NIH GUIDE, Volume 24, Number 36, October 13, 1995

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:  November 13-14, 1995

TITLE:  Symposium on International Research Concerns:  Ethical Issues

on the Protection of Human Subjects

LOCATION:  Marriott Hotel Inner Harbor, Baltimore, MD

SPONSORS:  Johns Hopkins University, Howard University


Ms. Donna M. Gebhardt, Program Coordinator

Johns Hopkins University

Office for Continuing Registration

720 Rutland Street

Baltimore, MD  21205-2195

Telephone:  (410) 955-6046

FAX:  (410) 955-0807



Ms. Kate Prendergast (410) 955-2527

Ms. Joan Poling (410) 955-1608

Ms. Marian Secundy (202) 806-6300

DESCRIPTION:  In this very contemporary conference, human subject

protections in research will be explored by focusing on the cross

cultural aspects from the national and international perspectives.

While nations and their particular mores are recognized for their

uniqueness, the theme of commonality will be stressed in relation to

the ethical approach to the rights of individuals in research.

Contributors from the international arena of research will present

in-depth forums on topics such as Cross Cultural Issues on Informed

Consent, The American Presence Abroad, Differences between

Observational and Intervention Research and Research vs Care in the

International Setting.  All plenary sessions will be followed by

individual panel discussions which will allow participants to further

explore particular issues in grater detail.  Speakers will include:

Dr. John Bryant, former Dean of the School of Public Health at

Columbia University, and one of the authors of the CIOMS

International Research Ethics Guidelines; Dr. Helene Gayle, Acting

Director of the National Center for HIV/STD/TB Prevention at CDC; Dr.

Gary B. Ellis, Director, Office for Protection from Research Risks,

Office of Extramural Research, National Institutes of Health (OPRR,

OER, NIH); F. William Dommel, Jr., J.D., OPRR, OER, NIH; Dr. Melody

H. Lin, OPRR, OER, NIH; Dr. Joan P. Porter, OPRR, OER, NIH; Dr.

Clifford C. Scharke, OPRR, OER, NIH; Dr. Kamal K. Mittal, OPRR, OER,

NIH; Ms. Diane L. Aiken, OPRR, OER, NIH; Dr. Susan L. Crandall, OPRR,

OER, NIH; Dr. Charles McCarthy, a scholar at the Kennedy Institute

for Bioethics in Washington, DC; Dr. Carl Taylor of International

Health at JHU; Dr. Segum Gbadegesian, Department of Philosophy at

Howard University College of Medicine; Mr. Ronnie Lupo, the Chief of

the White River Apache Tribe; and Dr. Ray Reid, who has spent

considerable time working the field of Indian Health Care and


This symposium will identify issues of concern regarding the

protection of human subjects in research when the location and the

culture and mores are different; discuss and clarify the status of

regulations and institutional requirements in governing the conduct

of research being sensitive to cross cultural and international

issues; heighten the awareness of the participants to the diversity

of populations; and establish a network of investigators,

administrators, IRB chairs and members, Federal representatives

sensitive and knowledgeable in this area.


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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