Comment from Anonymous

I am a hospital-employed researcher and data scientist who serves as an analyst on NIH-funded projects focused on child and adolescent mental health. My work centers on combining patient-level data across clinical trials to help clinicians identify the treatments most likely to benefit individual patients. This research depends on access to de-identified participant data from previously completed studies. As a result, my work would be significantly affected by the proposed changes in §200.220, §200.205, §200.340, and §200.202. The proposed changes in §200.220 regarding foreign collaboration are particularly concerning because they are broadly defined. The proposal states that “the prohibition would apply regardless of whether Federal funds are used for direct programmatic activities, research, technical assistance, travel, or indirect costs allocable to such collaborations.” NIH institutes have already issued guidance indicating that even limited international collaborations, including manuscript co-authorship, may require prior approval. In many cases, researchers who contribute clinical trial data appropriately request co-authorship or acknowledgment so they can help ensure that the data are interpreted accurately and responsibly. Restrictions on international collaboration would substantially reduce access to international clinical trial datasets and research networks. Even under the current system, obtaining de-identified participant-level data through data-sharing agreements is often a costly and time-consuming process that can take years to complete. Additional approval requirements would create further barriers and may render some projects infeasible. This is particularly problematic given that an estimated 65–76% of clinical trials are conducted outside the United States (doi:10.1038/nrd4260). Limiting access to these data would leave researchers unable to incorporate much of the available clinical evidence, reducing the completeness and generalizability of scientific findings. The proposed changes in §200.205, §200.340, and §200.202 also raise concerns for research involving human participants. Human-subjects research necessarily progresses at a measured pace to ensure participant safety, ethical oversight, and scientific rigor. Many NIH-funded projects span multiple years and often extend across changes in presidential administrations. Awarding or terminating grants based on shifting political priorities could result in substantial waste of taxpayer resources, as projects terminated prematurely may never generate meaningful scientific results. In addition, abrupt termination of ongoing clinical studies could negatively affect participants and undermine public trust in the research enterprise. Stable, long-term funding is essential for the incremental scientific progress needed to address major public health challenges. I am also concerned about provisions that could increase the role of political appointees in funding decisions while expanding mechanisms such as forward funding and removing effective constraints on grant size. Together, these changes could concentrate substantial decision-making authority in a relatively small number of individuals while reducing opportunities for ongoing evaluation of project performance. The current peer-review system relies on subject-matter experts to evaluate scientific merit, methodological rigor, feasibility, and potential public-health impact. This process provides an important safeguard against favoritism and helps ensure that federal research funds are allocated based on scientific excellence and public benefit. Political leadership already has meaningful mechanisms to shape NIH priorities through strategic planning, institute-level priorities, and funding initiatives. These tools allow elected administrations to influence the direction of biomedical research while preserving independent expert review of individual grant applications. Weakening the role of peer review risks reducing confidence in the fairness, quality, and effectiveness of the NIH funding process. Taken together, the proposed changes in §200.220, §200.205, §200.340, and §200.202 could hinder biomedical research by limiting international collaboration, disrupting long-term scientific projects, and weakening safeguards that help ensure funding decisions are guided by scientific merit. These changes could ultimately reduce the quality, efficiency, and impact of federally funded research. I respectfully urge careful reconsideration of these provisions. As written, they risk reducing access to critical scientific data, disrupting important long-term research programs, and weakening the merit-based review processes that have helped make the U.S. biomedical research enterprise a global leader.