The US government recently released a new U.S. Government Policy for Stopping High-Risk Life Sciences Research. The main highlights of this policy include:
- Bars federal support for what it calls “dangerous” gain-of-function, or DGOF, research. It defines two categories of research posing the highest risk: DGOF research and international research of concern.
- DGOF research is defined as work that makes a biological agent more dangerous across seven outcomes, including enhancing an agent’s harm, undermining vaccines or immunity, conferring resistance to therapeutics, increasing transmissibility, altering host range and reconstituting an eradicated or extinct agent. The definition explicitly includes creating “mirror organisms.”
- Research with “potential” DGOF characteristics can still receive federal funding, but only after an independent third-party review body clears it. The international research of concern category blocks funding for work conducted in unspecified “countries of concern” or with “entities of concern.”
- Principal investigators must now attest in writing whether their proposed work qualifies as DGOF, and institutions must establish an institutional review entity and name an internal contact for such research. Violations or false attestations can trigger revoked funding and up to five years of ineligibility for federal life sciences funds.
