Sec. 3023. PROTECTION OF HUMAN RESEARCH SUBJECTS
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## SEC. 3023 PROTECTION OF HUMAN RESEARCH SUBJECTS **[**[42 U.S.C. 289 note](/us/usc/t42/s289)**]** ###
(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 provisions, harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations in accordance with subsection (b). ###
(b)Avoiding Regulatory Duplication and Unnecessary 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 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. ###
(c)Consultation In harmonizing or modifying regulations or guidance under this section, 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). ###
(d)Timing The Secretary shall complete the harmonization described in subsection
(a)not later than 3 years after the date of enactment of this Act. ###
(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 toward 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 regulations). #####
(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 regulations). #####
(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 review board” under the HHS Human Subject Regulations.
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Sec. 3023
PROTECTION OF HUMAN RESEARCH SUBJECTS
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