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42 U.S.C. § 289a–1 — Certain provisions regarding review and approval of proposals for research
Federal law — U.S. Code and appendices · legal_authorities
**(a) Review as precondition to research**
(1) **Protection of human research subjects**
(A) In the case of any application submitted to the Secretary for financial assistance to conduct research, the Secretary may not approve or fund any application that is subject to review under [section 289(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289/a&num=0&edition=prelim) by an Institutional Review Board unless the application has undergone review in accordance with such section and has been recommended for approval by a majority of the members of the Board conducting such review.
(B) In the case of research that is subject to review under procedures established by the Secretary for the protection of human subjects in clinical research conducted by the National Institutes of Health, the Secretary may not authorize the conduct of the research unless the research has, pursuant to such procedures, been recommended for approval.
(2) **Peer review** — In the case of any proposal for the National Institutes of Health to conduct or support research, the Secretary may not approve or fund any proposal that is subject to technical and scientific peer review under [section 289a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289a&num=0&edition=prelim) unless the proposal has undergone such review in accordance with such section and has been recommended for approval by a majority of the members of the entity conducting such review, and unless a majority of the voting members of the appropriate advisory council under [section 284a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section284a&num=0&edition=prelim), or as applicable, of the advisory council u
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Source file: Laws/federal/codes/united-states-code/title-42/section-289a1-certain-provisions-regarding-review-and-approval-of-proposals-for-resear--13f0f1a191.md
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Source location: Title 42, Chapter 6A, § 289a–1; chapter-6a-public-health-service.md
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**(a) Review as precondition to research**
(1) **Protection of human research subjects**
(A) In the case of any application submitted to the Secretary for financial assistance to conduct research, the Secretary may not approve or fund any application that is subject to review under [section 289(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289/a&num=0&edition=prelim) by an Institutional Review Board unless the application has undergone review in accordance with such section and has been recommended for approval by a majority of the members of the Board conducting such review.
(B) In the case of research that is subject to review under procedures established by the Secretary for the protection of human subjects in clinical research conducted by the National Institutes of Health, the Secretary may not authorize the conduct of the research unless the research has, pursuant to such procedures, been recommended for approval.
(2) **Peer review** — In the case of any proposal for the National Institutes of Health to conduct or support research, the Secretary may not approve or fund any proposal that is subject to technical and scientific peer review under [section 289a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289a&num=0&edition=prelim) unless the proposal has undergone such review in accordance with such section and has been recommended for approval by a majority of the members of the entity conducting such review, and unless a majority of the voting members of the appropriate advisory council under [section 284a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section284a&num=0&edition=prelim), or as applicable, of the advisory council under [section 282(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section282/k&num=0&edition=prelim), has recommended the proposal for approval.
**(b) Ethical review of research**
(1) **Procedures regarding withholding of funds** — If research has been recommended for approval for purposes of subsection (a), the Secretary may not withhold funds for the research because of ethical considerations unless—
(A) the Secretary convenes an advisory board in accordance with paragraph (5) to study such considerations; and
(B)
(i) the majority of the advisory board recommends that, because of such considerations, the Secretary withhold funds for the research; or
(ii) the majority of such board recommends that the Secretary not withhold funds for the research because of such considerations, but the Secretary finds, on the basis of the report submitted under paragraph (5)(B)(ii), that the recommendation is arbitrary and capricious.
(2) **Rules of construction** — Paragraph (1) may not be construed as prohibiting the Secretary from withholding funds for research on the basis of—
(A) the inadequacy of the qualifications of the entities that would be involved with the conduct of the research (including the entity that would directly receive the funds from the Secretary), subject to the condition that, with respect to the process of review through which the research was recommended for approval for purposes of subsection (a), all findings regarding such qualifications made in such process are conclusive; or
(B) the priorities established by the Secretary for the allocation of funds among projects of research that have been so recommended.
(3) **Applicability** — The limitation established in paragraph (1) regarding the authority to withhold funds because of ethical considerations shall apply without regard to whether the withholding of funds on such basis is characterized as a disapproval, a moratorium, a prohibition, or other characterization.
(4) **Preliminary matters regarding use of procedures**
(A) If the Secretary makes a determination that an advisory board should be convened for purposes of paragraph (1), the Secretary shall, through a statement published in the Federal Register, announce the intention of the Secretary to convene such a board.
