NIH GUIDE, Volume 24, Number 10, March 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:  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

SPONSORS:  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.


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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