Important NIH Updates

Please see the following important updates from the National Institutes of Health (NIH). Topics include Supporting Fairness and Originality in NIH Research Applications, Updated Implementation Guidance for Foreign Subawards for Active Projects, the Inclusion of Women and Minorities as Subjects in Clinical Research, and Flexibilities for Registration and Results Reporting of Prospective Basic Experiment Studies with Human Participants.

Supporting Fairness and Originality in NIH Research Applications (NOT-OD-25-132):

NIH has provided guidance to researchers on the appropriate use of artificial intelligence (AI) to maintain the fairness and originality of NIH’s research application process, as of July 17, 2025. In this same update, NIH is instituting a new policy limiting the number of applications that NIH will consider per Principal Investigator (PI) per calendar year.

NIH will not consider applications that are substantially developed by AI or contain sections substantially developed by AI to be the original ideas of applicants. If use of AI is identified post award, NIH may refer the matter to the Office of Research Integrity.

NIH will only accept six new, renewal, resubmission, or revision applications from an individual Principal Investigator/Program Director or Multiple Principal Investigator for all council rounds in a calendar year. This applies to all activity codes except T activity codes and R13 Conference Grant Applications.

This policy is effective for applications submitted to the September 25, 2025 application receipt date and beyond.

For full details, please read NOT-OD-25-132.

Updated Implementation Guidance of NIH Policy on Foreign Subawards for Active Projects (NOT-OD-25-130):

NIH has released an update to its May 1, 2025 policy on foreign subawards for applications submitted before May 1, 2025, and projects active on or before May 1, 2025.

In summary, this update provides an alternative approach for removing the foreign subawards from existing grants and cooperative agreements involving human subjects research (e.g., clinical trials and clinical research) at the foreign site. NIH Institutes, Centers, and Offices (ICOs) will now have the option to renegotiate the award structure with a recipient such that foreign subawards are financially removed from the primary award and awarded as administrative supplement (i.e., Type 3) awards. Each foreign supplement award will only include funds allocated for a single foreign entity.

With this alternative approach:

  • Both the primary award and foreign supplement(s) will be removed from the streamlined non-competing award process (SNAP) and automatic carryover authority.
  • The primary award and each foreign supplement will be issued with a distinct document number and will need to submit separate annual Federal Financial Reports (FFR, SF-425).
  • There will be no rebudgeting allowed between the primary award and supplements within a budget period, although recipients may use the annual RPPR process as an opportunity to request a reallocation of future year commitments between the primary and foreign supplement awards, provided the total cost across all awards does not exceed previous committed levels.
  • This option is in addition to, and not in lieu of, the other options outlined in NOT-OD-25-104; namely, ICOs may renegotiate with the primary recipients to move activities to a domestic organization, remove the scope of the foreign component from the overall project scope, or bilaterally terminate the award.
  • This option is meant to be a short-term solution, permitted only for the current competitive segment, and it does not replace the new award structure announced in NOT-OD-25-104 that will apply to upcoming applications, including any planned renewals.

For full details, please read NOT-OD-25-130.

Revision: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research (NOT-OD-25-131):

NIH has revised its Policy and Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research as of July 17, 2025 to align with Executive Order 14168. Revisions are primarily focused on using “sex” instead of “sex/gender” and updating race and/or ethnicity information to align with the Office of Management and Budget’s Statistical Policy Directive No. 15.

The revised Policy is now titled “NIH Policy and Guidelines on the Inclusion of Women and Members of Racial and/or Ethnic Minority Groups in Clinical Research.”

The revised policy is effective 30 days after the date of publication, when it will replace NOT-OD-18-014 and NOT-OD-02-001.

For full details, please read NOT-OD-25-131.

Flexibilities for Registration and Results Reporting of Prospective Basic Experimental Studies with Human Participants (NOT-OD-25-134)

NIH has rescinded NOT-OD-24-118. This indefinitely extends policy flexibilities regarding registration and results reporting per the NIH Policy on the Dissemination of NIH Funded Clinical Trial Information (NOT-OD-16-149) for a  subset of NIH-funded research. This subset’s primary purpose is basic experimental studies with humans (BESH) submitted to designated BESH Notices of Funding Opportunity (NOFOs). The delayed enforcement is only applicable to BESH submitted to funding opportunities designated as basic experimental studies with humans.

NIH is indefinitely extending the period of delayed enforcement for registration and results reporting for designated BESH NOFOs, including those with application due dates on or after September 25, 2025. During this period of delayed enforcement, NIH continues to expect registration and results reporting for these BESH. There is continued flexibility to register and report results on alternative publicly available platforms, although the use of ClinicalTrials.gov is encouraged.

For full details, please read NOT-OD-25-134.

Please reach out to ospera@bu.edu with any questions.

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