[Federal Register Volume 65, Number 190 (Friday, September 29, 2000)]
[Notices]
[Pages 58554-58555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25018]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Notice for Comment on the Draft Report of the National Bioethics 
Advisory Commission (NBAC), Ethical and Policy Issues in International 
Research

SUMMARY: Pursuant to Section 10(d) of the Federal Advisory Committee 
Act, as amended (5 U.S.C. Appendix 2), notice is given for comment on a 
draft report written by the National Bioethics Advisory Commission 
(NBAC). The Commission will consider all comments it receives as part 
of its ongoing deliberations in finalizing this report.

Purpose of the Report

    The purpose of this report is to consider the ethical, legal, and 
policy issues that arise when research that is subject to U.S. 
regulations, is sponsored or conducted in other countries. NBAC's goal 
is to identify these issues and determine whether they are unique to 
international settings and deserve particular attention from 
policymakers. In this report NBAC is discussing issues such as: 
recruitment of subjects, informed consent, and the risks and potential 
benefits of conducting research. In addition, the Commission comments 
on the obligations of research sponsors to research participants, 
communities, and countries before, during, and after a trial. The draft 
report considers how and to what extent cultural and other factors 
influence these issues. Finally, NBAC analyzes

[[Page 58555]]

many national and international guidelines and statements to make 
recommendations about possible ways to enhance international 
collaborative research.

Providing Comments to the Draft Report

    You may provide written comments electronically or through mail or 
fax. Electronic submissions (by email or by website) are preferred as 
they will be processed more efficiently. The following are addresses 
for submitting comments: e-mail: [email protected], NBAC website: 
www.bioethics.gov, mail: 6705 Rockledge Drive, Suite 700, Bethesda, 
Maryland 20892-7979, fax: (301) 480-6900.
    If your comments are not postmarked by November 13, 2000, we can 
not guarantee they will be given full consideration.
    To Receive a Copy of this Draft Report Contact: National Bioethics 
Advisory Commission, 6705 Rockledge Drive, Suite 700, Bethesda, 
Maryland 20892-7979, telephone (301) 402-4242, fax number (301) 480-
6900, or visit the website at www.bioethics.gov.

SUPPLEMENTARY INFORMATION: The President established the National 
Bioethics Advisory Commission (NBAC) on October 3, 1995 by Executive 
Order 12975 as amended. The mission of the NBAC is to advise and make 
recommendations to the National Science and Technology Council, its 
Chair, the President, and other entities on bioethical issues arising 
from the research on human biology and behavior, and from the 
applications of that research.

    Dated: September 25, 2000.
Eric M. Meslin,
Executive Director, National Bioethics Advisory Commission.
[FR Doc. 00-25018 Filed 9-28-00; 8:45 am]
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