NIH GUIDE, Volume 23, Number 26, July 15, 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 the following:

DATES:  September 22-23, 1994

TOPIC:  Human Subject Protections Workshop

LOCATION:  Hyatt Regency Two Fountain Plaza, Buffalo, NY


University at Buffalo

National Institute of Mental Health, NIH


Office of Research

University at Buffalo

State University of New York

314 Crofts Hall

Buffalo, NY  14260-1234

Telephone:  (716) 645-3869

DESCRIPTION:  Human Institutional Review Boards (IRBs) are charged with

the responsibility to protect human subjects undergoing research while

at the same time permitting the advancement of the biomedical sciences

in alleviating human disease.  This workshop will address specific

complex issues confronting IRBs today including the issues involving

the mentally incapacitated individual, research in AIDS, children,

research in the emergency room, medical devices and multicenter FDA

monitoring.  Discussions of what constitutes an expedited review and

the elements of an informed consent are also included.  Full audience

participation in all presentations is welcomed and encouraged.  The

faculty consists of outstanding individuals with expertise in the

operation and function of IRBs including representatives of the OPRR,

the FDA, and local colleagues.  The workshop is intended for

physicians, nurses, pharmacists, basic scientists, students, legal

experts, members of IRBs and all persons with an interest in and

concern for human research.


For further information regarding these workshops or future NIH/FDA

National Human Subject Protections Workshops, contact:

Ms. Darlene M. Ross

Office for Protection from Research Risks

National Institutes of Health

Building 31, Room 5B63

Bethesda, MD  20892

Telephone:  (301) 496-8101


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