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NIH's Oversight Processes To Ensure Diversity Among Human Subjects Enrolled in Clinical Trials

Underrepresentation of racial and ethnic minorities, women, and individuals of all ages in clinical trials has been a longstanding concern and has garnered increased attention due to the COVID-19 pandemic's disproportionate impact on minority populations. The National Institutes of Health (NIH) is the largest funder of biomedical and public health research, supporting over $31 billion of research across the agency. NIH's responsibilities include reviewing annual progress reports that document grantees' progress toward NIH-approved enrollment plans, which may include a diversity and inclusion component. This study will assess and describe how NIH monitors and ensures enrollment of racial and ethnic minorities, women, and individuals of all ages within the clinical trials it funds and the actions it takes in response to clinical trials that are not meeting approved enrollment plans. This study will also identify NIH's challenges and the steps it takes to address these challenges while monitoring and ensuring that its grantees meet their commitments to inclusive enrollment in their clinical trials.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
July 2021 National Institutes of Health NIH's Oversight Processes To Ensure Diversity Among Human Subjects Enrolled in Clinical Trials Office of Evaluation and Inspections OEI-01-21-00320 2022