Single Source for continuation of the Human Pancreas Analysis Program for Type-2 Diabetes (HPAP-T2D) (U01 Clinical Trial Not Allowed) | RFA DK 25 002

FAQs: NIH RFA-DK-25-002 (HPAP-T2D) Cooperative Agreement (U01)

What is RFA-DK-25-002?

RFA-DK-25-002 is a National Institutes of Health (NIH) cooperative agreement (U01) that continues and expands the Human Pancreas Analysis Program (HPAP). The expansion extends HPAP's mission to include Type 2 Diabetes research, often referred to as HPAP-T2D.

What is the main purpose of this funding opportunity?

The main purpose is to broaden an established human pancreas tissue and data resource so it can systematically support research using pancreata from tissue donors with Type 2 Diabetes and related metabolic disorders, alongside appropriate control donors. The focus is on biospecimen acquisition, tissue characterization, and high-quality data generation and sharing as a community resource.

Is this a clinical trial opportunity?

No. The NOFO is explicitly marked "Clinical Trial Not Allowed." The supported work is centered on collecting and characterizing human pancreatic biospecimens and generating and sharing associated datasets, not testing clinical interventions.

What kind of award mechanism is this?

This opportunity uses the NIH cooperative agreement mechanism (U01). In a cooperative agreement, NIH typically has substantial programmatic involvement, and the awardee is expected to work closely with NIH staff on milestones, standards, and expectations for resource and data sharing.

How many awards does NIH expect to make?

NIH expects to support one team of investigators. This is designed as a single-source continuation and expansion effort rather than multiple independent awards.

What is meant by a "single-source continuation and expansion" of HPAP?

It means the opportunity is intended to build directly on the existing HPAP resource and infrastructure, expanding it to include Type 2 Diabetes and related metabolic disorder donor pancreata and associated data, rather than starting a separate, unrelated program.

What are the two main required deliverables?

The two required deliverables are:

1. Identify, collect, and intensively characterize primary pancreatic tissues from donors with Type 2 Diabetes and related forms of islet dysfunction, including age-matched control donors.
2. Analyze, organize, and share all resulting data by using and expanding PANC-DB, the open-access database resource associated with HPAP.

What types of donors are expected to be included?

The project must include donors with Type 2 Diabetes and related metabolic disorders or forms of islet dysfunction, as well as appropriate control donors. The information provided specifically notes the need for age-matched controls to support scientifically meaningful comparisons.

Why are age-matched control donors specifically mentioned?

Age-matched controls are emphasized so that observed differences between Type 2 Diabetes donors and controls can be interpreted more reliably, reducing the risk that differences are driven by age rather than metabolic disease status.

What does "intensively characterize" pancreatic tissue imply in this opportunity?

Based on the description, intensive characterization implies consistent tissue handling, multimodal analytic methods, and rich phenotyping and annotation (including relevant donor variables) so that downstream researchers can interpret biological differences in context.

What kinds of expertise does the funded team need to demonstrate?

The funded team is expected to have deep, practical expertise across the full pipeline, including:

• Identifying and obtaining donor pancreata
• Managing organ recovery logistics and associated metadata
• Processing and preserving pancreatic tissues
• Applying multimodal analytic methods to characterize tissues
• Building, curating, and managing data resources for broad community use

What is PANC-DB and what is required related to it?

PANC-DB is the existing open-access database resource associated with HPAP. The funded team must use and expand PANC-DB to analyze, organize, and share all resulting datasets. The description emphasizes that data should be standardized, well-documented, findable, and accessible for confident reuse by outside investigators.

Is the goal primarily to fund a specific hypothesis-driven research project?

No. The opportunity is described as a highly coordinated, resource-building effort. The emphasis is on building durable infrastructure and a shared community resource that can power many downstream studies, rather than funding a narrow, single-hypothesis project.

How does this opportunity relate to the Human Islet Research Network (HIRN)?

HPAP sits within HIRN, which NIH created in 2014 to accelerate translational research on human islet biology and diabetes. This NOFO signals a focused expansion of HPAP toward Type 2 Diabetes and related metabolic disease states within that broader network context.

What is the stated benefit of creating a centralized pancreas tissue and data resource?

The stated value proposition is that high-quality, well-annotated human pancreatic tissue data are difficult to obtain. A centralized shared resource can reduce duplication, improve reproducibility, and enable research studies that would be difficult for any single lab to execute alone.

What is the funding category and focus area for this opportunity?

The listing categorizes the opportunity as discretionary funding, with an activity focus in health. It is also listed under CFDA number 93.847.

What is the award ceiling?

The listed award ceiling is $2,000,000.

What was the original closing date listed for this opportunity?

The original closing date was February 28, 2024.

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

No. Foreign (non-U.S.) organizations cannot apply under the eligibility limitations provided.

Are non-domestic components of U.S. organizations eligible to apply?

No. Non-domestic components of U.S. organizations are also not eligible to apply.

Are foreign components allowed at all?

Yes. Foreign components, as defined under the NIH Grants Policy Statement, are allowed. This means a U.S.-based applicant may include certain international elements (for example, collaborations or specific activities abroad) if they meet NIH's definition and are justified and structured consistent with policy.

Can small businesses apply?

Yes. The listing notes that eligible applicants include small businesses, suggesting that certain non-academic entities may apply if they can meet the scientific, operational, and data-sharing demands of managing a national-scale tissue and database resource.

What kinds of activities are emphasized: collecting tissue, generating data, or sharing data?

All three are emphasized. The opportunity centers on acquiring donor pancreata, processing and preserving tissues, generating multimodal datasets and associated metadata, and then organizing and sharing those outputs through an expanded PANC-DB platform.

What does the opportunity suggest about data documentation and usability for outside researchers?

The description highlights that data should be standardized, well-documented, findable, and accessible. The intent is for outside investigators to be able to reuse the data confidently for secondary analyses and hypothesis generation.

What is the expected scope and scale of the effort?

The opportunity describes a national-scale, highly coordinated resource-building effort that spans donor identification and recovery logistics through tissue processing, multimodal characterization, and database expansion and management, all delivered by a single coordinated team.