Human Pancreas Analysis Program (HPAP) (U01 Clinical Trial Not Allowed) | RFA DK 18 015

Frequently Asked Questions (FAQs) - Human Pancreas Analysis Program (HPAP) (RFA-DK-18-015)

What is this funding opportunity?

This opportunity is the Human Pancreas Analysis Program (HPAP) funding opportunity announcement (FOA) RFA-DK-18-015. It is funded by the National Institutes of Health (NIH) as a cooperative agreement under the U01 activity code, intended to continue and expand the existing HPAP effort.

Which NIH mechanism is used, and what does that imply?

The FOA uses a U01 cooperative agreement mechanism. This generally means NIH will have substantial program involvement in coordinating goals, milestones, and expectations (including resource sharing), rather than the project operating as a fully investigator-initiated grant.

Is this FOA part of a broader program?

Yes. HPAP sits within the broader Human Islet Research Network (HIRN), launched in 2014. HIRN focuses on accelerating translational research into why functional human beta cell mass is lost in type 1 diabetes (T1D) and on supporting strategies to preserve, protect, or replace beta cells.

Are clinical trials allowed under this FOA?

No. The FOA is explicitly marked "Clinical Trial Not Allowed." The supported work is intended to focus on tissue-based activities and data/resource generation rather than prospective interventional clinical trials.

What is the overall purpose of the HPAP award?

The award is intended to support a single, highly integrated team that can act as a centralized resource hub for human pancreas and islet biology. The team is expected to collect high-value human pancreatic tissues, perform deep multimodal characterization, and build, curate, and manage datasets for broad community use.

What kind of team does NIH expect to fund?

The FOA describes support for one highly integrated team with end-to-end expertise covering: identification and acquisition of relevant human pancreatic tissues; tissue handling, processing, and preservation; deep, multimodal characterization; and robust database construction, curation, and long-term data management.

How many awards are expected?

The posting anticipates supporting one team, and the narrative description indicates a single team will be supported.

What are the main scientific deliverables emphasized in the FOA?

The FOA emphasizes two major deliverables: (1) collecting and intensively characterizing primary pancreatic tissues from key donor groups (including appropriate controls), and (2) analyzing, organizing, and sharing the resulting data while expanding the existing PANC-DB open-access database resource.

What types of human tissues and donor groups are prioritized?

The FOA emphasizes primary pancreatic tissues from: people with type 1 diabetes (T1D); individuals showing beta cell-specific autoimmunity (described as a key stage on the pathway to T1D); and people with rare forms of islet dysfunction that could inform mechanisms relevant to T1D pathogenesis.

Are control tissues required?

Yes. The program calls for age-matched control tissues, described as essential for interpreting disease-associated findings against appropriate baselines.

What does "multimodal analysis" mean in the context of this FOA?

In this FOA, "multimodal analysis" refers to integrating multiple complementary methods across biological levels. The description gives an example conceptually such as combining tissue imaging with molecular profiling and clinical or donor metadata to interrogate T1D-related changes in the pancreas.

What is PANC-DB, and what is expected regarding it?

PANC-DB is described as an open-access database resource associated with HPAP. The awardee is expected to expand PANC-DB and ensure that the resulting datasets are standardized, well-annotated, searchable, and accessible to outside investigators.

Is the program focused on one-off studies or durable community resources?

The FOA frames HPAP as investment in durable, reusable assets: curated datasets, harmonized metadata, and open-access distribution through PANC-DB so other researchers can replicate analyses, compare cohorts, and generate new hypotheses.

What kinds of activities are central to the funded work?

Based on the FOA description, core activities include: identifying and acquiring relevant pancreatic tissues; handling, processing, and preserving tissues; performing deep characterization (molecular, cellular, and histologic datasets are explicitly referenced); and building/curating/maintaining a robust database for long-term data management and sharing.

Who can apply (general eligibility)?

Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; 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 or without 501(c)(3) status (outside of higher education); for-profit organizations other than small businesses; and small businesses.

Are certain institution types specifically highlighted as eligible?

Yes. The FOA highlights categories including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, and certain federal agencies.

Are non-U.S. (non-domestic) entities eligible to apply?

No. Non-domestic (non-U.S.) entities and non-U.S. components of U.S. organizations are not eligible to apply.

Are any international elements allowed at all?

Yes, but with limits. The FOA indicates that foreign components are allowed as defined by the NIH Grants Policy Statement, meaning a U.S.-led application may include certain well-justified international elements under NIH rules.

Which agency is offering the funding?

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

What is the activity focus and CFDA number listed?

The listing indicates an activity focus in health and includes CFDA 93.847.

When was the FOA created, and what was the original closing date?

The FOA was created on October 10, 2018, and the original closing date listed is February 26, 2019.

What is the award ceiling shown in the posting?

The listing indicates an award ceiling of $30,000,000.

What is the program trying to achieve for the T1D research community?

HPAP is positioned as both a tissue analysis engine and an informatics resource. The goal is to maintain and grow capacity to obtain and deeply profile human pancreatic tissues relevant to T1D, then return those results to the field through an expanded, open-access PANC-DB platform.

What makes this opportunity different from a typical investigator-initiated research grant?

The FOA is structured to support a centralized, integrated team that functions as a community resource hub, and it uses a cooperative agreement mechanism that typically involves substantial NIH coordination around goals, milestones, and resource-sharing expectations.