In the interpretation of this deed, the following provisions apply unless the context otherwise reuires: headings are inserted for convenience only and do not affect the interpretation of this deed; a reference in this deed to a business day means a day other than a Saturday or Sunday on which banks are open for business generally in Melbourne, Victoria; if the day on which any act, matter or thing is to be done under this deed is not a business day, the act, matter or thing must be done on the next business day; a reference in this deed to dollars or $ means Australian dollars and all amounts payable under this deed are payable in Australian dollars; a reference in this deed to any law, legislation or legislative provision includes any statutory modification, amendment or re-enactment, and any subordinate legislation or regulations issued under that legislation or legislative provision; 165

180 INTELLECTUAL PROPERTY & PUBLICATION Material Transfer Deed continued a reference in this deed to any document or agreement is to that document or agreement as amended, novated, supplemented or replaced; a reference to a clause, part, schedule or attachment is a reference to a clause, part, schedule or attachment of or to this deed; an expression importing a natural person includes any company, trust, partnership, joint venture, association, body corporate or governmental agency; where a word or phrase is given a defined meaning, another part of speech or other grammatical form in respect of that word or phrase has a corresponding meaning; a word which indicates the singular also indicates the plural, a word which indicates the plural also indicates the singular, and a reference to any gender also indicates the other genders; a reference to the word include or including is to be interpreted without limitation; any schedules and attachments form part of this deed. Execution and date Executed as a deed Date: / / Executed by [name] acting by the following persons or, if the seal is affixed, witnessed by the following persons: Name of director/company secretary (print) Signature of director/company secretary Name of director (print) Signature of director Executed by [name] acting by the following persons or, if the seal is affixed, witnessed by the following persons: Name of director/company secretary (print) Signature of director/company secretary Name of director (print) Signature of director Schedule Material Delivery Date Delivery Address Research 166

181 INTELLECTUAL PROPERTY & PUBLICATION Non-Disclosure Agreement (NDA) Creation, Review and Execution Document ID: Version: <1.0> Author: [insert name of local author or approver] Author Signature: Date: / / Effective Date: [insert date that this procedure is effective from in your institution/ department] Review Before: [insert date of when this procedure should be reviewed] Department/institution name: [insert Department/institution name] Reviewed and Approved by: [insert name] [insert title/position] Signature: Date: / / Departmental Head: [insert name] Signature: Date: / / 167

182 INTELLECTUAL PROPERTY & PUBLICATION Non-Disclosure Agreement (NDA) Creation, Review and Execution continued 1. Aim To document the procedure for the creation, review and execution of Non-Disclosure Agreements (NDA) (also referred to as Confidentiality Agreements). 2. Scope This applies to all NDAs whether using this Organisation s template or reviewing an NDA proposed by an external party. The document covers scenarios where the organisation receives a reuest from an outside organisation for access to its confidential information or materials or where a Department seeks access to another organisation s confidential information or materials. 3. Applicability An NDA should be used when an employee wishes to protect the confidentiality of sensitive scientific or commercially valuable information of the organisation that will be disclosed to an external party. Examples of situations in which an NDA should be used include: When disclosing information concerning a patentable or potentially patentable invention. When disclosing information or know-how of potential commercial value for the purposes of exploring the possibility of a research collaboration or business relations. To pass on obligations of confidence owed to another party in relation to confidential information of that party that has been received by the organisation. 4. Procedure 4.1 Flowchart See Appendix Initiating the creation of a new NDA or revision of a proposed NDA. All staff may: identify the potential need for the organisation to provide access to a third party to the organisation s confidential information; or notify the internal Legal Counsel or Department Head (if applicable) and discuss the need with them. The Department will: provide access to the current version of the organisation s standard process management policy and template NDA. 4.3 Preparation of a new NDA or revision of a proposed NDA The Departmental /document reviewer will: for a new NDA, prepare a draft in accordance with the standard NDA template which includes the following sections: 1. Parties 2. Project 3. Definitions 4. Terms 5. Execution. distribute the draft new or modified NDA to the Legal Counsel or other document reviewer for review and comment; incorporate relevant comments and arrange for further review if reuired; print the final NDA and arrange for approval and authorisation by the Legal Counsel or the document reviewer; print the appropriate number of copies so all parties can have one original copy of the NDA and any attachments. The Legal Counsel will: assess and verify the identified need for an NDA and if appropriate; review all drafts for consistency with the organisation s template, the terms, commercial implications and completeness; correspond with the external party s legal department, if there are legal or commercial matters that need to be negotiated or resolved. identify the need to access another organisation s confidential information; and, 168

183 INTELLECTUAL PROPERTY & PUBLICATION Non-Disclosure Agreement (NDA) Creation, Review and Execution continued 4.4 Approval and Authorisation Prior to the release of the NDA it will be reviewed and approved by Legal Counsel or delegate and finally authorised by the department head or institutional delegate. The NDA will be executed by an officer with appropriate delegated authority. Copies of the NDA executed by the organisation will be forwarded to an external party. The external party executes the NDA and returns one original to the Department. The Department will ensure that the relevant operational and corporate departments have copies of the fully executed NDA. The Legal Counsel will: 5. Glossary Disclosing Party A party to the NDA that supplies or has supplied confidential information to the Recipient Party. Recipient Party A party to the NDA that receives the confidential information from the Disclosing Party. Confidential Information Confidential information is information that is not publicly available that the law protects from misuse or improper disclosure. It may concern a formula, practice, process, design, instrument, pattern and includes trade secrets. Document reviewer A person delegated the task of reviewing NDAs by the organisation. maintain a Document Register of approved NDAs that includes as a minimum the Document ID, collaborating party(s), effective date and non confidential summary of confidential information. 4.6 Distribution of the NDA At least one copy will be available for use by the Department team. The Department will ensure that the relevant operational and corporate departments have copies of the executed NDA. The executed, original NDA (ie. with original signatures) will be securely stored and used only for making further controlled copies if reuired. Copies of the NDA may be made available in an electronic form, such as a.pdf document. References Appendices Appendix 2: Flowchart Appendix 3: Standard NDA template 169

184 INTELLECTUAL PROPERTY & PUBLICATION Guidelines for Determining Authorship The 2007 publication Australian Code for the Responsible Conduct of Research, jointly issued by the National Health and Medical Research Council (NHMRC), the Australian Research Council and Universities Australia, notes that the accepted practice for attribution of authorship differs between disciplines; however, the following general principles should apply: in all cases, authorship must be based on substantial contributions in a combination of: conception and design of the project analysis and interpretation of research data drafting significant parts of the work or critically revising it so as to contribute to the interpretation. 1 The International Committee of Medical Journal Editors (ICMJE) has produced Uniform Reuirements for Manuscripts submitted to Biomedical Journals 2 and journals that have adopted these reuirements state so in their instructions to authors. ICMJE Uniform Reuirements include the general principles noted above. 1. Minimising Disputes In an effort to minimise the likelihood of disputes, the NHMRC Code suggests that the following practices be followed. 1.1 Agree on authorship Collaborating researchers should agree on authorship of a publication at an early stage in the research project and should review their decisions periodically. Authors should decide on the designated corresponding author, order of authors and author contributions to the publication. The corresponding author should be prepared to explain the presence and order of individuals. 1.2 Include all authors Researchers must offer authorship to all people, including research trainees, who meet the criteria for authorship listed above. Those offered authorship must accept or decline in writing. 1.3 Do not allow unacceptable inclusions of authorship Authorship should not be offered to those who do not meet the reuirements set out above. For example, none of the following contributions, in and of themselves, justifies including a person as an author: a. being head of department, holding other positions of authority, or personal friendship with the authors (honorary authorship is not acceptable); b. providing a technical contribution but no other intellectual input to the project or publication; c. providing routine assistance in some aspects of the project, the acuisition of funding or general supervision of the research team; d. providing data that has already been published or materials obtained from third parties, but with no other intellectual input. 1.4 Acknowledge others contributions fairly Researchers must ensure that all those who have contributed to the research, facilities or materials are properly acknowledged, such as research assistants and technical writers. Where individuals are to be named, their written consent must be obtained. Acknowledgements are listed at the end of the publication and should include financial support. 1.5 Extend the authorship policy to web-based publications Authors of web-based publications must be able to take responsibility for the publication s content and must be clearly identified in the publication. 1.6 All authors should accept responsibility for the data presented Published articles report honest observations. In the event of an honest error a correction or erratum is reuired to be published. If there is evidence of scientific misconduct in relation to falsification, fabrication or plagiarism of results, retraction of the article is reuired to maintain scientific integrity. 1 Australian Code for the Responsible Conduct of Research ICMJE Uniform Reuirements for Manuscripts 170

