NIH GUIDE, Volume 25, Number 17, May 24, 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:  July 25-26, 1996


TITLE:  Protecting the Rights of Human Subjects in Research:  Sharing

the Benefits and Burdens of Research


LOCATION:  Alana Waikiki Hotel, 1956 Ala Moana Boulevard, Honolulu,

HI 96815, telephone (808) 941-7275


SPONSORS:  Kapi'olani Health Research Institute, Honolulu, HI;

University of Hawaii, Honolulu, HI; Tripler Army Medical Center,

Honolulu, HI


REGISTRATION:  Ms. Lora Young, Grants Assistant

Kapi'olani Health Research Institute

1441 Kapi'olani Boulevard (18th Floor)

Honolulu, HI  96814

Telephone:  (808) 973-4759

FAX:  (808) 973-8080


FEE:  $120


DESCRIPTION:  Topics to be discussed include: Protecting the Rights

of Human Subjects:  Today's Challenges; FDA Compliance Update; Report

of Advisory Committee on Human Radiation Experiments; The IRB in

Depth (Regulations; Policies and Procedures - What You Can and Cannot

Review, Informed Consent, Expedited Reviews, Cooperative Agreements);

Legal Issues in the Protection of Human Subjects (Access to Records:

Hawaii Laws and Federal Regulations; Informed Consent; Liability

Issues:  The Institution Staff and Committee Members);  Resolving

Ethical Principles; Stressors for the IRB:  Adverse Reaction

Reporting Surviving Audits; The IRB's Obligation Regarding the

Continuing Review of the Protocols; and Points for the IRB to

Consider in Research Related to Human Genetics.




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 - MSC 7507

Rockville, MD  20892-7507

Telephone:  (301) 496-8101 x233

FAX:  (301) 402-0527




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