42 U.S.C. § 289a — Peer review requirements

Page 797 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 289a 1 See References in Text note below. ‘‘(c) REGULATIONS.—Not later than 6 months after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate proposed regula- tions related to the updating of the Federal Policy for the Protection of Human Subjects (the Common Rule), particularly with respect to informed consent. Not later than 2 years after such date of enactment, the Secretary shall promulgate final regulations based on such proposed regulations.’’ STUDY CONCERNING RESEARCH INVOLVING CHILDREN Pub. L. 107–109, § 12, Jan. 4, 2002, 115 Stat. 1416, pro- vided that: ‘‘(a) CONTRACT WITH INSTITUTE OF MEDICINE.—The Secretary of Health and Human Services shall enter into a contract with the Institute of Medicine for— ‘‘(1) the conduct, in accordance with subsection (b), of a review of— ‘‘(A) Federal regulations in effect on the date of the enactment of this Act [Jan. 4, 2002] relating to research involving children; ‘‘(B) federally prepared or supported reports relat- ing to research involving children; and ‘‘(C) federally supported evidence-based research involving children; and ‘‘(2) the submission to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, not later than two years after the date of enactment of this Act, of a report concerning the review conducted under paragraph (1) that in- cludes recommendations on best practices relating to research involving children. ‘‘(b) AREAS OF REVIEW.—In conducting the review under subsection (a)(1), the Institute of Medicine shall consider the following: ‘‘(1) The written and oral process of obtaining and defining ‘assent’, ‘permission’ and ‘informed consent’ with respect to child clinical research participants and the parents, guardians, and the individuals who may serve as the legally authorized representatives of such children (as defined in subpart A of part 46 of title 45, Code of Federal Regulations). ‘‘(2) The expectations and comprehension of child research participants and the parents, guardians, or legally authorized representatives of such children, for the direct benefits and risks of the child’s re- search involvement, particularly in terms of research versus therapeutic treatment. ‘‘(3) The definition of ‘minimal risk’ with respect to a healthy child or a child with an illness. ‘‘(4) The appropriateness of the regulations applica- ble to children of differing ages and maturity levels, including regulations relating to legal status. ‘‘(5) Whether payment (financial or otherwise) may be provided to a child or his or her parent, guardian, or legally authorized representative for the participa- tion of the child in research, and if so, the amount and type of payment that may be made. ‘‘(6) Compliance with the regulations referred to in subsection (a)(1)(A), the monitoring of such compli- ance (including the role of institutional review boards), and the enforcement actions taken for viola- tions of such regulations. ‘‘(7) The unique roles and responsibilities of institu- tional review boards in reviewing research involving children, including composition of membership on in- stitutional review boards. ‘‘(c) REQUIREMENTS OF EXPERTISE.—The Institute of Medicine shall conduct the review under subsection (a)(1) and make recommendations under subsection (a)(2) in conjunction with experts in pediatric medicine, pediatric research, and the ethical conduct of research involving children.’’ REQUIREMENT FOR ADDITIONAL PROTECTIONS FOR CHILDREN INVOLVED IN RESEARCH Pub. L. 106–310, div. A, title XXVII, § 2701, Oct. 17, 2000, 114 Stat. 1167, as amended by Pub. L. 106–505, title X, § 1001(a), Nov. 13, 2000, 114 Stat. 2350, provided that: ‘‘Notwithstanding any other provision of law, not later than 6 months after the date of the enactment of this Act [Oct. 17, 2000], the Secretary of Health and Human Services shall require that all research involving chil- dren that is conducted, supported, or regulated by the Department of Health and Human Services be in com- pliance with subpart D of part 46 of title 45, Code of Federal Regulations.’’ [Pub. L. 106–505, title X, § 1001(b), Nov. 13, 2000, 114 Stat. 2350, provided that: ‘‘The amendment made by subsection (a) [amending section 2701 of Pub. L. 106–310, set out above] takes effect on the date of the enact- ment of the Children’s Health Act of 2000 [Oct. 17, 2000].’’] § 289a. Peer review requirements (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 cooper- ative agreements under this chapter for bio- medical and behavioral research; and (B) applications made for biomedical and be- havioral research and development contracts to be administered through the National Insti- tutes 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 con- ducted— (A) to the extent practical, in a manner con- sistent with the system for technical and sci- entific peer review applicable