185 INTELLECTUAL PROPERTY & PUBLICATION Guidelines for Determining Authorship continued 1.7 Authors should disclose potential conflicts of interest based on financial or personal relationships 1.8 Maintain signed acknowledgments of authorship for all publications All authors must have the opportunity to read the final manuscript before submission. The department of the executive or senior author must obtain the written acknowledgment of authorship discussed above in the form of an original handwritten signature. Where it is not practical to obtain an original signature, it is acceptable to use faxed or ed consent. This also applies to published conference abstracts and similar publications. If an author is deceased or cannot be contacted, the publication can proceed provided that there are no grounds to believe that this person would have objected to being included as an author. 2. Dispute Resolution Disputes over authorship are best resolved at the local level by the authors themselves or in consultation with their laboratory or department head as appropriate. The type of formal process implemented within the institution for authorship dispute resolution should reflect the size, nature and culture of the institution. In addition, it is common for this matter to be included within an institution s research code of conduct and dealt with on the basis of code of conduct disputes. If there are persistent serious disagreements concerning authorship of an article, any of those involved should have the right to appeal to one of the persons designated by the institution as assessors with respect to research conduct, who shall meet with all of those involved and offer arbitration. Ultimately, the director or head of the institution will have the power of decision, without input from any member who is personally involved. 171

186 INTELLECTUAL PROPERTY & PUBLICATION Evidencing Inventorship What is Inventorship? A patent may only be granted to an inventor or a person (or entity) claiming ownership through an inventor. If a mistake is made (whether by omission or inclusion of incorrect individuals) in naming an inventor significant conseuences may arise, including invalidation of the patent. Inventorship is a legal notion that differs from country to country, thus inventorship determinations are best made with the assistance of experienced legal counsel. What follows is an overview of the tests for inventorship in three jurisdictions (Australia, USA and Europe) and a summary for the key uestions that need to be asked (and answered) and the key pieces of evidence that need to be collected in order to make a satisfactory determination. An invention is defined as the creation of a new configuration, composition of matter, device, or process. Some inventions are based on pre-existing models or ideas while others are radical breakthroughs that may extend the boundaries of human knowledge or experience. Jurisdiction Australia USA Europe Inventor 1. But for test a person is an inventor if the invention could not have been made in their absence. 2. Material Effect test a person is an inventor where their contribution had a material effect on the final concept of the invention. Joint inventorship will arise where the invention could only have occurred because of the involvement of (all) the individuals. The individual(s) who conceived the invention. Conception is the key issue and is complete when the inventor has conceived the means of reducing the invention to practice such that someone skilled in the art would have the capacity to carry out the invention without further experimentation. Inventorship is determined by the national laws in each Contracting State (individual country). For example: in the UK the Patents Act 1997 defines an inventor as the actual deviser of the invention. As inventorship is treated differently in each jurisdiction it is important that inventorship determinations are made on the basis of the most stringent reuirement. In most cases this will be the United States, although it will depend on the patent prosecution strategy and the jurisdictions in which the patent application is filed. Inventorship vs. Authorship As outlined above inventorship is a legal notion and the identified inventors invariably differ from those identified as authors on an academic paper. In general the potential pool of authors is significantly greater than those identified as inventors, often including thesis advisors, departmental heads, supporting technicians, academic suppliers of utilised materials etc. The use of external legal counsel in determining correct inventorship can be useful in deflecting potential anger arising from individuals not named as inventors. Questions and Evidence for determining Inventorship As the claims describe the patentable invention it is essential that each (possible) inventor s contribution is assessed against each claim. From this assessment, a matrix can be established that will aid in true determination of inventorship. An example of such a matrix has been provided on the following page. 172

187 INTELLECTUAL PROPERTY & PUBLICATION Evidencing Inventorship continued Claim # Claim Description Inventor(s) Location/Employer Date 1 JK DB UoAU UoAU JK UoAU LP UoUS JK DB UoAU UoAU JK UoAU 2002 The development of such a matrix supports not only inventorship determination when the patent is filed but also is valuable as prosecution progresses. In the brief example above, the inventors for the filed application (based on the identified claim set 1-5) would be JK, DB and LP. If during prosecution claim 3 was abandoned, LP would no longer be considered an inventor and the inventive entity would need to be changed by amendment to delete LP from the application. By including in the analysis the location or employer of the individual inventor, and the date of the invention, key information can be obtained to establish potential ownership claims. For each of the claims, a series of uestions need to be asked to make an inventorship determination. Harrison et al 3 have identified the following non-exhaustive list of uestions: Did the person: contribute specific ideas that resulted in the development of the invention? contribute more than labour to one or more of the inventive or technically significant features of the invention? make practical and/or concrete suggestions that contributed to the invention? provide a specific design or experimental improvement that made the invention operable? conceive an inventive step or part of the invention that you can identify? have some role in the final conception of an invention as it is (will be) patented? If the answer to one or more of the previous uestions is yes, the individual may be an inventor. If the answer to all of the above uestions is no, the individual is unlikely to be an inventor even if they answer yes to the following: Did your ideas serve as a general goal or objective of the research? Were you retained or employed to reduce the concept to practice? Did you contribute ideas while the invention was being developed, but those ideas didn t contribute to the invention in its final form or as disclosed in the patent application? Laboratory notebooks are a key element in evidencing inventorship. The Biotechnology Intellectual Property Manual developed by Spruson & Ferguson 4 sets out the following checklist for maintaining good laboratory notebooks: Entries written up in a consecutively numbered notebook. The notebook must be properly bound so that pages cannot be removed or inserted. Permanent ink used. No blank spaces on finished page, no skipped pages and no removed pages. Each entry written consecutively, signed, dated, verified by a witness and ruled off. 3 Harrison P, Tansey C, Zammit M. Inventorship versus Ownership of Patent Applications Chemistry in Australia July 2006 p17 4 Biotechnology Intellectual Property Management Manual by Spruson & Ferguson

188 INTELLECTUAL PROPERTY & PUBLICATION Evidencing Inventorship continued Entries are legible, thorough and complete. Entries include description of initial ideas, experiments conducted and work completed. Details of all persons involved in the project should be included with each entry. Any corrections made should be dated, initialled and witnessed. All non-standard terms, processes and abbreviations defined. Annexed material should be permanently attached (glue, not staple or sticky tape) and sealed, signed and dated. If it is not practical to annex it, store it separately, sign, date, witness and cross-reference it to the relevant entry. All laboratory notebooks and their attachments, should be stored appropriately and kept confidential. All laboratory notebooks and design workbooks should be kept for as long as is needed to verify the legitimacy of the work. Other evidence that can be used in inventorship determination includes relevant s, file notes, diary notes, and meeting notes. First to file vs. File to invent Maintaining accurate lab notebooks and other information relating to an invention is essential if a patent is to be filed as the US uses a first-to-invent system, unlike most other countries in the world. Invention in the US is generally defined to comprise two steps: (1) conception of the invention and (2) reduction to practice of the invention. When an inventor conceives of an invention and diligently reduces the invention to practice (by filing a patent application, by practicing the invention, etc.), the inventor s date of invention will be the date of conception. Thus, provided an inventor is diligent in reducing an application to practice, he or she will be the first inventor and the inventor entitled to a patent, even if another files a patent application (reduces the invention to practice) before the inventor. However, the first applicant to file has the prima facie right to the grant of a patent. Should a second patent application be filed for the same invention, the second applicant can institute interference proceedings to determine who was the first inventor (as discussed in the preceding paragraph) and thereby who is entitled to the grant of a patent. This can be an expensive and time-consuming process. In a first-to-file system, the right to the grant of a patent for a given invention lies with the first person to file a patent application for protection of that invention, regardless of the date of actual invention. Correcting an Error in Inventorship Where an error in identifying the inventors for a patent in Australia was made in good faith, inventorship can be corrected for a patent application or granted patent. In the US two types of error are considered misjoinder and nonjoinder. Misjoinder defines the situation where a person who is not an inventor is listed incorrectly while nonjoinder defines the situation where a person who is an inventor was not included. In Europe management of incorrect inventor designation is determined by the National laws of each Contracting State. 174

