NIH GUIDE, Volume 21, Number 34, September 25, 1992

P.T. 42


  Human Subjects Policy 

National Institutes of Health

Food and Drug Administration

The Office for Protection from Research Risks (OPRR) of 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



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, and

psychologists as well as 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. Issues such 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. IRB members, university and

hospital administrators, lawyers, ethicists, health care practitioners,

students, and other persons with interests in human subject protection


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

Building 31, Room 5B59

Bethesda, MD  20892

Telephone:  (301) 496-8101


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