By: Sarah Elliott
On May 5, 2025, President Donald J. Trump signed Executive Order 14,292: Improving the Safety and Security of Biological Research.[1] The order, published in the Federal Register three days later, directed federal agencies to pause or end funding for projects that meet the definition of “dangerous gain-of-function” until new safeguards are in place.[2] The message was clear: the government wanted tighter control over risky biological experiments.[3]
The National Institutes of Health (NIH) acted quickly. On June 18, 2025, it released Notice NOT-OD-25-127, which required all federally funded research institutions to review their portfolios by June 30, 2025.[4] If any project qualified as “dangerous gain-of-function,” it had to be reported.[5] NIH reserved the right to suspend or terminate awards immediately, putting universities and medical centers under intense compliance pressure.[6]
This was not NIH’s first move. Earlier, on May 7, 2025, the agency had issued Notice NOT-OD-25-112, which formally rescinded its 2024 DURC/PEPP framework.[7] That framework had consolidated two older oversight systems, Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP), but the Executive Order explicitly superseded it.[8] NIH announced that a brand-new policy consistent with the EO would be in place within 120 days.[9]
The U.S. Department of Agriculture (USDA) followed with its own program update. Through the Animal and Plant Health Inspection Service (APHIS), USDA announced that it would not accept competitive grant or contract proposals for dangerous gain-of-function research after June 20, 2025.[10] It also required institutions to self-report such projects by June 27, 2025.[11] Together, NIH and USDA made clear that federally funded science would now be subject to strict new rules.[12]
This abrupt policy shift raises several legal and business concerns. First, it shows the extraordinary power of the executive branch to reshape scientific research through regulation.[13] In a matter of weeks, a single Executive Order triggered a complete overhaul of federal oversight.[14] Second, it raises due process issues. By reserving the right to suspend or terminate grants without a detailed appeals process, NIH and USDA left researchers with limited recourse if their funding is pulled.[15] Third, the compliance burdens are heavy. Universities and medical centers had less than two weeks to review thousands of projects, creating significant pressure on compliance offices and in-house counsel.[16] Many institutions scrambled to develop internal procedures to avoid losing vital federal funding.[17] Fourth, the EO’s language extends beyond federally funded work. Section 5 directs agencies to explore how non-federally funded research should be handled, which hints at future regulation of private biotech labs.[18]
For the business law community, the stakes are high. Biotech companies face new risks, including project delays, potential losses of investment, and disclosure obligations if federally funded research is halted.[19] Universities and hospitals must enhance governance and compliance structures to meet rapid federal demands. At the same time, law firms advising these institutions will need to guide clients through uncertain and evolving regulatory terrain.
Not everyone agrees on the best approach. On September 3, 2025, the National Academies of Sciences, Engineering, and Medicine released a report calling for streamlining research regulations.[20] The report recognized the importance of biosafety oversight but warned that excessive bureaucracy could undermine American scientific competitiveness.[21] The report highlights the central tension: how to protect the public from catastrophic biosafety risks without strangling innovation.[22]
The 2025 Executive Order is more than a public health measure. It is a case study in how law and science collide. Compliance deadlines, executive authority, and due process concerns are now front and center for the biotechnology sector. As the federal government builds a new framework for dangerous gain-of-function research, businesses, universities, and lawyers will need to adapt quickly to stay compliant while pushing forward scientific progress.
[1] Exec. Order No. 14292, 90 Fed. Reg. 19611 (May 5, 2025).
[2] Id.
[3] See id.
[4] Implementation Update: Terminating or Suspending Dangerous Gain-of-Function Research in Accordance with the Executive Order on Improving the Safety and Security of Biological Research, Notice No. NOT-OD-25-127, Nat’l Insts. of Health (June 18, 2025), https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-127.html [https://perma.cc/4GEL-GUC8].
[5] Id.
[6] See id.
[7] Implementation Update: Improving the Safety and Security of Biological Research, Notice No. NOT-OD-25-112, Nat’l Insts. of Health (May 7, 2025), https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-112.html [https://perma.cc/TTG9-ZKYQ].
[8] Id.
[9] Id.
[10] Implementation Update: Improving the Safety and Security of Biological Research, Animal and Plant Health Inspection Servs., U.S. Dep’t of Agric. https://www.aphis.usda.gov/news/program-update/implementation-update-improving-safety-security-biological-research [https://perma.cc/7W7U-BHQP].
[11] See id.
[12] Id.
[13] See Exec. Order No. 14292, 90 Fed. Reg. 19611, 19612 (May 5, 2025).
[14] Sara Reardon, Lawsuit Aims to Broadly Overturn NIH Grant Terminations, Am. Ass’n for the Advancement of Sci. (April 2, 2025, 5:20 PM), https://www.science.org/content/article/lawsuit-aims-broadly-overturn-nih-s-grant-terminations [on file with the American University Business Law Review].
[15] Nat’l Insts. of Health, supra note 4; U.S. Dep’t of Agric., supra note 10.
[16] See Exec. Order No. 14292, 90 Fed. Reg. 19611, 19612 (May 5, 2025).
[17] Reardon, supra note 14.
[18] See Exec. Order No. 14292, 90 Fed. Reg. 19611, 19612 (May 5, 2025).
[19] Gwendolyn Wu, ‘Fear and Uncertainty’: Biotech Investors Warn of Impact from NIH Research Cuts, BioPharma Dive (Feb. 25, 2025), https://www.biopharmadive.com/news/biotech-nih-funding-research-trump-cuts-impact/740802/ [https://perma.cc/7HW9-F4SU].
[20] See New Report Identifies Policy Options to Improve Federal Research Regulations, Bolster U.S. Scientific Competitiveness, Nat’l Acads. of Scis., Eng’g & Med. (Sep. 3, 2025), https://www.nationalacademies.org/news/2025/09/new-report-identifies-policy-options-to-improve-federal-research-regulations-bolster-u-s-scientific-competitiveness [https://perma.cc/JTQ3-4HZY].
[21] See id.
[22] See id.
