NIH GUIDE, Volume 22, Number 44, December 10, 1993

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:  January 23-24, 1994


Doubletree Hotel, Pasadena, CA


City of Hope National Medical Center, Duarte, CA

Charles R. Drew University of Medicine and Science, Los Angeles, CA


Ms. Donna Pearce

Administrative Secretary, IRB

City of Hope National Medical Center

Beckman Research Institute

Duarte, CA  91010

Telephone:  (818) 359-8111 (x2700)

TITLE:  Ethical Issues in Human Subject Research:  Catastrophic

Diseases and Minorities

DESCRIPTION:  This workshop is intended for physicians, nurses,

pharmacists, and other health care professionals as well as

administrators, members of Institutional Review Boards, students,

ethicists and legal experts, and lay persons with interest and

concern for human subject research.  The program will address the

following issues: (1) new governmental policies on human subject

research; (2) resolving ethical principles in clinical research on

AIDS, gene transfer, and cancer prevention trials involving

catastrophic illnesses; (3) drug trials and parallel track protocols;

(4) minorities as research subjects; and (5) the uncertain fate of

clinical research in the current era of health care reform.

DATES:  February 17-18, 1994


Fairmont Hotel, New Orleans, LA


University of New Orleans - Lakefront, New Orleans, LA

Xavier University of Louisiana, New Orleans, LA


Ms. Anne O'Heren Jakob

Office of Conference Services

University of New Orleans - Lakefront

New Orleans, LA  70148

Telephone:  (504) 286-6680

TITLE:  Recent Trends in Human Subjects Research

DESCRIPTION:  The purpose of this conference is to explore recent

issues and trends related to the protection of human subjects in

research.  It will provide discussions and opportunities among

participants to share views on NIH's new guidelines on fetal

research, the inclusion of women and minorities in research, and

FDA's recent policy on enrolling women of childbearing age in drug


Workshops and meetings will be conducted by faculty of more than 25

national experts whose research interests include alzheimer's

disease, environmental research, women's health, human genome

research, biomedical research, and others.

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.


For further information regarding these workshop 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 5B63

Bethesda, MD  20892

Telephone:  (301) 496-8101


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