CNTR’s Comment on Proposed OMB Rule: Regulation for Federal Financial Assistance (OMB-2026-0034-0001)

The Coalition for National Trauma Research (CNTR) appreciates the opportunity to comment on the Office of Management and Budget’s proposed revisions to 2 CFR Part 200, “Regulation for Federal Financial Assistance.” CNTR is a national nonprofit research organization dedicated to advancing trauma research that improves outcomes for injured patients. Since 2006, CNTR has collaborated with federal agencies, academic institutions, professional societies, investigators, patients, and healthcare systems to develop research infrastructure, coordinate multi-center studies, facilitate data sharing, and accelerate the translation of evidence into improved trauma care. CNTR has supported projects funded by the Department of Defense (DoD), National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), Patient-Centered Outcomes Research Institute (PCORI), Medical Technology Enterprise Consortium (MTEC), and other federal partners.

Because trauma remains a leading cause of death and disability in the United States, federal investment in trauma research serves a critical national interest. The success of that investment depends upon stable, predictable, merit-based funding systems; effective collaboration among institutions; dissemination of scientific findings; patient engagement; and the ability to build long-term research infrastructure such as clinical trials networks, data repositories, patient engagement programs and multidisciplinary collaborations–all of which require sustained investment across funding cycles. CNTR is concerned that several provisions of the proposed rule would undermine these objectives and ultimately reduce the effectiveness and return on investment of federally funded research.

CNTR respectfully urges OMB to substantially revise or withdraw the provisions discussed below.

[200.202] Federal Program Planning and Design

CNTR is concerned by provisions requiring federal programs and funding decisions to be explicitly aligned with current Administration priorities.

Trauma research is inherently long-term and often produces benefits that cannot be anticipated at the time of initial funding. Major advances in hemorrhage control, trauma systems development, traumatic brain injury treatment, emergency medical services, rehabilitation, and injury prevention emerged from sustained investments in research spanning multiple administrations and changing policy priorities.

The trauma research community has spent decades building consensus regarding national civilian and military research priorities through initiatives such as the National Trauma Research Action Plan, which was funded by the Defense Health Agency. These priorities reflect broad scientific and clinical consensus rather than transient political considerations. CNTR is concerned that emphasizing alignment with current political priorities could discourage investigator-driven innovation, reduce support for emerging research areas, and diminish the long-term continuity necessary to address complex injury-related challenges.

Federal research programs should remain grounded in scientific merit, public health need, and evidence-based priority setting.

[200.205] Federal Agency Merit Review of Proposals

CNTR strongly opposes provisions that would expand senior political appointee review of discretionary awards and diminish the central role of expert peer review.

Trauma research proposals often involve highly specialized clinical, epidemiological, statistical, engineering, and implementation science expertise. Evaluating whether a proposed study is scientifically rigorous, feasible, ethically appropriate, and likely to improve patient outcomes requires reviewers with deep subject matter expertise. The peer review process, while not perfect, remains the most effective mechanism available for evaluating scientific merit.

CNTR regularly collaborates with investigators developing large multi-center proposals involving trauma centers, emergency medical services agencies, rehabilitation facilities, patient stakeholders, and community partners. The scientific complexity of these projects makes expert review particularly important.

The proposed rule creates uncertainty regarding the relative weight of peer review findings and introduces broad concepts such as “national interest” and “administration priorities” that may be interpreted inconsistently across agencies and administrations. If applicants perceive that scientific merit can be overridden by political considerations, confidence in the federal funding process will be diminished.

CNTR recommends that OMB preserve peer review as the primary basis for evaluating scientific merit and clearly limit political review to matters involving statutory compliance, programmatic alignment, or national security concerns.

[200.220] Covered Foreign Collaborations

CNTR recognizes the importance of protecting national security, safeguarding sensitive information, and preventing inappropriate foreign influence in federally funded research.

However, the proposed restrictions on covered foreign collaborations are overly broad and may unintentionally impede legitimate scientific collaboration that benefits the United States.

Modern trauma research frequently involves international collaboration—for instance CNTR participated in a recent project with the International Consortium for Health Outcomes Measurement (ICHOM), which defined a globally standardized set of patient-centered outcome measures for adults with major injury. Investigators routinely work with colleagues around the world to compare trauma systems, evaluate treatment approaches, develop common data standards, conduct multicenter studies, and share expertise in disaster response, military medicine, traumatic brain injury, and rehabilitation. These collaborations help strengthen American research leadership and improve patient care.

CNTR recommends that OMB adopt a targeted, risk-based approach focused on specific security concerns, prohibited entities, disclosure requirements, and conflict-of-interest management rather than broad restrictions that could inhibit beneficial scientific collaboration.

[200.340] Termination and Suspension

CNTR strongly opposes the proposed expansion of discretionary termination authority allowing awards to be terminated when they are determined to no longer advance agency priorities, program goals, or the national interest.

CNTR serves as a coordinating center for complex multi-site studies involving numerous institutions and investigators. Mid-award termination based on shifting priorities rather than performance deficiencies would create significant instability and waste taxpayer investments already made in study planning, infrastructure development, site activation, patient enrollment, and data collection.

