Human Pancreas Analysis Program for Type-2 Diabetes (HPAP-T2D) (U01 Clinical Trial Not Allowed) | RFA DK 18 016

HPAP-T2D (RFA-DK-18-016) Grant Opportunity FAQs

1) What is the HPAP-T2D funding opportunity?

HPAP-T2D (RFA-DK-18-016) is a National Institutes of Health (NIH) cooperative agreement (U01) designed to expand the existing Human Pancreas Analysis Program (HPAP). Its purpose is to systematically study human pancreata from deceased tissue donors with Type 2 Diabetes (T2D) and related metabolic disorders by building a well-organized collection of tissues and linked datasets that can be broadly used by the research community.

2) What is the main goal of the program?

The central goal is to create a deeply characterized, standardized, and discoverable community research resource based on real human pancreatic tissue from donors with T2D (and related islet dysfunction) and age-matched controls. The program emphasizes producing tissues, metadata, and integrated datasets that can help researchers better understand islet dysfunction in T2D.

3) What activity does the FOA specifically support?

The FOA supports an end-to-end pipeline that includes identifying appropriate donors, coordinating tissue recovery, processing primary human pancreatic tissue using standardized methods, conducting intensive multimodal characterization (molecular, cellular, histologic, physiologic, and related analyses), and building/curating/maintaining an integrated dataset for public use.

4) Is this grant focused on generating discoveries, building a resource, or both?

Both, but the FOA strongly emphasizes resource-building and data sharing. The expectation is that outputs will be broadly usable by external investigators, rather than remaining a closed dataset within a single lab.

5) What are the two required objectives of the award?

The program has two required objectives:

• Identify, collect, and comprehensively characterize pancreatic tissues from donors with T2D and related forms of islet dysfunction, along with age-matched control donors.
• Analyze, organize, and publicly share the resulting data by using and expanding PANC DB, the open-access resource database associated with HPAP.

6) What is PANC DB and how is it used in this program?

PANC DB is described as an existing open-access resource database associated with HPAP. Under this FOA, the awardee is expected to use and expand PANC DB to organize, curate, maintain, and publicly share the integrated datasets generated from the program's tissue collection and analyses.

7) What type of NIH award mechanism is this?

This opportunity uses the U01 cooperative agreement mechanism. That means NIH involvement is expected to be substantial and programmatic, with coordination typical of U01 awards, and with a strong emphasis on producing a shared research resource.

8) What does "cooperative agreement" imply for project execution?

It implies the NIH is not only funding the work, but is also expected to have substantial involvement and coordination in the project. The work is framed as a coordinated effort to deliver a community resource rather than a purely investigator-directed project.

9) How many awards is this FOA structured to support?

The FOA is structured to support a single, highly capable team with end-to-end expertise across donor identification, tissue recovery, standardized processing, multimodal characterization, and dataset creation and maintenance.

10) What kinds of donor tissues are expected to be included?

The program is intended to study human pancreata from deceased tissue donors with Type 2 Diabetes (T2D) and related metabolic disorders, and it also requires inclusion of age-matched control donors.

11) What is meant by "multimodal characterization" in the FOA?

The FOA describes multimodal characterization as including complementary molecular, cellular, histologic, and physiologic analyses. The emphasis is on intensive and standardized characterization to produce deeply informative, integrated datasets.

12) Is this funding opportunity part of a larger NIH effort?

Yes. HPAP-T2D sits within the broader Human Islet Research Network (HIRN), created by NIH in 2014 to accelerate collaborative translational research on diabetes. This FOA extends the HPAP platform to Type 2 Diabetes and metabolic disease contexts.

13) How does this FOA relate to the original focus of HIRN?

HIRN originally focused heavily on understanding loss of functional human beta cell mass in Type 1 Diabetes and on strategies to protect or replace beta cells. This FOA expands the HPAP platform so it can address T2D and related metabolic disease contexts while leveraging HPAP/HIRN standards and data-sharing norms.

14) Are clinical trials allowed under this opportunity?

No. The title explicitly states "Clinical Trial Not Allowed." The supported activities are focused on biospecimen collection, analysis, and data-resource development rather than interventional clinical studies.

15) What is the award ceiling?

The FOA indicates an award ceiling of $2,000,000.

16) What is the application closing date listed for this opportunity?

The source information lists an original application closing date of 2019-02-26 (noting this is historical timing as provided).

17) Which federal agency is offering this funding?

The agency is the National Institutes of Health (NIH).

18) What is the CFDA number associated with this opportunity?

The opportunity is associated with CFDA 93.847.

19) How is this opportunity categorized in terms of funding type and activity areas?

It is categorized as discretionary funding and falls under the Health and Food and Nutrition activity areas.

20) Who is eligible to apply?

Eligibility is broad across U.S.-based organizations. Eligible applicants listed include state, county, and local governments; special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities.

21) Are minority-serving institutions and community-based organizations eligible?

Yes. The FOA calls out additional eligible applicant types including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, and regional organizations.

22) Are U.S. territories or federal agencies eligible to apply?

Yes. The eligibility list includes eligible federal agencies and U.S. territories or possessions.

23) Are foreign (non-U.S.) institutions eligible to apply?

No. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible.

24) Are "foreign components" allowed at all?

Yes. While the primary applicant organization must be eligible and U.S.-based, "foreign components" (as defined in the NIH Grants Policy Statement) are allowed. This means certain project elements may be carried out internationally under NIH rules even though the applicant institution cannot be foreign.

25) What kind of team does NIH expect to carry out the work?

The FOA anticipates a single, highly capable team with end-to-end expertise. That includes operational capability for donor identification and recovery coordination, laboratory capability for standardized processing and multimodal characterization, and informatics/data capability to build and maintain an integrated, publicly shared dataset through PANC DB.

26) What is the expected impact for the broader research community?

The program is intended to strengthen the research community's ability to study human islet dysfunction and pancreatic pathophysiology in T2D by making high-quality tissues, metadata, and curated datasets usable and discoverable for external investigators through an open-access platform.

27) Does the FOA require use of existing standards or infrastructure?

Yes. A practical implication described is that the program is meant to capitalize on existing networks, standards, and data-sharing norms established by HPAP/HIRN, and to leverage and expand infrastructure HPAP already created.