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Incorporating the Intent of the Experiment into Gain-of-Function Oversight.

Michael J Imperiale¹

¹Microbiology and Immunology, University of Michigan, Ann Arbor, Michigan, USA.

Applied Biosafety : Journal of the American Biological Safety Association

|June 23, 2025

Summary

A new U.S. policy governs gain-of-function research. This research involves pathogens that could cause pandemics, and the policy has subjective criteria. A new criterion is proposed to better evaluate these experiments.

Keywords:

biosecurity dual-use research gain-of-function oversight policy

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Area of Science:

Biosecurity
Infectious Disease Research
Public Health Policy

Background:

The U.S. government has introduced a new policy for overseeing research with pandemic potential.
This policy addresses gain-of-function research, which involves modifying pathogens to study their epidemic potential.

Purpose of the Study:

To evaluate the criteria within the new U.S. gain-of-function research policy.
To propose a novel criterion for assessing experiments involving pathogens with pandemic potential.

Main Methods:

Policy analysis of the U.S. gain-of-function research oversight.
Development of a new criterion for evaluating subjective elements in the policy.

Main Results:

The current policy is generally comprehensive but contains subjective criteria.
A new, objective criterion is proposed to enhance the evaluation of high-risk research.

Conclusions:

The proposed criterion can improve the oversight of gain-of-function research.
Refining policy evaluation is crucial for managing risks associated with pandemic-potential pathogens.