[Federal Register Volume 59, Number 155 (Friday, August 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19688]


[[Page Unknown]]

[Federal Register: August 12, 1994]


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OFFICE OF SCIENCE AND TECHNOLOGY

 

National Bioethics Advisory Commission Proposed Charter

AGENCY: Office of Science and Technology Policy (OSTP).

ACTION: Request for Comments.

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SUMMARY: This notice describes a proposal to establish a National 
Bioethics Advisory Commission within the Executive Branch. The 
Commission would be charged to consider issues of bioethics arising 
from research on human biology and behavior, and the applications of 
that research.

DATES: Comments must be received on or before October 11, 1994.

ADDRESSES: Submit written comments by mail to: Bioethics Docket, Office 
of Science and Technology Policy, Room 436, OEOB, Washington, D.C. 
20500, or by FAX to: 202-456-6027.

FOR FURTHER INFORMATION CONTACT:
By mail: Rachel E. Levinson, Assistant Director for Life Sciences, 
Office of Science and Technology Policy, Room 436, OEOB, Washington, 
D.C. 20500. Office telephone number: 202-456-6137.

SUPPLEMENTARY INFORMATION: OSTP proposes that a standing advisory body 
be established within the Executive Branch to consider issues of 
bioethics arising from research on human biology and behavior, and the 
applications of that research. This action would fulfill a need 
recognized by all branches of the Federal government. For example, a 
report by the House of Representatives Committee on Government 
Operations recommended establishment of an advisory committee to 
examine the ethical, legal and social implications of the Human Genome 
Project. The proposed advisory body would expand the work of the 
National Commission for the Protection of Human Subjects of Biomedical 
and Behavioral Research; the Department of Health, Education and 
Welfare's Ethics Advisory Board; and the President's Commission for the 
Study of Ethics Problems in Medicine and Biomedical and Behavioral 
Research.
    OSTP seeks comments on a draft charter for a proposed National 
Bioethics Advisory Commission (NBAC). The NBAC would report to the 
President's National Science and Technology Council (NSTC). This 
arrangement will facilitate access to the deliberations and 
recommendations of the NBAC for the Executive Branch agencies most 
heavily invested in biological and behavioral research.
    The Commission would be asked to identify and develop broad 
overarching principles to govern the ethical conduct of biological and 
behavioral research, and the applications of that research. The 
proposed NBAC would not have responsibility for the review and approval 
of individual projects.
    The draft charter seeks to strike a balance between defining the 
NBAC's agenda so as to fulfill governmental needs, and allowing the 
Commission sufficient flexibility to advise the government on issues 
this group of experts and stakeholders believe should be addressed.
    The charter specifies two prospective areas of inquiry, issues in 
the management and use of genetic information and protection of the 
rights and welfare of research subjects. Discrete issues that full 
under these two broad topics include: issues of genetic privacy, 
screening for genetic disorders, intellectual property rights, access 
to research data or materials developed with public funding, current 
views on informed consent, adequacy and implementation of Federal human 
subject research guidelines, and the concept of ``minimal risk.''
    In addition, several other potential issues for consideration by 
the Commission have been raised in discussions to date including: 
adequacy and implementation of Federal human subject research 
guidelines, recommendations on requirements to maintain research data, 
and the ethical aspects of access to costly health care technology. The 
question is, how best might the scope of the Commission's charge be 
defined so as to meet public needs for deliberation of pressing issues 
in bioethics, without being so broad as to limit its effectiveness? An 
alternative option for addressing the last issue, for example, might be 
referral to a body more directly involved with decisions related to the 
provisions of health care and relevant cost/benefit analysis.
    The Commission would be established in accordance with the Federal 
Advisory Committee Act (FACA). As such, its meetings would be open tot 
he public and announced in advance to facilitate public participation. 
In addition, reports produced by the NBAC would be made available to 
public either in toto, or in summary. The purpose of these efforts 
would be to involve the public in the deliberations of the NBAC to the 
greatest extent possible.
    As a FACA committee, the NBAC will be required to have a balanced 
membership. Naturally, selection of Commission members is going to be a 
delicate process that should take into account the social and cultural 
mores of the times in order to establish a body that is sensitive to 
the potential impacts of its deliberations and recommendations. The 
draft charter proposes that members be appointed by the President. 
Suggestions for potential members or membership posts are sought 
through this Notice.

Draft Charter

Proposed National Bioethics Advisory Commission

Purpose

    The National Bioethics Advisory Commission will provide advice and 
make recommendations to the National Science and Technology Council, 
other appropriate entities and the public, on bioethical issues arising 
from research on human biology and behavior, and the applications of 
that research.

Authority

    42 U.S.C. 6617(a)(2). This Commission is governed by the provisions 
of the Federal Advisory Committee Act (FACA), Public Law 92-463, as 
amended (5 U.S.C. Appendix 2), which sets forth standards for the 
formation of advisory committees, and implementing regulations (41 CFR 
101-6.10).

Functions

    The National Bioethics Advisory Commission shall advise, consult 
with, and make recommendations to the National Science and Technology 
Council and other appropriate entities, and also make their advice and 
recommendations available to the public. The Commission's purview 
includes the appropriateness of departmental, agency, or other 
governmental programs, policies, assignments, missions, guidelines, and 
regulations as they relate to bioethical issues arising from research 
on human biology and behavior, and applications of that research. The 
Commission shall identify broad, overarching principles to govern the 
ethical conduct of research, citing individual projects only as 
illustrations for such principles. The Commission shall not be 
responsible for the review and approval of individual projects.
    As a first priority, the Commission will direct its attention to 
consideration of:

A. Issues in the management and use of genetic information; and
B. Protection of the rights and welfare of research subjects.

