NIH GUIDE, Volume 22, Number 1, January 8, 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 the following:


DATES:  January 14 and 15, 1993


Sheraton Sand Key Resort

1160 Gulf Boulevard

Clearwater Beach, FL  33515

Telephone:  (813) 595-1611


University of South Florida

Florida A & M University


Ms. Eileen Highsmith

Executive Secretary

University of South Florida

4202 E. Fowler Avenue (MP.FAO-126)

Tampa, FL  33620-7900

Telephone:  (813) 974-2897

TITLE:  Barriers to Informed Consent:  Language, Age Factors, Trauma,

and Women/Minority Issues

DESCRIPTION:  Today's researchers face numerous barriers to obtaining

an informed consent.  Such issues as age, language, mental capacity,

and sobriety may affect the ability of subjects to give a truly

informed consent.  Many of these barriers oftentimes impact the pool

of subjects which an investigator is willing (or able) to use in a

research project.  In addition, recent legislation from the Congress

was designed to address the issue of inadequate numbers of women and

minorities in research projects.  This conference has been designed

to address three main areas in which barriers to informed consent may

exist:  mental competence, ethnic and gender issues, and research

with children and the elderly.

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

nurses, pharmacists, scientific investigators, and other health care

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

administrators will also benefit from the conference.  Attention will

be given to Federal regulations governing research on human subjects,

with special emphasis placed on the assessment of risks---medical,

legal, and psychosocial.  Ample opportunities will be provided to

exchange ideas and interests, through question and answer sessions

and informal discussions.


DATES:  February 12 and 13, 1993


Sheraton Tempe Mission Palms Hotel

60 East 5th Street

Tempe, AZ  85281

Telephone:  (602) 894-1400


Arizona State University

Northern Arizona University


Ms. Carol Jablonski

IRB Coordinator

Office of the Assistant Vice President for Research

Arizona State University

Tempe, AZ  85287-3403

Telephone:  (602) 965-6788

TITLE:  Contemporary Issues in Human Subject Research:  Challenges

for Today's IRBs

DESCRIPTION:  This program is designed to be a practical working

session to explore contemporary issues in human subjects protection

including regulations and assurances, categorization of research

protocols, uses of special populations, experimental design and

scientific merit, fetal tissue research, ethical/legal issues in

human subjects research, and conflict of interest.  As appropriate,

topics will be discussed from the perspective of the clinical

researcher and the behavioral/social science researcher.  Issues will

be discussed in a panel format with ample time for audience

questions.  An outstanding faculty has been assembled.

This program should be of interest to researchers in clinical

medicine and the behavioral and social sciences. Institutional Review

Board members, university and hospital administrators, lawyers,

ethicists, health care practitioners, students, and other persons

with interests in human subject protection issues.


For further information regarding these workshops and future NIH/FDA

National Human Subject Protections Workshops, contact:

Ms. Darlene Marie Ross

Division of Human Subject Protections

Office for Protection from Research Risks

National Institutes of Health

Building 31, Room 5B59

Bethesda, MD  20892

Telephone:  (301) 496-8101


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