NIH Provides Clarification on New Policy Affecting Proposals for Animal Studies

By: Galen Cobb
Thursday, July 24, 2025
The National Institutes of Health (NIH) received considerable feedback after the initial announcement of a policy affecting notices of funding opportunities (NOFOs) for proposals of animal studies. Please see this article for more details of this policy. On July 18, NIH issued a clarification, “How Does the NIH Initiative to Prioritize Human-Based Research Affect Research Proposing the Use of Laboratory Animals?,” which provided links to several Q&As outlining current agency policy.

• When Are Alternatives to Animals Used in Research?
• Why Animals are Used in Research
• Ensuring the Care of Research Animals

Additionally, it specified that applicants may continue to propose research that uses any or all available biomedical research models, including “human participants (like clinical trials), particular laboratory animals, real-world data, in vitro methods, mathematical models, artificial intelligence, in silico approaches, other alternative approaches, or a combination of models.” Peer reviewers will assess proposals based on the merit of each approach proposed, its relevance to human disease, and whether it is best suited to answering the research question that advances biomedical research and discovery. 

More clarification came during a presentation at the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) Public Forum, held on July 21-22. In response to questions, Warren Casey, PhD, DABT, Director of Strategic Partnerships at the National Institute of Environmental Health Sciences and Executive Director of ICCVAM, confirmed that animal studies will continue to be considered for funding under the new policy without the need to pair animal models with an alternative method, but that translatability to human disease will be a key review criterion.