Lexology July 24, 2024
As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28, 2024, OIG published a report (“OIG Report”) summarizing its finding that, of the NIH‑funded clinical trials randomly selected by OIG for review, a majority failed to meet NIH’s requirements for inclusion of diverse trial participants.
As reiterated in the OIG Report, the 1993 NIH Revitalization Act recognizes that diversity in clinical trial enrollment is crucial for closing health disparities and for producing research that is scientifically generalizable. Accordingly, NIH requires biomedical researchers seeking NIH funding for clinical trials to submit, as part of their grant...
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