Research Ethics & Governance

Transcription

1 Research Ethics & Governance Mr Bill Karanatsios Manager, Office for Research (Western Health) Interim Manager, Clinical and Translational Science Platform The University of Melbourne WH Research Training Workshop 26 Feb 2015

2 OVERVIEW Research at Western Health Office for Research: what we do Governance of Human Research Ethics Why Research Ethics Matters? Research Misconduct Risks in Human Research Research Ethics Requirements 2

3 OVERVIEW Research at Western Health Office for Research: what we do Governance of Human Research Ethics Why Research Ethics Matters? Research Misconduct Risks in Human Research Research Ethics Requirements 3

4 Research Highlights for

5 OVERVIEW Research at Western Health Office for Research: what we do Governance of Human Research Ethics Why Research Ethics Matters? Research Misconduct Risks in Human Research Research Ethics Requirements 5

6 What we do The Western Health Office for Research oversees and co-ordinates research activities within Western Health. Provides guidance to investigators and staff in the conduct of research. Seeks to enhance the excellence, scope and efficiency of research efforts. Facilitates and integrates all required regulatory steps in the conduct of research. 6

7 OFFICE FOR RESEARCH Director: Prof Edward Janus Manager: Bill Karanatsios Research Coordinators Group Chair: Mr Bill Karanatsios WH Low Risk Ethics Panel Chair: Prof Edward Janus Ethics Admin Assistant Kerrie Russell Research Governance Officer Virginia Ma Biostatistician Dr Emily Karahalios Admin Assistant Volunteers Research Ethics Intern Event Management Team RESPONSIBILITIES: RESPONSIBILITIES: RESPONSIBILITIES: Low Risk Projects Quality Assurance / Improvement Single Site /Multisite Amendments Research Ethics / Governance: Single Site Ethics (CT & non-ct) Multisite Ethics (CT & non-ct) Low Risk Projects Quality Assurance/Improvement Study design Database development Analysis of data Biostatistics Training 7

8 OVERVIEW Research at Western Health Office for Research: what we do Governance of Human Research Ethics Why Research Ethics Matters? Research Misconduct Risks in Human Research Research Ethics Requirements 8

9 What is Human Research? Human research is conducted with or about people, or their data or their tissue. Examples of human research: Trials of clinical interventions Interviews Surveys Focus Groups Observations Medical records Clinical Audits 9

10 Australian Research Ethics National Framework NHMRC Statement on Human Experimentation and Supplementary Notes (First published 1966, multiple revisions, last revised 1992) National Statement on Ethical Conduct in Research Involving Humans (1999) National Statement on Ethical Conduct in Human Research (2007) Australian Code for the Responsible Conduct of Research (2007) Research Integrity not research ethics, but an important document for your research 10

11 In the National Statement (2007) Different research methods and disciplines: Qualitative research Human tissues Clinical trials Databanks Different types of participants Children Overseas Aboriginal and Torres Strait Island people Ethical review Membership and role of HRECs Low risk and negligible risk Duplication of review Researcher responsibilities Institutional responsibilities

12 OVERVIEW Research at Western Health Office for Research: what we do Governance of Human Research Ethics Why Research Ethics Matters? Research Misconduct Risks in Human Research Research Ethics Requirements 12

13 Principles of Ethics Six of the values that commonly apply : Autonomy - the right to refuse or choose their treatment. Beneficence - act in the best interest of the patient. Non-maleficence - "first, do no harm Justice - distribution of scarce health resources, and the decision of who gets what treatment Dignity - the patient (and the person treating the patient) have the right to be treated with dignity. Truthfulness & honesty - the concept of informed consent 13

14 Why research ethics matters? Responsibility to participants Professional obligations Use of public funds carries with it obligations to the community Requirements of research funding bodies, state, federal and international Requirements of the Hospital insurer indemnification of researchers Requirements of many journals Reputation of the Hospital 14

15 Historical Cases of Unethical Research Tuskegee Syphillis Study Denying standard care to a particular population by deception Willowbrook Study Exploitation of a vulnerable population Children with mental retardation being infected with HepA 15

