1. Measuring Ethical Goals of Research Oversight Holly Taylor, PhD, MPH Department of Health Policy and Management Bloomberg School of Public Health Berman Institute of Bioethics Johns Hopkins University

2. Overview Background Measuring Ethical Quality Ethical Goals of Research Oversight

3. Background Suspension of human research protections programs Attention to regulatory compliance –Diverting attention from ethics? Failure to manage conflicts of interest –Lack of confidence among investigators

4. Background Empirical Research on IRBs –Lack of consistency in reviews of same protocol by multiple IRBs –Variation in implementation of Federal policy –Summaries of regulatory compliance violations Does variation in review and outcomes indicate differences in ethical quality of review?

5. Measuring Ethical Quality Review of research proposal documents related to IRB review (ACHRE 1995) Assessment of ethical quality –Ranked sets of documents from 1 (no ethical concerns) to 5 (serious ethical concerns

6. Measuring Ethical Quality Concerns identified among sets ranked ≥ 3 –Factors likely to: affect adequacy of subject understanding affect voluntariness of decisions –Approaches to inclusion of subjects with limited decision-making capacity All studies ranked as 4 or 5 were proposals that would expose subjects to more than minimal risk Retrospective assessment of completed proposals

7. IRB Review in Context Administrative Review PI and Study Team Department Peers IRB Staff Committee IRB Staff Committee IRB Review Continuing Review Scientific Review Research Proposal

8. Ethical Goals of Research Oversight Scientific merit/value of proposed research Identification and assessment of risk to subjects/society Identification and assessment of benefit to subjects/society Acceptable risk/benefit ratio Fair approach to selection of subjects Adequate informed consent process Adequate mechanisms for respect of enrolled subjects (Faden et al 1986; CFR; Meslin et al 1994; Miller et al 2000; Emanuel et al 2000; King et al 1999, Beagan et al 2005)

9. Ethical Goals of Research Oversight How do we convert these concepts into a valid and reliable measure? –Explore meaning and definition of quality –Bring experts in measurement of quality together with experts in IRBs and research ethics Develop working definition of ethical quality in conduct of human subject research Identify most appropriate targets for measurement Develop preliminary measures –Solicit feedback from relevant stakeholders –Test feasibility of measure

10. Conclusion Measure of ethical quality –Human Subject Protection programs Local effectiveness Cost/benefit analysis Evidence-based changes in policy –Social Scientists Assessing innovative interventions