This October, AAI submitted comments in response to two National Institutes of Health (NIH) Requests for Information (RFIs): one seeking feedback on a proposal to alter peer review reporting outcomes, and the other requesting input on the draft NIH Biosafety Policy. AAI’s comments emphasize that any new NIH policies should be transparent, grounded in science, and evaluated for their potential unintended consequences, including increasing administrative burden.
Preserving Transparency in Peer Review
In comments submitted on October 13, AAI responded to NIH’s proposal to modify how peer review outcomes are reported to applicants. Under the proposal, NIH would withhold the final overall impact scores and percentiles from applicants, applicant institutions, NIH Institute, Center, and Office (ICO) leadership, NIH program staff, and relevant NIH Advisory Councils. Instead, each proposal would be assigned to one of three broader categories: “Most Competitive,” (based on the top 25% of overall impact scores), “Competitive” (impact scores between 26-50%), and “Not discussed” (scores >50%). Written critiques and other review information would continue to be provided.
NIH states that the changes are intended to align with its Unified Funding Strategy and encourage a more holistic consideration of peer review outcomes.
AAI expressed concern that eliminating access to overall impact scores would reduce transparency and limit investigators’ ability to assess the competitiveness of their applications and make informed decisions about resubmissions and future application strategies. AAI emphasized the value of maintaining comprehensive information from the peer review process in order to align with NIH’s goal of ensuring that scientific merit remains central to funding decisions.
The response highlighted the importance of a review system that serves applicants, reviewers, institutions, and NIH alike by providing meaningful feedback and maintaining trust in the integrity of NIH funding decisions.
Addressing Key Issues in NIH’s Draft Biosafety Policy
On October 19, AAI submitted comments on NIH’s draft biosafety policy, which would replace the current framework governing recombinant or synthetic nucleic acid molecules research with a broader policy covering a wider range of biological research. The proposed policy is intended to modernize biosafety oversight, expand the scope of covered research, and establish a more risk-based approach to institutional review and compliance.
In its response, AAI raised serious concerns that the draft policy would dramatically expand the scope of research subject to biosafety oversight by applying new requirements to many types of research and experiments that have historically been understood to pose low or negligible risk. AAI cautioned that this approach would substantially increase administrative workload for investigators and institutions, overwhelm institutional biosafety committees with reviews of low-risk activities, and create significant delays and disruptions in the conduct of biomedical research.
The response argued that the proposed framework risks shifting valuable time and resources away from both scientific discovery and oversight of higher-risk research.
AAI also raised concerns about proposed public reporting requirements for biosafety incidents, noting that disclosures lacking sufficient context could distort public understanding of research activities and create disincentives for institutions to report incidents candidly and consistently. AAI emphasized that incident reporting systems should prioritize safety and privacy if the intent is to strengthen biosecurity practices and identify meaningful areas of improvement.
