NIH Extramural Nexus (News)

On April 29, NIH announced it is prioritizing human-focused research and reducing animal use in research. To further this initiative, all new Notices of Funding Opportunity that relate to animal model systems (NOFOs) must now also support human-focused approaches such as clinical trials, real world data, or new approach methods (NAMs).

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NIH has simplified peer review for most research project grants for application due dates of January 25, 2025 or later to address the complexity of the peer review process and the potential for reputational bias to affect peer review outcomes. The initial applications are under review during summer study section meetings within the NIH Center for Scientific Review (CSR).

NIH recently updated its annual categorical information with actual spending data for fiscal year (FY) 2024. NIH has also moved from manual coding to automated coding for the Research, Condition, and Disease Categorization (RCDC) Women’s Health Research category, which further improves its accuracy and consistency in reporting and better distinguishes research focused on improving the health of women across the lifespan. 

NIH has issued a temporary policy exception to NIH GPS Section 12.3.7 to allow individuals whose mentored career development awards prematurely ended on or after January 1, 2025 to reapply for future awards. This exception is effective immediately and will remain in effect until July 31, 2026.

Today, NIH released a Research Opportunity Announcement for the Autism Data Science Initiative (ADSI). We are spotlighting this other transaction here as it is a high priority for leadership within NIH and the U.S. Department of Health and Human Services. It also encompasses several efforts of general interest for NIH supported research including supporting data resources, participant privacy, and research replicability/validation.   

The simplified review framework went into effect earlier in 2025, and NIH has been busy preparing staff, peer reviewers, and study section chairs for its arrival at summer 2025 review meetings. To avoid confusion and reduce reviewer burden at review meetings, NIH has expired identified NOFOs that were not expired or reissued as indicated in the implementation plan shared in early 2024.

NIH issued a Guide notice (NOT-OD-25-081) clarifying how to protect human genomic data obtained from NIH controlled-access repositories when using and developing generative artificial intelligence models consistent with the Genomic Data Sharing Policy.

NIH has granted the automatic extension of Early Stage Investigator (ESI) eligibility. This extension addresses delays impacting grant application submissions, peer review, or award processing timelines between January 1, 2025, and May 31, 2025.

NIH continues to follow all laws (e.g., 42 USC 289a-2) and existing NIH policies that help NIH ensure clinical research includes the appropriate participant demographics to make certain the scientific question under study is addressed in a robust and generalizable manner.