NIH GUIDE, Volume 23, Number 42, December 2, 1994

P.T. 42


  Human Subjects Policy 

National Institutes of Health

Food and Drug Administration

The National Institutes of Health (NIH) and the Food and Drug

Administration (FDA) are continuing to sponsor a series of workshops

on responsibilities of researchers, Institutional Review Boards

(IRBs), and institutional officials for the protection of human

subjects in research.  The workshops are open to everyone with an

interest in research involving human subjects.  The meetings should

be of special interest to those persons currently serving or about to

begin serving as a member of an IRB.  Issues discussed at these

workshops are relevant to all other Public Health Service agencies.

The current schedule includes:

DATES:  February 23 & 24, 1995


Kellogg Conference Center, Columbia University, New York, NY


Columbia University, New York, NY

Harlem Hospital Center, New York, NY

The John Conley Foundation for Ethics and Philosophy in Medicine,

Inc., New York, NY


David J. Rothman, Ph.D.

Bernard Schoenberg Professor of Social Medicine and Director College

of Physicians and Surgeons

Columbia University

630 West 168th Street, Black 101

New York, NY  10023

Telephone:  (212) 305-4184

FAX:  (212) 305-6416


TITLE:  Regulating Human Experimentation in the United States:  The

Lessons of History

DESCRIPTION:  The current organization and operation of Institutional

Review Boards (IRBs) cannot be understood apart from the history of

human experimentation.  During the 1950s and 1960s, a series of

exposes and scandals created the pressure for reform and oversight of

clinical research.  Over the 1970s, regulations were enacted that

reflected an increased public awareness of the atrocities committed

by Nazi doctors during World War II and such American incidents as

Tuskegee, Willowbrook, and those described by henry Beecher in his

whistle-blowing 1966 New England Journal of Medicine article.

Today, exposes of experiments with radioactive materials and mind

altering chemical substances of American citizens during the Cold War

are now prominent in the media.  Once again, reform must be like to

an understanding of history.  The past record is of primary relevance

to the design of an effective public policy in human experimentation

for the 21st century.  Hence, this two day conference will explore

the history of human experimentation in the United States in the 20th

century and analyze its critical implication for IRB performance and

policy today.

The first day of the conference will address such important and

heretofore unexplored questions as who were the primary sponsors of

clinical research in the period preceding 1950.  It will devote

significant attention to why the first subjects for human

experimentation were so often recruited from minorities and

institutionalized populations.  It will also analyze the changing

norms for informing subjects about clinical research and the place of

human experimentation in popular culture and the media.

The second day will examine cold war research and draw out its

implications for current IRB operations and policy.  In light of the

historical record, the discussion will place particular emphasis on

the use of vulnerable populations as human subjects in clinical



For further information regarding these workshops or future NIH/FDA

National Human Subject Protections Workshops, contact:

Ms. Darlene Marie Ross

Office for Protection from Research Risks

National Institutes of Health

6100 Executive Boulevard, Suite 3B01

Rockville, MD  20892-7507

Telephone:  (301) 496-8101

FAX:  (301) 402-0527


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