Sec. 2261. Protection of human subjects in research; applicability of rules
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/bill/114/hr/6/ih/section-2261A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
In order to simplify and facilitate compliance by researchers with applicable regulations for protection of human subjects in research, the Secretary of Health and Human Services shall, to the extent possible and consistent with other statutory provisions, harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations in accordance with subsection (b). The Secretary shall— make such modifications to the provisions of the HHS Human Subject Regulations and the vulnerable-populations rules as may be necessary— to reduce regulatory duplication and unnecessary delays; to modernize such provisions in the context of multisite and cooperative research projects; and to incorporate local considerations, community values, and mechanisms to protect vulnerable populations; and ensure that human subject research that is subject to the HHS Human Subject Regulations or to the FDA Human Subject Regulations may— use joint or shared review; rely upon the review of— an independent institutional review board; or an institutional review board of an entity other than the sponsor of the research; or use similar arrangements to avoid duplication of effort.
Not later than 12 months after the date of enactment of this Act , the Secretary, acting through the relevant agencies and offices of the Department of Health and Human Services, including the Office for Human Research Protections and relevant agencies and offices of the Food and Drug Administration, shall issue such regulations and guidance and take such other actions as may be necessary to implement this section and help facilitate the broader use of single, central, or lead institutional review boards.
Such regulations and guidance shall include clarification of requirements and policies relating to the following: Arrangements to avoid duplication described in paragraph (1)(A)(i), including— delineating the roles of institutional review boards in multisite or cooperative, multisite studies where one or more local institutional review boards are relied upon, or similar arrangements are used; the risks and benefits to human subjects; standardization of informed consent and other processes and legal documents; and incorporating community values through the use of local institutional review boards while continuing to use central or lead institutional review boards.
Concerns about regulatory and legal liability contributing to decisions by the sponsors of research to rely on local institutional review boards for multisite research. In issuing regulations or guidance pursuant to paragraph (2), the Secretary shall consult with stakeholders (including researchers, academic organizations, hospitals, institutional research boards, pharmaceutical, biotechnology and medical device developers, clinical research organizations, patient groups, and others).
The Secretary shall complete the harmonization described in subsection
(a)not later than 36 months after the date of enactment of this Act. Not later than 24 months after the date of enactment of this Act, the Secretary shall submit to Congress a report on the progress made towards completing such harmonization. In this section: 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 regulations). The term HHS Human Subject Regulations subject to clause (ii), means the provisions of subpart A of part 46 of title 45, Code of Federal Regulations (or any successor regulations). The term vulnerable-populations rules — subject to clause (ii), means the provisions of subparts B through D of such part 46 (or any successor regulations); or as applicable to the human subjects involved in research described in subparagraph (B), means the provisions applicable to vulnerable populations under part 56 of such title 21 (or any successor regulations) and subpart D of part 50 of such title 21 (or any successor regulations). Except as provided in subparagraph (B), the term human subject research means research, as defined in subpart A of part 46 of title 45, Code of Federal Regulations (or any successor regulations), that involves a human subject, as defined in such subpart A (or any successor regulations); and In the case of an investigation that is subject to the provisions of part 50 of title 21, Code of Federal Regulations (or any successor regulations), the term human subject has the meaning given such term in such part 50, and the term human subject research means a clinical investigation as defined in such part 50. In this section: The term institutional review board has the meaning that applies to the term institutional review board under the HHS Human Subject Regulations. The term lead institutional review board means an institutional review board that otherwise meets the requirements of the HHS Human Subject Regulations and enters into a written agreement with an institution, another institutional review board, a sponsor, or a principal investigator to approve and oversee human subject research that is conducted at multiple locations. References to an institutional review board include an institutional review board that serves a single institution as well as a lead institutional review board.