3.0.0 7845 2023-07-14T12:45:30Z 2023-07-14T12:45:30Z House HR 2022-05-19 117 [Congressional Record Volume 168, Number 86 (Thursday, May 19, 2022)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. KELLY of Illinois:H.R. 7845.Congress has the power to enact this legislation pursuantto the following:Clause 18 of Section 8 of Article 1 of the Constitution[Page H5208]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2022-05-20T14:39:45Z Referred to 2022-05-19T13:02:30Z Health Equity and Accountability Act of 2022 117 4486 S 2022-06-23 Read twice and referred to the Committee on Finance. Related bill CRS 2022-05-20 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2022-05-19 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2022-05-19 Introduced in House IntroReferral Intro-H 9 Library of Congress 2022-05-19 Introduced in House IntroReferral 1000 9 Library of Congress K000385 Rep. Kelly, Robin L. [D-IL-2] Robin Kelly D IL L. 2 N F000466 Rep. Fitzpatrick, Brian K. [R-PA-1] Brian Fitzpatrick R PA K. 1 2022-05-19 True C001097 Rep. Cárdenas, Tony [D-CA-29] Tony Cárdenas D CA 29 2022-05-19 True B001251 Rep. Butterfield, G. K. [D-NC-1] G. K. Butterfield D NC 1 2022-05-19 True C001067 Rep. Clarke, Yvette D. [D-NY-9] Yvette Clarke D NY D. 9 2022-05-19 True Health Congressional oversight Government information and archives Government studies and investigations Health information and medical records Medical research Minority health National Institutes of Health (NIH) Research administration and funding Women's health Health 00 2022-05-19 Introduced in House 2022-08-23T20:58:06Z NIH Clinical Trial Diversity Act of 2022

This bill sets out requirements to increase the diversity of clinical trial participants. The bill also requires other activities to foster participation in clinical trials.

As a condition of funding from the National Institutes of Health (NIH) for a clinical trial investigating a drug or device, a sponsor's application must include certain information related to diversity in its trial, such as

  • goals for recruiting and retaining trial participants,
  • plans for achieving the recruitment and retention goals and implementing less-burdensome clinical trial follow-up requirements, and
  • education and training requirements related to diversity in clinical trials for researchers and other individuals who conduct or support the trial.

A sponsor must also annually share demographic data of clinical trial participants with the NIH. The NIH must publish on its website information about the diversity of and other information concerning the clinical trials it funds.

If a sponsor fails to meet its goals or other requirements with respect to trial diversity, the sponsor must develop and implement a strategic plan to increase the diversity of the clinical trial participants.

Further, the NIH and the Food and Drug Administration must carry out a national campaign to increase awareness about the need for diverse clinical trials.

The bill also requires studies on barriers to participation in clinical trials. The Government Accountability Office must study actions taken by federal agencies to address such barriers while the NIH must study regulations that govern reimbursements of out-of-pocket expenses of and incentives for clinical trial participants.

]]> NIH Clinical Trial Diversity Act of 2022 Display Title NIH Clinical Trial Diversity Act of 2022 Short Title(s) as Introduced NIH Clinical Trial Diversity Act of 2022 Introduced in House IH Official Title as Introduced To direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. Introduced in House IH Introduced in House 2022-05-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117hr7845ih/xml/BILLS-117hr7845ih.xml 2022-05-20 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.