Washington Update

Recent NIH Policy Actions of Interest

By: Yvette Seger
Thursday, February 12, 2026
Over the past three weeks, the National Institutes of Health (NIH) has issued several policy updates of interest to the FASEB community, ranging from substantial departures from prior policy to extensions to accommodate for time lost during the extended lapse of federal appropriations during October and November of last year. A brief summary of all changes posted between January 22 through February 10 is posted below.

Key Changes to Human Fetal Tissue Research and Pause of New Submissions to NIH Human Embryonic Stem Cell Registry
On January 22, NIH issued a Notice updating the agency’s policy on the use of human fetal tissue (HFT). Effective immediately and applicable to both the NIH intramural and extramural communities, NIH funds may not be used to support research using HFT obtained from elective abortions. In a corresponding statement, NIH Director Jayanta Bhattacharya highlighted the sharp decline in research using HFT since 2019 and cited a need to prioritize resources towards efforts that will most effectively drive innovation.

The next day, NIH announced an immediate pause on the review and approval of applications for the addition of new human embryonic stem cell (hESC) lines to the NIH Human Embryonic Stem Cell Registry. Reiterating the decline noted in the previous day’s change regarding HFT research, the Notice also included a Request for Information (RFI) seeking input on the utility of hESCs in biomedical research, specifically:
  1. Research areas for which currently approved hESC lines sufficiently meet the needs of the research community as well as research areas for which new hESC lines are needed;
  2. Research areas for which hESCs are the gold standard and could not be pursued if hESCs were unavailable; 
  3. Research areas for which emerging biotechnologies, such as induced pluripotent stem cells, adult stem cells, etc., can replace the use of hESCs; and
  4. Research areas in which additional investments should be made to bolster validated models to replace the use of hESCs.
Feedback on the RFI should be submitted via the response form by April 24, 2026.

Basic Experimental Studies in Humans No Longer Considered Clinical Trials
On January 29, NIH announced an important pivot away from its 2014 definition of the research considered clinical trials. Effective for grant applications submitted on or after May 25. 20206, Basic Experimental Studies Involving Humans (BESH), or studies in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects on health-related biomedical or behavioral outcomes, will no longer be considered clinical trials. Cited as reflecting changes in how results are disseminated as well as advancing NIH’s broader effort to reduce administrative burden, this announcement also foreshadows the expiration of BESH-specific Notices of Funding Opportunities after the May deadline due to this definition change.

Temporary Extension of Eligibility for K99/R00 and Early-Stage Investigator Status
On January 30, NIH issued a pair of Notices intended to minimize the disruption of the extended government shutdown on key professional development milestones for early career researchers. One provided a temporary extension of eligibility for NIH Pathway to Independence Awards (R99/R00) for individuals whose eligibility would have expired from September through November 2025 or January through March 2026. For the former, eligibility for the last new/resubmission of K99/R00s was extended through February/March 2026, while eligibility for the latter was extended through June/July 2026.

Similarly, another Notice extended eligibility of Early-Stage Investigator (ESI) status for individuals for whom this status would have expired in September, October, or November 2025 through March 31, 2026. Defined as a Principal Investigator or Program Director who completed their terminal research degree or post-graduate clinical within the past 10 years, ESI status is used by NIH Institutes and Centers to prioritize meritorious grant applications and determine eligibility for designated roles on Advisory Councils.