(B) A statement issued under subparagraph (A) shall include a request that interested individuals submit to the Secretary recommendations specifying the particular individuals who should be appointed to the advisory board involved. The Secretary shall consider such recommendations in making appointments to the board.
(C) The Secretary may not make appointments to an advisory board under paragraph (1) until the expiration of the 30-day period beginning on the date on which the statement required in subparagraph (A) is made with respect to the board.
(5) **Ethics advisory boards**
(A) Any advisory board convened for purposes of paragraph (1) shall be known as an ethics advisory board (in this paragraph referred to as an “ethics board”).
(B)
(i) An ethics board shall advise, consult with, and make recommendations to the Secretary regarding the ethics of the project of biomedical or behavioral research with respect to which the board has been convened.
(ii) Not later than 180 days after the date on which the statement required in paragraph (4)(A) is made with respect to an ethics board, the board shall submit to the Secretary, and to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate, a report describing the findings of the board regarding the project of research involved and making a recommendation under clause (i) of whether the Secretary should or should not withhold funds for the project. The report shall include the information considered in making the findings.
(C) An ethics board shall be composed of no fewer than 14, and no more than 20, individuals who are not officers or employees of the United States. The Secretary shall make appointments to the board from among individuals with special qualifications and competence to provide advice and recommendations regarding ethical matters in biomedical and behavioral research. Of the members of the board—
(i) no fewer than 1 shall be an attorney;
(ii) no fewer than 1 shall be an ethicist;
(iii) no fewer than 1 shall be a practicing physician;
(iv) no fewer than 1 shall be a theologian; and
(v) no fewer than one-third, and no more than one-half, shall be scientists with substantial accomplishments in biomedical or behavioral research.
(D) The term of service as a member of an ethics board shall be for the life of the board. If such a member does not serve the full term of such service, the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.
(E) A member of an ethics board shall be subject to removal from the board by the Secretary for neglect of duty or malfeasance or for other good cause shown.
(F) The Secretary shall designate an individual from among the members of an ethics board to serve as the chair of the board.
(G) In carrying out subparagraph (B)(i) with respect to a project of research, an ethics board shall conduct inquiries and hold public hearings.
(H) In carrying out subparagraph (B)(i) with respect to a project of research, an ethics board shall have access to all relevant information possessed by the Department of Health and Human Services, or available to the Secretary from other agencies.
(I) Members of an ethics board shall receive compensation for each day engaged in carrying out the duties of the board, including time engaged in traveling for purposes of such duties. Such compensation may not be provided in an amount in excess of the maximum rate of basic pay payable for GS–18 of the General Schedule.
(J) The Secretary, acting through the Director of the National Institutes of Health, shall provide to each ethics board reasonable staff and assistance to carry out the duties of the board.
(K) An ethics board shall terminate 30 days after the date on which the report required in subparagraph (B)(ii) is submitted to the Secretary and the congressional committees specified in such subparagraph.
(6) **“Ethical considerations” defined** — For purposes of this subsection, the term “ethical considerations” means considerations as to whether the nature of the research involved is such that it is unethical to conduct or support the research.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Applications for biomedical and behavioral research grants, cooperative agreements, and contracts; regulations**
(1) The Secretary, acting through the Director of NIH, shall by regulation require appropriate technical and scientific peer review of—
(A) applications made for grants and cooperative agreements under this chapter for biomedical and behavioral research; and
(B) applications made for biomedical and behavioral research and development contracts to be administered through the National Institutes of Health.
(2) Regulations promulgated under paragraph (1) shall require that the review of applications made for grants, contracts, and cooperative agreements required by the regulations be conducted—
(A) to the extent practical, in a manner consistent with the system for technical and scientific peer review applicable on November 20, 1985, to grants under this chapter for biomedical and behavioral research, and
(B) to the extent practical, by technical and scientific peer review groups performing such review on or before November 20, 1985,
and shall authorize such review to be conducted by groups appointed under sections 282(b)(16) and 284(c)(3) of this title.
**(b) Periodic review of research at National Institutes of Health** The Director of NIH shall establish procedures for periodic technical and scientific peer review of research at the National Institutes of Health. Such procedures shall require that—
(1) the reviewing entity be provided a written description of the research to be reviewed, and
(2) the reviewing entity provide the advisory council of the national research institute involved with such description and the results of the review by the entity,
and shall authorize such review to be conducted by groups appointed under sections
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 289a
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Federal law — U.S. Code and appendices · legal_authorities
**(a)** This section applies to—
(1) positions that are classified above GS–15 pursuant to section 5108; and
(2) scientific or professional positions established under section 3104;
but does not apply to—
(A) any Senior Executive Service position under section 3132; or
(B) any position in the Federal Bureau of Investigation and Drug Enforcement Administration Senior Executive Service under section 3151.
