The National Institutes of Health (NIH) has announced the funding opportunity titled "ClinGen Genomic Curation Expert Panels (U24 Clinical Trial Not Allowed)" under the activity code U24 Resource-Related Research Projects Cooperative Agreements. This opportunity is a reissue of PAR-20-101 and is associated with various NIH institutes, including the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Eye Institute (NEI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Center for Advancing Translational Sciences (NCATS), and National Cancer Institute (NCI).

The purpose of this funding opportunity is to establish Expert Panels that will systematically select genes and genomic variants associated with high-priority diseases or conditions and determine their clinical significance for diagnosis and treatment. The initiative supports the NIH’s Clinical Genomics Resource (ClinGen) and the Clinical Variant Database (ClinVar), which provide openly accessible resources for data sharing and standardized clinical annotation. The funded panels will use ClinGen and ClinVar’s procedures, tools, and informatics infrastructure to conduct expert curation of genomic variants.

This grant supports research organizations in developing and leading Expert Panels focused on genomic variant curation. Priority research areas include genetic variants related to various diseases, including cancer, neurological disorders, mental health disorders, cardiovascular diseases, metabolic disorders, and rare diseases. Specific research interests vary by participating NIH Institutes, with a strong emphasis on clinical applicability, precision medicine, and the inclusion of underrepresented populations. The NIH strongly encourages collaborations among researchers in similar disease areas to submit joint applications rather than competing applications.

Eligible applicants include higher education institutions (public and private), nonprofit organizations, for-profit organizations (including small businesses), local governments, state governments, federally recognized tribal governments, independent school districts, public housing authorities, regional organizations, and faith-based or community-based organizations. Foreign institutions are not eligible to apply, but U.S.-based organizations with foreign components are allowed.

The funding ceiling is $220,000 per year in direct costs, with a maximum project period of three years. The anticipated number of awards is contingent on NIH appropriations and the quality of applications received. Applications may be submitted under new, renewal, or resubmission categories. Cost-sharing is not required.

The application process requires compliance with NIH’s standard application forms (SF424 R&R). The earliest submission date was June 19, 2023, and the final expiration date for submissions is May 26, 2025. Applications must adhere to NIH’s standard due dates. Letters of intent are encouraged and must be submitted 30 days prior to the application receipt date.

Applicants must submit their proposals through Grants.gov using one of three submission options: NIH ASSIST, an institutional system-to-system solution, or Grants.gov Workspace. Applications must strictly adhere to the NIH application instructions and guidelines. Applications that do not comply with these requirements may be delayed or not accepted for review.

Evaluation criteria for this funding opportunity include significance, investigator qualifications, innovation, approach, feasibility, and institutional environment. Expert Panels will be reviewed for their ability to contribute substantial, evidence-based interpretations of gene-disease relationships and genomic variants. The NIH will prioritize applications that demonstrate strong collaborations, robust methodologies, and alignment with ClinGen standards.

The primary scientific contact for inquiries is Jonathan Pevsner, Ph.D., at the National Institute of Mental Health (NIMH) (jonathan.pevsner@nih.gov, 301-728-5618). Financial or grants management inquiries can be directed to Heather Weiss at the National Institute of Mental Health (weissh@mail.nih.gov, 301-443-4415).