NIH GUIDE, Volume 23, Number 41, November 25, 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 researchers.


For further information on 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, MSC 7507

Bethesda, MD  20892-7507

Telephone:  (301) 496-8101

FAX:  (301) 402-2071


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