16 Responses to Ethical Violations The Nuremberg Code (1949) Produced in response to the Nuremburg trials, this international guideline specifies responsibilities of medical researchers. The Declaration of Helsinki (1964): Another important international document specifying rules for medical research. The Belmont Report (1978) Legislation in 1974 created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 16

17 The role of an HREC 1. risk to subjects are minimized; 2. risk to subjects are reasonable in relation to anticipated benefits; 3. selection of subjects is equitable, i.e. fair; 4. informed consent is sought form each subject or his/her legally authorized representative; 5. informed consent is appropriately documented; 6. when appropriate, the research plan makes provisions for monitoring data collection; 7. privacy and confidentiality of research subjects is appropriately protected; and 8. when some or all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included. 17

18 Risks in human research: Types A common mistake researchers make is to describe a project as involving no risks When what they actually mean is that there are strategies in place to negate or minimise the risks

19 Risks in human research: Types Any research also holds reputational risks for both the researcher and the institution. What are some of the risks of Human Research. Physical (Injury, illness, harm) Psychological (significant distress) Social (impact on social networks, access to services and support) Economic (loss of income, earnings and cost to participants) Legal (exposure to civil or criminal proceedings) Humiliation (devaluation of worth) Environment (see Code not NS) Recognition of burden on participants.

20 Risks in human research: Assessing Yet another common mistake is to focus only on the risks to the participants. Assessing Risks To whom do the risks apply? Participants, potential participants, third parties, environment, and / or researchers. Addressing risks Are there alternatives? Can risks be negated or minimised? Can risks be managed? Can the risks be justified? Disclosure to potential participants

21 Research Misconduct A failure to comply with the Code of Conduct for Research and includes conduct in, or in connection with, research that is (a) dishonest, reckless or negligent and (b) seriously deviates from accepted standards within the scientific and scholarly community for proposing, conducting or reporting research: the fabrication or falsification of data or results, the use of another person's ideas, work or data without appropriate acknowledgement (plagiarism), misleading ascription of authorship to a publication failure to disclose conflicts of interest failure to obtain the required prior ethical or regulatory approval for the research project to proceed; or failure to conduct the research project in accord with the approved ethical or regulatory protocol.

22 Research Misconduct: Disciplinary Action Procedures for dealing with allegations of misconduct in research are set out in: Staff: WH s disciplinary policy; University s Responsible Conduct of Staff Policy Students: University s Student Discipline Policy

23 OVERVIEW Research at Western Health Office for Research: what we do Governance of Human Research Ethics Why Research Ethics Matters? Research Misconduct Risks in Human Research Research Ethics Requirements 23

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26 OVERVIEW Research at Western Health Office for Research Governance of Human Research Ethics Why Research Ethics Matters? Research Ethics Requirements 26

27 Research Governance vs. Research Ethics ETHICS GOVERNANCE The Ethics Submission is created to facilitate the scientific and ethical review of a research project by an Human Research Ethics Committee (HREC). The Research Governance Submission is created to facilitate assessment of overall feasibility and compliance with institutional requirements of a research project by a governance or ethics officer. Any accredited HREC can perform this function Performed at individual institutions 27

28 QA, Low Risk & High Risk Research QA Low Risk Research High Risk Research STUDY DESIGN: Retrospective medical audit of current practice QUESTIONNAIRE BASED RESEARCH Questionnaires/survey of treatment group Impact on patients? If review will identify issues that will require pts to be contacted/ treatment amended Patients group survey of patients outside usual care Prospective study comparing "standard of care" vs. intervention DATA STORAGE: 12 months 5 years 5 years/ CT 15 years (For Children more) CONSENT: Consent or waiver of consent DATA IDENTIFIABILITY: Data reidentifiable or non-identifiable INTERVENTION & IMPACT RISK TO PARTICIPANTS minimal or none Consent or waiver of consent (data use related to purpose of collection) Collect and use identifiable data Participants minimal impact and able to consent for themselves Pts unable to consent for themself or waiver of consent (data use not related to purpose of collection) Collect, use and release of identifiable data Participants high impact, unable to consent and/or vulnerable e.g. Children, pregnant women, mentally impaired *Please note this table is a guide only and may not be applicable for all studies, please contact the Office for Research for guidance if unsure. 28

