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

susan.bull@auckland.ac.nz

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