Policy Checklist. March Date for further review March Name of Policy: Purpose of Policy:

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1 Name of Policy: Purpose of Policy: Directorate responsible for Policy Name & Title of Author: Policy Checklist Policy for the Management of Research and Development To encourage and support a quality Research and Development culture Medical Directorate Reviewed Policy Dr Peter Sharpe, Consultant Chemical Pathologist, Associate Medical Director Research and Development Yes Does this meet criteria of a Policy? Staff side consultation? Yes in 2008 when initially developed Equality Screened by: Research Governance Committee Date Policy submitted to Policy 30 March 2015 Scrutiny Committee: Members of Policy Scrutiny Committee in Attendance: Members of Policy Scrutiny Committee in Attendance: Vivienne Toal, Head of Employee Engagement & Relations (Chair) Anita Carroll, Assistant Director of Acute Services Functional Support Services Claire Graham, Head of Corporate Records Fiona Wright, Assistant Director of Nursing Governance Carmel Harney, Assistant Director of Allied Health Professionals, Governance & Workforce Planning Francesca Leyden, Assistant Director of Social Work & Social Care Governance, Workforce Development and Planning Policy Approved/Rejected/ Amended Policy Implementation Plan included? Any other comments: Date presented to SMT Director Responsible SMT Approved / Rejected / Amended SMT Comments Approved 30 March 2015 Reviewed Policy will be placed on the Trust s Intranet and brought to the attention of staff through staff Newsletters. N/A Dr John Simpson N/A N/A Date returned to Directorate Lead for implementation (Board Secretary) Date received by Board Secretary for database/intranet/internet N/A March 2015 Date for further review March 2017 Policy for the Management of Research and Development

2 Title Supersedes Originator Scrutiny Committee & SMT approval POLICY DOCUMENT VERSION CONTROL SHEET Title: Policy for the Management of Research and Development Version: 2 dated October 2013 Reference number/document name: /Policy for the Management of Research and Development Supersedes: Policy for the Management of Research and Development version 1.1 dated 17 May 2011 Description of Amendments(s)/Previous Policy or Version: Minor amendments include reference to DHSSPS now HSC PHA (3.1), update of 5.0 Scope of Policy responsibilities throughout 6.4 and removal of reference to Trust Research Management System this document is no longer in use and 9.0 Policy Approval. Name of Author: Dr Peter Sharpe Title: Associate Medical Director Research & Development Referred for approval by: Not Applicable Date of Referral: Scrutiny Policy Committee Approval SMT approval (Date) Circulation Issue Date: April 2015 Circulated By: Miss Irene Knox, Research Manager Issued To: Research Governance Committee Review Review Date: December March 2017 Responsibility of (Name): Dr Peter Sharpe Title: Associate Medical Director Research & Development

3 POLICY FOR THE MANAGEMENT OF RESEARCH AND DEVELOPMENT Author Dr Peter Sharpe Directorate responsible Medical Directorate for this Document Policy Number Date of Implementation 1 January 2008 Date of Review March 2015 Screened by Dr Peter Sharpe Screening Document 004 Reference Number Policy for the Management of Research and Development

4 Contents Page 1.0 Introduction Definitions Purpose and Aims Policy Statement Scope of the Policy Responsibilities Chief Investigator and Other Researchers Main Funder Sponsor Trust as Employing Organisation Trust as Provider of Care / Responsible Care Professional Legislative Compliance, Relevant Policies, 8 Procedures and Guidance 8.0 Equality and Human Rights Considerations Alternative Formats Copyright Policy Approval Policy Implementation, Training and Education Review of Policy Sources of Advice and Further Information 10

5 1.0 Introduction 1.1 The Southern Health & Social Care Trust (hereafter referred to as the Trust ) Research and Development Policy is based on the R&D Office, Research Governance Framework for Health and Social Care, February The Trust is committed to ensuring that robust integrated governance arrangements are in place in the operation of its business. This policy sets out how the Trust will manage research and development (R&D). It provides a simple, consistent approach for all staff involved in R&D. 1.3 The Trust is committed to providing a high quality service to all service users and considers that R&D should be used as a means of promoting continuous service improvement. 1.4 The Trust is committed to fostering, encouraging and supporting a quality R&D culture. 1.5 This Policy has been developed in accordance with the Trust s key principles for policy development. 1.6 This Policy has been developed in consultation with the appropriate internal stakeholders. 2.0 Definitions 2.1 Research is defined as a systematic activity that: Attempts to answer a clearly defined question; Employs systematic and rigorous methods including quantitative and/or qualitative paradigms; and Leads to new knowledge. For an activity to be classified as research it must meet all three qualifying elements. 2.2 Development is defined as: The planned implementation and utilisation of evidence through the use of systematic processes of change. 3.0 Purpose and Aims