29 Case Study Case Study: QA/QI Low Risk High Risk DESCRIPTION The clinical review of a single case report does not require review by the WH Low Risk Ethics Panel or notification to the Office for Research. However journal editors may require evidence of project approval prior to publication; if required, please the Office for Research to request formal acknowledgement. REVIEW Clinical Trials Not required by the WH Low Risk Ethics Panel however; Please provide a copy of the case study report/abstract being published/presented for acknowledgement. GMOs Others 29

30 Case Study QA/QI: QA/QI Low Risk High Risk Clinical Trials DESCRIPTION Evaluation or monitoring of a current service or practice, with the aim of improving that service or practice. Audits to identify and/or quantify 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 quality assurance. REVIEW QAs/QIs are reviewed out of session by one reviewer GMOs Others 30

31 Case Study Low Risk Projects: QA/QI Low Risk Description Research in which the only foreseeable risk is one of discomfort or involving a vulnerable population group. Research, in which the risk for participants is more serious than discomfort, is not low risk. (NS Chapter 2.1). High Risk Clinical Trials REVIEW At monthly LREP meeting, 3 rd Thursday of every month. GMOs Others 31

32 Case Study High Risk Projects QA/QI Low Risk DESCRIPTION Examples of projects considered higher risk would include the use of identifiable data in databanks, interventions or therapies, use of human genetic samples, participants unable to consent for themselves and research that may breach a National Privacy Principle. High Risk Clinical Trials REVIEW Full review via Melbourne Health HREC For paediatrics projects via RCH HREC GMOs Others 32

33 Case Study Clinical Trials QA/QI Low Risk High Risk Clinical Trials GMOs DESCRIPTION Western Health is an accepting site under the Streamlined Ethical Review Process (SERP) coordinated by the Department of Health. All projects reviewed under the multi-centre research umbrella are required to submit a Research Governance application (Site Specific Assessment) to the Office for Research. REVIEW Submit an application to Melbourne Health for ethical review and submit a SSA to Western Health for Research Governance and site authorisation SERP - Submit an application to an approved reviewing HREC for ethical review and submit a SSA to Western Health for Research Governance and site authorisation. Others 33

34 Case Study GMOs QA/QI Low Risk High Risk Clinical Trials GMOs DESCRIPTION Activities involving GMOs fall into four main categories: Exempt dealings Non-GMO Biohazard dealings and Risk Group 2/3 Notifiable Low Risk dealings (NLRD) Licensed dealings (DNIR and DIR) All dealings involving Genetically Modified Organisms (GMOs) conducted at Western Health must be reviewed and approved by either University of Melbourne /Victoria University Institutional Biosafety Committee (IBC) REVIEW University of Melbourne /Victoria University IBC confirmation letter Western Health provides a Site Specific Authorisation Others 34

35 Case Study Others: University projects QA/QI Low Risk High Risk DESCRIPTION Projects involving WH s staff or control subjects (not involving WH patients) REVIEW WH accepts University s Approval and provide Site Specific Authorisations Clinical Trials GMOs Others 35

36 Case Study QA/QI Review Outcomes: What do they mean? APPROVED UNCONDITIONALLY Low Risk CONDITIONAL APPROVAL/ APPROVED SUBJECT TO High Risk Clinical Trials ESCALATE TO FULL HREC REJECTED NO DECISION MADE GMOs Others 36

37 Case Study QA/QI Low Risk High Risk Clinical Trials Review Outcomes: What do they mean? APPROVED UNCONDITIONALLY The project has met all the principles and guidelines of the National Statement (2007) and WH Research Governance requirements. Investigators MAY COMMENCE THEIR PROJECT once they have received acknowledgment/approval correspondence from the Office for Research. Investigators are required to notify the Office for Research of the date when their project commences. GMOs Others 37

38 Case Study QA/QI Low Risk High Risk Clinical Trials Review Outcomes: What do they mean? CONDITIONAL APPROVAL/ APPROVED SUBJECT TO The project meets most of the principles and guidelines in the National Statement (2007) and/or requires further documentation for Research Governance. Investigators SHOULD NOT COMMENCE their study. Investigators are required to ADDRESS OR CLARIFY the concerns and queries raised by the LREP and RESUBMIT to the Office for Research. Approval is subject to a receipt of a satisfactory response to the LREP queries. GMOs Others 38