The impacts would extend beyond individual projects. Investigators would become less willing to undertake ambitious long-term studies. Institutions would become more cautious in hiring research personnel. Patients and trauma centers would be less likely to participate in federally funded studies if project continuity cannot be assured.

Furthermore, trauma research infrastructure itself depends on sustained support. CNTR’s work supporting clinical trial networks, investigator resources, patient engagement activities, data repositories, and research coordination requires long-term planning and investment.

Termination authority should remain tied to clearly defined causes such as noncompliance, failure to perform, fraud, misuse of funds, or statutory requirements, with appropriate procedural safeguards and opportunities for corrective action.

[200.432] Conferences

CNTR strongly opposes proposed restrictions requiring explicit approval of conference participation in award terms and conditions.

Scientific conferences are essential components of the research process. Conferences provide opportunities for investigators to present findings, receive expert feedback, establish collaborations, disseminate results, train early-career researchers, and identify emerging research priorities. Within trauma research, conferences frequently serve as venues for multidisciplinary collaboration among surgeons, emergency physicians, nurses, rehabilitation specialists, epidemiologists, military medicine experts, patients, and policymakers. Over the past five years, CNTR has managed five conferences supported by the NIH and AHRQ—all have fomented interactions leading directly to new research partnerships and improvements in clinical practice.

CNTR’s mission includes fostering collaboration across diverse stakeholder groups and supporting the development of new multi-center studies. Limiting conference participation would directly undermine these objectives and reduce the efficiency of federally funded research.

Existing travel cost oversight mechanisms are sufficient to prevent inappropriate expenditures. Additional restrictions are unlikely to generate meaningful savings while creating substantial barriers to scientific exchange.

[200.454] Memberships, Subscriptions, and Professional Activity Costs

CNTR opposes provisions making journal subscriptions unallowable and imposing new prior approval requirements for professional memberships.

Professional societies play a foundational role in trauma research and trauma system development. CNTR itself was established through collaboration among national trauma organizations and continues to work closely with numerous professional societies representing surgeons, emergency physicians, nurses, rehabilitation specialists, and patient advocates.

Memberships provide access to professional standards, educational resources, clinical guidelines, scientific working groups, conference participation opportunities, and collaborative research networks. These activities directly contribute to research quality and workforce development. Similarly, access to scientific literature remains essential for investigators developing research questions, designing studies, interpreting findings, and translating evidence into practice. While some institutions maintain extensive library subscriptions, many smaller institutions and community-based organizations do not.

These proposed restrictions could disproportionately affect early-career investigators, smaller institutions, rural research programs, and organizations serving as research partners in multi-center studies.

[200.461] Publication and Printing Costs

CNTR strongly opposes the proposed designation of publication costs, including article processing charges and open-access publication fees, as generally unallowable costs.

Dissemination is not a peripheral activity in research; it is a fundamental component of the scientific process and a primary mechanism through which the public realizes the benefits of federal research investments.

CNTR’s mission includes supporting dissemination, data sharing, evidence generation, and implementation of research findings. The National Trauma Research Repository, funded by the Defense Health Agency, was specifically established to increase data availability and maximize the value of federally funded research. Restricting publication costs would directly conflict with these objectives.

Open-access publication is increasingly required or encouraged by federal agencies to ensure taxpayer-funded research is accessible to clinicians, researchers, patients, and the public. If investigators cannot use grant funds to support publication expenses, many studies—particularly those conducted by smaller institutions or early-career investigators—may experience delays in dissemination or may not be published in the most appropriate journals.

The result would be reduced transparency, slower scientific progress, and diminished public benefit from federal investments.

Rather than making publication costs unallowable, OMB should continue to recognize dissemination as an essential and allowable research expense while encouraging cost-effective publication practices.

Impact on Trauma Research Infrastructure and Patient-Centered Research

Beyond the individual provisions discussed above, CNTR is concerned about the cumulative effect of the proposed rule on the national trauma research ecosystem.

Trauma research depends on sustained infrastructure that supports collaboration, patient engagement, data sharing, investigator development, and multi-center research. Many of these activities rely on stable federal partnerships and are designed to increase the efficiency, transparency, and impact of federally funded research. The proposed rule’s combined emphasis on political review, discretionary termination, restrictions on dissemination, limitations on professional engagement, and constraints on collaboration could significantly weaken the infrastructure that supports trauma research nationwide.

CNTR strongly supports accountability, transparency, and responsible stewardship of taxpayer funds. However, the proposed revisions to 2 CFR Part 200 would in many cases undermine rather than strengthen the effectiveness of federally funded research. Taken together, the proposed provisions risk politicizing scientific review, destabilizing ongoing research, discouraging collaboration, restricting dissemination of findings, limiting professional engagement, and weakening national research infrastructure. These outcomes would ultimately reduce the return on federal investments in trauma research and slow progress toward improving outcomes for injured patients.

CNTR respectfully requests that OMB withdraw or substantially revise the proposed changes to §§ 200.202, 200.205, 200.220, 200.340, 200.432, 200.454, and 200.461 and preserve a federal research system grounded in scientific merit, expert peer review, stable award administration, open dissemination of results, responsible collaboration, and long-term public benefit.

Thank you for the opportunity to comment on this important proposed rule.