Assessing Community Assessing Community Consultation in NETT: An Consultation in NETT: An

Ethics StudyEthics Study

Rebecca D. Pentz, PhDRebecca D. Pentz, PhDJeremy Sugarman, MD, MPH, MAJeremy Sugarman, MD, MPH, MA

Kevin Weinfurt,PhDKevin Weinfurt,PhDNeal Dickert, MD, PhDNeal Dickert, MD, PhD

Jeremy SugarmanJeremy Sugarman

Harvey M. Meyerhoff Harvey M. Meyerhoff Professor of Bioethics Professor of Bioethics and Medicineand Medicine

Academic DegreesAcademic DegreesMD Duke, 1986; MPH JHU, 1992; MA MD Duke, 1986; MPH JHU, 1992; MA Georgetown, 1983Georgetown, 1983

Kevin WeinfurtKevin Weinfurt

Deputy Director, Center for Clinical Deputy Director, Center for Clinical and Genetic Economicsand Genetic EconomicsDuke Clinical Research InstituteDuke Clinical Research Institute

Associate Professor of Psychiatry Associate Professor of Psychiatry and Behavioral Sciencesand Behavioral SciencesDuke University School of Duke University School of MedicineMedicine

Associate Professor of Psychology Associate Professor of Psychology and Neuroscienceand NeuroscienceDuke UniversityDuke University

Neal Dickert, MD, PhDNeal Dickert, MD, PhD In-coming cardiology fellow at Emory, In-coming cardiology fellow at Emory,

will work on this project during fellowship.will work on this project during fellowship.

Academic degrees: 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)Health (2006, Health Policy and Bioethics)

Relevant researchRelevant research Doctoral dissertation on ethics of research in Doctoral dissertation on ethics of research in

emergency settingsemergency settings Collaborated with Sugarman on Community Collaborated with Sugarman on Community

ConsultationConsultation Two-year fellowship focusing on ethics of clinical Two-year fellowship focusing on ethics of clinical

research- NIH Dept of Clinical Bioethics (1997-research- NIH Dept of Clinical Bioethics (1997-1999) 1999)

AimsAims

Aim 1:To assess the effectiveness and Aim 1:To assess the effectiveness and quality of different methods of community quality of different methods of community consultation (CC). consultation (CC).

Aim 2:To develop an instrument to assess Aim 2:To develop an instrument to assess quality of CC. quality of CC.

Why Focus on Community Why Focus on Community Consultation?Consultation?

Particularly confusing – who is the community? Particularly confusing – who is the community? Who count as true representatives of a Who count as true representatives of a

community?community? What numbers or types of activities should be What numbers or types of activities should be

undertaken? undertaken? How should effectiveness be measured?How should effectiveness be measured? What methods of consulting are best?What methods of consulting are best? How should the IRB use the information?How should the IRB use the information?

Two-Stage DesignTwo-Stage Design

1. During RAMPART, collect descriptive 1. During RAMPART, collect descriptive data.data.

2. During ProTECT, prospectively study 4-5 2. During ProTECT, prospectively study 4-5 IRBs that use different CC methods. Test IRBs that use different CC methods. Test a CC evaluation measure.a CC evaluation measure.

Overview of RAMPART PhaseOverview of RAMPART Phase

BEFORE RAMPARTBEFORE RAMPART

In depth interviews with IRB personnel.In depth interviews with IRB personnel.

Overview of RAMPART PhaseOverview of RAMPART Phase

During CCDuring CC Pentz attends and describes all CC Pentz attends and describes all CC

meetings in Atlanta.meetings in Atlanta. Pentz distributes a survey to CC Pentz distributes a survey to CC

participants n Atlanta.participants n Atlanta. Pentz tracks IRB’s response to CC in ATLPentz tracks IRB’s response to CC in ATL

Overview of RAMPART PhaseOverview of RAMPART Phase

After IRB approval and CCAfter IRB approval and CC

Web Survey to NETT IRB chairs, Web Survey to NETT IRB chairs, administratorsadministrators

Web Survey to All NETT InvestigatorsWeb Survey to All NETT Investigators

Plans for ProTECTPlans for ProTECT

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

Plans for ProTECTPlans for ProTECT

2. We will work with one IRB who expressed 2. We will work with one IRB who expressed dissatisfaction with its method to develop dissatisfaction with its method to develop CC using formative research used CC using formative research used successfully in AIDS/HIV CCsuccessfully in AIDS/HIV CC

Formative research involves in depth interviewing Formative research involves in depth interviewing of potential participants assessing their of potential participants assessing their willingness to enroll and the reasons for or willingness to enroll and the reasons for or against enrollmentagainst enrollment..

Taylor and Sugarman Ann Rheum Dis 2007:66:542-544Taylor and Sugarman Ann Rheum Dis 2007:66:542-544

Plans for ProTECTPlans for ProTECT

3.Based on the data gathered during 3.Based on the data gathered during RAMPART, we will design assessment RAMPART, we will design assessment methods to assess the IRB’s CC methods methods to assess the IRB’s CC methods

One method will be an instrument for One method will be an instrument for assessing quality of CC. assessing quality of CC.

Questions and Questions and DiscussionDiscussion