
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC6601]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
 CHAPTER 79--SCIENCE AND TECHNOLOGY POLICY, ORGANIZATION AND PRIORITIES
 
 SUBCHAPTER I--NATIONAL SCIENCE, ENGINEERING, AND TECHNOLOGY POLICY AND 
                               PRIORITIES
 
Sec. 6601. Congressional findings; priority goals

    (a) The Congress, recognizing the profound impact of science and 
technology on society, and the interrelations of scientific, 
technological, economic, social, political, and institutional factors, 
hereby finds and declares that--
        (1) the general welfare, the security, the economic health and 
    stability of the Nation, the conservation and efficient utilization 
    of its natural and human resources, and the effective functioning of 
    government and society require vigorous, perceptive support and 
    employment of science and technology in achieving national 
    objectives;
        (2) the many large and complex scientific and technological 
    factors which increasingly influence the course of national and 
    international events require appropriate provision, involving long-
    range, inclusive planning as well as more immediate program 
    development, to incorporate scientific and technological knowledge 
    in the national decisionmaking process;
        (3) the scientific and technological capabilities of the United 
    States, when properly fostered, applied, and directed, can 
    effectively assist in improving the quality of life, in anticipating 
    and resolving critical and emerging international, national, and 
    local problems, in strengthening the Nation's international economic 
    position, and in furthering its foreign policy objectives;
        (4) Federal funding for science and technology represents an 
    investment in the future which is indispensable to sustained 
    national progress and human betterment, and there should be a 
    continuing national investment in science, engineering, and 
    technology which is commensurate with national needs and 
    opportunities and the prevalent economic situation;
        (5) the manpower pool of scientists, engineers, and technicians, 
    constitutes an invaluable national resource which should be utilized 
    to the fullest extent possible; and
        (6) the Nation's capabilities for technology assessment and for 
    technological planning and policy formulation must be strengthened 
    at both Federal and State levels.

    (b) As a consequence, the Congress finds and declares that science 
and technology should contribute to the following priority goals without 
being limited thereto:
        (1) fostering leadership in the quest for international peace 
    and progress toward human freedom, dignity, and well-being by 
    enlarging the contributions of American scientists and engineers to 
    the knowledge of man and his universe, by making discoveries of 
    basic science widely available at home and abroad, and by utilizing 
    technology in support of United States national and foreign policy 
    goals;
        (2) increasing the efficient use of essential materials and 
    products, and generally contributing to economic opportunity, 
    stability, and appropriate growth;
        (3) assuring an adequate supply of food, materials, and energy 
    for the Nation's needs;
        (4) contributing to the national security;
        (5) improving the quality of health care available to all 
    residents of the United States;
        (6) preserving, fostering, and restoring a healthful and 
    esthetic natural environment;
        (7) providing for the protection of the oceans and coastal 
    zones, and the polar regions, and the efficient utilization of their 
    resources;
        (8) strengthening the economy and promoting full employment 
    through useful scientific and technological innovations;
        (9) increasing the quality of educational opportunities 
    available to all residents of the United States;
        (10) promoting the conservation and efficient utilization of the 
    Nation's natural and human resources;
        (11) improving the Nation's housing, transportation, and 
    communication systems, and assuring the provision of effective 
    public services throughout urban, suburban, and rural areas;
        (12) eliminating air and water pollution, and unnecessary, 
    unhealthful, or ineffective drugs and food additives; and
        (13) advancing the exploration and peaceful uses of outer space.

(Pub. L. 94-282, title I, Sec. 101, May 11, 1976, 90 Stat. 459.)


                               Short Title

    Section 1 of Pub. L. 94-282 provided that: ``This Act [enacting this 
chapter, amending section 1863 of this title, repealing sections 1, 2, 
3, and 4 of Reorganization Plan Numbered 2 of 1962 (76 Stat. 1253), set 
out as a note under section 1861 of this title, and section 2 of 
Reorganization Plan Numbered 1 of 1973 (87 Stat. 1089), set out as a 
note under section 5195 of this title, and enacting provisions set out 
as notes under this section and sections 1862 and 6611 of this title] 
may be cited as the `National Science and Technology Policy, 
Organization, and Priorities Act of 1976'.''
    Section 201 of title II of Pub. L. 94-282 provided that: ``This 
title [enacting subchapter II of this chapter] may be cited as the 
`Presidential Science and Technology Advisory Organization Act of 
1976'.''

