Comment from Bethany Moore

I oppose many key issues within OMB Uniform Guidance Revision Proposal (Docket OMB-2026-0034) and feel these should be withdrawn. I am writing in my personal capacity as a research scientist trained in both microbiology and immunology with 30 years of experience as a faculty member and scientist at a large public R1 research university. I am currently Chair of the Department of Microbiology and Immunology at the University of Michigan and feel this role has given me ample personal perspective into many of these key provisions. [200.205] has several troubling aspects. First, scientific inquiry should drive discovery and the merit of the proposals should be determined by scientific expert peer-review. Presidential policy priorities may change every 4 years, and grant cycles will likely span presidential appointments. The merit should be determined by scientific experts. The language proposed could harm proposals that seek to study true medically documented racial differences in disease incidence, pathogenesis or prognosis. There are murine experimental systems that allow for sex hormones and sex chromosomes to be disconnected and these can be very useful in studying sex-based disease outcomes. The language proposed could make such grants difficult to be funded despite the scientific usefulness of the approach. This section also references “gold standard science” which is not defined. The purpose of peer-review is to ensure that the proposed methods are appropriate for the questions being addressed. Thus, the gold standard is already addressed by scientific peer-review at both the grant review and the manuscript review and publication stages. How institutions will demonstrate success in implementing gold standard science is also not defined. An important point is that decisions about funding should not be taken out of the hand of scientific experts in any way for pre-issuance review. The language suggests that political appointees rather than career scientists might make funding decisions without the expertise to understand the impact. These appointees would not be directed to defer to peer-review or ratify their recommendations. This takes scientific merit out of the hands of scientists and is bad policy if the United States wants to remain the scientific and technological leaders of the world. [200.206 section 2 (vii)] suggests that NIH officials will review publicly available information for “engaging in activities or initiatives that are inconsistent with Federal civil rights laws”. This would require very specific language about what types of activities would fall into this category. As written, it could be interpreted very broadly and inconsistently and suggests privacy concerns if agencies were to check a history of social media post or likes for instance as evidence which could be misconstrued. Would participation in any environmental or public health advocacy group potentially disqualify applicants with such broad language? [200.220] the language here is too broad and could prohibit legitimate and useful international scientific collaborations that are in the best interests of the science and the U.S. [200.340] would allow termination of proposals for convenience. This should only happen if serious misconduct is identified. Termination of proposals in the middle of long-term studies could significantly impact the ability to analyze and interpret data meaningfully. It could disrupt the scientific training of the next generation workforce. This would waste federal monies that had already been spent in some cases. Scientific peer-review should determine the priority for funding. An overall concern with many provisions in this proposal is that science will no longer be insulated from political ideology. I do not think OMB should oversee and override the decisions of scientific expert peer-reviewers or career scientists that administer NIH programs. Thank you for considering these concerns.