§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, §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, §4(c), Nov. 23, 1993, 58 F.R. 62493, set out below. Ex. Ord. No. 12869, Sept. 30, 1993, §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, §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, §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.