H.R. 6867 — NIH Clinical Trial Integrity Act

This section requires the NIH Director to mandate that sponsors seeking NIH approval (or renewal) of protocols for clinical trials of drugs, devices, biological products, or behavioral interventions submit applications that include (1) clear and measurable recruitment and retention goals reflecting the race, ethnicity, age, and sex of patients with the disease or condition (or the U.S. general population if prevalence is unknown); (2) a rationale specifying calculation methods or enrollment/retention strategies; (3) a detailed plan for separate analyses by population group, community partner or IRB involvement, proportional recruitment to disease prevalence, sufficient numbers for meaningful safety/effectiveness determinations, and consistency with FDA guidance under 21 U.S.C. 355(b)(1) and NIH guidance on women and minorities in clinical trials; (4) a plan for (or explanation against) less burdensome follow-up options (e.g., phone/virtual visits, wearables, primary care providers); and (5) education/training requirements for researchers on diversity, health inequities, and clinical trial participation, consulting specified NIH committees (e.g., Equity Committee, National Advisory Council on Minority Health and Health Disparities). As a condition of NIH protocol approval effective on the date of enactment, sponsors must agree to annually share aggregate demographic data and retention rates (disaggregated by race, ethnicity, age, and sex, reflecting disease prevalence as appropriate) during recruitment/data collection; ensure diversity training for researchers and reviewers; and submit final disaggregated participant numbers at trial conclusion (with privacy protections barring individually identifiable or protected health information).

This section directs the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to complete a study not later than two years after enactment on (1) the need to review human subject protection regulations (45 C.F.R. part 46, or successor regulations) and related guidance; (2) modernizing such regulations and guidance to establish updated guidelines for reimbursing human subjects' out-of-pocket expenses, compensating them for time spent in clinical trials, and providing recruitment incentives; and (3) the need to update safe harbor rules under 42 C.F.R. 1001.952 (or successor regulations) and the Anti-Kickback Statute (42 U.S.C. 1320a-7b) regarding such assistance.

This section directs the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health and the Commissioner of Food and Drugs, to conduct a national campaign to increase awareness of the need for diverse clinical trials among specified demographic groups. The campaign must include (1) development and distribution of educational materials, public service announcements encouraging participation by underrepresented groups, and curricula for healthcare professionals on participating in and enrolling patients in trials; (2) efforts to ensure access for individuals with limited English proficiency; (3) best practices and training for recruiting underrepresented populations; and (4) focus groups to address participation barriers. This section requires the campaign to address health inequities and barriers specific to such groups; establishes a grant program for nonprofit private entities—including community-based and faith-based organizations, institutions of higher education eligible under 20 U.S.C. 1067q (i.e., certain minority-serving institutions such as Hispanic-serving institutions and historically Black colleges and universities), national organizations serving underrepresented populations, and community pharmacies—to test outreach strategies and cover administrative costs related to diversifying clinical trials; and authorizes $10 million for each of FY2027 through FY2030.

This section defines, for purposes of the Act, (1) the term "clinical trial" as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes; and (2) the term "sponsor" as having the meaning given that term in section 50.3 of title 21, Code of Federal Regulations (or successor regulations).