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

The Research Resource for Human Organs and Tissues (U42 Clinical Trial Not Allowed), issued by the National Institutes of Health (NIH), is a federal funding opportunity that supports a centralized resource for procuring, preserving, and distributing diverse human organs and tissues to the biomedical research community. The Notice of Funding Opportunity (NOFO) was posted on August 26, 2024, and is managed by the NIH’s Office of Research Infrastructure Programs (ORIP) in collaboration with participating Institutes such as NEI, NIAID, NIAMS, NIDDK, and NIDCD. The program supports the continuation and enhancement of infrastructure necessary to maintain broad access to human biospecimens critical to advancing research on both infectious and noninfectious diseases. This opportunity invites applications for cooperative agreements to develop and manage a comprehensive research resource that supplies high-quality human tissue and organ specimens from various systems and demographic groups to investigators. Eligible specimens include tissues from the nervous, cardiovascular, digestive, endocrine, lymphoid, renal, reproductive, pulmonary systems, and others such as eyes, skin, bone, cartilage, synovium, and muscle. These specimens are intended to serve studies related to both rare and prevalent diseases, as well as fundamental understanding of human physiology. The award mechanism is a U42 cooperative agreement, which denotes significant NIH involvement post-award. Only new applications are accepted under this NOFO, and clinical trials are not permitted. The total direct costs requested by applicants must not exceed $720,000 annually, and the project period can extend up to five years. NIH anticipates awarding one grant based on availability of funds and the merit of submitted proposals. Applications must detail an Overall Component, along with a required Management Section and Resource Section, each of which must describe plans for organizational structure, quality control, data management, customer service, and sustainability. Eligibility for this opportunity includes a wide range of U.S.-based applicants such as higher education institutions, nonprofits, for-profits including small businesses, local and state governments, tribal entities, and eligible federal agencies. Foreign organizations and foreign components of U.S. entities are not eligible to apply. Applicants must complete all registrations, including SAM, eRA Commons, and Grants.gov, and individuals applying as PDs/PIs must possess eRA Commons credentials. Applications open on December 24, 2024, and must be submitted by 5:00 PM local time on either January 24, 2025, or September 26, 2025, depending on the review cycle. All applicants are urged to apply early to allow time for submission corrections. This NOFO is not subject to Executive Order 12372. Though there is no Letter of Intent deadline, all applications must comply with the NIH’s Multi-Project Application Guidelines. Each application will undergo peer review and receive a written critique, with funding decisions made based on scientific merit, program relevance, and availability of funds. Applicants should direct scientific and research-related inquiries to Stephanie Murphy, V.M.D., Ph.D., or Yong Chen, Ph.D., both at ORIP. Contact information for other institute-specific program officers and grants management officials is also available in the NOFO. The expiration date for this funding opportunity is September 26, 2025, and it is considered a recurring grant opportunity. As such, the next anticipated cycle would likely open in September 2026.

Applicants must strictly adhere to NIH's multi-component application instructions and include robust data management and quality control protocols.