 Ex. Ord. No. 12039. Transfer of Certain Science and Technology Policy 
                                Functions

    Ex. Ord. No. 12039, Feb. 24, 1978, 43 F.R. 8095, as amended by Ex. 
Ord. No. 12399, Dec. 31, 1982, 48 F.R. 379, provided:
    By virtue of the authority vested in me by the Constitution and laws 
of the United States of America, including Section 7 of Reorganization 
Plan No. 1 of 1977 (42 FR 56101 (October 21, 1977)) [set out in Appendix 
of Title 5, Government Organization and Employees], Section 301 of Title 
3 of the United States Code, and Section 202 of the Budget and 
Accounting Procedures Act of 1950 (31 U.S.C. 581c) [31 U.S.C. 1531], and 
as President of the United States of America, in order to provide for 
the transfer of certain science and technology functions, it is hereby 
ordered as follows:
    Section 1. (a) The transfer, provided by Section 5A of 
Reorganization Plan No. 1 of 1977 (42 FR 56101) [set out in Appendix of 
Title 5, Government Organization and Employees], of certain functions 
under the National Science and Technology Policy, Organization, and 
Priorities Act of 1976, hereinafter referred to as the Act (90 Stat. 
459, 42 U.S.C. 6601 et seq.), from the Office of Science and Technology 
Policy and its Director to the Director of the National Science 
Foundation is hereby effective.
    (b) The abolition of the Intergovernmental Science, Engineering, and 
Technology Advisory Panel, the President's Committee on Science and 
Technology, and the Federal Coordinating Council for Science, 
Engineering and Technology (established in accordance with Titles II, 
III, and IV of the Act) [sections 6611 et seq., 6631 et seq., and 6651 
of this title] and the transfer of their functions (Sections 205(b)(1), 
303(a) and (b)(1), and 401 of the Act, 42 U.S.C. 6614(b)(1), 6633 (a) 
and (b)(1), and 6651(e)) to the President of the United States of 
America, provided by Section 5A of Reorganization Plan No. 1 of 1977 
[set out in Appendix of Title 5, Government Organization and Employees], 
are hereby effective.
    Sec. 2. (a) The intergovernmental science, engineering, and 
technology functions under Section 205(b)(1) of the Act (42 U.S.C. 
6614(b)(1)), which were transferred to the President (see Section 1(b) 
of this Order), are delegated to the Director of the Office of Science 
and Technology Policy; Except that, the responsibility for fostering any 
policies to facilitate the transfer and utilization of research and 
development results is delegated to the Director of the Office of 
Management and Budget.
    (b) The functions vested by subsection (a) of this Section in the 
Director of the Office of Management and Budget shall be performed in 
accord with the Director's responsibilities under the Intergovernmental 
Cooperation Act of 1968 (82 Stat. 1098, 42 U.S.C. 4201 et seq.) [31 
U.S.C. 6501 et seq.]. The Director of the Office of Science and 
Technology Policy shall advise the Director of the Office of Management 
and Budget with respect to the needs of State, regional, and local 
governments which may be assisted by the utilization of science, 
engineering, and technology research and development results.
    (c) The functions vested by subsection (a) of this Section in the 
Director of the Office of Science and Technology Policy shall be 
performed in coordination with the Director of the Office of Management 
and Budget and with others as designated by the President.
    (d) [Revoked by Ex. Ord. No. 12399, Dec. 31, 1982, 48 F.R. 379.]
    Sec. 3. The Federal science, engineering, and technology functions 
under Section 303 (a) and (b)(1) of the Act (42 U.S.C. 6633 (a) and 
(b)(1)), which were transferred to the President (see Section 1(b) of 
this Order), are delegated to the Director of the Office of Science and 
Technology Policy: Except that, those functions concerned with 
reorganization, including Federal-State liaison, are delegated to the 
Director of the Office of Management and Budget, who shall be provided 
advice and assistance thereon by the Director of the Office of Science 
and Technology Policy.
    Sec. 4. The science, engineering, and technology and related 
activities functions under Section 401(e) of the Act (42 U.S.C. 
6651(e)), which were transferred to the President (see Section 1(b) of 
this Order), are delegated to the Director of the Office of Science and 
Technology Policy.
    Sec. 5. There is hereby established the Federal Coordinating Council 
for Science, Engineering, and Technology. The Council shall be composed 
of the Director of the Office of Science and Technology Policy, who 
shall be Chairman, and representatives of such other Executive agencies 
designated by the Chairman. The head of an agency so designated shall 
designate an appropriate individual to serve on the Council. The Council 
shall advise and assist the Director of the Office of Science and 
Technology Policy in the performance of those functions delegated under 
Section 4 of this Order.
    Sec. 6. The records, property, personnel, and unexpended balances of 
appropriations, available or to be made available, which relate to the 
functions transferred, reassigned, or redelegated by this Order are 
hereby transferred to the Director of the Office of Management and 
Budget, the Director of the Office of Science and Technology Policy, or 
the Director of the National Science Foundation, as appropriate.
    Sec. 7. The Director of the Office of Management and Budget shall 
make such determinations, issue such orders, and take all actions 
necessary or appropriate to effectuate the transfers or reassignments 
provided by this Order, including the transfer of funds, records, 
property, and personnel.
    Sec. 8. This Order shall be effective on February 26, 1978.
                                                           Jimmy Carter.

