ADLM submitted comments to the Office of Management and Budget (OMB) regarding proposed government-wide changes to federal financial assistance requirements. The association warned that several provisions could create unintended consequences for clinical laboratory research, scientific publication, peer review, and public health. The proposed rule would expand senior-appointee review of discretionary awards, state that peer review is advisory, allow funding decisions to consider changing policy priorities, and broaden federal authority to terminate awards. It would also revise requirements affecting publication costs, international research collaboration, and the collection and analysis of demographic and population-level data.
ADLM urged OMB to preserve independent scientific peer review as the primary basis for evaluating research proposals. Federal grants support work involving diagnostic testing, biomarker development, reference intervals, laboratory quality, infectious disease surveillance, artificial intelligence, and other areas directly connected to patient care. Greater uncertainty surrounding award decisions or mid-award termination could interrupt ongoing studies and reduce the value of prior federal investments.
The comments also emphasized that representative data are a scientific requirement. Laboratory tests, reference intervals, biomarkers, and AI-enabled tools must be evaluated using data that reflect the populations for which they are intended. Federal policies should not discourage lawful demographic data collection, subgroup analysis, representative recruitment, or evaluation of potential bias.
Federal grant policies should promote scientific integrity, transparency, and the responsible dissemination of research findings. ADLM will continue to advocate for a science-based, objective grantmaking process that supports rigorous research and ensures federal investments advance laboratory medicine, public health, and patient care.