NIH GUIDE, Volume 23, Number 35, October 7, 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:  December 8-9, 1994


Seven Hills Center

San Francisco State University

San Francisco, CA


San Francisco State University, San Francisco, CA

California State University, Los Angeles, CA


Darlene Yee, Ph.D.

Chair, Committee for the Protection of Human Subjects

Office of Research Sponsored Programs

San Francisco State University

20 Tapia Drive

San Francisco, CA  94132

Telephone:  (415) 452-1908

FAX:  (415) 338-6378

TITLE:  Current Issues in Research Involving Human Subjects

DESCRIPTION:  Institutional Review Boards (IRBs) are charged with

responsibilities for ethical review and oversight of the use of human

subjects in research protocols.  The primary principle governing the

IRB's review and action is the protection of human subjects from risks

while permitting the advancement of research.  IRBs are faced today

with complex concerns that require deep ethical and moral judgements,

and they are challenged to act in an objective and timely fashion.  Our

workshop will focus on current issues in research involving human

subjects:  evolving concerns for protection of human subjects from

research risks; FDA regulatory update; new guidelines on the inclusion

of women and communities of color in clinical research; guidelines for

human embryo research; ethics and philosophy of research with

vulnerable populations such as children, the elderly, and those who are

cognitively impaired and/or physically challenged; lessons learned from

historical episodes in research; changing demographics of research in

California; and emerging issues in research involving prisoners.  The

workshop formats will include facilitated forums, information

exchanges, panel discussions, and active audience participation.  We

have assembled an outstanding faculty of distinguished experts to

provide authoritative and provocative discussion of challenging issues

in the field of human subjects research review.

Participants will (1) learn how Federal regulations and community

participation can protect human subjects in research, (2) become

familiar with the issues involved in protecting the rights of

vulnerable populations in research, (3) explore how regulations and

community participation can collaborate to protect human subjects, (4)

become more knowledgeable about policies, procedures, and expectations

of an IRB, and (5) discuss the rights and responsibilities of



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

Building 31, Room 5B-59

Rockville, MD  20892-2018

Telephone:  (301) 496-8101

FAX:  (301) 402-0527


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