39 Case Study QA/QI Low Risk High Risk Clinical Trials Review Outcomes: What do they mean? REJECTED The project does not meet the principles and guidelines set out in the National Statement (2007). Investigators SHOULD NOT COMMENCE their study. Investigators are to revise their application completely and address the points raised by the LREP, this includes requesting signatures from Investigators and Head of Departments. GMOs Others 39

40 Case Study QA/QI Low Risk High Risk Clinical Trials GMOs Review Outcomes: What do they mean? ESCALATE TO FULL HREC The project may not fall under the jurisdiction of the Western Health LREP and require review by a fully constituted Human Research Ethics Committee (HREC). Investigators must submit to Melbourne Health HREC according to their requirements. Once ethical approval has been issued by the HREC, investigators are required to submit a Governance application to the Office for Research. Investigators SHOULD NOT COMMENCE THEIR STUDY at Western Health UNTIL THEY HAVE RECEIVED AUTHORISATION from the Office for Research. Others 40

41 Case Study QA/QI Low Risk High Risk Review Outcomes: What do they mean? NO DECISION The project is incomplete where the LREP cannot adequately review the project. Investigators are required to clarify and revise submission according to the LREP comments. Investigators SHOULD NOT COMMENCE their study. Clinical Trials GMOs Others 41

42 Summary Consider early: discuss with your supervisor/manager Consult the Office for Research or see the website for advice. Website: Intranet/Internet Apply for the right level of review Know the standards and justify the approach Consider the perspective of a potential participant Have someone (who has done it before) help you! Don t get disheartened if you have to do revisions Ethical issues doesn t mean the research is not permissible Fully complete the form & include your attachments 42

43 Contact Us Director: Prof E Janus Manager: Mr Bill Karanatsios RGO: Ms Virginia Ma Ethics Admin Assistant: Mrs Kerrie Russell Office for Research, Level 3 Western Centre for Health Research & Education Sunshine Hospital - Furlong Road, St Albans VIC 3021 Phone: ethics@wh.org.au Web: 43

44 Western Health Research Training Workshops 2015 Please contact the Office for Research for any queries: Tel:(03) ; E: Topic Presenters Department Date Presenting Site Introduction to Clinical Research Prof Edward Janus General Medicine 12 Feb 15 Auditorium WCHRE, Sunshine Footscray VC Site NONE Time 10:00AM-11:00AM Research Ethics & Governance Mr Bill Karanatsios Office for Research 26 Feb 15 Lecture Theatre WCHRE, Sunshine Padua 10:30AM-11:30AM Evaluating the literature TBC TBC 12 Mar 15 Auditorium WCHRE, Sunshine Padua 10:30AM-11:30AM Writing a research proposal Dr Lizzie Skinner Physiotherapy, WH 02 Apr 15 Auditorium WCHRE, Sunshine Mavis Mitchell 12:30PM-1:30PM Beginners statistics: Study Design Dr Emily Karahalios WH/UoM 16 Apr 15 Auditorium WCHRE, Sunshine Mavis Mitchell 12:30PM-1:30PM Using Excel for research Dr Lizzie Skinner Physiotherapy, WH 30 Apr 15 Auditorium WCHRE, Sunshine Mavis Mitchell 12:30PM-1:30PM Mixed Methods: Quantitative & Qualitative Referencing and EndNote Making Sense of your results Prof Paul Bennett TBC (Referencing) Lynn Higgins (Endnote) Deakin School of Nursing Office for Research / Library 14 May 15 Auditorium WCHRE, Sunshine 28 May 15 Lecture Theatre WCHRE, Sunshine Dr Emily Karahalios WH/UoM 11 Jun 15 Auditorium WCHRE, Sunshine Mavis Mitchell NONE NONE 12:30PM-1:30PM 12:30PM-1:30PM 10:30AM-11:30AM Getting your work published TBC TBC 02 Jul 15 Auditorium WCHRE, Sunshine Padua 10:30AM-11:30AM Writing Abstract for Research Week/ Conferences TBC TBC 16 Jul 15 Auditorium WCHRE Mavis Mitchell 12:30PM-1:30PM