Research ethics committees:
Assessment and support
Susan BullHonorary Senior Lecturer, FMHS, University of AucklandSenior Researcher in the Ethics of Genomics and Global
Health, University of OxfordEditor, GlobalHealthReviewers.org
Research ethics committeesAlmost 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’ interestsInternationally:
Increasing numbers of committees being established
Committees being asked to review increasingly wide range of research
Evidence of effectiveness?
Critiques of review systems ...EffectivenessAppropriateness and consistency of decision-making
Cursory or disproportionate reviewIndependence / conflict of interest / representationCapacity (training, experience and resources)AccountabilityTransparency
In multi-centre researchOnerous logisticsPower imbalances and inconsistency between committeesLack of communication
Why seek consistency?Arguments for consistency:
Researchers need to know where they standCommunities need to know where they stand Judgements should be consistent unless there is a morally
significant difference between casesRECs 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.
Supporting effective and appropriate ethical reviewWhat might be appropriate standards against
which to assess a committee’s performance?
How might performance be assessed?Submission of test protocolsReviews of committee processes and
correspondenceProxy outcome measures assessing factors
such as Resources and training Processes for review and responding Compliance with relevant guidance
A research proposalQualitative study comparing ethics committees’,
researchers’ and participants’ views of what constitutes effective ethical reviewDo 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
Praxis ... Capacity building as a good in itself in the
absence of agreed outcome measures and assessmentDevelopment of local, regional and
international training resourcesProvision of free or cheap online trainingDevelopment of regional networksAttempts to promote communication between
committees
Other sites include
A research proposalGlobal Health Reviewers is developing a number
of specialised online courses in issues such as Reviewing genomic researchReviewing social science researchReviewing cluster randomised trialsReviewing 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.)
A challengeBuilding effective online communities where
committee members (and researchers) feel able to communicateUS IRB Forum is active and 7 years oldNewer and quieter forums for international
audiences GlobalHealthReviewers MARC MERETI