Alerts & News

Immediate: Regulatory and Policy Changes

NIH Policy on Training Senior/Key Personnel on Other Support Disclosure Requirements: NIH requires recipients to provide training to all faculty and researchers identified as Senior/Key Personnel on the requirement to disclose all research activities and affiliations (active and pending) in Other Support (see Other Support form). Recipients must implement trainings, in addition to maintaining a written and enforced policy, on requirements for the disclosure of other support to ensure Senior/Key Personnel fully understand their responsibility to disclose all resources made available to the researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant. Effective October 1, 2025

NIH Research Applications Guidance: NIH will not consider applications that are either substantially developed by AI, or contain sections substantially developed by AI, to be original ideas of applicants. If the detection of AI is identified post award, NIH may refer the matter to the Office of Research Integrity to determine whether there is research misconduct while simultaneously taking enforcement actions including but not limited to disallowing costs, withholding future awards, wholly or in part suspending the grant, and possible termination.

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. Effective for submissions on September 25, 2025 and beyond. 

Updated NIH Policy on Foreign Subawards: NIH will not issue awards to domestic or foreign entities (new, renewal or non-competing continuation), that include a subaward to a foreign entity. Additionally, NIH will no longer accept prior approval requests to add a new foreign component or subaward to an ongoing project. NIH plans to expand this policy to domestic subawards in the future. In addition, NIH is establishing a new award structure that will prohibit foreign subawards from being nested under the parent grant. For current awards with foreign subawards, NIH Institutes, Centers, and Offices (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. They also 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. Updated July 18, 2025.

2024 NIH Public Access Policy: Requires Author Accepted Manuscripts accepted for publication in a journal, on or after July 1, 2025, to be submitted to PubMed Central upon acceptance for publication, for public availability upon the Official Date of Publication. The Policy applies to any Author Accepted Manuscript accepted for publication in a journal that is the result of funding by NIH in whole or in part through a grant or cooperative agreement, including training grants, a contract, an Other Transaction, NIH intramural research, or the official work of an NIH employee. NIH has developed a new website dedicated to the Public Access Policy which includes an overview of the policy, supplemental guidance, tips for submitting to PubMed Central, contact information, and FAQs.  Effective July 1, 2025

Updated NIH Processes for No-Cost Extensions: NIH has temporarily disabled the No-Cost Extension functionality in eRA Commons as of May 7, 2025. At this time, all requests for NCEs must be submitted as a prior approval request in eRA Commons, for NIH review and approval.

NIH SBIR and STTR Foreign Disclosure Post-Award Requirements for Active SBIR and STTR Awardees: Active Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) recipients that did not undergo foreign risk assessment at the time of their original application may be required to disclose all funded and unfunded relationships with foreign countries. Effective April 29, 2025

Research Security Training: Covered individuals as defined by NSPM-33: January 2025

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Watchlist: Future Regulatory and Policy Changes 

Executive Orders and Research Policy Changes 2025 - Harvard OVPR website

NIH Implementation Update: Promoting Maximal Transparency Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NOT-OD-25-082): On June 1, 2025, the NIH Office of Science Policy (OSP) will publicly post the rosters of all active IBCs registered with OSP via the IBC-Registration Management System (RMS). In addition, the NIH expects that approved meeting minutes from all IBC meetings occurring on, or after June 1, 2025 will be posted publicly on an institutional website.

Research Security Program: National Security Presidential Memorandum 33 (NSPM-33) requires Research Institutions receiving over $50 million to establish and operate a research security program which includes elements of cybersecurity, foreign travel security, insider threat awareness and identification, and export control training. Estimated Implementation Date: January 2026