High-Resolution Exploration of the Human Islet Tissue Environment [HIRN Human Pancreas Analysis Consortium (HPAC)] (U01 - Clinical Trial Not Allowed) | RFA DK 21 017

Frequently Asked Questions (FAQs) - NIH RFA-DK-21-017 (HPAC/HIRN)

What is the funding opportunity RFA-DK-21-017 about?

This NIH funding opportunity supports research projects that can map and explain the human pancreatic islet tissue environment at much higher resolution than has typically been possible. The goal is to clarify how human pancreatic tissue is organized and how that organization influences islet function and dysfunction, with a strong focus on the islet microenvironment and surrounding peri-islet architecture.

Which NIH award mechanism is used?

The opportunity uses the U01 cooperative agreement mechanism. Under a cooperative agreement, awardees are expected to work closely with NIH program staff and to coordinate actively with the larger consortium, rather than operating as fully independent, stand-alone projects.

Are clinical trials allowed under this FOA?

No. The opportunity is explicitly labeled "Clinical Trial Not Allowed," so applications must not propose an interventional clinical trial. The supported work should be basic, translational, and/or focused on human tissue without proposing a clinical trial intervention.

What kinds of scientific questions does NIH want applicants to address?

The FOA emphasizes research that improves understanding of the cellular composition and functional roles of key components within the pancreatic islet and the surrounding peri-islet environment. Priority areas include how tissue organization affects islet function, what cellular and structural features define the islet ecosystem, and how those features relate to normal physiology or disease processes.

What does the FOA mean by "mapping at higher resolution"?

Based on the description provided, the FOA is seeking detailed, fine-grained descriptions of human pancreatic islet tissue organization and its environment. This includes high-detail characterization of which cell types and subtypes are present, how they are arranged, and how they relate to each other within the islet and surrounding tissues.

Is the focus limited to the islet itself, or does it include surrounding tissue?

It includes surrounding tissue. A major theme is the peri-islet architecture and adjacent pancreatic compartments. Applicants are expected to consider how nearby non-islet tissues or neighboring tissue contexts influence islet cell behavior, including pathways that may contribute to stress, failure, or degeneration of insulin-producing beta cells.

How important is cell-to-cell communication in this solicitation?

It is central. The FOA highlights understanding cell-to-cell relationships and communication, including which cell types interact, how they interact physically and chemically, what signaling pathways or communication modes are involved, and how those interactions shape normal function or contribute to dysfunction.

Does the FOA prioritize research related to beta cells and type 1 diabetes?

Yes, the opportunity is tied to the Human Islet Research Network (HIRN), which focuses on understanding how functional human beta cell mass is lost in type 1 diabetes and identifying strategies to protect, restore, or replace beta cells. The FOA specifically calls attention to mechanisms and contexts that may drive beta cell stress, failure, or degeneration.

How does this opportunity connect to HPAC and HIRN?

This initiative is designed to integrate awardees into the Human Pancreas Analysis Consortium (HPAC), which sits within HIRN. The FOA is not positioned as funding isolated efforts; instead, it funds contributions to a shared, networked scientific program where projects should align with HPAC goals, complement other consortium efforts, and contribute to an interoperable body of knowledge about the human pancreas and islet ecosystem.

What does it mean to be part of a consortium under a U01?

In this context, it means funded teams are expected to coordinate actively with the larger consortium and work closely with NIH program staff. The emphasis is on collaboration, alignment with consortium goals, and contributing outputs that fit into a broader, shared research program.

Is the research required to be human-focused rather than animal model-focused?

Yes. The FOA states that supported studies must primarily increase understanding of human tissue structure and function and human disease biology, rather than focusing on mechanisms specific to animal models. The central questions, data generation, and conclusions should be anchored in human pancreatic tissue and a human-relevant disease context.

Does the FOA prohibit all non-human work?

The provided description does not say that every activity must be performed only in humans. However, it does clearly set the boundary that the main purpose and primary outcomes must be directly tied to understanding human pancreatic tissue and human disease biology, not animal-model-specific biology.

What is the NIH assistance listing (CFDA) number for this opportunity?

The assistance listing (CFDA) number provided is 93.847.

What is the award ceiling listed for this opportunity?

The award ceiling listed in the provided information is $600,000.

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

The creation date shown is 2021-08-12, and the original closing date shown is 2022-03-03.

How many awards does NIH expect to make?

The excerpt includes the label "ExpectedAwards:" but does not provide a number. Based on the information provided only, the anticipated count of awards is not specified.

Who is eligible to apply?

Eligibility is broad and includes many U.S.-based organization types, including state, county, and city or township 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education where applicable); for-profit organizations other than small businesses; small businesses; and other entities.

Are minority-serving institutions and community-based organizations included in eligibility?

Yes. The FOA calls out additional eligible categories including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It also includes faith-based or community-based organizations, among other categories.

Are U.S. territories or possessions eligible?

Yes. The eligibility list explicitly includes U.S. territories or possessions.

Can a foreign institution apply as the primary applicant?

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization.

Can a U.S. organization apply if it has a non-domestic component?

Non-domestic components of U.S. organizations are not eligible to apply. However, foreign components (as defined in the NIH Grants Policy Statement) are allowed, meaning a U.S.-based applicant may include certain foreign collaborations or activities if they meet NIH definitions and requirements for a foreign component.

Is this opportunity intended to fund stand-alone projects or coordinated contributions?

It is intended to fund coordinated contributions within a shared program. The FOA emphasizes integration into HPAC and collaboration across the consortium, rather than independent, stand-alone efforts.

What is the overarching purpose of this initiative in plain terms?

In plain terms, it is a consortium-building, human-tissue-centered research call intended to produce a sharper picture of the human islet and peri-islet environment. It prioritizes detailed mapping of cellular and structural organization, decoding intercellular communication, and understanding how neighboring tissues shape islet health or failure, aligned with HIRN's mission related to beta cell loss and dysfunction in type 1 diabetes.