OHRP Conference—“Crossing the Line:
What is Acceptable Risk?”
September 25 -26, 2006

Plenary Sessions

1. Opening Address
   How Much Risk Can Research Subjects Ethically Be Exposed to in Order to Advance Knowledge?
   Ross McKinney, MD
   Duke University
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2. First Day Opening Keynote Address
   What Does Belmont Tell Us About Risk?
   Robert J. Levine, MD
   Yale University
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3. The National Perspective: How do the Rules Speak to Risk and What New Rules are Coming? Bernard Schwetz, DMV, OHRP
   David Korn, MD, AAAMC
   Marguerite Barratt, PhD, NIH
   Lynn Cates, MD, VA
   Joan Porter, MSc, DPA, MPH VA
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4. Overview of Vulnerability: What It Means to be Vulnerable
   Biomedical Speaker – Jeffrey P. Kahn, PhD, MPH, University of Minnesota
   Behavioral Speaker – Jeffrey Cohen, PhD, HRP Associates
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5. Dilemma of Psychiatric Studies
   Donald L. Rosenstein, MD
   National Institute of Mental Health
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6. Second Day Opening Keynote Address
   Christopher J. Portier, PhD
   NIEHS
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7. Panel Discussion: Media Coverage of Research
   Joe Palca, National Public Radio
   Richard Weiss, Washington Post
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8. Closing Debate
   How Much Risk is Permissible? Societal Good versus the Individual
   Robert J. Levine, MD Yale University
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   Jeffrey P. Kahn, PhD, MPH University of Minnesota
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Breakout Sessions

A1: Psychiatric Studies
Scott Stroup, MD, MPH, UNC
David Miller, PhD, FAClinP, VA

A2: Update on Subpart C, Prisoners IOM & SACHARP reports
Nancy Dubler, LLB, Montefiore Medical Center
Ann Quinlan-Colwell, RN, Duke University
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A3: Managing Risk in Deception Research with Children
Steven Asher, PhD, Duke Psychology
Lorna Hicks, MS, CIP, Duke University
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A4: Consideration of Risk in VA Research
Lynn Cates, MD, Veterans’ Administration
Marisue Cody, RN, PhD, Veterans’ Administration
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A5: IRB Basics
Elyse Summers, JD, OHRP
John Falletta, MD, Duke University
David Borasky, Family Health International
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A6: Assessing Risk in Developing Country Settings
Robert Ssengonzi, PhD, RTI
Steven Shaber, JD, Poyner & Spruill, LLP
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A7/B7: Research With Children & Adolescents
Abigail English, JD, Center for Adolescent Health & the Law
Susan Kornetsky, MPH, CIP, Children’s Hospital, Boston
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A8: Engaged in Research Guidance
Ivor Pritchard, PhD, OHRP
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B1: Temporarily Incompetent Subjects Because of their Illness—Emergency Research
John Harrelson, MD, Duke University
Ken Mahaffey, MD, Duke University
Nancy King, JD, UNC-CH
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B2: Protecting Subject Identity & Confidentiality in Research
Susan Bankowski, MS, JD, Oregon Health & Science University
Alvan O. Zarate, Ph.D., National Center for Health Statistics
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B3: Understanding Local Concepts of Risk and Autonomy in HIV/AIDS Research in Uganda
Kearsley Stewart, PhD, Northwestern University
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B4: Use of the Short Consent Form, The Risks of Reducing Information to Subjects
Carol Dukes Hamilton, MD, Duke University
William Burman, MD, Denver Public Health Department
Elyse Summers, JD, OHRP
David Borasky, CIP, FHI
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B5: Internet Research: It’s Cheap & Seductive, But What Are the Risks?
Christopher Cramer, PhD, Duke University
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B6: The Role of Accreditation in Reducing the Organization’s Risk Exposure
Marjorie A. Speers, PhD, AAHRPP
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B8: New OHRP Adverse Event Reporting Guidance
Shirley Hicks, OHRP
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C1: Ethical Issues in Research on Health Hazards in the Home: Lessons from the CHEERS and Kennedy Krieger Studies
David Resnik, JD, PhD, NIEHS
Steve Wing, PhD, UNC-CH
Michael Stegman, PhD, UNC-CH
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C2: Community Recruitment of Vulnerable Population Groups
Charlie Knott, MPA, Battelle Memorial Institute
Giselle Corbie-Smith, MD, MSc, UNC-CH
Jacqueline Clements, Lincoln Community Health Center
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C3: Reproductive Risks in Research:
How Do We Measure and Minimize Them, and Should We Even Try?
Evan Myers, MD, MPH, Duke University
Anne Lyerly, MD, Duke University
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C4/D6: Financial Incentives for Research Participation: Ethical and Practical Issues.
Christine Grady, RN, PhD, NIH
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C5: Central IRBs-Balancing Risk to the Research Enterprise and to the Institution
Carol Dukes Hamilton, MD, Duke University
Bernard Schwetz, DVM, PhD OHRP
William Burman, MD, Denver Public Health Department
John Falletta, MD, Duke University
Lynn Cates, MD, Veterans’ Administration
Mark Gustafson, JD, Duke University
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C6: Risk of Genetic Testing & Stored Specimens
Robert Cook-Deegan, MD, Duke University
Ross McKinney, MD, Duke University

C8: Risk in Evidence Based Research in Schools
Ivor Pritchard, PhD, OHRP
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D1: A New Perspective for Evaluating Risk in Clinical Research –
Identifying Latent Errors in Drug Trials
John Kessler, PharmD, BCPS, SecondStory Health, LLC
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D2: How do IRB Members Decide About Risk?
Ivor Pritchard, PhD, OHRP
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D3: Environmental Dosing
David Resnik, JD, PHD, NIEHS|
Roger Cortesi, PhD, EPA
Howard Kehrl, MD, EPA
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D4: Media Coverage of Research: Role of Advocacy Groups, Local Area Coverage, Perceptions and Mis-Perceptions of Risk
Sarah Avery, N&O
Beth Robinson, MS, FHI
Linda Tuxen, BS, EPA

D6: Vaccine Risks: The Case of Thimerosol and Autism
Jeffrey Baker, MD, PhD, Duke University
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