SCCM has submitted formal comments opposing several proposed changes to federal research funding policies from the Office of Management and Budget (OMB) that would affect how federal grants and other financial assistance are reviewed, administered, and terminated.
The Society of Critical Care Medicine (SCCM) has submitted formal comments opposing several proposed changes to federal research funding policies that could disrupt critical care studies, weaken scientific peer review, and jeopardize patients enrolled in active clinical trials.
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proposed revisions from the Office of Management and Budget (OMB) would affect how federal grants and other financial assistance are reviewed, administered, and terminated. SCCM’s comments focus on the potential consequences for research involving patients with life-threatening conditions such as sepsis, acute respiratory distress syndrome (ARDS), cardiac arrest, and traumatic brain injury.
SCCM thanks the members of its American Medical Association (AMA) Delegation and Robert MacLaren, MPH, PharmD, MCCM; Philippe R. Bauer, MD, MS, PhD, FCCM; Ashish Khanna, MD, MS, FCCM, FASA, FCCP; and Sheila A. Alexander, BSN, PhD, RN, FCCM, for their leadership in developing the Society’s response.
As stated in SCCM’s formal comments:
“Critical care research should remain under the guidance and leadership of clinical experts. Sepsis and ARDS kill within hours to days, and the entire premise of pragmatic emergency-care trial networks is speed to evidence. Inserting an additional, discretionary political review, of uncertain duration and subject to changing priorities across administrations, introduces delay and unpredictability into precisely the time-sensitive research that saves lives.”
Critical care studies are often conducted through complex, multisite clinical trial networks and may enroll patients during medical emergencies. Delays or interruptions can therefore create serious scientific, clinical, and ethical consequences.
SCCM urged OMB to revise the proposal to:
- Preserve independent scientific peer review. SCCM opposed provisions that would allow senior political appointees to review discretionary awards before they are issued and make scientific peer review advisory rather than determinative. Expert peer review should remain the primary basis for evaluating scientific and technical merits.
- Protect patients enrolled in active studies. The proposed rule would allow agencies to terminate active, multi-year awards when the work no longer aligns with agency priorities or the “national interest.” In critical care, this could abruptly halt studies involving patients who are already enrolled, receiving an intervention, or undergoing safety monitoring.
- Require safeguards when grants are terminated. SCCM recommended protecting studies with actively enrolled human participants from discretionary termination unless there is a safety risk, misconduct, or legal violation. When termination is unavoidable, agencies should provide sufficient time and funding to protect participants and complete required follow-up.
- Allow research findings to be published and presented. Proposed restrictions on publication and scientific meeting costs could prevent federally funded discoveries from reaching clinicians. Research improves care only when findings are shared and translated into clinical guidance and bedside practice.
- Maintain access to scientific and professional resources. SCCM opposed restrictions affecting professional society memberships and subscriptions to scientific journals. Investigators rely on these resources for clinical guidelines, education, research networks, standards, and current evidence.
- Protect clinically relevant research variables. SCCM asked OMB to clarify that researchers may continue studying patient age, sex, race, and ethnicity when scientifically and clinically relevant. These variables can influence disease progression, treatment response, diagnostic accuracy, and outcomes.
SCCM also requested additional time for the research and patient-care communities to review and respond to the proposed rule.
Across its recommendations, SCCM called on OMB to keep critically ill patients at the center of federal research policy and avoid changes that could delay lifesaving research, interrupt active clinical trials, or prevent important findings from reaching the bedside.
Thank you to the leadership of SCCM’s AMA Delegation: Robert MacLaren, Philippe R. Bauer, Ashish Khanna, and Sheila A. Alexander.
