[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