Population Genomic Screening in Primary Care Coordinating Center(U01 -Clinical Trials Optional)

The National Institutes of Health (NIH) is offering funding under the RFA-HG-24-022 FOA, which supports a Coordinating Center (CC) as part of a pilot program for implementing and evaluating population genomic screening in primary care. Through the NIH's National Human Genome Research Institute (NHGRI), this opportunity seeks to fund a CC that will work with a network of Clinical Groups (CGs) and a Sequencing Center (SeqC) to conduct genomic screening for common, actionable genetic conditions. The program's goals are to establish evidence for screening effectiveness, engage diverse communities, and connect patients with care pathways for genomic risks, aiming ultimately to facilitate the integration of population genomic screening into primary care. This project will help set best practices for sustainable, equitable genomic screening across diverse patient populations. The funded CC will play a central role in coordinating protocol development, data collection, and quality control across the network. The FOA emphasizes that the CC should be capable of conducting various activities, such as serving as a single Institutional Review Board (IRB), monitoring patient recruitment, data quality, and follow-up, and handling network logistics including data sharing and dissemination efforts. The CC will collaborate closely with CGs and the SeqC, standardizing data management and interoperability practices. In addition to Tier 1 genomic conditions, applicants are encouraged to propose additional conditions with promising evidence for actionable care to be incorporated into the screening protocol. A key priority for the program is to achieve widespread patient enrollment and ensure representation of health disparity populations. The total funding for this project is $5.75 million, allocated over five years with an annual budget cap of $680,000 for direct costs. NIH anticipates funding one award through this FOA, with applications due December 2, 2024, and an earliest project start date in July 2025. Eligible applicants include higher education institutions, nonprofit organizations, for-profit organizations, and local governments. NIH requires registration in multiple systems (SAM.gov, eRA Commons, Grants.gov) for application processing, and compliance with NIH’s updated Genomic Data Sharing policies is mandatory for all applicants. Applications must include a comprehensive plan detailing the CC's approach to coordinating protocol development, managing data from the SeqC and CGs, and ensuring adherence to program goals across the network. Essential submission requirements include a project narrative, budget justification, letters of support, and a detailed description of the applicant's capabilities for managing a large-scale genomic screening network. NIH will review applications based on criteria such as significance, investigator qualifications, innovation, approach, and environment, with emphasis on the applicant's capacity to integrate screening into primary care and enhance accessibility for diverse communities. Applicants are encouraged to attend a pre-application webinar on October 10, 2024, to gain insights on application requirements and ask NIH representatives any questions. For submission, NIH specifies the use of the ASSIST platform or institutional system-to-system solutions to ensure compliance with formatting and procedural guidelines, and any errors must be corrected by the submission deadline. The final review process includes evaluations by scientific review panels and advisory councils, with notifications expected by May 2025.