NATIONAL BIOETHICS ADVISORY COMMISSION CHARTER

Purpose

The National Bioethics Advisory Commission will provide advice and make recommendations to the National Science

and Technology Council, chaired by the President; other appropriate entities and the public, on bioethical issues arising

from research on human biology and behavior, and the applications, including the clinical applications, of that research.

Authority

Executive Order 12975, as amended. 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 (41C.F.R. 101.6.10).

Functions

The National Bioethics Advisory Commission shall advise, consult with, and make recommendations to the National

Science and Technology Council, chaired by the President; Federal agencies; and other appropriate entities, and also make

available to the public the Commission's advice and recommendations. 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,

including the clinical 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. Protection of the rights and welfare of human research subjects; and

B. Issues in the management and use of genetics information including but not limited to

human gene patenting.

In addition to responding to requests for advice and recommendations from the National science and Technology Council,

the Commission also may accept suggestions for issues for consideration from both the Congress and the public. The

Commission also may identify other bioethical issues for the purpose of providing advice and recommendations, subject

to the approval of 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 deliberate fruitfully 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.)
Structure

The National Bioethics Advisory Commission shall consist of not more than 18 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. At least

one member shall be selected from each of the following categories of primary expertise: (1) philosophy/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. Close attention will be given to

equitable geographic distribution and to ethnic and gender representation.

Members of the Commission will serve for terms of 2 years and may continue to serve after the expiration of their term

until a successor is appointed. A member appointed to fill an unexpired term will be appointed to the remainder of such

terms. 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 heads of executive departments and agencies shall, to the extent permitted by law, provide the Commission with such

information as it may require for purposes of carrying out its functions.

The Commission may conduct inquiries, hold hearings and establish subcommittees, as necessary.

The Commission is authorized to solicit information form relevant human research subject groups.

The Commission is authorized to conduct analyses and develop reports or other materials. In order to augment the

expertise present on the Commission, the Secretary of Health and Human Services 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 is encouraged to review the deliberations of other entities. The

Commission may incorporate or otherwise use the results of the deliberations of other entities, as it deems appropriate.

The Assistant to the President for Science and Technology and the Secretary of Health and Human Services 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.
To the extent permitted by law, the subject to the availability of appropriations, the Department of Health and Human

Services (DHHS) shall provide NBAC with such funds as may be necessary for the performance of its functions.

Management and support services shall be provided by the DHHS.

Meetings

Meetings of the Commission shall be held up to 12 times a year at the call of the Chairperson.

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 and the Secretary of Health and Human Services. 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 them 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 is

$3,000,000.

Reports

Reports by the National Bioethics Advisory Commission on specific issues shall be submitted to the National Science and

Technology Council, chaired by the President, and then to 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 recommendation.

Executive summaries of each report of the Commission shall be published in the Federal Register or on the World Wide

Web. 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, (1) 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.
General Provisions

Notwithstanding the provisions of any other Executive Order, the functions of the President under the Federal Advisory

Committee Act that are applicable to the Commission, except that of reporting annually to the Congress, shall be

performed by the Secretary of Health and Human Services, in accordance with the guidelines and procedures established

by the Administrator of General Services.

Termination Date

Unless renewed by Executive Order prior to its expiration, this National Bioethics Advisory

Commission will terminate on October 3, 2001.

Approved:

OCT 20, 1999 /s/ Donna E. Shalala

Date Secretary