NIH GUIDE, Volume 24, Number 6, February 17, 1995

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, and will 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 Public Health Service agencies.  The current schedule

includes the following:

DATES:  February 23 & 24, 1995

TITLE:  Regulating Human Experimentation in the United States:  The

Lessons of History

LOCATION:  Kellogg Conference Center, Columbia University, New York,



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


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.  During 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 on American citizens during the Cold War

are prominent in the media.  Once again, reform must be linked 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 the critical implications for IRB performance and

policy today.

The first day of the conference will address questions such as, "Who

were the primary sponsors of clinical research in the period

preceding 1950?"  Significant attention will be devoted to why the

first subjects for human experimentation were so often recruited from

minority group and institutionalized populations.  The changing norms

for informing subjects about clinical research and the place of human

experimentation in popular culture and the media will be analyzed.

Cold war research and its implications for current IRB operations and

policy will be examined on the second day.  In light of the

historical record, the discussion will place particular emphasis on

the use of vulnerable populations as human subjects in clinical


DATES:  May 4-5, 1995

TITLE:  Contemporary Issues in Human Research Subject Protection in

Vulnerable and Minority Populations:  Sharing the Benefits and

Burdens of Research

LOCATION:  Regal Riverfront Hotel, St. Louis, MO


Washington University School of Medicine

Jewish Hospital of St. Louis at Washington University

Meharry Medical College


Barb Woodson

Secretary, Research Administration

Jewish Hospital of Saint Louis

216 South Kingshiway, Room 1768-69

Saint Louis, MO  63110

Telephone:  (314) 454-8322

FAX:  (314) 454-4241


DESCRIPTION:  The HHS and FDA mandate to Institutional Review Boards

is to protect the rights and welfare of human subjects while

supporting scientific advancement.  This protection is extended to

all human subjects, but additional safeguards are provided by both

the HHS/FDA regulations and basic ethical principles to protect the

rights and welfare of vulnerable subjects who, by reason of their

disability or illness, exhibit diminished personal autonomy.  Neither

the Federal regulations, nor ethical codes, including The Belmont

Report, proscribe inclusion of vulnerable persons as research

subjects, although special justification of any plan to involve

vulnerable persons as research subjects is required.  Women and

members of certain racial groups -- particularly Afro-Americans and

Hispanics -- have been excluded from research.  Inasmuch as these

groups have not been involved, they also are vulnerable -- vulnerable

to exclusion and to the possibility of being deprived of proven new

advances from research.

This Conference will focus particularly on evolving concerns for the

protection of vulnerable subjects from research risks, inappropriate

or inadvertent exploitation, or discrimination by exclusion.

Presentations will highlight FDA regulatory updates; explore the new

guidelines for the inclusion of women and people of color and diverse

racial and ethnic backgrounds in clinical research; examine the

claims that women have been systematically excluded from research and

potentially deprived thereby of proven diagnostic and therapeutic

strategies; review current issues in research in vulnerable

populations including unconscious patients in emergency rooms, AIDS

patients, children, the elderly, and the cognitively-impaired.  IRB

challenges in research in psychiatry will be discussed, including the

validity of initial and continuing informed consent for research in

schizophrenic patients, justification for the use of a placebo, the

social and medical implications of genetic screening for

vulnerability to psychiatric disease, the ethical difficulties

involved in research in child psychiatry, and the influence of

cultural patterns on psychiatric research in minority populations.

The Conference will include keynote addresses, panel presentations,

facilitated forums, information exchanges, and active audience

participation.  An outstanding faculty of experts in each area of

discussion has been selected on the basis of expertise and ability to

communicate authoritatively and comprehensively.


For further information regarding these workshops and 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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