NIH GUIDE, Volume 25, Number 14, May 3, 1996


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:  June 3-5, 1996


TITLE:  Basic Training for IRB Members - June 3, 1996; Cultural

Diversity and Other Human Research Issues with Emphasis on Native

Americans -June 4-5, 1996


LOCATION:  Marriott Hotel; Oklahoma City, OK


SPONSORS:  University of Oklahoma Health Sciences Center, College of

Public Health, Oklahoma City, OK; Cherokee Nation of Oklahoma,

Tahlequal, OK; Langston University, Langston, OK; Indian Health

Affairs, Office of Health Program Research and Development,

Albuquerque, NM


REGISTRATION:  Kay Holladay, M.P.H.

Conference Coordinator, Dean's Office

University of Oklahoma Health Sciences Center

College of Public Health

P.O. Box 26901

Oklahoma City, OK  73190

Telephone:  (405) 271-2342

FAX:  (405) 271-3039


REGISTRATION FEE:  $150 ($165 on-site registration)


DESCRIPTION:  This conference will provide a forum for participants

to explore issues in human subjects protection in the conduct of

research, including regulations and assurances, research protocols,

uses of special populations, ethical/legal issues in human subjects

research, and conflict of interest.  Participants will learn the

function, responsibilities, and process of an Institutional Review

Board (IRB); how Federal regulations and community participation can

protect human subjects in research; how to maximize the benefits and

minimize the risks from research for individuals and communities; and

how to protect individual rights as well as the rights of

communities, especially those of cultural diversity.


Basic training concerning IRB procedures and protocol review will

take place on the afternoon of the first day and conclude on the

second day at noon.  At 1:00 p.m., on the second day, the conference

will re-convene.  Individual presentations, panels, and workshop

sessions will provide maximum opportunity for participants to gain

information and engage in discussions on a wide range of issues

concerning human subjects research.


Experts from research, regulatory, pharmaceutical, medical,

legislative, and ethical backgrounds have been assembled to share

their knowledge of the relevant issues.


This conference should be of interest to researchers in clinical

medicine and the behavioral and social sciences, IRB members and

coordinators, tribal leaders and other Native Americans, university

and hospital administrators, agency personnel, lawyers, ethicists,

health care practitioners, health care insurers, graduate students,

and others interested in human subject protection issues.




For further information regarding these workshops or future NIH/FDA

National Human Subject Protections Workshops, contact:


Ms. Darlene Marie Ross

Office for Protection from Research Risks

National Institutes of Health

6100 Executive Boulevard, Suite 3B01

Rockville, MD  20892-7507

Telephone:  (301) 496-8101 x233

FAX:  (301) 402-0527




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