189 INTELLECTUAL PROPERTY & PUBLICATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Invention Disclosure Template 1 Title of Invention 2 Description of Invention Describe general purpose and problem solved by the invention, a brief technical description, advantages and improvements over existing methods/devices/materials and explain commercial applications. Refer to and attach supplementary documents, if reuired. 3 Inventors An inventor is any person who has conceived of an essential element of the invention either independently or jointly with others. Please list all inventors (including any student inventors). Please attach additional Invention Disclosure Forms if there are more than 3 inventors. 4 Student Involvement Have any students been involved directly or indirectly in the development of the invention? If so, please list students names, University of enrolment and a brief description of their involvement (even if the student is not a co-inventor of the invention). Please attach additional Invention Disclosure Forms if there are more than 3 students. Name University Involvement 5 Sponsorship and Funding If any research grant(s) or other external funds were used in developing the invention, please complete the table below. Please attach additional Invention Disclosure Forms if there are more than 3 sponsors or funders. Sources of Funding Description Number of Project/Grant/Contract 175

190 INTELLECTUAL PROPERTY & PUBLICATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Invention Disclosure Template continued 6 Other Third Party Interests List all persons, companies and other entities (other than those listed at item 4 above) that are a party to any agreements relating to the invention (such as confidentiality and material transfer agreements) or that may have any interest in the invention, for instance, by reason of the provision of background IP, facilities etc. Please attach additional Invention Disclosure Forms if there are more than 3 such third parties. Third Party Interest 7 Creation and Disclosure of Invention Please provide the information relating to the creation and disclosure of the invention reuested below. Public disclosure of the invention may prevent patent protection in Australia. As reuired by the [NAME OF INSTITUTION/ ORGANISATION] s Intellectual Property Policy, please contact the [Director Commercialisation or euivalent] prior to making public disclosures concerning a potentially patentable invention. Event Date Details Conception being the date on which the essence of the means of solving the problem was conceived First Written Disclosure being the date on which any person, without the restriction of confidentiality, would first have been able to gain access to sufficient written description to enable a person skilled in the field to understand and to make use of the invention First Presentation being the date on which any person, without the restriction of confidentiality, would first have been able to gain access to sufficient oral description to enable a person skilled in the field to understand and to make use of the invention Future intended disclosures being the future dates of any proposed nonconfidential written or oral disclosures relating to the invention [Include details of how this is documented] [Provide details of written disclosures, including references of relevant publications if any] [Provide details of oral disclosures, including identity of persons to whom information disclosed and where] [Provide details of future disclosures, including names of publications and conferences] 176

191 INTELLECTUAL PROPERTY & PUBLICATION Document: [xxxxxxxxx] Implementation Date: dd-mm-yyyy Invention Disclosure Template continued 8 Interested Commercial Parties Provide a list of commercial entities that may be interested in the invention. Please include names and details of specific Party Interest 9 Contact Person Name Telephone 10 Inventors Declaration All inventors listed in item 3 must complete the declaration below I declare that, to the best of my knowledge, all statements made and information provided in this Invention Disclosure Form are correct. Inventor s Name Inventor s Signature Date of Signing Witnessed This form must be lodged with the [institutional office that administers commercialisation and Intellectual Property matters] 177

192 INTELLECTUAL PROPERTY & PUBLICATION APPENDIX 1: Standard Terms and Conditions on Intellectual Property 1. Introduction These Standard Terms and Conditions set out the obligations of the [NAME OF INSTITUTION/ ORGANISATION] ( the organisation ) and its employees and students with respect to Intellectual Property, and are made pursuant to the organisation Policy on IP. These obligations apply to all employees and students, and form part of each employee s and student s contract of engagement with the organisation. The capitalised words in these Standard Terms and Conditions are defined in Section 7 ( Definitions ). 2. Confidentiality a. All employees and students must keep confidential all confidential information. Any person who is in doubt as to whether information falls within the definition of confidential information should seek clarification from Head of Business Development of the organisation. b. Employees and students must not, without the prior written consent of the Organisation, disclose the confidential information unless the confidential information is reuired to be disclosed by law, in which case such disclosure must be reported to the organisation prior to the disclosure occurring. c. Confidential information must only be used for activities that are authorised by the organisation or activities that fall within the scope of the employee s or student s engagement with the organisation. d. Confidential information shall not be copied or used by the employee or student except for the purposes of their employment or studies, respectively. e. All employees and students must immediately notify the organisation of any potential, suspected or actual breach of the obligations contained in this Section 2 ( Confidentiality ). f. Confidential information shall not be removed from the organisation s premises without the prior consent of the organisation unless the removal of the information is necessary to enable the employee or student to fulfil their respective functions and duties to the organisation. g. On termination of an employee s employment with the erganisation or a student s studies at the organisation, or at the reuest of the organisation, all documents and other materials in any medium in that employee s or student s possession, power or control and which contain or refer to any confidential information shall be delivered up immediately to the organisation. h. The obligations of confidentiality contained in this agreement shall survive and continue in perpetuity even after the termination of an employee s employment or a student s studies at the organisation. 3. Intellectual Property 3.1 Ownership of Intellectual Property Every right, title and interest in any and all IP developed: a. by an employee in the course of his or her employment or engagement by the organisation; or b. by a student in the course of his or her engagement, studies, scholarship or research at the organisation; or c. with the assistance of the organisation (or by a third party on behalf of the organisation) including by way of funding, resources, facilities, apparatus, supervision or any other means, shall vest in the organisation at the time of development. Each employee and student agrees to execute all documents, forms and authorisations and do any and all such acts and things as may be reasonably necessary to vest in the organisation the rights assigned to the organisation under this Section 3.1 ( Ownership of Intellectual Property ). 3.2 Acknowledgment of moral rights The organisation acknowledges the moral rights of the author of any copyright work. The assignment of IP under Section 3.1 ( Ownership of Intellectual Property ) does not affect the moral rights of the author of any copyright work. 178

193 INTELLECTUAL PROPERTY & PUBLICATION APPENDIX 1: Standard Terms and Conditions on Intellectual Property continued 3.3 Duty to disclose All employees and students must, at the earliest possible opportunity, fully disclose to the Head of Business Development of the organisation, or his or her delegate the following details of any IP developed in the course of his or her involvement with the organisation: a. the nature and scope of the Intellectual Property; b. details of any person/s involved in the development of the Intellectual Property and the nature of their involvement; and c. details of any past, current or proposed discussions, negotiations and/or correspondence relating to the commercialisation, use or exploitation of the Intellectual Property. 3.4 Background Intellectual Property All Background Intellectual Property that is owned by an Employee or Student must be identified in an agreement between the organisation and the Employee or Student either: a. prior to, or at the time of, commencement of the Employee s or Student s engagement with the organisation; or b. if at the time of commencement of their engagement with the organisation the Employee or Student is unaware that he or she owns relevant Background Intellectual Property, as soon as reasonably practicable after the Employee or Student becomes aware of the existence and relevance of such Background Intellectual Property. The agreement must also identify the value of the Background Intellectual Property, its ownership, and how any proceeds from commercial exploitation are to be proportioned. 3.5 Ownership of copyright in academic publications Where a copyright work is created solely for the purpose of publication in an academic publication, the organisation shall assign copyright in that copyright work to the person who created that copyright work or to the publisher of that copyright work, as the case may be. Any such assignment shall be subject to conditions that: a. the organisation will have a non-exclusive, royalty-free and irrevocable licence to reproduce, publish, disseminate or otherwise use the copyright work for the organisation s own purposes, unless such a licence is inconsistent with the publication terms reuired by the academic publication; and b. any contribution of the organisation is expressly acknowledged in the relevant academic publication. 3.6 Discretionary assignment of copyright The organisation may, at its sole discretion and at any time, assign its copyright interests (in whole or in part) in any copyright work to the author of the copyright work. Unless otherwise agreed between the organisation and the author of the copyright work in writing, any such assignment shall be subject to conditions that the organisation will have: a. a non-exclusive, royalty-free and irrevocable licence to reproduce, publish, perform, broadcast, adapt, transmit, disseminate and otherwise use the copyright work or any adaptation of such work for the organisation s own educational and research purposes; and b. the right to recover any substantial direct costs incurred by the organisation in directly contributing to the production of the copyright work from the income (excluding public lending rights) received by the author from the relevant copyright work. 3.7 The organisation may decide not to commercialise IP For the avoidance of doubt, the organisation does not have an obligation to commercialise any IP that is developed by the organisation or a student or an employee. 179

