Sec. 203. Increasing diversity in clinical trials
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The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall— not later than 90 days after the date of the enactment of this Act, submit to the Food and Drug Administration, and provide to the Congress, an updated version of the report under section 907(a) of the Food and Drug Administration Safety and Innovation Act ( Public Law 115–52 ); and not later than 1 year after the publication of the updated report pursuant to paragraph (1), publish on the website of the Food and Drug Administration, and provide to the Congress, an updated version of the action plan under section 907(b) of such Act.
Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall— complete a study— to review how the Department of Health and Human Services addresses barriers to participation by individuals from underrepresented populations in conducting or supporting clinical trials; and to formulate recommendations for addressing such barriers; and submit a report to the Congress on the results of such study. The Secretary of Health and Human Services shall— carry out a public awareness campaign to increase awareness and understanding, particularly in minority communities, of— upcoming and ongoing clinical trials; how to enroll as subjects in such clinical trials; and the availability of databases and other resources relevant to clinical trial enrollment, such as ClinicalTrials.gov; and in carrying out such campaign, utilize a variety of communication channels, including through use of the explanation of Medicare benefits under section 1806 of the Social Security Act ( 42 U.S.C. 1395b–7 ).
The Secretary of Health and Human Services shall convene a permanent task force to propose, on a biennial basis, recommendations for improving ClinicalTrials.gov by making it more user-friendly, including for patients. The membership of the task force shall include representatives of— the National Institutes of Health; the Food and Drug Administration; academic researchers; and patient organizations. In this section, the term ClinicalTrials.gov refers to the data bank described in section 402(i) of the Public Health Service Act ( 42 U.S.C. 282(i) ).
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- 42 USC 1395b–7
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Sec. 203
Increasing diversity in clinical trials
Cite42 USC 1395b–7
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