What should RECs be reviewing? Criteria Define minimal risk Who decides Student research Health care vs social research

Criteria? Research is designed to produce generalisable knowledge Exemptions? –Minimal risk defined Expedited review as a third category Vulnerable groups e.g. children N.B. publication requires prior ethical review

Define minimal risk Not only involving physical contact? All vulnerable groups Include behavioural studies? Not only internal controls/ self-regulation? Depends on topic especially mental health Risk is the risk that a person is exposed to in their usual environment and activities. Different for different subjects e.g. healthy and sick child

Who decides Elaborate review only for more than minimal : decided by initial process (e.g. ethics advisors or chairperson)

examples South Africa two layers expedited and full Council of Europe additional protocol: all health care interventions, risk of psychological harm Kenya: no categories. Surveys a problem (PEPFAR) El Salvador: expedited and full reviews. But no clear guidelines

Student research Same criteria. Also because of training role of REC (incorporate into existing research) Not all reviewed in all countries (Lithuania, Nigeria) Classify level (undergraduate etc.) expedite minimal risk (exclude vulnerable groups) Include supervisors / faculty in review process Support and feedback for students? Is this the role of the REC? Probably not Can REC members provide individual advice or support?

Same standards for students? Fair ? Appropriate for the type of research performed eg retrospective chart review Essential as educational exercise/ experience Ethical review is for subjects! Supervisors role Time pressures?

Fair that students collect data for their supervisors? Part of their research experience, but must always be evaluated according to project

Specific qualifications for student reviewers? No distinction from other researchers But recurring errors in groups Student members of REC?

Distinctions between health research vs social (behavioural) research Categories of research important Consider community impact in behavioural research Research methodology e.g. qualitative different review process? Unusual projects e.g. oral histories Mental health research