194 INTELLECTUAL PROPERTY & PUBLICATION APPENDIX 1: Standard Terms and Conditions on Intellectual Property continued If the organisation decides not to commercialise certain IP, the employee or student who developed that IP may seek the organisation s consent to pursue commercialisation opportunities in respect of that IP in his or her own right. In the event the organisation grants such consent, it may: a. assist the employee or student in commercialising the IP (subject to the organisation s right to be reimbursed for any services it provides to the employee or student); and/or b. assign or grant appropriate licence rights to the IP to the employee or student. In all circumstances, the employee or student must keep the Director of Research or Head of Business Development where applicable of the organisation fully informed of any commercialisation activities that are undertaken in respect of the IP. 3.8 Inconsistency Where the ownership, licensing or exploitation of any IP owned by the organisation is governed by any agreement in writing between the organisation and an employee or student or any other person, the provisions of the agreement shall prevail to the extent of any inconsistency between that agreement and these standard terms and conditions. 3.9 Infringement of organisation IP Any employee or student who becomes aware of any alleged unauthorised use or infringement of any IP owned by the organisation must immediately inform the Head of Business Development of the organisation in writing of all relevant details of the unauthorised use or infringement Infringement of third party IP Any employee or student who becomes aware of any alleged unauthorised use or infringement by the organisation of any IP owned by a third party must immediately inform the Head of Business Development of the organisation in writing of all relevant details of the unauthorised use or infringement. 4. Publications 4.1 Onus on lead author to consider IP issues An Employee or Student who is the lead author of a proposed publication must, prior to any publication, consider: a. whether there is a reasonable likelihood of the publication disclosing a patentable invention; and b. whether the publication may place at risk the commercial exploitation of any IP owned by the organisation. If the employee or student considers that there is such a likelihood or risk, they must refer the matter to the Director of Research or Head of Business Development (where applicable) prior to submission for publication. The Director of Research or the Head of Business Development will then make a decision as to whether or not to proceed with publication. 4.2 Overriding right of consent Notwithstanding the above, the organisation retains an overriding right to: a. reuire any publication (including any academic publication) to be submitted to the Director of Research or the Head of Business Development for consent; and/or b. prevent or delay any publication, where there is a reasonable likelihood of the publication disclosing a patentable invention or if the publication may place at risk the commercial exploitation of any IP owned by the organisation. 4.3 Theses a. The organisation must not prevent the publication of a student s thesis within the time frame established by the student s tertiary institution. b. In the event that the disclosure of certain information relating to any IP owned by the organisation: i. is necessary for the preparation of a student s thesis; and 180

195 INTELLECTUAL PROPERTY & PUBLICATION APPENDIX 1: Standard Terms and Conditions on Intellectual Property continued ii. the public disclosure of that information may compromise the organisation s current or future rights to that IP, the student and the relevant tertiary institution shall, prior to the disclosure of that information, enter into a confidentiality agreement that allows disclosure of the information only to specified employees and students with a need to know and only to the extent necessary for the preparation, submission and examination of the Student s thesis. Any such confidentiality agreement is subject to the prior written approval of the organisation. c. Notwithstanding Section 3.1 ( Ownership of Intellectual Property ), all Students shall retain copyright in their thesis. d. For the avoidance of doubt and notwithstanding any terms of this agreement or any other agreement to the contrary, the organisation reserves the right not to consent to disclosure of any information relating to any IP owned by the organisation if the disclosure of that information may compromise the organisation s current or future rights to that IP. 5 Net Royalty Income 5.1 Distribution of Net Royalty Income Subject to Section 5.4 ( Inconsistency with another agreement ), the Net Royalty Income in relation to any Intellectual Property owned by the organisation, shall be distributed by the organisation. <here each Organisation can insert their own royalty distribution agreement> 5.2 The Organisation Share The organisation share shall be allocated by the organisation s Director at his/her absolute discretion. In making the decision as to how the organisation share should be allocated, the Director must consider: <insert organisational items here> 5.3 Responsibility for distribution of Net Royalty Income The Director of Research or Head of Business Development in agreement with the Committee is responsible for the distribution of Net Royalty Income under this Section 5 ( Net Royalty Income ). 6 Miscellaneous 6.1 Assistance All employees and students shall, both during and after the termination of their employment or studies, as the case may be, provide all reasonable assistance to the organisation in protecting its interest in any IP. Such assistance shall include, but not be limited to, the execution of any and all applications, assignments or other documents which the organisation may deem necessary for the registration, protection or commercial exploitation of any of its interests in the IP in any country of the world. Following termination of an employee s employment or a student s studies the organisation will meet the reasonable costs of the employee or student with respect to execution of documents reuired pursuant to this Section 6.1 ( Assistance ). 6.2 Dispute resolution Any dispute arising in relation to this agreement will be referred to the organisation s Director for consideration and final determination in accordance with procedures prescribed by the Board. Where appropriate the Committee may be consulted by the Board. 6.3 Records management For the avoidance of doubt, the organisation retains all IP rights in and to any data, laboratory books and records and associated material produced by employees or students utilising the organisation s resources. It is recommended that no person shall remove original documentation relating to research completed at the organisation, whether or not this relates to confidential information, from the organisation. When appropriate, and with the agreement of the organisation, photocopies or other replicated details of research may be taken by the employee or student if this will facilitate the ongoing development of the employee s or student s career. Original data is to be kept in the laboratory where it was generated. 181

196 INTELLECTUAL PROPERTY & PUBLICATION APPENDIX 1: Standard Terms and Conditions on Intellectual Property continued 7 Definitions Data, including laboratory workbooks and records in any other form that pertain to the research are to be kept for a minimum of seven years from the date of production in an accessible and identifiable manner as directed by the Director of Research or the Head, Business Development where applicable. Academic Publication means any book, journal, periodical, thesis or like publication, including any abstract or poster created for a conference, or any part thereof, which contains materials or articles or text written by members of educational or research bodies on areas of educational or scholastic learning, research or debate but does not include any publication that is brought into existence for the dominant purpose of seeking financial gain or commercial benefit. Background Intellectual Property means a. any IP of any employee that: i. was pre-existing at the time of commencement of the employee s engagement with the organisation and belongs to the employee; or ii. is developed by the employee outside the course of his or her duties to the organisation and without the use of any resources of the organisation; or b. any Intellectual Property of any student that: i. was pre-existing at the time of commencement of the student s engagement, studies, scholarship or research at the organisation and belongs to the student; or ii. is developed by the student outside the course of his or her duties to the organisation and without the use of any resources of the organisation. Board means the Board of Directors of the organisation. Committee means the IP and Commercialisation Committee established under the organisation policy on confidentiality and IP. Confidential Information means all information (regardless of form) disclosed or otherwise made available by the organisation to any employee or student, which: a. is marked or otherwise designated as being proprietary or confidential to the organisation; b. is confidential to a third party to whom the organisation owes an obligation of confidence; c. in the circumstances surrounding disclosure or because of the nature of the information, ought in good faith, to be treated as confidential; d. includes or relates to any IP; or e. is derived from or produced partly or wholly from such information, but excludes information which: i. i s in or becomes part of the public domain otherwise than through a breach of this agreement or an obligation of confidentiality owed to the organisation or a third party; ii. the employee or student can prove by contemporaneous written documentation was already known to them at the time of disclosure by the organisation (unless such knowledge arose from disclosure of information in breach of an obligation owed to or by a third party); or iii. the employee or student obtained from a third party permission to disclose it. Employee means any member of staff or research fellow of the organisation, or any consultant, contractor or visiting scientist to the organisation. The Organisation means the [NAME OF INSTITUTION/ORGANISATION]. The Organisation Share has the meaning as defined in Section 5.2. Intellectual Property means all rights resulting from intellectual activity whether capable of protection by statute, common law or in euity and including copyright, discoveries, inventions, patent rights, registered and unregistered trade marks, design rights, circuit layouts and plant varieties and all rights and interests of a like nature, together with any and all documentation relating to such rights and interests. 182

197 INTELLECTUAL PROPERTY & PUBLICATION APPENDIX 1: Standard Terms and Conditions on Intellectual Property continued Moral Rights means any of the rights described in Article 6bis of the Berne Convention for the Protection of Literary and Artistic Works 1886, being the droit moral or other analogous rights arising under any statute (including the Copyright Act 1968 or any other law of the Commonwealth), that exist or may come to exist, anywhere in the world. Net Royalty Income in relation to: Employees and Students encompasses all members of staff, students, research fellows, consultants, contractors and visiting scientists and any other person who carries out, or proposes to carry out, research using (the Organisation s) funds or facilities. Student means any student of the Organisation enrolled through a tertiary institution. a. any granted patents that form part of the Intellectual Property owned by the Organisation, means the total income received by the Organisation (or its related parties) from the commercialisation of any granted patent in the preceding calendar year; b. any know-how that forms part of the Intellectual Property owned by the Organisation, means the total income received by the Organisation (or its related parties) from the licensing of any know-how in the preceding calendar year; or c. any copyright works that form part of the Intellectual Property owned by the Organisation, means the total income received by the Organisation (or its related parties) from the commercial exploitation of the copyright work in the preceding calendar year, less the total direct costs incurred by the Organisation for the commercialisation, licensing and/or protection of the relevant patent, know-how and/or copyright work. 183

