Comment from Anonymous

I am a research director with over 15 years of experience overseeing and facilitating dozens of clinical research studies and clinical trials that rely on federal financial assistance. These studies involve long term commitments to patients, research staff, and partner institutions, and they are governed by strict ethical and regulatory standards. The proposed rule would seriously jeopardize the stability, integrity, and scientific independence of clinical research in the United States. §200.205 would require senior political appointees, rather than career program officers or scientists, to conduct a "pre-issuance review" of every discretionary grant. These appointees are explicitly forbidden from routinely ratifying or deferring to peer reviewers, and must apply ideological criteria. Awards must “demonstrably advance the President’s policy priorities.” For clinical research, this change is especially dangerous: 1. Funding decisions would hinge on political ideology rather than scientific merit, patient need, and ethical review. 2. Research on sensitive but critical topics could be blocked despite strong scientific justification. 3. Institutions would face uncertainty about whether carefully peer reviewed clinical trials will be funded, undermining planning for multi site studies, staffing, and patient enrollment. Clinical trials directly affect patient care and safety. Allowing political appointees to override expert peer review without any requirement to show scientific cause threatens both the quality of evidence generated and the protection of research participants. §200.340 expands agency authority to terminate active grants mid award whenever they are deemed "inconsistent with program goals or agency priorities," requiring only a brief written rationale and no finding of noncompliance or fraud. In the context of clinical research I have supported: 1. Trials are designed with multi year protocols, IRB approvals, and informed consent that presume the study will reasonably run to completion. 2. Researchers hire specialized staff, build data and monitoring infrastructure, and commit to long term follow up for participants, especially in chronic disease and oncology trials. 3. Abrupt termination can leave patients without access to investigational interventions or promised follow up, compromise data integrity, and raise serious ethical questions. Treating clinical research grants as revocable at will, based on shifting priorities rather than misconduct or feasibility concerns, will discourage institutions from launching ambitious or long duration trials. It also opens the door to politically motivated cancellations of controversial but scientifically necessary studies, wasting public resources and damaging public trust. §200.202 would require that program goals, including for science and clinical research programs, "align with administration policies and priorities." This requirement is embedded directly in the regulatory text governing program design. Historically, federal clinical research programs have been structured around: 1. Statutory mandates from Congress. 2. Identified public health needs (e.g., cancer, cardiovascular disease, infectious diseases, mental health). 3. The advice of the scientific and medical communities regarding unmet clinical questions and patient populations in need. By requiring explicit alignment with current administration policy priorities, §200.202: 1. Subordinates scientific and public health considerations to partisan agendas when new programs are designed or existing ones are renewed. 2. Risks deprioritizing important areas of clinical research if they are politically disfavored. 3. Encourages agencies to write funding announcements around ideological themes rather than around the most pressing clinical and scientific questions. Clinical research programs should be designed to answer the most urgent medical questions and serve the needs of patients and communities, not to mirror the political preferences of any particular administration. Embedding this alignment requirement in regulation politicizes program design and narrows the scope of federally supported clinical science. Taken together, §200.205, 200.340, and 200.202 would: 1. Replace expert driven, peer reviewed decision making for clinical trials with direct political control and ideological tests. 2. Make active, multi year clinical studies vulnerable to termination based on shifting agency or political priorities rather than misconduct or feasibility. 3. Require clinical research programs to be designed around administration policy priorities instead of statutory mandates, public health needs, and scientific consensus. These changes would destabilize ongoing and future clinical research, undermine the ethical commitments made to trial participants, and erode the United States’ global leadership in evidence based medicine. I strongly urge OMB to withdraw these provisions.