1. Assessing Community Consultation in NETT: An Ethics Study Rebecca D. Pentz, PhD Jeremy Sugarman, MD, MPH, MA Kevin Weinfurt,PhD Neal Dickert, MD, PhD

2. Jeremy Sugarman Harvey M. Meyerhoff Professor of Bioethics and Medicine Academic Degrees MD Duke, 1986; MPH JHU, 1992; MA Georgetown, 1983

3. Kevin Weinfurt Deputy Director, Center for Clinical and Genetic Economics Duke Clinical Research Institute Deputy Director, Center for Clinical and Genetic Economics Duke Clinical Research Institute Associate Professor of Psychiatry and Behavioral Sciences Duke University School of Medicine Associate Professor of Psychology and Neuroscience Duke University

4. Neal Dickert, MD, PhD  In-coming cardiology fellow at Emory, will work on this project during fellowship.  Academic degrees: MD- Johns Hopkins (2006), MD- Johns Hopkins (2006), PhD- Bloomberg School of Public PhD- Bloomberg School of Public Health (2006, Health Policy and Bioethics)  Relevant research Doctoral dissertation on ethics of research in emergency settings Doctoral dissertation on ethics of research in emergency settings Collaborated with Sugarman on Community Consultation Collaborated with Sugarman on Community Consultation Two-year fellowship focusing on ethics of clinical research- NIH Dept of Clinical Bioethics (1997- 1999) Two-year fellowship focusing on ethics of clinical research- NIH Dept of Clinical Bioethics (1997- 1999)

5. Aims Aim 1:To assess the effectiveness and quality of different methods of community consultation (CC). Aim 2:To develop an instrument to assess quality of CC.

6. Why Focus on Community Consultation?  Particularly confusing – who is the community?  Who count as true representatives of a community?  What numbers or types of activities should be undertaken?  How should effectiveness be measured?  What methods of consulting are best?  How should the IRB use the information?

7. Two-Stage Design 1. During RAMPART, collect descriptive data. 2. During ProTECT, prospectively study 4-5 IRBs that use different CC methods. Test a CC evaluation measure.

8. Overview of RAMPART Phase BEFORE RAMPART  In depth interviews with IRB personnel.

9. Overview of RAMPART Phase During CC  Pentz attends and describes all CC meetings in Atlanta.  Pentz distributes a survey to CC participants n Atlanta.  Pentz tracks IRB’s response to CC in ATL

10. Overview of RAMPART Phase After IRB approval and CC  Web Survey to NETT IRB chairs, administrators  Web Survey to All NETT Investigators

11. Plans for ProTECT 1.Based on the results obtained during RAMPART, we will identify 4-5 IRBs to study prospectively, choosing IRBs that use a diversity of methods and are diverse geographically.

12. Plans for ProTECT 2. We will work with one IRB who expressed dissatisfaction with its method to develop CC using formative research used successfully in AIDS/HIV CC Formative research involves in depth interviewing of potential participants assessing their willingness to enroll and the reasons for or against enrollment. Taylor and Sugarman Ann Rheum Dis 2007:66:542-544

13. Plans for ProTECT 3.Based on the data gathered during RAMPART, we will design assessment methods to assess the IRB’s CC methods One method will be an instrument for assessing quality of CC.

14. Questions and Discussion