Key Updates to NIH Policies and Application Requirements

By: Yvette Seger
Thursday, July 24, 2025
On July 17, the National Institutes of Health (NIH) issued several policy notices of interest to the FASEB community, including a new training requirement for grant applicants, an update on clinical trial reporting requirements to align with existing administrative directives, and an extended delay of a previously announced policy for research involving human participants.

New Training Requirement
Effective October 1, 2025, NIH will require all award recipients to provide training on the requirement to disclose all active and pending research activities and affiliations as “Other Support” to individuals identified as Senior/Key Personnel. In addition to implementing training, recipients are expected to maintain and enforce a written policy regarding compliance with these disclosures.

Revision of Inclusion Policy
NIH announced revision of its Policy and Guidelines on the Inclusion of Women in Minorities as Subjects in Clinical Research to align with Executive Order 14168. Main updates include referring to “sex” rather than “sex/gender” and updating race and ethnicity information to reflect the Office of Management and Budget’s Statistical Policy Directive 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Research and Ethnicity. The revised policy will apply to all grants, cooperative agreements, contracts, other transactions, and intramural studies on August 15, 2025.

Extension of Delayed Enforcement for BESH
Finally, NIH issued a notice indefinitely extending policy flexibilities regarding registration and results reporting for basic experimental studies with humans (BESH) submitted to Notices of Funding Opportunities specific funding opportunities.