198 INTELLECTUAL PROPERTY & PUBLICATION APPENDIX 2: NDA Flowchart Identify Reuirement Create and Draft Documentation Review Corporate Counsel Yes Approve Corporate Counsel No Execution Head of department Distribute, Record and Store 184

199 INTELLECTUAL PROPERTY & PUBLICATION APPENDIX 3: Standard NDA Template Non-Disclosure Agreement Agreement between Disclosing Party and Recipient Disclosing Party Name: [insert name] Address: [insert adress] and Recipient Name: [insert name] Title: [insert address] Company: [insert company] Address: [insert address] The Project The Project is as described hereunder: Project Title: [insert title] Brief Description: [insert description] Confidential Information Confidential Information means confidential technical, commercial or information of the Disclosing Party (whether oral, written or pictorial) of, or relating directly to, the Project but does not include information which: i. was in the public domain, or in the Recipient s possession prior to the date of this agreement; ii. comes into the public domain after the date of this agreement; iii. is supplied to the Recipient by another party who is under no obligation of confidence to the Disclosing Party. Terms of Agreement 1. The Recipient acknowledges that the confidential information provided or conveyed to it concerning the Project is made available by the Disclosing Party for the purpose of considering, advising on, and/or evaluating the Project. 2. The Recipient undertakes that it will not use the confidential information so provided for any other purpose than as stated in Clause 1 above without the consent of the Disclosing Party. 3. The Recipient undertakes that it will not disclose the confidential information provided to any other party, nor publish, use, reproduce or copy the confidential information, or allow it to be published, used, reproduced or copied by any other party without the prior consent of the Disclosing Party except: i. as necessary for the the purpose outlined in Clause 1; ii. as reuired by law; iii. as permitted by the Disclosing Party. 185

200 INTELLECTUAL PROPERTY & PUBLICATION APPENDIX 3: Standard NDA Template Non-Disclosure Agreement continued 4. The Recipient undertakes to maintain effective security measures to protect the confidential information from unauthorised access, use or disclosure. 5. On the reuest of the Disclosing Party the Recipient undertakes to deliver up all the confidential information provided by the Disclosing Party with 14 days (fourteen days). 6. The Recipient acknowledges that any breach of the terms and conditions of this agreement may result in legal action. Authorisation Who warrants that they are duly authorised to execute this agreement on behalf of the party. Disclosing Party Name (printed) Signature Witness (printed) Signature Date: / / Recipient Party Name (printed) Signature Witness (printed) Signature Date: / / 186

201 Research Risk Management How to use the Research Risk Management Guide 187 Tools and Templates 188 Risk Management Glossary 189 Risk Management Process 194 Risk Management Policy and Procedure 195 Risk Management Framework Checklist 196 Opportunities for identifying risks in Research Organisations 198 Risk Reporting by Category (sample only) 199 Research risks and risk categories (sample only) 200 Research risks and risk categories Template 201 Risk Summary Heat Map 1 (sample only) 202 Risk Summary Heat Map 2 (sample only) 203 Risk Summary Heat Map 3 (sample only) 204 Risk Assessment Template (sample only) 205 Risk Register Template (sample only) 206 An introduction to Risk Management Powerpoint 207 RESEARCH RISK MANAGEMENT

202 Preamble Risk is ubiuitous and as such, there is a growing emphasis on the importance of effective risk management in organisations. It is now recognised by the NHMRC as an essential element of good research governance. By definition risk management describes the activities an organisation undertakes to manage the effect of uncertainty on its objectives. Importantly, risk management is not only concerned with responding to threats, but seizing opportunities as well. The purpose of this guide is to provide the RGO with a practical resource for enhancing risk management practice. It is not intended to replace existing practices that are working well in your organisation. It is not the intent of this guide to provide a comprehensive resource manual for all risk management activities. More detailed information is available in the VMIA s Guide for developing and implementing your risk management framework available on the VMIA website As research is fundamentally concerned with deliberately exploring what is unknown and unpredictable, it is important that a realistic balance is maintained between risk management and epistemology. Risk management should add value to a research organisation, not stifle innovation and creativity.

203 RESEARCH RISK MANAGEMENT How to use the Research Risk Management Guide The materials contained in this section reflect the reuirements of the Australian risk management standard and the Victorian Government Risk Management Framework The Risk Management Framework Checklist identifies the key elements of a risk management framework. That is, the structures, processes and culture an organisation uses to manage risks. The checklist could be used by research organisations to address three key uestions: How sophisticated do we want our risk management framework to be? How effective are our current risk management practices? What is the most effective and efficient way of closing any gaps? The associated tools and templates have been specifically designed to support the reader s understanding and application of the checklist. The tools and templates are simply a guide and should be customised to meet the uniue needs of individual organisations. Each institute should ensure that its Research Risk Management endeavours are consistent with the institute s Enterprise Risk Management activities and processes. Importantly, the VMIA provides risk management and insurance services to Victorian public sector organisations. This includes the provision of resource material, publications and an extensive client training program. Further information regarding all services is available via the VMIA website 187

204 RESEARCH RISK MANAGEMENT Tools and Templates To be used in conjunction with the Risk Management Framework Checklist. An introduction to risk management A series of Power Point slides outlining risk management fundamentals. Risk management glossary Definition of commonly used risk management terms. Risk management process A brief description of each element of the risk management process. Sample research risks and risk categories The aim of this tool is to encourage organisations to consider a wide range of risks that may impact on their business activities it is not a comprehensive list of all risks. Research organisations must always identify risks and risk categories that reflect their own uniue context. Sources of risk identification Accurate risk identification is a core component of the risk management process. This document identifies opportunities for identifying risks in research organisations. Risk assessment template A sample template for recording an emerging risk. Useful websites NHMRC Australian code for the responsible conduct of research. Guide to the development, evaluation and implementation of clinical practice guidelines. National Statement on Ethical Conduct in Human Research Challenging ethical issues in contemporary research in human beings. Dangerous Goods Publications dangerous/publications.aspx Office of the Gene Technology Regulator Australian Quarantine & Inspection Service Dangerous Goods Training Security Sensitive Biological Agents nsf/content/ssba.htm#standards Risk Register template A sample template for documenting a risk register. Risk management policy and procedure This document identifies the key headings for a risk management policy and procedure. Research organisations are encouraged to review current policies and procedures in other like organisations. Risk reporting templates: Risk summary heat map. Risk reporting heat map. Risk reporting by category. Sample templates for reporting key risks to the Board, Committees or executive group. 188

205 RESEARCH RISK MANAGEMENT Risk Management Glossary Agency-level risks Risk that have the potential to impact the outputs or organisational objectives of a SPECIFIC AGENCY. These can become risks to the state because of their size and significance, because of their wider impact of measures to manage them, or because of poor management by agencies (VGRMF). Audit committee The Standing Directions of the Minister for Finance state that an audit committee is appointed to oversee and advise the department or agency on matters of accountability and internal control. This committee is a subset of the Responsible Body (or Board), which has been formulated to deal with issues of a specific nature (VGRMF). Australian/ New Zealand Risk Management Standard (or ISO Standard) A generic and flexible standard that is not specific to any government or industry sector. The Standard identifies elements or steps in the risk management process that can be applied to a wide range of activities at any stage of implementation (VGRMF). Communication and consultation Continual and iterative processes that an organization conducts to provide, share or obtain information and to engage in dialogue with stakeholders regarding the management of risk. Notes: 1. The information can relate to the existence, nature, form, likelihood, significance, evaluation, acceptability and treatment of the management of risks. 2. Consultation is a two-way process of informed communication between an organisation and its stakeholders on an issue prior to making a decision or determining a direction on that issue. Consultation is: A process which impacts on a decision through influence rather than power, and An input to decision making, not joint decision making. Conseuence Outcome of an event impacting objectives. Notes: 1. An event can lead to a range of conseuences. 2. A conseuence can be certain or uncertain and can have positive or negative effects on objectives. 3. Conseuences can be expressed ualitatively or uantitatively. 4. Initial conseuences can escalate through knock-on effects. Control Measure that is modifying risk. 1. Controls include any policy, process, device, practice or other actions which modify risk. 2. Controls may not always exert the intended or assumed modifying effect. Control assessment Systematic review of to ensure that controls are still effective and appropriate. Enterprise-Wide Risk Management (ERM) An integrated approach to assessing and addressing all risks that threaten achievement of the organization s strategic objectives. The purpose of ERM is to understand, prioritise, and develop action plans to maximise benefits and mitigate top risks. Establishing the context Defining the external and internal parameters to be taken into account when managing risk and setting scope and risk criteria for the risk management policy. Event Occurrence or change of a particular set of circumstances. Notes: 1. An event can be one or more occurrences, and can have several causes. 2. An event can consist of something not happening. 3. An event can sometimes be referred to as in incident or accident. 4. An event without conseuences can also be referred to as a near miss, incident, near hit or close call. Exposure Extent to which an organisation and/or stakeholder is subject to an event. External context External environment in which the organisation seeks to achieve its objectives. Note: External context can include: The cultural, social, political, legal, regulatory, financial, technological, economic, natural and competitive environment whether international, national, regional or local. Key drivers and trends having impact on the objectives of the organisation, and Relationships with, and perceptions and values of external stakeholders. 189

