Separating the Policy from the Noise: Evolving Guidelines on Animal Models and Open Access
The National Institutes of Health (NIH) continues to align its policies with the current Administration’s view on scientific priorities. Two recent NIH policies have been released that have caused an upheaval in an already tumultuous time for science:
- A policy announcement on New Approach Methodologies (NAMs);
- A notice of policy change on allowable publication costs
These changes underscore a broader transformation in how research is designed, funded, and disseminated. However, all we know right now is what has been released and that is where the focus should be.
The Reframing of Animal Models
NIH announced that all new funding opportunities will incorporate language encouraging the consideration of NAMs, and that it will no longer seek proposals exclusively for animal models. This announcement came on the heels of a joint FDA-NIH workshop on reducing animal testing. Officials from both agencies spoke about plans to reduce the use of animals in research and to shift to increased use of New Approach Methodologies (NAMs). While the presentation was presented in a way that would lead those in attendance and watching online to believe that the FDA and NIH were eliminating animal research, this is not the case.
The new policy still allows animal research while opening the scope of funding opportunities to better reflect the full range of modern research tools, such as NAMs. The policy modifies the Notices of Funding Opportunities (NOFOs) to create consistency within NIH’s grantmaking language and allow funding opportunities so that all models/techniques are eligible to apply for that opportunity.
NIH released a clarification from the statements made at the workshop. The clarification confirms that research proposals involving animals are still permitted and will be fairly reviewed under its new initiative to prioritize human-based research technologies. ASPET is actively monitoring this change and continues to look for opportunities to engage with NIH on the use of animal models and the future of NAMs.
The New Era of Open Access: NIH and Publication Costs
NIH is also preparing to implement a new policy to support compliance with the 2022 OSTP Public Access Guidance, known as the Nelson Memo. This directive requires that all federally funded research articles be made publicly available immediately upon publication without paywalls or embargoes. The new NIH Open Access policy was originally to be effective December 31, 2025: however it became effective July 1 to meet the spirit of the Nelson Memo.
In another recent announcement, NIH has committed to developing new guidance on allowable publication costs, such as Article Processing Charges (APCs) and repository fees, that can be charged to grants.
The specific rules have not yet been released. Through various coalition partners, ASPET has learned that the NIH is expected to release some form of feedback solicitation on the new policy once it is released. The expectation is that the policy will recognize the complexity of the publishing ecosystem including the value and cost of peer review, while balancing the need to not overcharge the public for research it has funded.
When the solicitation for feedback is open, ASPET will be submitting comments and feedback on the new policy as it has done in the past with other policies surrounding Open Access.
ASPET’s Role in the Continuous Policy Change
When policy changes occur, ASPET works to make sure your voices are heard by decision makers and that our members are aware of the impacts of these changes. As the professional home for pharmacology, ASPET’s Government Affairs & Science Policy Department is committed to:
- Monitoring and interpreting policy changes on your behalf
- Providing educational resources so you can be better prepared for your roles
- Sharing your concerns and opinions with decision makers, both in the Administration and in Congress
- Promoting the field of pharmacology
We understand that it feels like the entirety of the scientific enterprise is rapidly changing without clear guidance. Admittedly, in many ways, it is. Yet, we are all in this marathon masquerading as a sprint together. We will continue to share with you any information that ASPET learns on these policies as well as any new ones on the horizon. We are all in this together and when we work together, the impossible becomes possible.