    In receiving and responding to requests for advice and 
recommendations from the National Science and Technology Council, the 
Commission shall consider four criteria in establishing priority for 
its activities:

A. The public health or public policy urgency of the bioethical issue.
B. The relation of the bioethical issue to the goals for Federal 
investment in science and technology.
C. The absence of another body able to fruitfully deliberate on the 
bioethical issue.
D. The extent of interest in the issue across the government. (The 
Commission ordinarily will not deliberate on a bioethical issue of 
interest to just one department or agency.)

    The Commission also shall have the authority to identify bioethical 
issues, on its own behalf, for deliberation. The Commission will accept 
suggestions of issues for consideration from Federal agencies, Congress 
and the public. The Commission's decision to deliberate on a specific 
topic shall be made in consultation with the National Science and 
Technology Council. In all such instances, the four stated criteria for 
establishing priority shall pertain.

Structure

    The National Bioethics Advisory Commission shall consist of not 
more than 15 members, including the Chairperson. Appointments shall be 
made by the President, who shall select from knowledgeable non-
Government experts and community representatives with special 
qualifications and competence to deal effectively with bioethical 
issues of concern to the participating departments and agencies. At 
least one member shall be selected from each of the following 
categories of primary expertise: (i) bioethics/theology; (ii) social/
behavioral science; (iii) law; (iv) medicine/allied health professions; 
and (v) biological research. At least three members shall be selected 
from the general public, bringing to the Commission expertise other 
than that listed. The membership shall be approximately evenly balanced 
between scientists and non-scientists.
    Members shall be appointed for overlapping four-year terms. 
Initially, members will be appointed for two-, three- or four-year 
terms. Terms of more than two years are contingent upon renewal of the 
National Bioethics Advisory Commission by appropriate action prior to 
its termination. The Chairperson shall be appointed by the President. 
The term of office for the Chairperson shall be two years, renewable by 
appropriate action of the President.
    If a vacancy occurs on the Commission, the President shall make an 
appointment to fulfill the term. Any member appointed to fill a vacancy 
occurring prior to expiration of the term for which his or her 
predecessor was appointed shall serve for the remainder of such term. 
Members may serve after the expiration of their terms until their 
successors have taken office.
    The Commission may conduct inquiries, hold hearings and establish 
subcommittees, as necessary.
    The Commission is authorized to conduct analyses and develop 
reports or other materials. In order to augment the expertise present 
on the Commission, the Commission is also authorized to contract for 
the services of non-governmental consultants who may conduct analyses, 
prepare reports and background papers or prepare other materials for 
consideration by the Commission, as appropriate.
    In order to avoid duplication of effort, the Commission may, in 
lieu of, or as part of any of its authorized activities, incorporate 
the results of the deliberations of another entity as long as the 
Commission sets forth its reasons for doing so.
    The Assistant to the President for Science and Technology shall be 
notified upon establishment of each subcommittee, and shall be provided 
information on the name, membership (including chair), function, 
estimated duration of the subcommittee, and estimated frequency of 
meetings.
    Management and support services shall be provided by the Office for 
Protection from Research Risks, Department of Health and Human 
Services. Additional resources including, but not limited to personnel, 
office support and printing will be provided by other NSTC member 
agencies.

Meetings

    Meetings of the Commission shall be held up to 10 times a year at 
the call of the Chairperson with the advance approval of a Federal 
Government official who shall also approve the agenda. Meetings of the 
subcommittee(s) shall be convened as necessary. A Federal Government 
official shall be present at all meetings.
    Meetings shall be open to the public except as determined otherwise 
by the Assistant to the President for Science and Technology. Advance 
notice of all meetings shall be given to the public.
    Meetings shall be conducted, and records of proceedings kept, as 
required by applicable laws and Federal regulations.

Compensation

    Members may be compensated at a rate not to exceed the maximum pay 
authorized by 5 U.S.C. 3109, plus per diem and travel expenses as in 
accordance with standard government travel regulations.

Annual Cost Estimate

    The estimated annual cost for operating the National Bioethics 
Advisory Commission, including compensation and travel expenses for 
members and contracting and publication services costs, but excluding 
that for staff support, $1,500,000. The estimated annual person years 
of staff support is six, at an estimated annual cost of $500,000.

Reports

    Reports by the National Bioethics Advisory Commission on specific 
issues shall be submitted to the National Science and Technology 
Council, the appropriate committees of Congress, and other appropriate 
entities. The Commission may specifically identify the Federal 
department, agency or other entity to which particular recommendations 
are directed and request a response from the Federal department, agency 
or other entity within 180 days of publication of such recommendations.
    Executive summaries of each report of the Commission shall be 
promulgated in the Federal Register. Such summaries shall specifically 
list the department, agency, or other entity to which any 
recommendations are directed and the date by which such responses are 
expected.
    An annual report shall be submitted to the National Science and 
Technology Council and the appropriate committees of Congress. It shall 
contain, at a minimum, (i) the Commission's function; (ii) a list of 
members and their business addresses; (iii) the dates and places of 
meetings; (iv) a summary of the Commission's activities during the 
year; (v) a summary of the Commission's recommendations made during the 
year; and (vi) a summary of responses made by departments, agencies, or 
other entities to the Commission's recommendations during the year.

Termination Date

    Unless renewed by appropriate action prior to its expiration, this 
National Bioethics Advisory Commission will terminate two years from 
the date this charter is approved.
Barbara Ann Ferguson,
Administrative Officer, Office of Science and Technology Policy.
[FR Doc. 94-19688 Filed 8-11-94]
BILLING CODE 3170-01 OSTP-M