NIH GUIDE, Volume 25, Number 24, July 19, 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.


DATES:  September 26-27, 1996


TITLE:  Role of the IRB in Collaborative Research


LOCATION:  Jumer's Castle Lodge, Peoria, IL


SPONSORS:  University of Illinois College of Medicine at Peoria,

Peoria, IL; Meharry Medical College, Nashville, TN


REGISTRATION:  Ms. Nancy Hibser


University of Illinois College of Medicine at Peoria

One Illini Drive

P.O. Box 1649

Peoria, IL  61656-1649

Telephone:  (309) 671-8437

FAX:  (309) 671-8513


REGISTRATION FEE:  $125 ($135 after September 16, 1996)


DESCRIPTION:  The biomedical and behavioral research currently being

conducted within academic institutions promises exciting advances in

scientific knowledge, as well as unprecedented opportunities for the

betterment of individual and society life.  Increasingly, however,

these dramatic achievements and opportunities are accompanied by

scientific, ethical, regulatory, and legal intricacies, and dilemmas.

Within the academic community, understanding these rapidly changing

complexities is central to the Institutional Review Board's (IRB)

ability to protect the rights and welfare of human research subjects

while supporting scientific endeavor and its potential benefits to



This conference is designed to examine a broad range of contemporary

scientific, ethical, regulatory, and legal issues relating to

biomedical, social behavioral, and anthropological research involving

human subjects.  Each of these issues will be discussed within the

framework of the academic research environment, and presentations

will focus on the unique challenges presented to (IRBs).  Designed

for both experienced and novice participants, the workshop will

provide opportunities for greater depth and specificity on

contemporary IRB issues.  Along with sessions examining common IRB

issues - including liability, informed consent, and deception - the

conference will feature special focus sessions on issues related to

historical perspectives, issues in mental health, the establishment,

structure, and management of IRBs, computerized management

information systems for the IRB office, FDA regulations for clinical

trials, guidelines on inclusion of minorities and women, research

involving special population, including children and elderly research



Guest speakers will include representatives from OPRR:  Mr. F.

William Dommel, Jr., J.D., Dr. Kammal K. Mittal, and

Ms. Darlene M. Ross; FDA:  Dr. Gary L. Chadwick, Mr. Paul Goebel,

Jr., Dr. Michael Norcross; NIMH:  Dr. Andrea Baruchin.  Distinguished

members of the academic and clinical research community will also be

present, including:  Dr. Patricia Finn, St. Jude Children's Hospital

at Memphis; Dr. Ernest Prentice, University of Nebraska; and co-host

Dr. John Estrada, Meharry Medical College.  The format will encourage

audience participation and informational exchanges, with question and

answer sessions throughout the program.




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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