How policy changes at NIH may affect research at SMHS

Recent changes at the National Institutes of Health (NIH) are likely to affect current and future research activities at the UND School of Medicine & Health Sciences. Below are two such changes for your information:

1. NIH is providing guidance to researchers on the appropriate use of artificial intelligence (AI) to maintain the fairness and originality of the NIH research application process. Via Notice Number NOT-OD-25-132, “Supporting Fairness and Originality in NIH Research Applications,” NIH is also instituting a new policy limiting the number of applications that NIH will consider per Principal Investigator per calendar year.

Relevant portions of the policy:

• 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. This policy applies to all activity codes except T activity codes and R13 Conference Grant Applications. Based on recent data, this limit will affect a relatively small number of Principal Investigators while enabling the NIH to maintain consistently high-quality grant application review and appropriately steward taxpayer dollars.

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

2. On April 29, NIH announced that it is prioritizing human-focused research and reducing animal use in research. As NIH noted in an announcement, “…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). Examples of NAMs include ex vivo human-based approaches, including perfused human organs and precision-cut tissue slices; in vitro methods, including microphysiological systems and organoids; computational and artificial intelligence-based approaches; and combinations thereof.”

If you have questions about either of these changes as they relate to your research, contact the Office of Research Affairs or colin.combs@UND.edu, bryant.smalley@UND.edu, or susan.i.holden@UND.edu.