                        Executive Order No. 12700

    Ex. Ord. No. 12700, Jan. 19, 1990, 55 F.R. 2219, as amended by Ex. 
Ord. No. 12768, June 28, 1991, 56 F.R. 30302, which established the 
President's Council of Advisors on Science and Technology and provided 
for its functions, administration, and termination on June 30, 1993, was 
revoked by section 4(c) of Ex. Ord. No. 12882, Sec. 4(c), Nov. 23, 1993, 
58 F.R. 62493, set out below. Ex. Ord. No. 12869, Sept. 30, 1993, 
Sec. 2, 58 F.R. 51751, set out as a note under section 14 of the Federal 
Advisory Committee Act in the Appendix to Title 5, Government 
Organization and Employees, which reestablished the President's Council 
of Advisors on Science and Technology in accordance with the provisions 
of Ex. Ord. No. 12700 and extended its term until Sept. 30, 1995, was 
also revoked by Ex. Ord. 12882, Sec. 4(c).

  Ex. Ord. No. 12881. Establishment of National Science and Technology 
                                 Council

    Ex. Ord. No. 12881, Nov. 23, 1993, 58 F.R. 62491, provided:
    By the authority vested in me as President by the Constitution and 
the laws of the United States of America, including section 301 of title 
3, United States Code, it is hereby ordered as follows:
    Section 1. Establishment. There is established the National Science 
and Technology Council (``the Council'').
    Sec. 2. Membership. The Council shall comprise the:
        (a) President, who shall serve as Chairman of the Council;
        (b) Vice President;
        (c) Secretary of Commerce;
        (d) Secretary of Defense;
        (e) Secretary of Energy;
        (f) Secretary of Health and Human Services;
        (g) Secretary of State;
        (h) Secretary of the Interior;
        (i) Administrator, National Aeronautics and Space 
    Administration;
        (j) Director, National Science Foundation;
        (k) Director of the Office of Management and Budget;
        (l) Administrator, Environmental Protection Agency;
        (m) Assistant to the President for Science and Technology;
        (n) National Security Adviser;
        (o) Assistant to the President for Economic Policy;
        (p) Assistant to the President for Domestic Policy; and
        (q) Such other officials of executive departments and agencies 
    as the President may, from time to time, designate.
    Sec. 3. Meetings of the Council. The President or, upon his 
direction, the Assistant to the President for Science and Technology 
(``the Assistant''), may convene meetings of the Council. The President 
shall preside over the meetings of the Council, provided that in his 
absence the Vice President, and in his absence the Assistant, will 
preside.
    Sec. 4. Functions. (a) The principal functions of the Council are, 
to the extent permitted by law: (1) to coordinate the science and 
technology policy-making process; (2) to ensure science and technology 
policy decisions and programs are consistent with the President's stated 
goals; (3) to help integrate the President's science and technology 
policy agenda across the Federal Government; (4) to ensure science and 
technology are considered in development and implementation of Federal 
policies and programs; and (5) to further international cooperation in 
science and technology. The Assistant may take such actions, including 
drafting a Charter, as may be necessary or appropriate to implement such 
functions.
    (b) All executive departments and agencies, whether or not 
represented on the Council, shall coordinate science and technology 
policy through the Council and shall share information on research and 
development budget requests with the Council.
    (c) The Council shall develop for submission to the Director of the 
Office of Management and Budget recommendations on research and 
development budgets that reflect national goals. In addition, the 
Council shall provide advice to the Director of the Office of Management 
and Budget concerning the agencies' research and development budget 
submissions.
    (d) The Assistant will, when appropriate, work in conjunction with 
the Assistant to the President for Economic Policy, the Assistant to the 
President for Domestic Policy, the Director of the Office of Management 
and Budget, and the National Security Adviser.
