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Categories: children; clinical research; ethics; IRB's

THE NATIONAL ACADEMIES

Institute of Medicine

Board on Health Sciences Policy

Committee on Clinical Research Involving Children

*****

Congressional Briefing

Wednesday, March 24, 2004

428 Dirksen Senate Office Bldg. -- 2:00 p.m.

on

The Ethical Conduct of Clinical Research Involving Children

by

Richard E. Behrman, Chair, Education Steering Committee of the Federation of Pediatric Organizations; Clinical Professor of Pediatrics, University of California San Francisco and the George Washington University, Washington, D.C.; and Chair, Committee on Clinical Research Involving Children, Board on Health Sciences Policy, Institute of Medicine

Marilyn Field, Study Director, Committee on Clinical Research Involving Children and Associate Division Director, Board on Health Sciences Policy, Institute of Medicine

In response to a request by Congress in PL107-109, this new report addresses concerns about the adequacy of the current system for protecting child participants in research given a public commitment to expanding pediatric clinical research. The study covers three broad themes: creating a robust system for protecting child research participants; providing appropriate pediatric expertise at all stages in the design, review, and conduct of studies that include children; and encouraging the inclusion of children in research when that is ethically and scientifically appropriate.

This briefing was for members of Congress and congressional staff only. The report was publicly released on March 25, 2004 and can be found, in its entirety, on the Web site of the National Academies Press.