Improving the Safety and Security of Biological Research

The order directs the Office of Science and Technology Policy (OSTP), coordinating with the Office of Management and Budget and the National Security Advisor, to issue guidance that immediately ends federal funding for dangerous gain-of-function research by foreign entities in countries of concern (specifically naming China) and in other countries lacking adequate U.S.-compatible oversight. It also directs OSTP to issue guidance suspending federally funded dangerous gain-of-function research domestically, at minimum until a revised national oversight policy is completed. Separately, it requires agencies to begin immediately inserting new enforcement terms into all life-science research contracts and grants, including a False Claims Act materiality certification and authorization to revoke funding and bar violators for up to five years.

The order further requires OSTP to revise or replace the 2024 federal dual-use research oversight policy within 120 days and the 2024 Framework for Nucleic Acid Synthesis Screening within 90 days. Within 180 days, OSTP must develop a strategy governing dangerous gain-of-function research that occurs without federal funding, and submit any legislative proposals needed to fill authority gaps. A public reporting mechanism for covered research programs — including suspended or stopped programs — must be built into the revised oversight policy. Both revised frameworks must be reviewed and updated at least every four years.

Universities, research hospitals, biotech firms, and other institutions that receive federal life-science research grants or contracts — especially those conducting gain-of-function or dual-use research. Foreign entities, particularly in China, that currently receive U.S. federal life-science funding are directly targeted. Private-sector researchers operating without federal funding are also covered under the non-federally funded research strategy.

Research institutions now face new certification requirements in every federal life-science grant or contract, with noncompliance potentially triggering False Claims Act liability, immediate funding revocation, and up to five years of ineligibility for HHS and other federal research funds. Programs with foreign ties — especially in China — face immediate suspension of U.S. funding pending new guidance.

OSTP must issue two sets of guidance without a firm deadline (described in the order as "immediate"): one ending foreign gain-of-function funding and one suspending domestic dangerous gain-of-function research. Agencies report any exceptions to OSTP for National Security Advisor review. The domestic suspension bridges to the permanent revised policy due in 120 days. Section 7 contract terms take effect in new awards immediately, with the False Claims Act materiality hook (31 U.S.C. 3729(b)(4)) giving the government a fraud-liability tool and the five-year debarment provision providing a significant deterrent against noncompliance.