There is no question that diversity matters—it does. In the context of clinical trials, a lack of diverse representation can lead to medicines and vaccines that are less effective in treating disease and health conditions in groups underrepresented in such trials, giving rise to health equity concerns. The issue of health equity has become even more pressing in light of the recent COVID-19 pandemic.

In an effort to address health equity concerns and mitigate health disparities, a U.S. House of Representatives bill—The NIH Clinical Trial Diversity Act of 2022 (H.R. 7845)—has sought to seize upon the National Institute of Health’s (NIH) vital role in increasing diversity in clinical trials by tying receipt of federal funding from the NIH to an application process requiring a clinical trial sponsor’s demonstrated commitment to diversity in clinical trials. The regulatory framework of H.R. 7845 is anchored in the following pillars of accountability: (1) transparency, (2) goal-setting and action planning, (3) education and awareness, and (4) identification and elimination of barriers to diverse participation in clinical trials.

• Transparency: The bill requires that the sponsor of a clinical trial annually share demographic data of its clinical trial participants with the NIH including with sufficient detail reflecting race, ethnicity, age, and sex. Under the bill, the NIH must publish on its website, for public access, such information regarding the diversity of the clinical trials it funds.

• Goal-setting/Action Planning: The bill requires that clinical trial sponsors set goals for recruiting and retaining diverse trial participants and develop detailed plans for achieving such goals. If a sponsor fails to meet the goals or other requirements with respect to trial diversity, the sponsor must develop and implement a strategic plan to increase the diversity of its clinical trial participants.

• Education/Awareness: The bill also provides that a trial sponsor’s plan must include its education and training requirements—for researchers and other individuals who conduct or support the trial—with respect to diversity and health inequities, among other things. Further, under the bill, the NIH and the Food and Drug Administration must carry out a national campaign to increase awareness about the need for diverse clinical trials.

• Identifying/Eliminating Barriers: Finally, the bill requires studies on barriers to participation in clinical trials and that sponsors implement less-burdensome clinical trial follow-up requirements (or explain why such less-burdensome requirements are unavailable). Under the bill, 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 and incentives for clinical trial participants.