    Sec. 5. Administration. (a) The Council will oversee the duties of 
the Federal Coordinating Council for Science, Engineering, and 
Technology, the National Space Council, and the National Critical 
Materials Council.
    (b) The Council may function through established or ad hoc 
committees, task forces, or interagency groups.
    (c) To the extent practicable and permitted by law, executive 
departments and agencies shall make resources, including, but not 
limited to, personnel, office support, and printing, available to the 
Council as requested by the Assistant.
    (d) All executive departments and agencies shall cooperate with the 
Council and provide such assistance, information, and advice to the 
Council as the Council may request, to the extent permitted by law.
                                                     William J. Clinton.

  Ex. Ord. No. 12882. President's Committee of Advisors on Science and 
                               Technology

    Ex. Ord. No. 12882, Nov. 23, 1993, 58 F.R. 62493, as amended by Ex. 
Ord. No. 12907, Apr. 14, 1994, 59 F.R. 18291, provided:
    By the authority vested in me as President by the Constitution and 
the laws of the United States of America, including section 301 of title 
3, United States Code, and in order to establish an advisory committee 
on science and technology, it is hereby ordered as follows:
    Section 1. Establishment. There is established the President's 
Committee of Advisors on Science and Technology (``PCAST''). PCAST shall 
be composed of not more than 19 members, one of whom shall be the 
Assistant to the President for Science and Technology (``Assistant''), 
and 18 of whom shall be distinguished individuals from the nonfederal 
sector appointed by the President. The nonfederal sector members shall 
be representative of the diverse perspectives and expertise in this 
Nation's investments in science and technology. The Assistant to the 
President for Science and Technology shall co-chair PCAST with a 
nonfederal sector member selected by the President.
    Sec. 2. Functions. (a) The PCAST shall advise the President, through 
the Assistant, on matters involving science and technology.
    (b) In the performance of its advisory duties, PCAST shall assist 
the National Science and Technology Council (``Council'') in securing 
private sector involvement in its activities.
    Sec. 3. Administration. (a) The heads of executive departments and 
agencies shall, to the extent permitted by law, provide PCAST such 
information with respect to scientific and technological matters as 
required for the purpose of carrying out its functions.
    (b) In consultation with the Assistant to the President for Science 
and Technology, PCAST is authorized to convene ad hoc working groups to 
assist the Council.
    (c) Members of PCAST shall serve without any compensation for their 
work on PCAST. However, members may be allowed travel expenses, 
including per diem in lieu of subsistence, as authorized by law for 
persons serving intermittently in the government service (5 U.S.C. 5701-
5707).
    (d) Any expenses of PCAST shall be paid from the funds available for 
the expenses of the Office of Science and Technology Policy.
    (e) The Office of Science and Technology Policy shall provide such 
administrative services as may be required.
    Sec. 4. General. (a) I have determined that the Committee shall be 
established in compliance with the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.). Notwithstanding any other Executive order, the 
functions of the President under the Federal Advisory Committee Act, as 
amended, except that of reporting to the Congress, which are applicable 
to PCAST shall be performed by the Office of Science and Technology 
Policy in accordance with the guidelines and procedures established by 
the Administrator of General Services.
    (b) PCAST shall terminate 2 years from the date of this order unless 
extended prior to that date.
    (c) Executive Orders Nos. 12700, 12768, and Section 2 of Executive 
Order No. 12869 [set out as a note under section 14 of the Federal 
Advisory Committee Act in the Appendix to Title 5, Government 
Organization and Employees] are hereby revoked.
                                                     William J. Clinton.


