ClinGen Genomic Curation Expert Panels (U24 Clinical Trial Not Allowed)

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Description

This opportunity supports the formation of Genomic Curation Expert Panels to systematically select and assess the clinical significance of genes and genomic variants associated with diseases or conditions of high priority to participating NIH Institutes and Centers. Funded panels will use the NHGRI Clinical Genomics Resource (ClinGen) and NCBI ClinVar infrastructure, procedures, and tools to standardize variant annotation and interpretation, and to implement evidence-based, expert consensus assertions for use in precision medicine and research.

Panels are expected to address diseases or conditions relevant to the missions of participating NIH Institutes, including but not limited to cancer, rare diseases, neurological, mental health, musculoskeletal, skin, vision, hearing, and reproductive disorders. The initiative aims to improve the clinical utility of genetic testing by reducing the number of variants of unknown significance and supporting evidence-based clinical decision-making.

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Due Dates

• Application Deadline: May 25, 2025 (for renewal, resubmission, and revision applications)
• Letter of Intent: 30 days prior to application due date (encouraged, not required)
• Expiration Date: May 26, 2025

All applications are due by 5:00 PM local time of the applicant organization.

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Funding Amount

• Direct Costs: Up to $220,000 per year
• Project Period: Maximum of 3 years
• Funding Mechanism: Cooperative Agreement (U24)
• Number of Awards: Contingent on NIH appropriations and the number of meritorious applications

Budget should reflect the actual needs of the proposed project. Funds may support partial salary for panel leadership, project coordinators, curation scientists, bioinformatics specialists, and meeting/travel costs. Nominal consulting fees are allowed for panel experts.

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Eligibility

Eligible Applicants

• Public and private institutions of higher education
• State, county, city, township, and special district governments
• Independent school districts
• Federally recognized and other Native American tribal governments/organizations
• Public housing authorities/Indian housing authorities
• Nonprofits (with or without 501(c)(3) status), excluding institutions of higher education
• For-profit organizations (including small businesses)
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions
• Eligible agencies of the federal government

Note:

• Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply.
• Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as PD(s)/PI(s) may apply. Multiple PDs/PIs are allowed.

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
• Required Registrations: Applicant organizations must have active registrations in SAM, eRA Commons, and Grants.gov. All PDs/PIs must have eRA Commons accounts.
• Letter of Intent: Strongly encouraged; submit to the relevant NIH contact at least 30 days before the application deadline.
• Application Forms: Use SF424 (R&R) forms, following the NIH Forms-H instructions.
• Research Plan: Must address the clinical domain, justification for gene/variant selection, panel structure and expertise, curation procedures, integration with ClinGen/ClinVar, and data management/sharing.
• Budget: May use modular or detailed budget forms, as appropriate. Justify all costs, especially for personnel and data management/sharing activities.

Key Requirements:

• All panels must use ClinGen and ClinVar tools, procedures, and interfaces.
• Data Management and Sharing Plan is required.
• Clinical trials are not allowed.
• Letters of support from ClinGen are strongly encouraged.

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Additional Information

• Scope: Panels may focus on gene curation, variant curation (germline or somatic), or both, but must justify the scope and demonstrate feasibility.
• Panel Composition: Should include experts from at least three institutions, be international in scope, and cover all relevant expertise (clinical, laboratory, research, bioinformatics).
• Collaboration: Panels are expected to integrate with existing ClinGen Clinical Domain Working Groups where appropriate.
• Training: Panel members must participate in ClinGen training and working groups.
• Data Sharing: All curated data must be submitted to ClinGen and ClinVar for public access.
• Renewals: Existing panels may apply for renewal if expanding or shifting focus; justification and evidence of productivity are required.

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External Links

• NIH Funding Opportunity Announcement (PAR-23-199)
• Grants.gov Opportunity Listing
• NIH Application Guide (Forms-H)
• ClinGen Resource
• ClinVar Database
• Guidelines for ClinGen Expert Panels
• NIH Data Management and Sharing Policy
• NIH Standard Due Dates

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Contact Information

For additional contacts and details, see the full opportunity announcement.

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