EO 12975
Effective Date: October 03, 1995

Responsible Office: Office of Life and Microgravity Sciences and Applications


By the authority vested in me as President by the Constitution
and the laws of the United States of America, it is hereby
ordered as follows:

Section 1. Review and Policies and Procedures.  (a) Each
executive branch department and agency that conducts, supports,
or regulates research involving human subjects shall promptly
review the protection of the rights and welfare of human research
subjects that are afforded by the department's or agency's
existing policies and procedures.  In conducting this review,
departments and agencies shall take account of the recommendation
contained in the report of the Advisory Committee on Human
Radiation Experiments.

(b) Within 120 days of the date of this order, each department
and agency that conducts, supports, or regulates research
involving human subjects shall report the results of the review
required by paragraph (a) of this section to the National
Bioethics Advisory Commission, created pursuant to this order.
The report shall include an identification of measures that the
department or agency plans or proposes to implement to enhance
human subject protection.  As set forth in section 5 of this
order, the National Bioethics Advisory Commission shall pursue,
as its first priority, protection of the rights and welfare of
human research subjects.

(c) For purposes of this order, the terms "research" and "human
subject" shall have the meaning set forth in the 1991 Federal
Policy for the Protection of Human Subjects.

Sec. 2. Research Ethics.  Each executive branch department and
agency that conducts, supports, or regulates research involving
human subjects shall, to the extent practicable and appropriate,
develop professional and public educational programs to enhance
activities related to human subjects protection, provide forums
for addressing ongoing and emerging issues in human subjects
research, and familiarize professionals engaged in nonfederally-
funded research with the ethical considerations associated with
conducting research involving human subjects.  Where appropriate,
such professional and educational programs should be organized
and conducted with the participation of medical schools,
universities, scientific societies, voluntary health
organizations, or other interested parties.

Sec. 3. Establishment of National Bioethics Advisory Commission.
(a) There is hereby established a National Bioethics Advisory
Commission ("NBAC").  NBAC shall be composed of not more than 15
members to be appointed by the President.  NBAC shall be subject
to the Federal Advisory Committee Act, as amended (5 U.S.C.

(b) The President shall designate a Chairperson from among the
members of NBAC.

Sec. 4. Functions.  (a) NBAC shall provide advice and make
recommendations to the National Science and Technology Council
and to other appropriate government entities regarding the
following matters:
   (1) 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 
   (2) applications, including the clinical applications, of that
(b) NBAC shall identify broad principles to govern the ethical
conduct of research, citing specific projects only as
illustrations for such principles.

(c) NBAC shall not be responsible for the review and approval of
specific projects.

(d) In addition to responding to requests for advice and
recommendations from the National Science and Technology Council,
NBAC also may accept suggestions of issues for consideration from
both the Congress and the public.  NBAC 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.

Sec. 5. Priorities. (a) As a first priority, NBAC shall direct
its attention to consideration of:  protection of the right and
welfare of human research subjects; and issues in the management
and use of genetic information including but not limited to,
human gene patenting.

(b) NBAC shall consider four criteria in establishing the other
priorities for its activities:
   (1) the public health or public policy urgency of the
bioethical issue;

   (2) the relation of the bioethical issue to the goals for
Federal investment in science and technology;

   (3) the absence of another entity able to deliberate
appropriately on the bioethical issue; and

   (4) the extent of interest in the issue within the Federal

Sec. 6. Administration. (a) The heads of executive departments
and agencies shall, to the extent permitted by law, provide NBAC
with such information as it may require for purposes of carrying
out its functions.

(b) NBAC may conduct inquiries, hold hearings, and establish
subcommittees, as necessary.  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, and
estimated frequency of meetings of the subcommittee.

(c) NBAC is authorized to conduct analyses and develop reports or
other materials.  In order to augment the expertise present on
NBAC, the Secretary of Health and Human Services may contract for
the services of nongovernmental consultants who may conduct
analyses, prepare reports and background papers, or prepare other
materials for consideration by NBAC, as appropriate.

(d) Members of NBAC shall be compensated in accordance with
Federal law.  Members of NBAC may be allowed travel expenses,
including per diem in lieu of subsistence, to the extent
permitted by law for persons serving intermittently in the
government service (5 U.S.C. 5701-5707).

(e) To the extent permitted by law, and subject to the
availability of appropriations, the Department of Health and
Human Services shall provide NBAC with such funds as may be
necessary for the performance of its functions.  The Secretary of
Health and Human Services shall provide management and support
services to NBAC.

Sec. 7. General Provisions. (a) Notwithstanding the provisions of
any other Executive order, the functions of the President under
the Federal Advisory Committee Act that are applicable to NBAC,
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.

(b) NBAC shall terminate two years from the date of this order
unless extended prior to that date.

(c) This order is intended only to improve the internal
management of the executive branch and it is not intended to
create any right, benefit, trust, or responsibility, substantive
or procedural, enforceable at law or equity by a party against
the United States, its agencies, its officers, or any person.

                    /s/William J. Clinton

October 3, 1995


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