NIH GUIDE, Volume 21, Number 41, November 13, 1992

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:  November 16 & 17, 1992


Wyndham Warwick

5701 Main Street

Houston, TX  77005

Telephone:  (713) 526-1991


University of Texas Health Science Center at Houston

Prairie View A&M University


Ms. Paula Knudson

Executive Coordinator

Office of Research Support Committee

University of Texas Health Science Center at  Houston

P.O. Box 20036

Houston, TX  77225

Telephone:  (713) 792-5048

TITLE:  Geriatric Research as an Ethical Mandate:  Politics, Policy,

and Problems

DESCRIPTION:  Expanded life expectancies and expanding technologies are

swelling the ranks of the frail and disabled elderly.  Minimal research

has been carried out to understand the problems this subject group and

their families encounter in finding solutions to their health and

social needs.  The conference will identify key problems that need to

be studied; isolate the risks and benefits associated with behavioral,

clinical, or evaluation research designed to enroll this group as

subjects; and pose solutions that will meet the needs of regulators,

scientists, and the elderly.

The program is designed to be of interest to physicians, nurses,

pharmacists, scientific investigators, and other health care

professionals, clergy, lawyers, medical, nursing, social work students,

psychologists, and IRB members and administrators.  Attention will be

paid to Federal regulations with special emphasis on the assessment of

risks---medical, legal, and psychosocial.  Opportunities will be

available through workshops, question periods, and informal discussions

for participants to exchange ideas and interests with faculty and OPRR

and FDA representatives.


DATES:  January 14 & 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.

For further information regarding these workshop and future NIH/FDA

National Human Subject Protections Workshops, please 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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