42 U.S.C. § 289 — Institutional review boards; ethics guid-

Page 796 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 289 PART H—GENERAL PROVISIONS Editorial Notes CODIFICATION Pub. L. 103–43, title I, § 141(a)(2), June 10, 1993, 107 Stat. 136, redesignated part G ‘‘General Provisions’’ as H. Former part H ‘‘National Foundation for Biomedical Research’’ redesignated I. § 289. Institutional review boards; ethics guid- ance program (a) The Secretary shall by regulation require that each entity which applies for a grant, con- tract, or cooperative agreement under this chap- ter for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or coopera- tive agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall pre- scribe) a board (to be known as an ‘‘Institutional Review Board’’) to review biomedical and behav- ioral research involving human subjects con- ducted at or supported by such entity in order to protect the rights of the human subjects of such research. (b)(1) The Secretary shall establish a program within the Department of Health and Human Services under which requests for clarification and guidance with respect to ethical issues raised in connection with biomedical or behav- ioral research involving human subjects are re- sponded to promptly and appropriately. (2) The Secretary shall establish a process for the prompt and appropriate response to informa- tion provided to the Director of NIH respecting incidences of violations of the rights of human subjects of research for which funds have been made available under this chapter. The process shall include procedures for the receiving of re- ports of such information from recipients of funds under this chapter and taking appropriate action with respect to such violations. (July 1, 1944, ch. 373, title IV, § 491, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 873.) Statutory Notes and Related Subsidiaries PROTECTION OF HUMAN RESEARCH SUBJECTS Pub. L. 114–255, div. A, title III, § 3023, Dec. 13, 2016, 130 Stat. 1098, provided that: ‘‘(a) IN GENERAL.—In order to simplify and facilitate compliance by researchers with applicable regulations for the protection of human subjects in research, the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall, to the extent practicable and consistent with other statutory provi- sions, harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Reg- ulations in accordance with subsection (b). ‘‘(b) AVOIDING REGULATORY DUPLICATION AND UNNEC- ESSARY DELAYS.—The Secretary shall, as appropriate— ‘‘(1) make such modifications to the provisions of the HHS Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable pop- ulations rules as may be necessary— ‘‘(A) to reduce regulatory duplication and unnec- essary delays; ‘‘(B) to modernize such provisions in the context of multisite and cooperative research projects; and ‘‘(C) to protect vulnerable populations, incor- porate local considerations, and support commu- nity engagement through mechanisms such as con- sultation with local researchers and human re- search protection programs, in a manner consistent with subparagraph (B); and ‘‘(2) ensure that human subject research that is subject to the HHS Human Subject Regulations and to the FDA Human Subject Regulations may— ‘‘(A) use joint or shared review; ‘‘(B) rely upon the review of— ‘‘(i) an independent institutional review board; or ‘‘(ii) an institutional review board of an entity other than the sponsor of the research; or ‘‘(C) use similar arrangements to avoid duplica- tion of effort. ‘‘(c) CONSULTATION.—In harmonizing or modifying regulations or guidance under this section, the Sec- retary shall consult with stakeholders (including re- searchers, academic organizations, hospitals, institu- tional research boards, pharmaceutical, biotechnology, and medical device developers, clinical research organi- zations, patient groups, and others). ‘‘(d) TIMING.—The Secretary shall complete the har- monization described in subsection (a) not later than 3 years after the date of enactment of this Act [Dec. 13, 2016]. ‘‘(e) PROGRESS REPORT.—Not later than 2 years after the date of enactment of this Act, the Secretary shall submit to Congress a report on the progress made to- ward completing such harmonization. ‘‘(f) DEFINITIONS.— ‘‘(1) HUMAN SUBJECT REGULATIONS.—In this section: ‘‘(A) FDA HUMAN SUBJECT REGULATIONS.—The term ‘FDA Human Subject Regulations’ means the provisions of parts 50, 56, 312, and 812 of title 21, Code of Federal Regulations (or any successor regu- lations). ‘‘(B) HHS HUMAN SUBJECT REGULATIONS.—The term ‘HHS Human Subject Regulations’ means the provisions of subpart A of part 46 of title 45, Code of Federal Regulations (or any successor regula- tions). ‘‘(C) VULNERABLE POPULATION RULES.—The term ‘vulnerable population rules’ means— ‘‘(i) except in the case of research described in clause (ii), the provisions of subparts B through D of part 46, Code of Federal Regulations (or any successor regulations); and ‘‘(ii) in the case of research that is subject to FDA Human Subject Regulations, the provisions applicable to vulnerable populations under part 56 of title 21, Code of Federal Regulations (or any successor regulations) and subpart D of part 50 of such title 21 (or any successor regulations). ‘‘(2) INSTITUTIONAL REVIEW BOARD DEFINED.—In this section, the term ‘institutional review board’ has the meaning that applies to the term ‘institutional re- view board’ under the HHS Human Subject Regula- tions.’’ INFORMED CONSENT FOR NEWBORN SCREENING RESEARCH Pub. L. 113–240, § 12, Dec. 18, 2014, 128 Stat. 2857, pro- vided that: ‘‘(a) IN GENERAL.—Research on newborn dried blood spots shall be considered research carried out on human subjects meeting the definition of section 46.102(f)(2) of title 45, Code of Federal Regulations, for purposes of Federally funded research conducted pursu- ant to the Public Health Service Act [42 U.S.C. 201 et seq.] until such time as updates to the Federal Policy for the Protection of Human Subjects (the Common Rule) are promulgated pursuant to subsection (c). For purposes of this subsection, sections 46.116(c) and 46.116(d) of title 45, Code of Federal Regulations, shall not apply. ‘‘(b) EFFECTIVE DATE.—Subsection (a) shall apply only to newborn dried blood spots used for purposes of Federally funded research that were collected not ear- lier than 90 days after the date of enactment of this Act [Dec. 18, 2014]. 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