A Standardized Framework for Assessing High-Risk Life Sciences Research

Defining Objective Criteria That Can Facilitate Expert and AI Reviews of Dangerous Gain-of-Function Research

Matt Sharkey, Adeline E. Williams, John P. Tarangelo, Barbara Del Castello, Christopher Rodriguez, Celine Robinson, Graham Griffin, Skye A. Miner, Rebecca Moritz, Tyler Hoard, et al.

Published Sep 2, 2026

Two recent federal policies establish funding prohibitions and research review requirements for certain life sciences pathogen or toxin research. Based on the definition of dangerous gain-of-function research (DGOF), the authors recommend that relevant federal agencies adopt an objective, transparent decisionmaking framework with defined DGOF criteria. This framework builds on previous RAND work to assess high-risk research.

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Sharkey, Matt, Adeline E. Williams, John P. Tarangelo, Barbara Del Castello, Christopher Rodriguez, Celine Robinson, Graham Griffin, Skye A. Miner, Rebecca Moritz, Tyler Hoard, and Elizabeth Cameron, A Standardized Framework for Assessing High-Risk Life Sciences Research: Defining Objective Criteria That Can Facilitate Expert and AI Reviews of Dangerous Gain-of-Function Research. Santa Monica, CA: RAND Corporation, 2026. https://www.rand.org/pubs/working_papers/WRA5251-1.html.
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