NIH Clinical Trial Integrity Act

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 6867 Introduced in House (IH)] <DOC> 119th CONGRESS 1st Session H. R. 6867 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. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES December 18, 2025 Ms. Kelly of Illinois (for herself and Mr. Fitzpatrick) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ A BILL 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. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``NIH Clinical Trial Integrity Act''. SEC. 2. DIVERSITY GOALS FOR CLINICAL TRIALS. (a) Applications.--Beginning on the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (in this section referred to as the ``Secretary''), shall require that a sponsor seeking to conduct a clinical trial investigating a drug, device (as those terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.)), biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))), or behavioral intervention, the protocol for which is approved by the National Institutes of Health, to submit an application (or renewal thereof) for such approval that includes-- (1) clear and measurable goals for the recruitment and retention of participants that reflect-- (A) the race, e