NIH GUIDE, Volume 23, Number 12, March 25, 1994



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:  April 27-28, 1994


Magovern Conference Center, Allegheny General Hospital, Pittsburgh,



Allegheny-Singer Research Institute, Pittsburgh, PA

Delaware State College, Dover, DE


Ms. Kathleen Hrdlicka

Continuing Medical Education

Allegheny General Hospital

320 E. North Avenue

Pittsburgh, PA  15212

Telephone:  (412) 359-4952

TITLE:  Contemporary Issues in Human Subject Protection

DESCRIPTION:  The protection of human subjects is the fundamental

responsibility of institutional review boards.  Today there are many

challenges facing IRBs and research investigators in accomplishing

this objective.  This Workshop will focus on current legal, ethical,

and media issues related to human subjects participating in research.

Emphasis will be directed at risk assessment (including mechanisms to

minimize risk), research fundamentals, regulatory updates, and a

special session will address the impact of the media on biomedical

research.  The format for the Workshop will include large and small

group didactic presentations and panel discussions providing a forum

for audience participation.

DATES:  July 11, 12, 13, 1994


Mall of American Grand Hotel, Bloomington, MN


University of Minnesota of Minneapolis, Minneapolis, MN

American Indian Health Care Association, St. Paul, MN

Indian Health Service, Albuquerque, NM


Office of Continuing Medical Education

University of Minnesota

Radisson Hotel Metrodome, Suite 107

615 Washington Avenue, SE

Minneapolis, MN  55414

Telephone:  (612) 626-7600 or (800) 776-8636

TITLE:  Contemporary Issues on Existing and New Research Guidelines

on Women and Minority Groups:  Special Emphasis on American Indians

DESCRIPTION:  The Conference will examine existing NIH research

guidelines, and discuss contemporary issues in the research

environment.  There will be IRB training; conference participants

will be in small mock IRBs to review three protocols, with

facilitation by experienced IRB staff.  The Conference will examine

how protecting American Indian individuals and communities by IRBs

and community participation:  (1) increases research benefit, (2)

decreases research risk, and (3) improves quality of the research.

Because Native (American Indian and Canadian First Nation) people are

covered by the new NIH guidelines about inclusion of women and

minorities in research, the Conference will also examine that policy

in depth.  The focus on Native communities and volunteers will

illuminate how the new Guidelines, current IRB regulations, and

community involvement fit together in practice.


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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