 Extension of Term of President's Committee of Advisors on Science and 
                               Technology

    Term of the President's Committee of Advisors on Science and 
Technology extended until Sept. 30, 1997, by Ex. Ord. No. 12974, Sept. 
29, 1995, 60 F.R. 51875, formerly set out as a note under section 14 of 
the Federal Advisory Committee Act in the Appendix to Title 5, 
Government Organization and Employees.
    Term of the President's Committee of Advisors on Science and 
Technology extended until Sept. 30, 1999, by Ex. Ord. No. 13062, 
Sec. 1(g), Sept. 29, 1997, 62 F.R. 51755, formerly set out as a note 
under section 14 of the Federal Advisory Committee Act in the Appendix 
to Title 5.
    Term of the President's Committee on Advisors on Science and 
Technology extended until Sept. 30, 2001, by Ex. Ord. No. 13138, Sept. 
30, 1999, 64 F.R. 53879, set out as a note under section 14 of the 
Federal Advisory Committee Act in the Appendix to Title 5.

 Ex. Ord. No. 12975. Protection of Human Research Subjects and Creation 
                of National Bioethics Advisory Commission

    Ex. Ord. No. 12975, Oct. 3, 1995, 60 F.R. 52063, as amended by Ex. 
Ord. No. 13018, Sept. 16, 1996, 61 F.R. 49045; Ex. Ord. No. 13046, May 
16, 1997, 62 F.R. 27685; Ex. Ord. No. 13137, Sept. 15, 1999, 64 F.R. 
50733, provided:
    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 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 6 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. 
There is established in the Department of Health and Human Services a 
National Bioethics Advisory Commission (NBAC). The NBAC shall be subject 
to the Federal Advisory Committee Act, as amended (5 U.S.C. App.).
    Sec. 4. Structure. (a) The National Bioethics Advisory Commission 
shall be composed of not more than 18 nongovernment members appointed by 
the President. At least one member shall be selected from each of the 
following categories of primary expertise: (1) philosophy/theology; (2) 
social/behavioral science; (3) law; (4) medicine/allied health 
professions; and (5) 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.
    (b) 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 term.
    (c) The President shall designate a Chairperson from among the 
members of the NBAC.
    Sec. 5. 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. 6. 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. 7. 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. 8. 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 on October 3, 2001, unless extended by the 
President 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.
                                                     William J. Clinton.

