9:00 a.m. Welcome and Introduction of Panel

Stuart L. Nightingale, M.D., Senior Medical Advisor to the Assistant Secretary for Planning and Evaluation, DHHS (Introduction)

9:05 a.m. Perspective from NIH

Ruth L. Kirschstein, M.D., Principal Deputy Director, NIH (Speech)(Transcript)

9:20 a.m. Perspective from FDA

Jane E. Henney, M.D., Commissioner of Food and Drugs, FDA (Speech)(Transcript)

9:35 a.m. Perspective from DHHS

William F. Raub, Ph.D., Deputy Assistant Secretary for Science Policy, Office of the Secretary, DHHS (Speech)  (Transcript)

9:50 a.m. A Non-Federal Perspective 

Thomas Bodenheimer, M.D., M.P.H., Clinical Professor of Family and Community Medicine, University of California, San Francisco (UCSF) School of Medicine (Abstract)(Speech) (Transcript)

10:20 a.m. Break

10:50 a.m. Panel: Perspectives of National Organizations

Moderator:

• Wendy Baldwin, Ph.D., Deputy Director for Extramural Research, NIH (Transcript)

Panelists:

• Mark Brenner, Ph.D., Association of American Universities (AAU)  (Slides)(Transcript)
• Angus Grant, Ph.D., Biotechnology Industry Organization (BIO) (Transcript)
• David Korn, M.D., Association of American Medical Colleges (AAMC)   (Abstract)(Speech)(Transcript)
• John R. Seffrin, Ph.D., National Health Council (Transcript)
• Savio L.C. Woo, Ph.D., American Society of Gene Therapy   (Abstract)(Transcript)

12:15 p.m. Lunch Break

1:15 p.m. Panel: Approaches Taken by Institutions and Institutional Review Boards (IRBs)

Moderator:

• Sanford Chodosh, M.D., President, Public Responsibility in Medicine and Research (PRIM&R) (Transcript)

Panelists Representing IRBs:

• Susan Kornetsky, M.P.H., Children’s Hospital, Boston   (Abstract) (Slides)(Transcript)
• Steven Peckman, University of California at Los Angeles (UCLA) (Transcript)

Panelists Representing Institutions:

• Theodore J. Cicero, Ph.D., Washington University in St. Louis (Transcript)
• Julie Gottlieb, M.A., Johns Hopkins University School of Medicine  (Slides)(Transcript)

2:30 p.m. Public Comment on Questions in Federal Register Notice of Conference

Moderator:

• Yvonne T. Maddox, Ph.D., Acting Deputy Director for Research Management, NIH (Transcript)

3:15 p.m. Break

3:30 p.m. Concurrent Breakout Groups  - Topic: Questions in Federal Register Notice of Conference

Moderators:

• David A. Lepay, M.D., Ph.D., Director, Division of Scientific Investigations, FDA

• John Livengood, M.D., M.P.H., Associate Deputy Director for Science, CDC
• Michele Russell-Einhorn, J.D., Director of Regulatory Affairs, Office for Human Research Protections (OHRP), DHHS
• Lana R. Skirboll, Ph.D., Associate Director for Science Policy, NIH
• Robert J. Temple, M.D., Director of Medical Policy and Acting Director, Office of Drug Evaluation, FDA

5:30 p.m. Adjourn for the Day

Wednesday, August 16, 2000

8:30 a.m. Plenary Presentation

Moderator:

• Robert J. Temple, M.D., Director of Medical Policy and Acting Director, Office of Drug Evaluation, FDA

Raising Ethical Questions Concerning Conflict of Interest Throughout the Process of Clinical Research

• Jeremy Sugarman, M.D., M.P.H., M.A., Director, Center for Study of Medical Ethics and Humanities, Duke University School of Medicine   (Abstract) (Transcript)

9:00 a.m. Plenary: Reports from Breakout Sessions

Moderator:

• Dixie E. Snider, Jr., M.D., M.P.H., Assistant Director for Science, CDC  (Transcript)

Moderators:

• David A. Lepay, M.D., Ph.D., FDA  (Transcript)
• John Livengood, M.D., M.P.H., CDC  (Transcript)
• P. Pearl O’Rourke, M.D., NIH  (Transcript)
• Michele Russell-Einhorn, J.D., DHHS  (Transcript)
• Lana R. Skirboll, Ph.D., NIH  (Transcript)
• Robert J. Temple, M.D., FDA  (Transcript)

10:30 a.m. Break

11:00 a.m. Plenary: Reaction to Conference Proceedings

Moderator:

• David Blumenthal, M.D., M.P.P., Director, Massachusetts General Hospital Institute for Health Policy  (Transcript)

Panelists:

• Marcia Angell, M.D., F.A.C.P., Former Editor-in-Chief, New England Journal of Medicine (Comments) (Transcript)
• James S. Benson, Advanced Medical Technology Association (AdvaMed, formerly HIMA)  (Transcript)
• Dennis DeRosia, P.A.-C, Association of Clinical Research Professionals  (Transcript)
• Abby S. Meyers, National Organization for Rare Diseases (NORD)  (Transcript)
• Sidney Wolfe, M.D., Public Citizen  (Transcript)

12:45 p.m. Plenary: Concluding Remarks

Greg Koski, Ph.D., M.D., Director-Designate, OHRP, DHHS  (Transcript)

1:00 p.m. Adjournment

Conference
Top of Page | Purpose |  Background Materials | Conference Front Page | Comments Received

Conference Sponsor's Web Sites
U.S. Department of Health and Human Services (HHS) - Office of the Secretary
Assistant Secretary for Planning and Evaluation (ASPE)
National Institutes of Health (NIH)
Centers for Disease Control and Prevention (CDC)
Food and Drug Administration (FDA)

Back to OHRP Home Page

Questions/suggestions about this web page?  Webmaster
Updated July 16, 2001