Cardiovascular Biorepository for Type 1 Diabetes (U24 Clinical Trial Not Allowed) | RFA DK 21 010

Frequently Asked Questions (FAQs)

What is the title and identifier of this NIH funding opportunity?

The funding opportunity is titled "Cardiovascular Biorepository for Type 1 Diabetes (U24 Clinical Trial Not Allowed)" and is identified as RFA-DK-21-010.

What is the overall goal of this opportunity?

The goal is to support a single national shared resource focused on cardiovascular complications in type 1 diabetes (T1D) by building a cardiovascular tissue biorepository and enabling coordinated data generation and sharing to accelerate discovery and mechanistic research.

How many awards are expected under this FOA?

This FOA supports a single award.

What grant mechanism will be used?

The award will be made as a cooperative agreement using the U24 mechanism.

What does it mean that this is a cooperative agreement (U24)?

A cooperative agreement indicates substantial NIH programmatic involvement. The funded organization should plan for an ongoing partnership model with NIH staff rather than a hands-off grant relationship.

Why is NIH investing in a cardiovascular biorepository specifically for T1D?

The FOA describes a major gap: cardiovascular disease (CVD) remains the leading cause of illness and death among people with T1D, yet there are no therapies designed specifically for T1D-related cardiovascular complications. Progress has been slow in part because existing models do not adequately capture human disease, complications can take decades to develop, and the biological drivers of CVD in T1D are not well defined or may differ from type 2 diabetes (T2D).

What type of samples will the biorepository collect?

The biorepository is expected to center on human cadaveric cardiovascular tissues, including tissues from donors with T1D, donors with T2D, and donors without diabetes (as comparison groups).

What are the main phases of the project?

The project is structured as a two-phase plan: (1) establish and operate a biorepository centered on human cadaveric cardiovascular tissues with quality control and baseline histopathologic examination, plus an efficient distribution process; and (2) serve as a Data Coordinating Center (DCC) for a consortium performing multimodal deep phenotyping, with broad data access through a public portal.

What is required in Phase 1?

Phase 1 requires establishing and operating the biorepository, collecting and storing tissues across T1D, T2D, and non-diabetes donors, implementing quality control procedures, performing basic histopathologic examinations, and creating an efficient and transparent biospecimen and data distribution process for qualified investigators.

What does "quality control" and "baseline characterization" mean in this FOA?

Based on the FOA description, the biorepository must implement procedures that allow downstream users to trust sample integrity and provenance, and it must conduct basic histopathologic examinations to provide baseline characterization of the stored tissues.

What is meant by an "efficient and transparent distribution process"?

The program must define how qualified investigators can request biospecimens and associated data, how requests will be reviewed, how materials will be shipped and tracked, and how data will be shared in a way that protects donor privacy while maximizing scientific value.

What is required in Phase 2?

Phase 2 expands the awardee role to serve as the Data Coordinating Center for a consortium. The DCC is expected to organize and support a network of investigators who will use multimodal approaches to deeply phenotype the tissues and to make resulting datasets and analyses broadly accessible through a public data portal.

What does "deep phenotyping" mean in this opportunity?

In this FOA, deep phenotyping refers to generating integrated, multi-level descriptions of cardiovascular tissues, such as anatomical structure, cellular composition, and molecular features, and combining complementary data types to build a detailed picture of pathology in T1D compared with T2D and non-diabetes controls.

Will the data generated by the consortium be publicly available?

Yes. A key requirement is broad accessibility of the resulting datasets and analyses via a public data portal to enable reuse by the wider research community and accelerate discovery beyond the initial consortium.

Are clinical trials allowed under this FOA?

No. This is explicitly designated as "Clinical Trial Not Allowed," meaning supported activities should focus on biorepository establishment, tissue-based research infrastructure, and coordinated data generation and sharing rather than interventional human studies.

What kinds of organizations are eligible to apply?

Eligibility is broad across U.S.-based organizations, including many government entities (state, county, city/township, special districts), public and private institutions of higher education, independent school districts, tribal governments (including federally recognized tribes), public housing authorities/Indian housing authorities, tribal organizations not otherwise federally recognized, nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations other than small businesses, small businesses, and other NIH-specified categories.

Are certain institution types specifically highlighted as eligible?

Yes. The FOA highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, and U.S. territories or possessions.

Are non-U.S. (foreign) organizations eligible to apply as the applicant?

No. The FOA states that non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible.

Are any foreign activities allowed at all?

Yes, foreign components (as defined in the NIH Grants Policy Statement) are allowed. This typically implies limited, well-justified international elements may be included as part of an otherwise eligible U.S. applicant organization.

What NIH assistance listings (CFDA) are associated with this opportunity?

The opportunity is associated with NIH assistance listings (CFDA) 93.837 and 93.847.

When was this FOA posted and when did it close?

The FOA creation date is August 4, 2021, and the original closing date is October 20, 2021.

What gap or challenge is this FOA designed to address?

It is designed to address the lack of T1D-specific therapies for cardiovascular complications and the slow pace of progress driven by limitations of animal and preclinical models, the long timeline of complication development, and uncertainty about the biological drivers of CVD in T1D (including how they may differ from T2D).

What is the intended impact of creating this biorepository and data resource?

The FOA aims to create a durable, standardized pipeline for acquiring rare human cardiovascular tissues linked to diabetes status, applying consistent baseline characterization, enabling fair and efficient distribution to researchers, and producing widely available, high-dimensional datasets that can clarify mechanisms of T1D-associated CVD and inform better prevention and treatment strategies.