Sec. 4. Promoting inclusion in clinical research
564 words·~3 min read·
/bill/114/s/2745/is/section-4A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 492B(a) of the Public Health Service Act ( 42 U.S.C. 289a–2(a) ) is amended by adding at the end the following: The directors of the national institutes and national centers shall consult at least once annually with the Director of the National Institute on Minority Health and Health Disparities and the Director of the Office of Research on Women’s Health regarding objectives of the national institutes and national centers to ensure that future activities by such institutes and centers take into account women and minorities and are focused on reducing health disparities.
Any strategic plan issued by a national institute or national center shall include details on the objectives described in subparagraph (A). . Section 492B(c) of the Public Health Service Act ( 42 U.S.C. 289a–2(c) ) is amended— by striking In the case and inserting the following: In the case ; and by adding at the end the following: For any new and competing project of clinical research subject to the requirements under this section that receives a grant award 1 year after the date of enactment of the Advancing NIH Strategic Planning and Representation in Medical Research Act , or any date thereafter, for which a valid analysis is provided under paragraph (1)— and which is an applicable clinical trial as defined in section 402(j), the entity conducting such clinical research shall submit the results of such valid analysis to the clinical trial registry data bank expanded under section 402(j)(3), and the Director of NIH shall, as appropriate, consider whether such entity has complied with the reporting requirement described in this subparagraph in awarding any future grant to such entity, including pursuant to section 402(j)(5)(A)(ii) when applicable; and the Director of NIH shall encourage the reporting of the results of such valid analysis described in paragraph
(1)through any additional means determined appropriate by the Director. . Section 492B(f) of the Public Health Service Act ( 42 U.S.C. 289a–2(f) ) is amended— by striking biennial each place such term appears and inserting triennial in each such place; by striking The advisory council and inserting the following: The advisory council ; and by adding at the end the following: Each triennial report prepared by an advisory council of each national research institute as described in paragraph
(1)shall include each of the following: The number of women included as subjects, and the proportion of subjects that are women, in any project of clinical research conducted during the applicable reporting period, disaggregated by categories of research area, condition, or disease, and accounting for single-sex studies. The number of members of minority groups included as subjects, and the proportion of subjects that are members of minority groups, in any project of clinical research conducted during the applicable reporting period, disaggregated by categories of research area, condition, or disease and accounting for single-race and single-ethnicity studies. For the applicable reporting period, the number of projects of clinical research that include women and members of minority groups and that— have been completed during such reporting period; and are being carried out during such reporting period and have not been completed. The number of studies completed during the applicable reporting period for which reporting has been submitted in accordance with subsection (c)(2)(A). . Section 486(c)(2) of the Public Health Service Act ( 42 U.S.C. 287d(c)(2) ) is amended by striking designees and inserting senior-level staff designees .
Connectionstraces to 1
Traces to 1 document
3 references not yet in our index
- 42 USC 289a–2(a)
- 42 USC 289a–2(c)
- 42 USC 289a–2(f)
Citation graph
cites case law
Sec. 4
Promoting inclusion in clinical research
Cite42 USC 289a–2(a)
Cite42 USC 289a–2(c)
Cite42 USC 289a–2(f)
Cites 4Cited by 0 across 0 sources