Welcome and Overview of Agenda

Harold T. Shapiro, Ph.D.

Executive Director’s Report

Eric M. Meslin, Ph.D.

8:45 am

UNAIDS Washington Meeting Update

Alexander M. Capron, LL.B.

9:00 am

Ethical Issues in International Research: Review of UNAIDS Activities

Ruth Macklin, Ph.D., Albert Einstein College of Medicine

Basic Protections for Human Subjects in International Research:

The FDA Perspective

Stuart L. Nightingale, M.D., Food and Drug Administration

Basic Protections for Human Subjects in International Research:

The CDC Perspective

Marjorie A. Speers, Ph.D., Centers for Disease Control and Prevention

10:45 am

Draft Proposal for NBAC’s Study of International Research

Alexander M. Capron, LL.B., Eric M. Meslin, Ph.D., and Commissioners

Research Involving Persons with Mental Disorders

Affecting Decisionmaking Capacity Report Overview

James F. Childress, Ph.D.

1:05 pm

National Institutes of Health Panel Report Update

David Shore, M.D., National Institute of Mental Health

Psychiatric Symptom Provoking Studies

Donald L. Rosenstein, M.D., National Institute of Mental Health

Discussion of Research Involving Persons with Mental Disorders

Affecting Decisionmaking Capacity Staff Draft Report

James F. Childress, Ph.D., Jonathan Moreno, Ph.D., and Commissioners

3:00 pm

Break

Next Steps

Harold T. Shapiro, Ph.D.

8:00 am

Welcome

Harold T. Shapiro, Ph.D.

8:05 am

Human Biological Materials Report Overview

and Introduction of Speaker

Thomas H. Murray, Ph.D.

IRB Policy Regarding Genetic Research

C. Christopher Hook, M.D., Mayo Clinic

8:40 am

Discussion of Human Biological Materials Staff Draft Report

Thomas H. Murray, Ph.D., Kathi Hanna, Ph.D., and Commissioners

10:10 am

Break

12 Noon

Lunch

1:00 pm

Discussion Continues on Human Biological Materials Staff Draft Report

2:50 pm

Next Steps

Harold T. Shapiro, Ph.D.

3:00 pm

Adjournment