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Executive Order 12975

Issued by William J. Clinton on Tuesday 3 October 1995


Protection of Human Research Subjects and Creation of National Bioethics Advisory Commission

Federal Register, Volume 60 Issue 193 (Thursday, October 5, 1995)

[Federal Register Volume 60, Number 193 (Thursday, October 5, 1995)]
[Presidential Documents]
[Pages 52063-52065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24921]





                        Presidential Documents 



Federal Register / Vol. 60, No. 193 / Thursday, October 5, 1995 / 
Presidential Documents

___________________________________________________________________

Title 3--
The President

[[Page 52063]]

                Executive Order 12975 of October 3, 1995

                
Protection of Human Research Subjects and 
                Creation of
                National Bioethics Advisory Commission

                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 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 

[[Page 52064]]

                    (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.

                (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. 

[[Page 52065]]


                (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.

                    (Presidential Sig.)

                THE WHITE HOUSE,

                    October 3, 1995.

[FR Doc. 95-24921
Filed 10-3-95; 2:11 pm]
Billing code 3195-01-P

Citation: 60 FR 52063
Amended by: EO 13018, September 16, 1996; EO 13046, May 16, 1997; EO 13137, September 15, 1999;; ; Revoked by: EO 13316, September 17, 2003
 

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