NIH GUIDE, Volume 21, Number 36, October 9, 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, 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.


DATES:  February 12 & 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 workshop or future NIH/FDA

National Human Subject Protections Workshops, contact:

Ms. Darlene Marie Ross

Executive Assistant for Education

Division of Human Subject Protections

Office for Protection from Research Risks

National Institutes of Health

9000 Rockville Pike

Building 31, Room 5B59

Bethesda, MD  20892

Telephone:  (301) 496-8101


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