Oversight of Gain-of-Function Research with Pathogens: Issues for Congress

government

US Congress·congress.gov/crs-product/R47114

Credibility Rating

5/5

Gold(5)

Gold standard. Rigorous peer review, high editorial standards, and strong institutional reputation.

Rating inherited from publication venue: US Congress

Relevant to AI safety discussions around dual-use research governance and oversight frameworks; offers a concrete legislative case study for how governments manage high-risk, high-reward research with catastrophic misuse potential.

Metadata

Importance: 52/100policy briefanalysis

Summary

This CRS report provides a comprehensive analysis of federal oversight mechanisms for gain-of-function (GOF) research, which enhances pathogen transmissibility or virulence. It reviews existing frameworks like the Federal Select Agent Program and NIH guidelines, then outlines congressional policy options ranging from maintaining the status quo to banning GOF research entirely. The report is directly relevant to biosecurity governance and dual-use research of concern (DURC) policy.

Key Points

•GOF research can accelerate vaccine development but poses significant biosecurity risks if pathogens escape labs or are misused.
•Existing oversight includes the Federal Select Agent Program and NIH DURC policies, but gaps and inconsistencies in enforcement remain.
•Executive Order 14292 reshaped the federal oversight landscape, prompting congressional review of existing regulatory frameworks.
•Policy options range from status quo maintenance to stricter lab standards, funding restrictions, or outright bans on GOF research.
•Pending legislation (H.R. 1864, S. 738, S. 854) reflects growing congressional interest in tightening GOF research oversight.

Cited by 1 page

Page	Type	Quality
Bioweapons Risk	Risk	91.0

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# Oversight of Gain-of-Function Research with Pathogens: Issues for Congress

## CRS PRODUCT (LIBRARY OF CONGRESS)

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| CRS Product Type: | Reports |
| CRS Product Number: | R47114 |
| Referenced Legislation: | [H.R. 1864](https://www.congress.gov/bill/119th-congress/house-bill/1864); [S. 738](https://www.congress.gov/bill/119th-congress/senate-bill/738); [S. 854](https://www.congress.gov/bill/119th-congress/senate-bill/854) |
| Topics: | Federal Government Management & Organization; Health Care; Homeland Security & Emergency Management; Science & Technology |
| Publication Date: | 07/01/2025 |
| Author: | Kuiken, Todd |

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Oversight of Gain-of-Function Research with Pathogens: Issues for Congress

Updated July 1, 2025
(R47114)


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# Contents

- [Introduction](https://www.congress.gov/crs-product/R47114#_Toc202874934)
- [History of Concern with GOF Research](https://www.congress.gov/crs-product/R47114#_Toc202874935)
- [Benefits and Risks of GOF Research with Pathogens](https://www.congress.gov/crs-product/R47114#_Toc202874936)
- [Oversight of GOF Research Involving Pathogens](https://www.congress.gov/crs-product/

... (truncated, 98 KB total)

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