(a) The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter 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 cooperative agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an "Institutional Review Board") to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research.
(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 behavioral research involving human subjects are responded to promptly and appropriately.
(2) The Secretary shall establish a process for the prompt and appropriate response to information 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 reports of such information from recipients of funds under this chapter and taking appropriate action with respect to such violations.
Protection of Human Research Subjects
Pub. L. 114–255, div. A, title III, §3023, Dec. 13, 2016, 130 Stat. 1098, provided that:
"(1) make such modifications to the provisions of the HHS Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable populations rules as may be necessary—
"(A) to reduce regulatory duplication and unnecessary delays;
"(B) to modernize such provisions in the context of multisite and cooperative research projects; and
"(C) to protect vulnerable populations, incorporate local considerations, and support community engagement through mechanisms such as consultation with local researchers and human research 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 duplication of effort.
"(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).
Informed Consent for Newborn Screening Research
Pub. L. 113–240, §12, Dec. 18, 2014, 128 Stat. 2857, provided that:
Study Concerning Research Involving Children
Pub. L. 107–109, §12, Jan. 4, 2002, 115 Stat. 1416, provided that:
"(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 relating 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 includes recommendations on best practices relating to research involving children.
"(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 research 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 applicable 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 participation 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 compliance (including the role of institutional review boards), and the enforcement actions taken for violations of such regulations.
"(7) The unique roles and responsibilities of institutional review boards in reviewing research involving children, including composition of membership on institutional review boards.
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 children that is conducted, supported, or regulated by the Department of Health and Human Services be in compliance 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 enactment of the Children's Health Act of 2000 [Oct. 17, 2000]."]