**(b)**
(1) Subject to such regulations as the Office of Personnel Management prescribes, the head of the agency concerned shall fix the rate of basic pay for any position within such agency to which this section applies. A rate fixed under this section shall be—
(A) not less than 120 percent of the minimum rate of basic pay payable for GS–15 of the General Schedule; and
(B) subject to paragraph (3), not greater than the rate of basic pay payable for level III of the Executive Schedule.
The payment of a rate of basic pay under this section shall not be subject to the pay limitation of section 5306(e) or 5373.
(2) Subject to paragraph (1), effective at the beginning of the first applicable pay period commencing on or after the first day of the month in which an adjustment takes effect under section 5303 in the rates of pay under the General Schedule, each rate of pay established under this section for positions within an agency shall be adjusted by such amount as the head of such agency considers appropriate.
(3) In the case of an agency which has a performance appraisal system which, as designed and applied, is certified under section 5307(d) as making meaningful distinctions based on relative performance, paragraph (1)(B) shall apply as if the reference to “level III” were a reference to “level II”.
(4) No employee may suffer a reduction in pay by reaso
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 5376
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Federal law — U.S. Code and appendices · legal_authorities
The oath of office shall be administered by the President of the Senate to each Senator who shall be elected, previous to his taking his seat.
Source: Supplied U.S. Code snapshot — release unconfirmed · 2 U.S.C. § 21
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment; acceptance of conditional gifts; functions**
(1) Except as provided in subsection (h), the Secretary shall appoint an advisory council for each national research institute which (A) shall advise, assist, consult with, and make recommendations to the Secretary and the Director of such institute on matters related to the activities carried out by and through the institute and the policies respecting such activities, and (B) shall carry out the special functions prescribed by part C.
(2) Each advisory council for a national research institute may recommend to the Secretary acceptance, in accordance with [section 238 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section238&num=0&edition=prelim), of conditional gifts for study, investigation, or research respecting the diseases, disorders, or other aspect of human health with respect to which the institute was established, for the acquisition of grounds, or for the construction, equipping, or maintenance of facilities for the institute.
(3) Each advisory council for a national research institute—
(A)
(i) may on the basis of the materials provided under [section 289a(b)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289a/b/2&num=0&edition=prelim) respecting research conducted at the institute, make recommendations to the Director of the institute respecting such research,
(ii) may review applications for grants and cooperative agreements for research or training and for which advisory council approval is required under [section 284(b)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section284/b/2&num=0&edition=prelim) and recommend for approval applications for projec
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 284a
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Relation to Public Health Service** The National Institutes of Health is an agency of the Service.
**(b) National research institutes and national centers** The following agencies of the National Institutes of Health are national research institutes or national centers:
(1) The National Cancer Institute.
(2) The National Heart, Lung, and Blood Institute.
(3) The National Institute of Diabetes and Digestive and Kidney Diseases.
(4) The National Institute of Arthritis and Musculoskeletal and Skin Diseases.
(5) The National Institute on Aging.
(6) The National Institute of Allergy and Infectious Diseases.
(7) The Eunice Kennedy Shriver National Institute of Child Health and Human Development.
(8) The National Institute of Dental and Craniofacial Research.
(9) The National Eye Institute.
(10) The National Institute of Neurological Disorders and Stroke.
(11) The National Institute on Deafness and Other Communication Disorders.
(12) The National Institute on Alcohol Abuse and Alcoholism.
(13) The National Institute on Drug Abuse.
(14) The National Institute of Mental Health.
(15) The National Institute of General Medical Sciences.
(16) The National Institute of Environmental Health Sciences.
(17) The National Institute of Nursing Research.
(18) The National Institute of Biomedical Imaging and Bioengineering.
(19) The National Human Genome Research Institute.
(20) The National Library of Medicine.
(21) The National Center for Advancing Translational Sciences.
(22) The John E. Fogarty International Center for Advanced Study in the Health Sciences.
(23) The National Center for Complementary and Integrative Health.
(24) The National Institute on Minority Health and Health Disparities.
(25) Any other national center that, as an agency separate from
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 281
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