[Weekly Compilation of Presidential Documents Volume 31, Number 40 (Monday, October 9, 1995)]
[Pages 1759-1761]
[Online from the Government Publishing Office, www.gpo.gov]

<R04>
Executive Order 12975--Protection of Human Research Subjects and 
Creation of National Bioethics Advisory Commission

October 3, 1995

    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 of Policies and Procedures. (a) Each executive 
branch department and agency that conducts, supports, or regulates 
research involving human subjects shall promptly review the protections 
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

[[Page 1760]]

shall take account of the recommendations 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 protections. 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. App.).
    (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 
research.
    (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 rights 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 
            Government.
    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.

[[Page 1761]]

    (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, it 
agencies, its officers, or any person.
                                            William J. Clinton
The White House,
October 3, 1995.

[Filed with the Office of the Federal Register, 2:11 p.m., October 3, 
1995]

Note: This Executive order was published in the Federal Register on 
October 5.