NIH GUIDE, Volume 24, Number 29, August 11, 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:  September 18-19, 1995

TITLE:  Contemporary Human Subject Issues in Academic Research

LOCATION:  The University of Mississippi, Oxford, MS

SPONSORS:  The University of Mississippi; Jackson State University


Mr. D. Russell Cooper

OPRR Conference Registration

c/o Center for Public Service and Continuing Studies

The University of Mississippi

P.O. Box 879

University, MS  38677

Telephone:  (601) 232-7282

FAX:  (601) 232-5138

REGISTRATION FEE:  $95 ($115 after September 5)

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 societal 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 IRBs ability to protect the rights and

welfare of human research subjects while supporting scientific

endeavor and its potential benefits to humankind.

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,

researchers, subjects, and administrators in academic institutions.

Designed for both experienced and novice participants, the workshop

will provide opportunities for greater depth and specificity on

contemporary IRB issues.  Along with sessions on 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 genetic/DNA testing, and research involving special

populations, including American Indians children, and elderly

research subjects.  Sessions will feature issues particularly

pertinent to historically black colleges and universities and

institutions newer to the IRB process.

Speakers will include representatives from OPRR and FDA, including

Dr. Gary B. Ellis, Mr. Paul Goebel, Jr., and Dr. Gary Chadwick, and

other Federal agencies such as the Congressional Office of Technology

Assessment, the Office of Research on Women's Health at NIH, and the

National Institute of Mental Health.  Distinguished members of the

academic and clinical research community will also include Dr.

William L. Freeman of the Indian Health Service, Dr. Diane Brown from

the University of California at Berkeley, Dr. Ernest D. Prentice of

the University of Nebraska, and Dr. John Estrada of Meharry Medical

College.  The format will encourage audience participation and

informal information exchanges, with ample question and answer

opportunities throughout the program.

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 that 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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