   Strengthened Protections for Human Subjects of Classified Research

    Memorandum of President of the United States, Mar. 27, 1997, 62 F.R. 
26369, provided:
    Memorandum for the Secretary of Defense, the Attorney General, the 
Secretary of Agriculture, the Secretary of Commerce, the Secretary of 
Labor, the Secretary of Health and Human Services, the Secretary of 
Housing and Urban Development, the Secretary of Transportation, the 
Secretary of Energy, the Secretary of Education, the Secretary of 
Veterans Affairs, the Director of Central Intelligence, the 
Administrator of the Environmental Protection Agency, the Administrator 
of the Agency for International Development, the Administrator of the 
National Aeronautics and Space Administration, the Director of the 
National Science Foundation, the Chair of the Nuclear Regulatory 
Commission, the Director of the Office of Science and Technology Policy, 
[and] the Chair of the Consumer Product Safety Commission
    I have worked hard to restore trust and ensure openness in 
government. This memorandum will further our progress toward these goals 
by strengthening the Federal Government's protections for human subjects 
of classified research.
    In January 1994, I established the Advisory Committee on Human 
Radiation Experiments (the ``Advisory Committee'') to examine reports 
that the government had funded and conducted unethical human radiation 
experiments during the Cold War [see Ex. Ord. No. 12891, set out as a 
note under section 2210 of this title]. I directed the Advisory 
Committee to uncover the truth, recommend steps to right past wrongs, 
and propose ways to prevent unethical human subjects research from 
occurring in the future. In its October 1995 final report, the Advisory 
Committee recommended, among other things, that the government modify 
its policy governing classified research on human subjects 
(``Recommendations for Balancing National Security Interests and the 
Rights of the Public,'' Recommendation 15, Final Report, Advisory 
Committee on Human Radiation Experiments). This memorandum sets forth 
policy changes in response to those recommendations.
    The Advisory Committee acknowledged that it is in the Nation's 
interest to continue to allow the government to conduct classified 
research involving human subjects where such research serves important 
national security interests. The Advisory Committee found, however, that 
classified human subjects research should be a ``rare event'' and that 
the ``subjects of such research, as well as the interests of the public 
in openness in science and in government, deserve special protections.'' 
The Advisory Committee was concerned about ``exceptions to informed 
consent requirements and the absence of any special review and approval 
process for human research that is to be classified.'' The Advisory 
Committee recommended that in all classified research projects the 
agency conducting or sponsoring the research meet the following 
requirements:
    --obtain informed consent from all human subjects;
    --inform subjects of the identity of the sponsoring agency;
    --inform subjects that the project involves classified research;
    --obtain approval by an ``independent panel of nongovernmental 
experts and citizen representatives, all with the necessary security 
clearances'' that reviews scientific merit, risk-benefit tradeoffs, and 
ensures subjects have enough information to make informed decisions to 
give valid consent; and
    --maintain permanent records of the panel's deliberations and 
consent procedures.
    This memorandum implements these recommendations with some 
modifications. For classified research, it prohibits waiver of informed 
consent and requires researchers to disclose that the project is 
classified. For all but minimal risk studies, it requires researchers to 
inform subjects of the sponsoring agency. It also requires permanent 
recordkeeping.
    The memorandum also responds to the Advisory Committee's call for a 
special review process for classified human subjects research. It 
requires that institutional review boards for secret projects include a 
nongovernmental member, and establishes an appeals process so that any 
member of a review board who believes a project should not go forward 
can appeal the boards' decision to approve it.
    Finally, this memorandum sets forth additional steps to ensure that 
classified human research is rare. It requires the heads of Federal 
agencies to disclose annually the number of secret human research 
projects undertaken by their agency. It also prohibits any agency from 
conducting secret human research without first promulgating a final rule 
applying the Federal Policy for the Protection of Human Subjects, as 
modified in this memorandum, to the agency.
    These steps, set forth in detail below, will preserve the 
government's ability to conduct any necessary classified research 
involving human subjects while ensuring adequate protection of research 
participants.
    1. Modifications to the Federal Policy for the Protection of Human 
Subjects as it Affects Classified Research. All agencies that may 
conduct or support classified research that is subject to the 1991 
Federal Policy for the Protection of Human Subjects (``Common Rule'') 
(56 Fed. Reg. 28010-28018) shall promptly jointly publish in the Federal 
