Meeting Agenda

Agenda: Meeting 1

1:00   Welcome and Introductions

Richard E. Behrman, M.D., Chair, Committee on Clinical Research Involving Children

1:10   Overview of research ethics compliance activities and data resources

Michael Carome, M.D., Associate Director for Regulatory Affairs
Office of Human Research Protections
U.S. Department of Health and Human Services

David Lepay, M.D., Ph.D., Senior Advisor on Clinical Science
U.S. Food and Drug Administration

2:40   Break

3:00   Survey of IRBs chairs on issues related to children
         David Wendler, Ph.D., Head, Unit on Vulnerable Populations
         Department of Clinical Bioethics
         National Institutes of Health

3:45   Work of National Human Research Protections Advisory Committee
         Alan Fleischman, M.D., Senior Vice President
         New York Academy of Medicine

4:15   NICHD perspectives and activities
         Duane Alexander, M.D., Director
         National Institute of Child Health and Development

4:45   Proposed IOM/NRC study: housing interventions involving children
         Jane Ross, Ph.D., Acting Director
         IOM/NRC Board on Children Youth and Families

5:00    Opportunity for Public Comment

5:15    Adjourn

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