Life Sciences Research

On July 20, 2026, the Office of Science and Technology Policy issued the U.S. Government Policy for Stopping High-Risk Life Sciences Research. It defines the following:

• "Life sciences research" means research pertaining to the study or use of living organisms, viruses, or their products, including all disciplines, methodologies, and applications of biology (including biotechnology, genomics, proteomics, bioinformatics, and pharmaceutical and biomedical research and techniques). 
• "Dangerous gain-of-function (DGOF)" research enhances a property or properties of a biological agent in ways that make it more dangerous.
• "International research of concern (IROC)" is research conducted in foreign countries of concern or by foreign entities of concern.

Research falls under "potential dangerous gain of function" if it could potentially result in any of the following outcomes: 

1. enhancing the harmful consequences of the biological agent;
2. disrupting beneficial immunological response or the effectiveness off an immunization imm against the biological agent;
3. conferring to the biological agent resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that biological agent or facilitating its ability to evade detection methodologies;
4. increasing the stability, transmissibility, or ability to disseminate the biological agent;
5. altering the host range or tropism of the biological agent;
6. enhancing the susceptibility of a human, animal, or plant host population to the biological agent; or
7. generating or reconstituting an eradicated or extinct biological agent.

Activities that fall under the definition of "potential dangerous gain of function" must be reviewed by the Institutional Review Entity (IRE) and a sponsor's own independent third-party review body (ITPRB).

Research that seeks, achieves, or has substantial risk of achieving one of the outcomes listed above is prohibited from receiving federal funding.

If you have questions about this policy and how it relates to your research, please contact our office at ire@nd.edu.