36th MEETING
NATIONAL BIOETHICS ADVISORY COMMISSION

Doubletree Inn at the Colonnade
4 West University Parkway
Baltimore, MD 21218
December 2-3, 1999

DRAFT AGENDA

DAY ONE-Thursday, December 2, 1999

8:30 am

Opening Remarks
Harold T. Shapiro, Ph.D.

Executive Director's Report
Eric M. Meslin, Ph.D.

ETHICAL ISSUES IN INTERNATIONAL RESEARCH

8:40am

Overview of Work to Date
Ruth Macklin, Ph.D., Albert Einstein College of Medicine
Alice Page, J.D., M.P.H.

9:00 am

Panel I: Risk -Benefit Assessment in International Research
Christopher C. Whalen, M.D., Case Western Reserve University
Sidney M. Wolfe, M.D., Public Citizen's Health Research Group, Washington, DC

9:30 am

Discussion with Commissioners

10:15 am

Break

10:30 am

Panel II: Research Design Methodology
Stephen Lagakos, Ph.D., M.P.H., Harvard School of Public Health
Dennis Dixon, Ph.D., National Institute of Allergy and Infectious Disease
Kay Dickersin, Ph.D., Brown University
Gary Chase, Ph.D., Henry Ford Health Sciences Center

11:30 am

Discussion with Commissioners

12 Noon

Lunch

1:00 pm

PUBLIC COMMENT

ETHICAL ISSUES IN INTERNATIONAL RESEARCH

1:30 pm

Overview of FDA
David Lepay, M.D., Ph.D. Food and Drug Administration

2:00 pm

Discussion with Commissioners

2:30 pm

Break

2:45 pm

Discussion with Commissioners Continues
Ruth Macklin, Ph.D.
Alice Page, J.D., M.P.H.

4:45 pm

Next Steps
Harold T. Shapiro, Ph.D.

5:00 pm

Adjournment

DAY TWO- Friday, December 3, 1999

8:00 am

Opening Remarks
Harold T. Shapiro, Ph.D.

OVERSIGHT OF HUMAN SUBJECTS PROJECT

8:15 am

Summary of IRB Studies
Jonathan D. Moreno, Ph.D., University of Virginia

8:35 am

Discussion with Commissioners

9:15 am

Summary of Federal Agencies Input
Kathi E. Hanna, M.S., Ph.D.

9:30 am

Discussion with Commissioners

9:45 am

Review of Revised Outline
Eric M. Meslin, Ph.D.

10:00 am

Discussion with Commissioners

10:30 am

Break

10:45 am

Discussion with Commissioners Continues

11:45 am

Next Steps
Harold T. Shapiro, Ph.D.

12 Noon

Adjournment