00-25018. 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 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: [e-mail], NBAC website: www.bioethics.gov,, mail: 6705 Rockledge Drive, Suite 700, Bethesda, Maryland 20892-7979, fax: [phone].

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 [phone], fax number [phone], 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.