[Federal Register Volume 65, Number 244 (Tuesday, December 19, 2000)]
[Notices]
[Pages 79369-79370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32200]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Bioethics Advisory Committee Request; International 
Research Ethical and Policy Issues; Comment Request

ACTION: Notice for comment on the draft report of the National 
Bioethics Advisory Commission (NBAC), Ethical and Policy Issues in the 
Oversight of Human Research.

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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

    In October 1995, President Clinton established NBAC to advise on 
bioethics and public policy issues related to conducting human 
research. NBAC makes recommendations to the White House and other 
departments and agencies. This report, therefore, falls within NBAC's 
mandate.
    Prior to NBAC's creation, in 1994, the Advisory Committee on Human 
Radiation Experiments (ACHRE) was created to investigate reports of 
federally sponsored human research involving radioactive materials and 
to assess the current state of protections for research participants. 
With regard to the latter charge they found, ``evidence of serious 
deficiencies in some parts of the current system.'' Specifically, ACHRE 
was concerned with variability in the quality of IRBs, persistent 
confusion among human participants as to whether they were involved in 
research or therapy, and insufficient attention to the implications of 
diminished decision-making capacity in the consent process. ACHRE also 
recommended the creation of a national advisory group to examine these 
issues. When NBAC was established, one of its first priorities was to 
examine the system for protecting human research participants.
    In May of 1997, NBAC unanimously resolved that ``No person in the 
United States should be enrolled in research without the twin 
protections of informed consent by an authorized person and independent 
review of the risks and benefits of the research.'' The following year, 
NBAC wrote to the President indicating areas of concern and preliminary 
findings regarding the oversight of human research in the United 
States. The key concerns identified were:
     Federal protections for persons serving as subjects in 
research do not yet extend to all Americans.
     Despite widespread implementation of federal regulations 
by those departments and agencies sponsoring substantial amounts of 
biomedical research, a number of departments and agencies who sponsor 
primarily non-biomedical research or little research overall have 
failed to implement fully these federal protections.
     Federal protections do not always include specific 
provisions for especially vulnerable populations of research subjects.
     Many federal agencies find the interpretation and 
implementation of the Common Rule confusing and/or unnecessarily 
burdensome.
     Federal protections are difficult to enforce and improve 
effectively throughout the Federal Government, in part because no 
single authority or office oversees research protections across all 
government agencies and departments.
     New techniques are needed to ensure implementation at the 
local level.

[[Page 79370]]

    In October 1999, Dr. Neal Lane, Assistant to the President for 
Science and Technology, reinforced the request that NBAC examine the 
federal system of oversight. This report addresses the basic purpose, 
structure, and implementation of research oversight. We recommend 
broad, strategic changes to the oversight system. This report is not 
intended to be a rewrite of federal regulations but instead to provide 
the guidance, direction, and justification for change. 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 February 17, 2001, 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: December 13, 2000.
Eric M. Meslin,
Executive Director, National Bioethics Advisory Commission.
[FR Doc. 00-32200 Filed 12-18-00; 8:45 am]
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