on November 20, 1985, to grants under this chapter for bio- medical 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 Insti- tutes 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 writ- ten description of the research to be reviewed, and (2) the reviewing entity provide the advisory council of the national research institute in- volved 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 282(b)(6) 1 and 284(c)(3) of this title. (c) Compliance with requirements for inclusion of women and minorities in clinical research (1) In technical and scientific peer review under this section of proposals for clinical re- search, the consideration of any such proposal Page 798 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 289a–1 (including the initial consideration) shall, ex- cept as provided in paragraph (2), include an evaluation of the technical and scientific merit of the proposal regarding compliance with sec- tion 289a–2 of this title. (2) Paragraph (1) shall not apply to any pro- posal for clinical research that, pursuant to sub- section (b) of section 289a–2 of this title, is not subject to the requirement of subsection (a) of such section regarding the inclusion of women and members of minority groups as subjects in clinical research. (July 1, 1944, ch. 373, title IV, § 492, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 874; amended Pub. L. 103–43, title I, § 132, June 10, 1993, 107 Stat. 135; Pub. L. 109–482, title I, § 102(f)(1)(B), Jan. 15, 2007, 120 Stat. 3685.) Editorial Notes REFERENCES IN TEXT Section 282(b)(6) of this title, referred to in subsec. (b), was redesignated section 282(b)(16) by Pub. L. 109–482, title I, § 102(a)(3), Jan. 15, 2007, 120 Stat. 3681. AMENDMENTS 2007—Subsec. (a)(2). Pub. L. 109–482 substituted ‘‘sec- tions 282(b)(16)’’ for ‘‘sections 282(b)(6)’’ in concluding provisions. 1993—Subsec. (c). Pub. L. 103–43 added subsec. (c). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2007 AMENDMENT Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title. § 289a–1. Certain provisions regarding review and approval of proposals for research (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 ap- prove or fund any application that is subject to review under section 289(a) of this title by an Institutional Review Board unless the ap- plication 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 sub- jects in clinical research conducted by the Na- tional Institutes of Health, the Secretary may not authorize the conduct of the research un- less the research has, pursuant to such proce- dures, been recommended for approval. (2) Peer review In the case of any proposal for the National Institutes of Health to conduct or support re- search, the Secretary may not approve or fund any proposal that is subject to technical and scientific peer review under section 289a of this title 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 con- ducting such review, and unless a majority of the voting members of the appropriate advi- sory council under section 284a of this title, or as applicable, of the advisory council under section 282(k) of this title, has recommended the proposal for approval. (b) Ethical review of research (1) Procedures regarding withholding of funds If research has been recommended for ap- proval for purposes of subsection (a), the Sec- retary may not withhold funds for the re- search because of ethical considerations un- less— (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 consider- ations, the Secretary withhold funds for the research; or (ii) the majority of such board rec- ommends that the Secretary not withhold funds for the research because of such con- siderations, but the Secretary finds, on the basis of the report submitted under para- graph (5)(B)(ii), that the recommendation is arbitrary and capricious. (2) Rules of construction Paragraph (1) may not be construed as pro- hibiting 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 rec- ommended for approval for purposes of sub- section (a), all findings regarding such quali- fications made in such process are conclu- sive; or (B) the priorities established by the Sec- retary for the allocation of funds among projects of research that have been so rec- ommended. (3) Applicability The limitation established in paragraph (1) regarding the authority to withhold funds be- cause of ethical considerations shall apply without regard to whether the withholding of funds on such basis is characterized as a dis- approval, a moratorium, a prohibition, or other characterization. (4) Preliminary matters regarding use of proce- dures (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 Sec- retary to convene such a board. (B) A statement issued under subparagraph (A) shall include a request that interested in- dividuals submit to the Secretary rec- ommendations specifying the particular indi- viduals who should be appointed to the advi-