Research ethics committees: Assessment and support

1. Research ethics committees:Assessment and support Susan Bull Honorary Senior Lecturer, FMHS, University of Auckland Senior Researcher in the Ethics of Genomics and Global Health, University of Oxford Editor, GlobalHealthReviewers.org susan.bull@auckland.ac.nz

2. Research ethics committees • Almost 50 years since first call for ethics committees to provide objective scrutiny of research protocols following widely publicised examples of unethical research • Role: protect research participants’ interests • Internationally: • Increasing numbers of committees being established • Committees being asked to review increasingly wide range of research • Evidence of effectiveness?

3. Critiques of review systems ... • Effectiveness • Appropriateness and consistency of decision-making • Cursory or disproportionate review • Independence / conflict of interest / representation • Capacity (training, experience and resources) • Accountability • Transparency • In multi-centre research • Onerous logistics • Power imbalances and inconsistency between committees • Lack of communication

4. Why seek consistency? • Arguments for consistency: • Researchers need to know where they stand • Communities need to know where they stand • Judgements should be consistent unless there is a morally significant difference between cases • RECs should be able to provide reasons for their decisions • What are the arguments against this? • the primary role of ethics committees is as places where researchers are subject to the scrutiny of a group of local people • committee members should use ‘their moral judgement’ • No two cases are ever really the same. Research is highly contextual.

5. Supporting effective and appropriate ethical review • What might be appropriate standards against which to assess a committee’s performance? • How might performance be assessed? • Submission of test protocols • Reviews of committee processes and correspondence • Proxy outcome measures assessing factors such as • Resources and training • Processes for review and responding • Compliance with relevant guidance

7. A research proposal • Qualitative study comparing ethics committees’, researchers’ and participants’ views of what constitutes effective ethical review • Do committees appropriately identify factors that participants consider important • Risks and comfort • Do they make appropriate recommendations regarding such factors • Specificity of responses • Policy development for issues such as inducements • Pilot in Asian and Latin American committees

8. Praxis ... • Capacity building as a good in itself in the absence of agreed outcome measures and assessment • Development of local, regional and international training resources • Provision of free or cheap online training • Development of regional networks • Attempts to promote communication between committees

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12. A research proposal • Global Health Reviewers is developing a number of specialised online courses in issues such as • Reviewing genomic research • Reviewing social science research • Reviewing cluster randomised trials • Reviewing epidemiological research • Designing an assessment of the value of the social science module for committees without specific expertise in this field (Taylor, H.A.; Kass, N.E.; Ali, J.; Sisson, S.; Bertram, A.; Bhan, A. (2012) Development of a research ethics knowledge and analytical skills assessment tool. Journal of Medical Ethics, 38(4), 236-242.)

13. A challenge • Building effective online communities where committee members (and researchers) feel able to communicate • US IRB Forum is active and 7 years old • Newer and quieter forums for international audiences • GlobalHealthReviewers • MARC • MERETI