206 RESEARCH RISK MANAGEMENT Risk Management Glossary continued Freuency Number of events or outcomes per defined unit of time. Note: Freuency can be applied to past events or to potential future events, where it can be used as a measure of likelihood/probability. General government The largest sector comprising government departments, offices and other government bodies engaged in providing public services free of charge or at prices significantly below the cost of production (VGRMF). Hazard A source of potential harm. Note: Hazard can be a risk source. Inter-agency risks Which id unmitigated by one agency, become risks for other agencies. Internal audit Independent, objective assurance and consulting activity designed to add value and improve an organisation s operations accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of: (1) Risk management (2) Control, and (3) Governance processes. (IIA Professional Practices Framework). Internal context Internal environment in which the organization seeks to achieve its objectives. Note: Internal context can include: governance, organisational structure, roles and accountabilities. policies, objectives and the strategies that are in place to achieve them. the capabilities, understood, and in terms of resources and knowledge (eg. capital, time, people, processes, systems and technologies). information systems, information flows and decision making processes (both formal and informal). relationships with, and perceptions and values of internal stakeholders. the organisation s culture. standards, guidelines and models adopted by the organisation, and form and extent of contractual relationships. Key control indicator (KCI) Measures or metrics that demonstrate a change in a specific control s effectiveness. Key performance indicators (KPIs) Metrics or measures used to monitor changes in business performance in relation to specific business objectives (eg. volumes of business, revenue etc). Key risk Indicators (KRI) Measures and metrics that relate to a specific risk and demonstrate a change in the likelihood or conseuence of the risk occurring. Level of Risk Magnitude of a risk or combination of risks, expressed in terms of the combination of conseuences and their likelihood. Likelihood Chance of something happening. Note: 1. In risk management terminology, the word likelihood is used to refer to the chance of something happening, whether defined, measured or determined objectively or subjectively, ualitatively or uantitatively, and described using general terms or mathematically [such as probability or freuency over a given time period]. 2. The English term likelihood does not have a direct euivalent in some languages; instead the term probability is often used. However, in English, probability is often narrowly interpreted as a mathematical term. Therefore, in risk management terminology, likelihood is used with the intent that it should have the same broad interpretation as the term probability has in many languages other than English. Loss Any negative conseuence or adverse effect, financial or otherwise. Mitigation Measures taken in advance of, or after, a disaster aimed at decreasing or eliminating its impact on society and the environment (COAG 2004). Monitoring Continual checking, supervising, critically observing or determining the status in order to identify change from the performance level reuired or expected. Note: Monitoring can be applied to a risk management framework, risk management process, risk or control. 190

207 RESEARCH RISK MANAGEMENT Risk Management Glossary continued Natural disaster A serious disruption to a community or region caused by the impact of a naturally occurring rapid onset event that threatens or causes death, injury or damage to property or the environment and which reuires significant and coordinated multi-agency and community response. Such serious disruption can be caused by any one, or a combination, of the following natural hazards: bushfire; earthuake; flood; storm; cyclone; storm surge; landslide; tsunami; meteorite strike; or tornado (COAG 2004). Probability Measure of the chance of occurrence expressed as as a number between 0 and 1, where 0 is impossibility and 1 is absolute certainty. Public financial corporations (PFC) Entities primarily engaged in the provision of financial services (eg. Treasury Corporation Victoria, Transport Accident Commission, Rural Finance Corporation, State Trustees) (VGRMF). Public Non-financial Corporations (PNFC) Provide goods and services (of a non-financial nature) within a competitive market. (For example: water and port authorities, cemetery trusts, waste management groups, or Federation Suare Pty Ltd) (VGRMF). Public sector Entities that are controlled by the Victorian Government Sector classification used by the AFR include general government, public non-financial corporations and the public financial corporations (VGRMF). Residual risk Risk remaining after risk treatment. Notes: 1. Residual risk can contain unidentified risk. 2. Residual risk can also be known as retained risk. Resilience Adaptive capacity of an organisation in a complex and changing environment. Responsible body For a Government Department, the Accountable Officer and for every other Public Sector Agency, the board (VGRMF). Review Activity undertaken to determine the suitability, adeuacy and effectiveness of the subject matter to achieve established objectives. Note: Review can be applied to a risk management framework, risk management process, risk or control. Risk Effect of uncertainty on objectives. Notes: 1. An effect is a deviation from the expected - positive and/or negative. 2. Objectives can have different aspects (such as financial, health and safety, and environmental goals) and can apply at different levels (such as strategic, organisation-wide, project, product or process). 3. Risk is often characterised by reference to potential events and conseuences, or a combination of these. 4. Risk is often expressed in terms of a combination of the conseuences of an event (including changes in circumstances) and the associated likelihood of occurrence. 5. Uncertainty is the state, even partial, of deficiency of information related to, understanding or knowledge of an event, its conseuence or likelihood. Risk acceptance Informed decision to take a particular risk. Note: 1. Risk acceptance can occur without risk treatment or during the process of risk treatment. 2. Accepted risks are subject to monitoring and review. Risk aggregation Combination of a number of risks into one risk to develop a more complete understanding of the overall risk. Risk analysis Process to comprehend the nature of risk and to determine the level of risk. Note: 1. Risk analysis provides the basis for risk evaluation and decisions about risk treatment. 2. Risk analysis includes risk estimation. Risk appetite Amount and type of risk that an organisation is willing to pursue or retain. Risk assessment Overall process of risk identification, risk analysis and risk evaluation. Risk attitude An organisation s approach to assess and eventually pursue, retain, take or turn away from risk. Risk aversion Attitude to turn away from risk. 191

208 RESEARCH RISK MANAGEMENT Risk Management Glossary continued Risk avoidance Informed decision not to be involved in, or to withdraw from, an activity in order not to be exposed to a particular risk. Risk criteria Terms of reference against which the significance of risk is evaluated. Notes: 1. Risk criteria are based on organisational objectives and internal and external context 2. Risk criteria can be derived from standards, laws, policies and other reuirements. Risk description Structured statement of risk usually containing four elements: sources, events, causes and conseuences. Risk evaluation Process of comparing the results of risk analysis with risk criteria to determine whether the risk and/or its magnitude is acceptable or tolerable. Note: Risk evaluation assists the decision about risk treatment. Risk financing Form of risk treatment involving contingent arrangements for the provision of funds to meet or modify the financial conseuences should they occur. Risk Framework Quality Review (RFQR) Risk Framework maturity review performed by the VMIA for its clients. The review assesses and benchmarks a client s risk management processes/ documents and outcomes against best practice in order to provide practical improvement recommendations. Risk identification Process of finding, recognising and describing risks Notes: 1. Risk identification involves the identification of risk sources, events, their causes and their potential conseuences. 2. Risk identification can involve historical data, theoretical analysis, informed and expert opinions, and stakeholders needs. Risk management Coordinated activities to direct and control an organisation with regard to risk. Risk management audit Systematic, independent and documented process of obtaining evidence and evaluating it objectively in order to determine the extent to which the risk management framework, or any selected part of it is adeuate and effective. Risk management framework Set of components that provide the foundations and organisational arrangements for designing, implementing, monitoring, reviewing and continually improving risk management throughout the organisation. Notes: 1. The foundations include the policy, objectives, mandate and commitment to manage risk. 2. The organisational arrangements include plans, relationships, accountabilities, resources, processes and activities. 3. The risk management framework is embedded within the organisation s overall strategic and operational policies and practices. Risk management plan Scheme within the risk management framework specifying the approach, the management components and resources to be applied to the management of risk. Notes: 1. Management components, typically include procedures, practices, assignment of responsibilities, seuence and timing of activities. 2. The risk management plan can be applied to a particular product, process and project, and part or whole of the organisation. Risk management policy Statement of the overall intentions and direction of an organisation related to risk management. Risk management process Systematic application of management policies, procedures and practices to the activities of communicating, consulting, establishing the context, and identifying, analysing, evaluating, treating, monitoring and reviewing risk. Risk management reports A regular report made available to executive management, boards and audit committees that inform how key risks (state-wide risks, strategic risks and emerging risks) are being managed (VAGO). Risk matrix (or heat map) Tool for ranking and displaying risks by defining ranges for conseuence and likelihood. Risk mitigation Measures taken to reduce an undesired conseuence (ISO 31000). Risk owner Person or entity with the accountability and authority to manage a risk. 192

