NIH GUIDE, Volume 22, Number 34, September 24, 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 persons and those 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:  November 4-5, 1993


Radisson Hotel Denver South, Denver, CO


University of Colorado Health Sciences Center, Denver, CO

University of Southern Colorado, Pueblo, CO


Ms. Mary Peratt, Secretary IRB

University of Colorado Health Sciences Center

4200 East Ninth Avenue (Box C-290)

Denver, CO  80262

Telephone:  (303) 270-7960

TITLE:  Medical Research:  Protection of Vulnerable Subjects

DESCRIPTION:  IRBs are confronted with a complexity of questions and

ethical issues that seldom have defined answers or ready resolve.

Some of the more perplexing clinical research protocols presented for

review are studies involving human subjects in overt, at-risk groups.

This human subjects workshop will address protections of highly

vulnerable and protected human populations.  Discussions will focus

on the ethical principles, protective measures, and definitions of

criteria for informed consent that are tantamount for IRB reviews

when members of these vulnerable groups are subjects of research

studies.  Subject groups and protocols to be covered will be focused

on prisoners, children, mentally compromised, AIDS and HIV-infected,

geriatric, and emergency room.

The conference program is designed to be of value to physicians,

nurses, pharmacists, scientific investigators, pharmaceutical and

medical device company representatives, and other health care

professionals.  All IRB members, faculty, and students in health care

areas and administrators will benefit from the conference.  Critical

attention will be given to Federal regulations governing these

special groups, professional judgment, real and perceived elements of

"implied," "second," and "third" party consents.  Conference emphasis

will be placed on the assessment of risks and protection of the

vulnerable subject with the application of medical, legal,

psychosocial and ethical standards and principles.  The conference

format is structured to promote the optimum exchange of ideas and

discussion through small and large group, topic-defined, informal,

and provocative sessions.


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, ext. 2700

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'Hearn Jakob

Office of Conference Services

University of New Orleans - Lakefront

New Orleans, LA  70148

Telephone:  (504) 286-7118

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.


For further information regarding these workshop and 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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