6 3.1 The purpose and aims of this policy are to: Encourage and support a quality R&D culture; Introduce support and management structures that will allow R&D active professionals to perform in an environment that is conducive to the highest standards of quality, transparency and integrity; and Align Trust practices with those of the DHSSPS R&D Office Research Governance Framework for Health and Social Care. Since 2009, under a major reform of Health Structures in Northern Ireland this agency is now known as HSC PHA R&D Office (Health & Social Care Public Health Agency) 4.0 Policy Statement 4.1 The Trust encourages and supports a high quality R&D culture and the delivery of research within appropriate governance arrangements. In this regard this policy is: An underpinning mechanism for R&D conducted in or with the Southern Health and Social Care Trust. 5.0 Scope of the Policy 5.1 The scope of this policy extends to all HSC sponsored Research and Development and also to all other Research and Development applications e.g those sponsored by Third Parties such as Commerce Industries and Charities which may be approved by the Trust s Research Governance Committee following consideration and approval of a full and complete business case: Clinical and non-clinical research, undertaken by Health and Personal Social Services Staff (HPSS) using HPSS resources; and Research undertaken by industry, the charities, the research councils and universities associated with health and social care systems This policy is of direct relevance to all those who host, conduct, participate in, fund and manage health and social care research.

7 5.1.4 : In accordance with no Research staff will be employed until the signed Agreement is in place detailing the source of funding for the associated staff. All such staff will be employed in accordance with Trust Policies and Procedures for the Recruitment of Staff for the fixed term of the research study. All research studies are approved in accordance with the Trust s Research Governance approval process. 6.0 Responsibilities 6.1 The Trust s Chief Executive, as Accountable Officer has overall responsibility for ensuring the aims of this policy are met. 6.2 The Medical Director is the designated Executive Director with responsibility for the management of R&D. 6.3 The Associate Medical Director Research & Development will be responsible for the development and delivery of a research strategy that will support and promote research as a core function of the Southern Health and Social Care Trust. 6.4 The following is a summary of the key responsibilities of people and organisations accountable for the proper conduct of a Study: Chief Investigator, Investigators and other researchers Developing proposals that are scientifically sound and ethical Submitting the design for independent expert review Submitting the study application for independent ethical review Obtaining the appropriate regulatory approvals for all study documentation and processes eg NHS Research Ethics Committee, MHRA (Medicines and Healthcare Products Regulatory Agency), Research Governance Committee. The type of approval required will be dependent on the study type Conducting a study to the agreed protocol in accordance with legal requirements, guidance and accepted standards of good practice including ICH GCP (International Conference on Harmonisation (ICH) Good Clinical Practice standards (GCP) Conducting the study in accordance with the Trust s Standard Operating Procedures (available on the Trust Intranet) Preparing and providing information for participants and seeking their consent (if required)to participate in the study Ensuring participants welfare while in the study Arranging to make findings and data accessible following expert review Feeding back results to research participants Conducting the study in accordance with agreed funding arrangements, ensuring where required that invoices for payment of services are submitted in a timely manner using the financial tools available.

8 6.4.2 Main Funder Assessing the scientific quality of the research proposed Assessing the risks involved in undertaking the study Establishing the value for money of the research proposed Considering the suitability of the research environment in which the research will be undertaken, particularly the experience of the Chief Investigator and other key researchers involved Ensuring that appropriate sponsorship arrangements are in place before the research begins Ensuring that the Intellectual Property element (if any) of the study is identified and protected. Full guidance can be obtained from HSC Innovations ( Sponsor Confirming that everything is ready for the research to begin by: Taking on responsibility for putting and keeping in place arrangements to initiate, manage and fund the study Satisfying itself that the research protocol, research team and research environment has passed appropriate scientific quality assurance Satisfying itself that the study has all relevant regulatory approvals before it begins For clinical trials involving medicines, seeking a clinical trial authorization and making arrangements for investigational medicinal products Ensuring that research staff will conduct the study in line with Good Clinical Practice standards (GCP) and that all staff have current certified proof of having received this training (GCP certificate) Ensuring that all necessary approvals have been obtained for the conduct of the study including those from an NHS Research Ethics Committee and MHRA if required and the Trust s Research Governance Committee. Satisfying itself that arrangements are kept in place for good practice in conducting the study, and for monitoring and reporting, including prompt reporting of suspected unexpected serious adverse events or reactions in accordance with the Trust s Policy for the Management of Adverse Incidents. Ensuring that appropriate protection is in place for any identified Intellectual Property and arranging appropriate Agreements eg Collaboration Agreement Trust as Employing Organisation Promoting a quality research culture Ensuring studies are properly designed and submitted for independent review