209 RESEARCH RISK MANAGEMENT Risk Management Glossary continued Risk perception Stakeholder s view on risk. Note: Risk perception reflects the stakeholder s needs, issues, knowledge, belief and values. Risk profile Description of any set of risks. Note: The set of risks can contain those that relate to the whole organisation, part of the organisation, or as otherwise defined. Risk reduction Actions taken to lessen the likelihood, negative conseuences, or both, associated with a risk. Risk register Record of. Information about identified risks. Note: The term risk log is sometimes used instead of risk register. Risk reporting Form of communication intended to inform particular internal or external stakeholders by providing information regarding the current state of risk and its management. Risk retention Acceptance of the potential benefit of gain, or burden of loss, from a particular risk. Notes: 1. Risk retention includes the acceptance of residual risks. 2. The level of risk retained can depend on risk criteria. Risk severity A measure of the magnitude of a risk, based an a combination of the likelihood and conseuence of a risk. Risk sharing Form of risk treatment involving the agreed distribution of risk with other parties. Notes: 1. Legal or regulatory reuirements can limit, prohibit or mandate risk sharing. 2. Risk sharing can be carried out through insurance or other forms of contract. 3. The extent to which risk is distributed can depend on the reliability and clarity of the sharing arrangements. 4. Risk transfer is a form of risk sharing. Risk source Element which alone or in combination has the intrinsic potential to give rise to risk. Note: A risk source can be tangible or intangible. Risk tolerance Organisation s or stakeholder s readiness to bear the risk, after treatment in order to achieve its objectives. Note: Risk tolerance can be influenced by legal or regulatory reuirements. Risk treatment Process to modify risk. Note: 1. Risk treatment can involve: avoiding the risk by deciding not to start or continue with the activity that gives rise to the risk. taking or increasing the risk tin order to pursue an opportunity. removing the risk source. changing the likelihood. changing the conseuence. sharing the risk with another party or parties [including contracts or risk financing]; and retaining the risk by informed decision. 2. Risk treatments that deal with negative conseuences are sometimes referred to as risk mitigation, risk elimination, risk prevention and risk reduction. 3. Risk treatment can create new risks or modify existing risks. Stakeholder Person or organisation that can affect, be affected by, or perceive themselves to be affected by a decision or activity. Note: A decision maker can be a stakeholder. Statewide risks Those risks which are beyond the boundaries of only one agency, other agencies, or impact at a whole-ofgovernment level. Victorian Government Risk Management Framework (VGRMF) Guidance document released by the Department of Treasury and Finance in July 2007, which has been developed to support good practice in public sector risk management. Specifically the framework provides for a minimum common risk management standard for public sector entities and attestation by accountable officers that risk management processes are consistent with that standard in annual reports. (Victorian Government Risk Management Framework). Vulnerability Intrinsic properties of something resulting in susceptibility to a risk source that can lead to an event with a conseuence. References VMIA Guide for developing and implementing risk management frameworks - July

210 RESEARCH RISK MANAGEMENT Risk Management Process The risk management process described in the Australian risk management standard can be used to guide the management of all risks. Establish context Communicate and Consult Identify risks Analyse risks Evaluate risks Treat risks Monitor and Review Communicate and Consult Establish context Identify risks What could happen? Analyse risks What does that mean for us? Evaluate risks What are our priorities? Treat risks What are we going to do to address the risk? Monitor & review Actively engage with stakeholders throughout each step of the process. Consider the organisation s culture, environment and parameters that influence how risks are managed. Identify what can happen and then why, where, when and how it can occur. What is currently in place (controls) to manage the risk? Taking into account the effectiveness of the current controls, what is the likelihood of the event happening and the conseuences should it occur? Use your organisation s risk rating matrix to calculate the level of risk. Use the risk rating to inform decision making about whether the risk is acceptable or not. Consider the degree of control possible for that risk, and the costs and benefits associated with treating it. Prioritise unacceptable risks and communicate the rationale for your decisions. Consider treatment options and action plans for controlling risks. Options include- Avoiding the risk by ceasing to perform the activity, function or service. Reducing the likelihood and / or impact of the risk by modifying work practices, systems and processes. Sharing the risk with another party, such as an insurer or contractor. Retention of the remaining risks - but developing a plan for responding, should it occur. Monitor and review the effectiveness of actions taken to address the risk. 194

211 RESEARCH RISK MANAGEMENT Risk Management Policy and Procedure Risk management policy key headings Rationale for managing risk Risk management purpose and objectives Links between the policy and the organisation s objectives Accountabilities and responsibilities for managing risk Risk management governance How risk management performance will be measured and reported Risk management resources Commitment to the periodic review and improvement of the risk management policy and framework Detailed roles and responsibilities How risk management is integrated with other key activities Definition of risk management terms - glossary How the risk management process will be applied activities for managing risks Risk reporting content, process, tools and templates Risk rating criteria: likelihood scale conseuence scale risk rating matrix Risk escalation criteria 195

212 RESEARCH RISK MANAGEMENT Risk Management Framework Checklist Reuirement Yes / No Outcome / Progress Action still reuired By whom? By when? 1 Has the Board and Executive expressed their support for a risk management programme? 2 Have you liaised with relevant personnel in your organisation to identify what risk management structures and resources are currently in place? eg. Risk Manager, OHS, Quality Manager. 3 Have you identified the internal and external influences impacting on how risk is managed in Research Organisations? eg. key drivers, industry standards, regulatory reuirements etc 4 Have you identified those people who will be responsible for implementing any changes to how risks are managed in the organisation? 5 Does that person/s have reasonable access to staff and management across the organisation? Do he/she have the authority to implement the changes? 6 Have you defined categories of risk relevant to your organisation and the research environment? 7 Have you defined and agreed a likelihood scale to promote consistency in how important risks are rated across the organisation? 8 Have you defined and agreed a conseuence scale to promote consistency in how important risks are rated across the organisation? 9 Does your conseuence scale describe both financial and non-financial impacts? eg. impact to reputation. 10 Have you defined and agreed a risk rating matrix? (combination of likelihood and conseuences) 11 Have you established mechanisms for identifying risks? Note: The risk management process outlined in The Australian Standard should be utilised to manage all risks. 12 Do your risk rating tools prompt staff to consider the effectiveness of risk controls? i.e. A control is a measure to modify risk. Controls are the end result of risk treatment. 13 Have you defined and agreed a risk escalation criteria to ensure the right people are aware of important risks? 14 Is there an agreed template or format for recording an important risk? Risk assessment template (single risk) Risk Register or Profile (multiple risks) Risk Treatment Plan Note: The risk management process outlined in The Australian Standard should be used to manage all risks. 196

