Federal Research Policy Updates

Reminders of NIH Policies on Other Support and Policies to Reduce Foreign Influence Concerns

Over the past year, the FBI and federal lawmakers have raised concerns regarding undue foreign influence on federally funded research. As a result, many federal funding agencies, including the National Institutes of Health (NIH), are revisiting what information they require from investigators to appropriately assess other sources of support. A summary of NIH’s efforts to address foreign influence concerns can be found at their webpage Protecting U.S. Biomedical Intellectual Innovation.

As part of this effort, NIH issued Policy Notice NOT-OD-19-114, Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components, and the accompanying FAQ, in July 2019. This clarifying guidance from NIH outlines requirements that differ from what was previously understood to be required of applicants and awardees.  In addition, the NIH has provided a reminder via NOT-OD-25-133 that institutions train Senior/Key Personnel on OS/CPS according to their policies per the accompanying FAQ. 

A summary of these current NIH requirements follows.

Positions, Appointments, and Affiliations

Any position or scientific appointment held by investigators that is relevant to the application must be disclosed including domestic or foreign, paid or unpaid, or full/part-time/voluntary. Titled academic, professional, or institutional appointments, including adjunct, visiting, or honorary, must be disclosed.  Outside activities that are not research related (e.g. serving on a science advisory board for a start-up company where the investigator will not perform research) do not need to be included in the disclosure.  However, disclosure of the activity may still be required  by Lurie Children’s Hospital (LCH) in the Annual Compliance Attestation & Workforce Conflict of Interest Disclosure.

Financial Support

This includes sponsored awards held at LCH, held at another institution/entity, or held as an individual that support an investigator’s research efforts. This also includes start-up packages from entities other than LCH, and institutional awards at LCH or other institutions that are separately budgeted and accounted for. Investigators do not need to disclose LCH start-up packages, gifts, or endowed chairs, nor do NIH training grants need to be disclosed.

Non-Financial Resources

This includes non-monetary resources that are uniquely available to key personnel such as office or laboratory space, equipment, supplies, employees, scientific materials, and participation in a foreign “talents” or similar-type program. Non-financial resources that are available to the LCH research community at large, such as core facilities or shared equipment, do not need to be reported. Non-financial resources that are provided by entities other than LCH are of particular interest to NIH, and investigators should take care to ensure that all necessary disclosures are made.

• All other support and affiliations must be reported during Just-in-Time (JIT) via the OS/CPS document.
• Applicants are responsible for promptly notifying NIH of any substantive changes to previously submitted JIT information up to the time of award. Please contact your Sponsored Programs Administrator (SPA) in the Office of Sponsored Programs for assistance.
• Other support obtained after the initial NIH award period must be disclosed in the annual research performance progress report (RPPR) or when changes occur.

NIH Statement ”Advancing NIH’s Mission Through a Unified Strategy” Outlines New Research Priorities 

Release Date: August 15, 2025

Summary: The National Institutes of Health director outlined his “unified strategy” in an August statement posted on the NIH website. This statement details funding priorities for the NIH, including chronic disease and nutrition, artificial intelligence, alternative testing models, and real-world data platforms. Additionally, the statement outlines significant shifts of focus for research related to health disparities, autism, and transgender health care for children and teenagers.

Questions: Contact osp@luriechildrens.org

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

Effective Date: Applications submitted to the September 25, 2025, receipt date and beyond

Summary: 

• AI use in applications: NIH will not consider applications that are substantially developed by AI, or that contain sections substantially developed by AI, to be original ideas of the applicants. If the use of AI in this manner is detected, applicants may face consequences, including referral to the Office of Research Integrity, and other enforcement actions such as disallowance of costs, withholding future awards, and/or suspension or termination of grants. 
• Limitation on number of NIH proposal submissions: NIH will only accept six new, renewal, resubmission, or revision applications from an individual principal investigator/program director or multiple principal investigators for all council rounds in a calendar year. This applies to all activity codes except T activity codes and R13 conference grant applications. 

Please note, it is the responsibility of investigators to maintain an accurate accounting of their submissions to remain within conformance of NIH policy.

Additional Resources: Information about the use of AI in research is located on the Research Security website, which will be updated soon with information related to this new NIH policy. Please look for future communications in the coming weeks.

Questions: Contact researchcompliance@luriechildrens.org.

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

Release Date: July 18, 2025

Summary: NIH Institutes, Centers, and Offices will 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, allowing NIH better ability to track obligations to foreign entities.

Questions: Contact osp@luriechildrens.org.

Updated NIH Public Access Policy (NOT-OD-25-047)

Effective Date: July 1, 2025  

Summary:

• Public access/embargo period: Author accepted manuscripts must be made available to the public in PubMed Central without embargo upon the official date of publication. Full text must be available in PubMed Central (PMC) immediately upon publication (including first online publication: ePub ahead of print) for all publications accepted on or after July 1, 2025. 
• Publication costs: The policy defines what are allowable and unallowable costs related to publications. 
• Government use license and rights: By accepting NIH funding, the recipient grants to NIH a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use the work for federal purposes and to authorize others to do so, which includes making author accepted manuscripts publicly available in PMC upon the official date of publication. 

Additional Resources: Information, FAQs, and resources on this updated policy can be found in the Updates to the NIH Public Access Policy document.

Questions: Contact osp@luriechildrens.org.

Notice of Short-Term Extension to Early-Stage Investigator Eligibility Period (NOT-OD-25-114)

Release Date: May 20, 2025

Summary: The notice grants an automatic extension of ESI eligibility. The extension addresses delays impacting grant application and submissions, peer review, or award processing timelines between January 1, 2025 and May 31, 2025. 

Questions: Contact researchdevelopment@luriechildrens.org.

Implementation of SciENcv

Update:  As of March 25, 2025, The implementation of SciENcv has been postponed. At this time, continue to use the current NIH Biographical Sketch and Other Support format pages for applications, Just-In-Time submissions, and Research Performance Progress Reports.

The NIH will issue further Guide Notices outlining the new effective date and additional details as they are finalized. Follow the changes on the Implementation of New Initiatives and Policies page.

Effective January 25, 2025: NIH Simplified Peer Review Framework

NIH research project grant applications submitted on or after January 25, 2025, will be evaluated using the new Simplified Peer Review Framework.

From NIH NOT-OD-24-010 and NOT-OD-24-085, we know that:

• The NIH Simplified Peer Review Framework has been created in response to feedback from the extramural research community concerning the complexity of the peer review process and the increasing responsibilities of peer reviewers.
• To focus reviewers on the scientific merit and feasibility of research (away from investigator and institutional reputation that may create bias), the five criteria that authors are familiar with will be condensed into three:
  • Factor 1: Importance of the Research (Significance, Innovation)
  • Factor 2: Rigor and Feasibility (Approach, including Clinical Trial Study Timeline)
  • Factor 3: Expertise and Resources (Investigators, Environment)
• NIH has created a comprehensive website to support the transition from the current peer review criteria to the Simplified Peer Review Framework.