9 Ensuring all necessary study documentation and regulatory approvals are in place, including provision of current GCP Certificates and CVs for all researchers actively involved in a study Ensuring researchers understand and discharge their responsibilities Ensuring studies are managed, monitored and reported as agreed, according to the research protocol Ensuring a database of studies is maintained differentiated by type i.e. academic, commercial or non-commercial Providing written procedures, training and supervision with regard to research Taking action if misconduct or fraud is suspected Trust as Provider of Care / Responsible Care Professional Arranging for an appropriate person to give permission for research involving patients, service users, carers or staff, before the research starts. In the Southern Trust the appropriate person is the Chair of the Research Governance Committee. Research approval will be granted following review of proposals by the multi-disciplinary Research Governance Committee. Copies of research proposals will also be forwarded to appropriate Directorates for consideration and feedback if necessary to the Chair of the Research Governance Committee. Ensuring that adequate governance checks have been undertaken and a completed report has been prepared. Requiring evidence of ethical review, if relevant, before recruitment to any research that affects the Trust s duty of care. Types of studies requiring review by a Research Ethics Committee have been revised and are defined in the Governance Arrangements for Research Ethics Committees (GAfREC), which came into effect on 01 September 2011 Before recruitment to trials with medicines, requiring evidence of a positive ethical opinion and a clinical trials authorisation Retaining responsibility for the care of participants to whom the Trust has a duty 7 Legislative Compliance, Relevant Policies, Procedures and Guidance 7.1 Staff must comply with relevant professional standards and guidance and other HSC PHA publications including, but not exclusively or exhaustively the following:-

10 7.1.1 Research Governance Framework for Health and Social Care, DHSSPS R&D Office, February ICH GCP (International Conference on Harmonisation (ICH) Good Clinical Practice standards (GCP) MRC Guidelines for Good Clinical Practice in Clinical Trials, MRC Medicines for Human Use (Clinical Trials) Regulations, Consent to Examination, Treatment of Care, DHSSPS, Human Tissue Act, Animals (Scientific Procedures) Act Protection and Use of Patient Client Information Guidance for the HPSS, DHSSPS 8 Equality and Human Rights Considerations 8.1 This policy has been screened for equality implications as required by Section 75, Schedule 9, of the Northern Ireland Act, Equality Commission for Northern Ireland Guidance states that the purpose of screening is to identify those policies which are likely to have a significant impact on equality of opportunity so that greatest resources can be targeted at them. 8.2 Using the Equality Commission s screening criteria, no significant equality implications have been identified. This policy will therefore not be subject to an equality impact assessment. 8.3 This policy has been considered under the terms of the Human Rights Act, 1998, and was deemed to be compatible with the European Convention Rights contained in that Act. 8.4 This policy will be included in the Trust s register of screening documentation and maintained for inspection whilst it remains in force. Alternative Formats 8.5 This document can be made available on request in alternative formats, e.g., Braille, disc, audio cassette and in other languages to meet the needs of those who are not fluent in English. Copyright

11 8.6 The supply of information under the Freedom of information does not give the recipient or organization that receives it the automatic right to re-use it in any way that would infringe copyright. This includes, for example, making multiple copies, publishing and issuing copies to the public. Permission to re-use the information must be obtained in advance from the Trust. 9 Policy Approval 9.1 During development, this policy was considered in draft form by Trust Directors/Assistant Directors. 9.2 This policy was presented in final draft and approved by the Trust Records Management/Policy Committee on 06 December This policy was presented in draft form and approved by the Trust Senior Management Team at its meeting on 09 January Since November 2013 arrangements have been put in place which ensures that: No research study will be given Trust Research Governance approval to commence until the full cost of conducting the research has been agreed by the Company, the Trust s Management Accounts and any support Departments involved in the research; and the signed Agreement for the Study is in place between the Trust and the Company/Third Party No Research staff will be employed until the signed Agreement is in place detailing the source of funding for the associated staff. All such staff will be employed in accordance with Trust Policies and Procedures for the recruitment of staff for the fixed term of the research study. All research studies are approved in accordance with the Trust s Research Governance approval process. 10 Policy Implementation, Training and Education 10.1 Following approval by the Senior Management Team, this policy was circulated to all Trust staff by the Senior Manager - Patient & Client Safety, Medical Directorate in January The Associate Medical Director Research & Development will provide any necessary training with regard to this policy and ensure that the

12 conditions specified in Paragraph 9.4 are understood and applied to relevant research studies A copy of this policy was placed on the Trust s intranet in January All Trust managers must ensure that their staff have access to this policy, understand its content, and are aware of its aims and purpose immediately upon its release All Trust staff must comply with this policy. 11 Review of Policy 11.1 The Trust is committed to ensuring that all policies are kept under review to ensure that they remain compliant with relevant legislation This policy will be reviewed by the Associate Medical Director Research & Development in March 2017 or earlier if relevant guidance is issued. That review will be noted on a subsequent version of this policy, even where there are no substantive changes made or required. 12 Sources of Advice and Further Information 12.1 Further advice and information regarding this document can be obtained from the Associate Medical Director Research & Development or by contacting the Trust Research & Development Office.