Register the following proposed revisions to the Common Rule as it 
affects classified research. The Office for Protection from Research 
Risks in the Department of Health and Human Services shall be the lead 
agency and, in consultation with the Office of Management and Budget, 
shall coordinate the joint rulemaking.
    (a) The agencies shall jointly propose to prohibit waiver of 
informed consent for classified research.
    (b) The agencies shall jointly propose to prohibit the use of 
expedited review procedures under the Common Rule for classified 
research.
    (c) The joint proposal should request comment on whether all 
research exemptions under the Common Rule should be maintained for 
classified research.
    (d) The agencies shall jointly propose to require that in classified 
research involving human subjects, two additional elements of 
information be provided to potential subjects when consent is sought 
from subjects:
    (i) the identity of the sponsoring Federal agency. Exceptions are 
allowed if the head of the sponsoring agency determines that providing 
this information could compromise intelligence sources or methods and 
that the research involves no more than minimal risk to subjects. The 
determination about sources and methods is to be made in consultation 
with the Director of Central Intelligence and the Assistant to the 
President for National Security Affairs. The determination about risk is 
to be made in consultation with the Director of the White House Office 
of Science and Technology Policy.
    (ii) a statement that the project is ``classified'' and an 
explanation of what classified means.
    (e) The agencies shall jointly propose to modify the institutional 
review board (``IRB'') approval process for classified human subjects 
research as follows:
    (i) The Common Rule currently requires that each IRB ``include at 
least one member who is not otherwise affiliated with the institution 
and who is not part of the immediate family of a person who is 
affiliated with the institution.'' For classified research, the agencies 
shall define ``not otherwise affiliated with the institution,'' as a 
nongovernmental member with the appropriate security clearance.
    (ii) Under the Common Rule, research projects are approved by the 
IRB if a ``majority of those (IRB) members present at a meeting'' 
approved the project. For classified research, the agencies shall 
propose to permit any member of the IRB who does not believe a specific 
project should be approved by the IRB to appeal a majority decision to 
approve the project to the head of the sponsoring agency. If the agency 
head affirms the IRB's decision to approve the project, the dissenting 
IRB member may appeal the IRB's decisions to the Director of OSTP. The 
Director of OSTP shall review the IRB's decision and approve or 
disapprove the project, or, at the Director's discretion, convene an IRB 
made up of nongovernmental officials, each with the appropriate security 
clearances, to approve or disapprove the project.
    (iii) IRBs for classified research shall determine whether potential 
subjects need access to classified information to make a valid informed 
consent decision.
    2. Final Rules. Agencies shall, within 1 year, after considering any 
comments, promulgate final rules on the protection of human subjects of 
classified research.
    3. Agency Head Approval of Classified Research Projects. Agencies 
may not conduct any classified human research project subject to the 
Common Rule unless the agency head has personally approved the specific 
project.
    4. Annual Public Disclosure of the Number of Classified Research 
Projects. Each agency head shall inform the Director of OSTP by 
September 30 of each year of the number of classified research projects 
involving human subjects underway on that date, the number completed in 
the previous 12-month period, and the number of human subjects in each 
project. The Director of OSTP shall report the total number of 
classified research projects and participating subjects to the President 
and shall then report to the congressional armed services and 
intelligence committees and further shall publish the numbers in the 
Federal Register.
    5. Definitions. For purposes of this memorandum, the terms 
``research'' and ``human subject'' shall have the meaning set forth in 
the Common Rule. ``Classified human research'' means research involving 
``classified information'' as defined in Executive Order 12958 [50 
U.S.C. 435 note].
    6. No Classified Human Research Without Common Rule. Beginning one 
year after the date of this memorandum, no agency shall conduct or 
support classified human research without having proposed and 
promulgated the Common Rule, including the changes set forth in this 
memorandum and any subsequent amendments.
    7. Judicial Review. This memorandum is not intended to create any 
right or benefit, substantive or procedural, enforceable at law by a 
party against the United States, its agencies, its officers, or any 
other persons.
    8. The Secretary of Health and Human Services shall publish this 
memorandum in the Federal Register.
                                                     William J. Clinton.

                  Section Referred to in Other Sections

    This section is referred to in section 6614 of this title.