213 RESEARCH RISK MANAGEMENT Risk Management Framework Checklist continued Reuirement Yes / No Outcome / Progress Action still reuired By whom? By when? 15 Have you defined and agreed which risks should be recorded? eg. Risks with a high or extreme rating Risks that cannot be addressed by taking immediate local action Risks beyond the individual s scope of practice or experience Risks associated with new projects or initiatives Risks associated with new euipment All risks? 16 Has a Risk Management Policy been defined and endorsed? 17 Do position descriptions of key stakeholders include responsibility for risk management? 18 Do relevant committee charters include responsibility for risk management? 19 Is there an agreed format / template for reporting risks? eg. Heat map Risk Register Summary Risk assessment template (single risk) Emerging risks 20 Have the Executive and the Board provided guidance on what information they would like to see in reports? 21 Is there a risk owner for each important risk? Do managers / supervisors know they are responsible for managing risk in their own areas? 22 Is an Internal Audit function in place? 23 Have you identified the risk management priorities for the coming year? 24 Have you developed a Risk management plan to support the implementation of improved risk management practices? 25 Have you developed an education program to ensure staff and key stakeholders are aware of their risk management responsibilities? 26 Has your organisation made a risk management attestation in the Annual Report? 27 Has the Board and Executive expressed their support for the ongoing evaluation of risk management practice? 28 Have you identified a strategy for monitoring the effectiveness of risk management? 197

214 RESEARCH RISK MANAGEMENT Opportunities for identifying risks in Research Organisations Literature / publications Strategic and business plans Legislation Meetings & brainstorming activities Industry standards & regulatory reuirements Event analysis eg. Adverse events, RCA, claims Identify risks in your organisation by reviewing: Research applications Process mapping & analysis eg. FMEA Research outcomes Feedback & complaints Incident & hazard reports Data performance indicators Risk assessment eg. hazardous goods 198

215 RESEARCH RISK MANAGEMENT Risk reporting by category Financial Infrastructure Commercial Operational Safety Human Resources Governance Strategic Liuidity failure to secure timely / adeuate funding Failure of key utility - electricity IT failure Breach of contract Failure to protect intellectual property Serious errors in research data analysis Laboratory hazards serious staff injury Failure to recruit and retain staff to critical roles Failure Risk to Management comply with guidelines regulatory reuirements Significant change in gov t research policy Fraud misappropriation of funds Failure of key infrastructure eg. cooling Publication of inaccurate or incomplete information Damage / loss of key research specimens Failure to identify & treat adverse clinical outcomes Failure to verify credentials and scope of practice Interruption to business continuity Approval of a project with unjustified net research risk Underfunding projects to ensure success rates Lost, damaged or incomplete research records Manual handling serious staff injury Breach of employment contract Serious research misconduct Staff exposure to genetically modified organisms Example 1 Assessed risk Inherent risk High risk Medium risk Low risk This document is a sample only. Organisations must always identify risks and risk categories that reflect their own uniue context. 199

216 RESEARCH RISK MANAGEMENT Research risks and risk categories Financial Infrastructure Commercial Operational Safety Human Resources Governance Strategic Liuidity failure to secure timely / adeuate funding Fraud misappropriation of funds Failure of key utilities - eg. electricity Failure of key infrastructure eg. cooling Breach of contract Poor research outcomes Failure to protect intellectual property Serious errors in research data analysis Laboratory hazards serious staff injury Failure to identify and treat adverse clinical outcomes Failure to recruit and retain staff to critical roles Failure to verify credentials and scope of practice Failure to comply with regulatory reuirements Undeclared conflicts of interest Significant change in goverment research policy Significant change in regulatory reuirements Over reliance on primary funding source Underfunding projects to ensure success rates IT failure Loss of / inadeuate communications Breach of intellectual property or patent Breach of privacy or confidentiality Damage / loss of key research specimens Lost, damaged or incomplete research records Security threat to personnel Staff exposure to genetically modified organisms Breach of employment contract Industrial dispute Other? Disruption to business continuity Ineffective project management Breakdown of key internal or external relationships Financial crisis reduced opportunities for fund raising Other? Other? Theft Other? Coercion of research participants Inadeuate consent of research participants Other? Approval of a project with unjustified net research risk Serious research misconduct Inappropriate disposal of hazardous waste Other? Publication of inaccurate or incomplete information Inappropriate storage or use of hazardous materials Other? Failure to procure the right supplies within budget Security breach of information systems Other? Risk description (sample only) Risk IT failure Causes Power failure Ageing server This document is a sample only. Organisations must always identify risks and risk categories that reflect their own uniue context. Impact Loss of critical research data 200

217 RESEARCH RISK MANAGEMENT Research risks and risk categories Template Risk description (sample only) Risk IT failure Causes Power failure Ageing server Impact Loss of critical research data This document is a sample only. Organisations must always identify risks and risk categories that reflect their own uniue context. 201

218 RESEARCH RISK MANAGEMENT Risk Summary Heat Map 1 Likelihood Conseuence Insignificant Minor Moderate Major Catastrophic Almost Certain Likely Records Change in gov t policy Utilities - electricity Possible Privacy Liuidity Adverse clinical outcomes Failure to protect IP Credentialling Unlikely Procurement Breach of contract Fraud Fundraising Rare High risk Medium risk Low risk This document is a sample only. Organisations must always identify risks and risk ratings that reflect their own uniue context. 202

219 RESEARCH RISK MANAGEMENT Risk Summary Heat Map 2 Rank Risk Owner Risk Category Risk description Risk rating Status Reason for change in ranking Action reuired 1 Infrastructure Unreliable electricity supply may result in significant interruption to business continuity. Likelihood likely Conseuence catastrophic Rating extreme 2 Strategic Proposed changes in federal government research policy may result in reduced opportunities for funding. Likelihood likely Conseuence major Rating extreme 3 Safety Failure to identify and treat adverse clinical outcomes in research participants. Likelihood possible Conseuence major Rating high 4 Financial Liuidity - failure to secure timely or adeuate research funding. Likelihood possible Conseuence major Rating high 5 Human Resources Failure to verify credentials and scope of practice of research personnel. Likelihood possible Conseuence major Rating high 6 Commercial Failure to protect the intellectual property of XX Institute. Likelihood possible Conseuence major Rating high 7 Operational Lost, damaged or incomplete research records. Likelihood likely Conseuence moderate Rating high 8 Commercial Failure to maintain privacy or confidentiality of research participants. Likelihood possible Conseuence moderate Rating high Risk has increased in past 3 months Risk has decreased in past 3 months Risk has remained constant in past 3 months This document is a sample only. Organisations must always identify risks and risk categories that reflect their own uniue context. 203

220 RESEARCH RISK MANAGEMENT Risk Summary Heat Map 3 Rank Risk Owner Risk Category Risk description Risk rating Status Reason for change in ranking Action reuired 1 Infrastructure Unreliable electricity supply may result in significant interruption to business continuity. 2 Strategic Proposed changes in federal government research policy may result in reduced opportunities for funding. 3 Safety Failure to identify and treat adverse clinical outcomes in research participants. 4 Financial Liuidity - failure to secure timely or adeuate research funding. Likelihood likely Conseuence catastrophic Rating extreme Likelihood likely Conseuence major Rating extreme Likelihood possible Conseuence major Rating high Likelihood possible Conseuence major Rating high 5 Human Resources Failure to verify credentials and scope of practice of research personnel. Likelihood possible Conseuence major Rating high 6 Commercial Failure to protect the intellectual property of XX Institute. 7 Operational Lost, damaged or incomplete research records. 8 Commercial Failure to maintain privacy or confidentiality of research participants. Likelihood possible Conseuence major Rating high Likelihood likely Conseuence moderate Rating high Likelihood possible Conseuence moderate Rating high This document is a sample only. Organisations must always identify risks and risk ratings that reflect their own uniue context. Risk has increased in past 3 months Risk has decreased in past 3 months Risk has remained constant in past 3 months 204

221 RESEARCH RISK MANAGEMENT Risk Assessment Template LOGO Area / Department: Risk Assessment completed by: Date assessed: Risk description and impact Causes Current controls Controls effectiveness Risk rating What can happen - when and where? What is the impact? How - what are the causes of this risk? What is currently in place to manage this risk? How effective are the current controls? Use your organisation s risk rating matrix to assess the risk 2 Likelihood Conseuence Rating Escalation Risk treatment Monitor and review How needs to know about this risk? Ensure the right people are notified. What do we need to do to control this risk? Avoid? Reduce? Share? Retain? By whom? By when? How will we monitor our progress with this risk? 205

222 RESEARCH RISK MANAGEMENT Risk Register Template LOGO Risk title Inherent risk rating Risk status Risk category Target risk rating Risk owner Risk description and impact Causes Current controls Controls effectiveness Risk rating 2 What are the causes of this risk? What is currently in place to manage this risk? How effective are the current controls? Use your organisation s risk rating matrix to assess the risk Likelihood Conseuence Rating Risk treatment Monitor and review What do we need to do to control this risk? Avoid? Reduce? Share? Retain? By whom? By when? Controls assurance mechanisms How will we monitor progress with this risk? KPIs? 206

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