Release Date:  January 22, 1999


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

DATES: APRIL 21-23, 1999

TITLE: Research Involving Infants, Children & Adolescents' Issues and Ethics For
the Twenty-first Century

Hyatt Regency Crown Center
2345 McGee
Kansas City, MO

SPONSORS:  Children's Mercy Hospital, Kansas City, MO

Wellington Group
Workshop Management Co.
4707 College Blvd., Suite 213
Leawood, KS 66211
Phone: 913-345-1990
FAX: 913-345-0893

REGISTRATION FEE: $175 before March 31, 1999; $200 after April 1, 1999

DESCRIPTION: As the new millennium approaches, now is the time to address issues
that affect our most precious resource: our children.  This will be one of the
first opportunities to address and discuss the new federal policies for inclusion
of children in human research.  With keynote speakers and breakout sessions to
address both legal and ethical issues, you'll leave this workshop more informed,
more effective and more excited about protecting research subjects than ever
before.  Plenary sessions include:  (1) The Impact of Federal Regulations on
Research Involving Children; (2) Parental Permission and Assent by Children:
Therapy vs. Research The Patientþs/Parentþs Understanding of the Elements of
Assent/Permission; (3) The Risk of Not Doing Research Involving Children; and (4)
Lost Souls in Pediatric Research: Cultural Diversity, Gender Neutrality and
Special Needs Children.

DATES: MAY 7-8, 1999

TITLE: Therapeutic Bias and Cultural Diversity: Two Barriers To Informed
Participation In Research

Olympia Park Hotel and Conference Center
1895 Sidewinder Drive
Park City, UT 84060

SPONSORS:  The University of Utah School of Medicine, Salt Lake City, UT; Centro
de La Familia, Salt Lake City, UT; Indian Health Service, Albuquerque, NM

University of Utah School of Medicine
Continuing Medical Education
50 North Medical Drive
Salt Lake City, UT 84132
Telephone:  (801) 581-8664
FAX:  (801) 581-3647


DESCRIPTION: This program is a combination of short lectures from acknowledged
experts and focused working sessions with researchers, IRB members, and
representatives of the research subjectsþ community.  Lectures and workshops are
designed to focus on barriers to informed participation in research trials and
to share strategies that make trials better understood, more equitable, and more
representative of the ultimate patient population.  Participants will act as an
IRB in protocol, reviews, and receive constructive feedback.

This program will be of interest to clinical investigators, epidemiologists,
health educators, Institutional Review Board members, university and hospital
administrators, lawyers, ethicists, potential research subjects, and
representatives of different cultural communities.


For further information regarding these workshops or future NIH/FDA National
Human Subject Protections Workshops, contact:

Darlene Marie Ross, B.S.
Office for Protection from Research Risks
National Institutes of Health
6100 Executive Boulevard, Suite 3B01
Rockville, MD  20892-7507
Telephone:  (301) 435-5648
FAX: (301) 402-0527

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