Comment from Kent Lloyd

I am a biomedical researcher whose work depends on NIH-funded research, rigorous scientific peer review, publication of results, participation in scientific meetings, collaboration with specialized experts, and the ability to train and sustain a research workforce. My research is part of the biomedical research enterprise that advances understanding of human and animal health, improves disease models, supports development and validation of new approach methodologies, and contributes to future therapies, diagnostics, and public health interventions. The proposed revisions to 2 CFR part 200 would substantially disrupt NIH-funded biomedical research. Several provisions would replace scientific merit review with political or administrative criteria, create uncertainty around ongoing awards, limit dissemination of research findings, and impose case-by-case prior approval requirements that are incompatible with the pace and structure of modern science. I respectfully request that OMB not finalize the following provision. [200.206] Federal agency review of risk posed by applicants. Proposed section 200.206 would expand applicant risk review to include vague and subjective factors such as “discredited or non-replicable studies,” “questionable practices,” memberships and affiliations, and activities deemed inconsistent with certain federal policy positions. This provision would cause concrete harm because biomedical science advances through revision, replication, disagreement, correction, and refinement. A provision that allows agencies to treat disputed, non-replicated, or later-revised scientific publications as institutional “risk” could punish ordinary scientific progress. It could also unfairly penalize large research universities and biomedical centers because, by their size, they employ thousands of researchers and publish thousands of papers across many fields. My research depends on an environment where scientific uncertainty can be investigated openly. Risk review should focus on financial management, compliance, audit history, human and animal research protections, biosafety, and demonstrated ability to carry out the award. It should not become a broad reputational or ideological screen that allows agencies to second-guess scientific debate or penalize institutions for the speech, memberships, or publications of individual employees. I request that OMB not finalize proposed section 200.206.