Improving the Safety and Security of Biological Research
This Executive Order directs the federal government to sharply tighten oversight, funding restrictions, and transparency for life-science research that could increase the harmfulness or spread of infectious agents — commonly called “gain-of-function” (GOF) research. It orders immediate steps to stop federal funding for certain GOF and other high-risk research conducted in specified foreign countries or where U.S. oversight is insufficient, suspends some federally funded GOF projects pending new rules, and requires agencies to adopt stronger policies, enforcement terms, and public reporting. The stated purpose is to reduce biological risks to public health, national security, and the economy while preserving U.S. leadership in biotechnology. The Order sets near-term deadlines (90–180 days) for the Office of Science and Technology Policy (OSTP) and partner agencies to revise existing federal guidance and a nucleic acid screening framework, to produce a national strategy for non‑federally funded high-risk research, and to build enforceable contract/grant terms (including funding suspension and debarment-like penalties). It expands reporting and screening expectations for DNA/RNA synthesis providers and creates certification and compliance requirements for grant recipients, with potential funding revocation and up to five years’ ineligibility for violations. The changes will increase compliance obligations for researchers and institutions, constrain some international collaborations, and push for tighter controls on synthetic nucleic acid procurement.
Key Points
- 1Immediate funding restrictions and suspensions: Federal funding for dangerous GOF research conducted by foreign entities in “countries of concern” (explicit example: China) or in countries lacking adequate oversight must be ended; federally funded GOF projects may be suspended until new OSTP policy is completed. (“Gain-of-function” refers to experiments that increase a pathogen’s ability to cause disease or spread.)
- 2Rapid policy overhaul deadlines: OSTP must revise or replace the 2024 U.S. policy on dual‑use research and the 2024 nucleic acid synthesis screening Framework within 120 and 90 days, respectively, strengthening independent oversight, enforcement, audits, and public transparency, and requiring periodic review (at least every 4 years).
- 3Stronger contract/grant enforcement: HHS and other agencies must add terms to life‑science awards making compliance material to government payments (triggering False Claims Act consequences), requiring certification of no prohibited foreign activities, and allowing immediate funding revocation and up to a 5‑year bar from federal life‑science grants for violations.
- 4Addressing non‑federally funded research: Within 180 days OSTP (with OMB, NS adviser, and others) must develop a strategy to govern, limit, and track dangerous GOF and other high‑consequence life‑science research done without federal funding, and propose legislation for any authority gaps.
- 5Transparency and reporting: Federal recipients must report dangerous GOF research (to the extent lawful), and OSTP must create a publicly available source of information on identified programs and awards, while protecting national security and legitimate intellectual property.