Research Resource for Human Organs and Tissues (U42 Clinical Trial Not Allowed)

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Description

This opportunity supports the continued operation and enhancement of a national Human Tissue and Organ Research Resource. The program’s primary goal is to ensure the ongoing availability of diverse, high-quality human tissues and organs—both normal and diseased—to the biomedical research community. The resource is expected to facilitate the procurement, preservation, and distribution of these biospecimens, supporting a broad range of research areas including basic, translational, and disease-focused studies.

The resource should provide specimens from a variety of organ systems (e.g., nervous, cardiovascular, endocrine, renal, digestive, reproductive, musculoskeletal, skin, eye, and more), and must serve the needs of investigators studying both common and rare diseases, as well as normal tissue biology. The program is funded as a cooperative agreement (U42), with substantial NIH programmatic involvement.

Applicants must demonstrate a strong track record in managing a human tissue and organ resource, including expertise in biospecimen procurement, quality control, data management, and customer service.

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Due Dates

• Earliest Submission Date: December 24, 2024
• Application Due Dates:
  • January 24, 2025
  • September 26, 2025 (final deadline; also the expiration date)
• Review and Award Cycles:
  • January 24, 2025 due date: Review July 2025 | Council August 2025 | Earliest start December 2025
  • September 26, 2025 due date: Review March 2026 | Council May 2026 | Earliest start July 2026

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

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Funding Amount

• Maximum Direct Costs: $720,000 per year
• Project Period: Up to 5 years
• Number of Awards: One award is anticipated, contingent on NIH appropriations and the submission of a meritorious application.
• Funding Mechanism: Cooperative Agreement (U42)
• Cost Sharing: Not required

Requested budgets must reflect the actual needs of the proposed project.

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Eligibility

Eligible Organizations

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

Not eligible: Non-domestic (non-U.S.) entities, non-domestic components of U.S. organizations, and foreign components as defined in the NIH Grants Policy Statement.

Eligible Individuals

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

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Application Process

• Application Type: New (no renewals, resubmissions, or revisions allowed)
• Submission: Applications must be submitted electronically via Grants.gov using ASSIST or an institutional system-to-system solution.
• Required Registrations: SAM, eRA Commons, Grants.gov (allow at least 6 weeks for completion)
• Application Format: Multi-component application, including:
  • Overall Component (6 pages)
  • Management Section (12 pages)
  • Resource Section (12 pages)
• Page Limits: Strictly enforced; see NIH Table of Page Limits
• Key Attachments: Data Management and Sharing Plan, Resource Sharing Plan, Letters of Support, Biographical Sketches

Note: Applications not conforming to instructions may be delayed or not accepted for review.

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Additional Information

• Scope: The resource must provide a wide range of human tissues and organs, including both normal and diseased specimens, and support both basic and clinical research.
• Track Record: Applicants must demonstrate experience in operating a human tissue and organ resource, including quality control, data management, and customer service.
• Pilot Award Program: Optional; may provide limited biospecimens at no cost to support pilot research, especially for early-stage or new-to-human-biospecimen investigators.
• Data Management: All applications must include a Data Management and Sharing Plan in accordance with NIH policy.
• Clinical Trials: Not allowed under this opportunity.
• Program Income: Applicants should describe how program income (e.g., user fees) will contribute to sustainability and cost reduction.

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External Links

• NIH Funding Opportunity Announcement (PAR-24-258)
• NIH Office of Research Infrastructure Programs (ORIP)
• NIH Grants Policy Statement
• NIH Multi-Project Application Guide (Forms-H)
• Apply via Grants.gov

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Contact Information

For technical assistance with electronic submission:

• eRA Service Desk: https://www.era.nih.gov/need-help | 301-402-7469 or 866-504-9552
• Grants.gov Support: support@grants.gov | 800-518-4726

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