This Executive Order establishes a policy of the United States to ensure that federally funded research benefits American citizens without jeopardizing national security, strength or prosperity. The order seeks to strengthen oversight of dangerous gain-of-function research on biological agents and pathogens and other high-risk life science research. It contains the following directives and deadlines.
- Section 3(a): The Director of the Office of Science and Technology Policy (“OSTP”) must immediately establish guidance for relevant agencies to: (i) end federal funding of dangerous gain-of-function research conducted by foreign entities in countries of concern (e.g., China) or in countries lacking adequate oversight; and (ii) end federal funding of other life science research in countries of concern or in countries lacking adequate oversight and that may reasonably pose a threat to public health, safety, and economic or national security.
- Section 3(b): The Director of OSTP must establish guidance for Health and Human Services and other relevant agencies concerning the suspension of federally funded dangerous gain-of-function research, at least until the Director completes the new policy called for in Section 4(a).
- Section 4(a): Within 120 days of the order, the Director of OSTP must revise or replace the 2024 “United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential” to strengthen independent oversight, increase accountability, ensure compliance with the Administration’s policy on dangerous gain-of-function research, and provide for regular review at least every 4 years.
- Section 4(b): Within 90 days of the order, the Director of OSTP must revise or replace the 2024 “Framework for Nucleic Acid Synthesis Screening” (“Framework”) to ensure that the Framework promotes practical, verifiable synthetic nucleic acid procurement screening mechanisms, ensures provider or manufacturer compliance with the updated Framework, and incorporates enforcement mechanisms. The Framework will also undergo regular review at least every 4 years.
- Section 5: Within 180 days of the order, the Director of OSTP must develop and implement a strategy to govern and track dangerous non-federally funded gain-of-function research across the United States and other high-risk life science research.
- Section 6: The Director of OSTP must ensure that the policy in section 4(a) includes a reporting mechanism for federally funded research institutions to report dangerous gain-of-function research. The mechanism will also include, to the extent legally permissible, non-federally funded research and public access to this information without compromising national security or intellectual property.
- Section 7: The Secretary of Health and Human Services and the heads of other relevant agencies must include the following terms in every life science research contract or grant award:
- a term requiring compliance with this order and any applicable regulation material to the Government’s payment decisions;
- a term requiring the contractual counterparty or recipient’s certification that it does not operate, participate in, or fund any dangerous gain-of-function research or other life science research in foreign countries that could risk significant societal consequences or generate unnecessary national security risks;
- a term stating that the violation of this order and any applicable regulation by any grant recipient may be considered a violation by their employer or institution;
- a term stating that any grant recipient employer, or institution that violates this order or any applicable regulation may face immediate funding revocation and up to five years of ineligibility for federal life science grants.
