Opportunity Information: Apply for RFA DK 17 021
The National Institutes of Health (NIH) issued this funding opportunity (RFA-DK-17-021) to support research aimed at finding early, human-specific biomarkers of type 1 diabetes (T1D) within the pancreas, with a strong emphasis on understanding what is happening biologically before classic symptoms appear. The core idea is to use studies of human pancreatic tissue to uncover molecular or cellular signals that mark the earliest stages of T1D pathogenesis, clarify the signaling and processing pathways that drive the asymptomatic (preclinical) phase, and translate those discoveries into practical tools that could help clinicians detect, stage, and ultimately intervene earlier in people who are at risk or recently diagnosed. In addition to biomarkers and diagnostics, the FOA also encourages projects that pinpoint therapeutic targets that could inform prevention strategies or early treatments designed to preserve remaining beta cell mass.
Awards are made through a U01 cooperative agreement mechanism, which means the funded projects are expected to operate in close coordination with NIH program staff and within a larger organized effort rather than as fully independent investigator-initiated grants. Successful applicants become members of the HIRN Consortium on Beta Cell Death and Survival (CBDS). CBDS is focused on defining the mechanisms of beta cell stress, dysfunction, and destruction in humans, since those processes sit at the center of T1D development. The consortiums long-term goals are practical and disease-driven: detect beta cell destruction as early as possible, protect residual beta cell mass in people with T1D early in the disease course, and ideally prevent progression to autoimmunity when feasible. CBDS sits under the broader Human Islet Research Network (HIRN), a collaborative translational research framework designed to accelerate understanding of how human beta cells are lost in T1D and to support innovative strategies to protect and replace functional beta cell mass.
A key constraint of this announcement is its insistence on human disease biology. The FOA explicitly prioritizes studies that increase understanding based on human pancreatic tissues and human-relevant biology, rather than relying primarily on rodent or other animal models. Another important boundary is that clinical trials are not allowed under this FOA; proposals must not include a clinical trial as part of the application. The intended scope is discovery and translational-enabling work (for example, biomarker identification and validation in human samples, mechanistic pathway mapping in human tissue, and development of diagnostic approaches) rather than interventional testing in trial settings.
From an administrative perspective, this opportunity falls under the Health activity area (CFDA 93.847) and was offered as a discretionary program by NIH. The original application closing date listed was May 10, 2018, with a stated award ceiling of $500,000. The announcement anticipates supporting a set of projects (the expected number of awards is not clearly specified in the provided text), and it was created on February 15, 2018.
Eligibility is broad and includes many types of domestic organizations, such as public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), small businesses, and multiple levels of government (state, county, city/township, special districts), as well as independent school districts and public housing authorities/Indian housing authorities. It also explicitly welcomes a wide range of other eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, tribal governments and tribal organizations (including those not federally recognized), eligible federal agencies, faith-based or community-based organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations) and regional organizations. Overall, the opportunity is designed to pull together a diverse set of investigators and institutions to accelerate the discovery of early pancreatic biomarkers and mechanisms of T1D in humans, while building toward diagnostic and therapeutic paths that could shift detection and intervention earlier in the disease timeline.Apply for RFA DK 17 021
- The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Discovery of Early Type 1 Diabetes Disease Biomarkers in the Human Pancreas [HIRN Consortium on Beta Cell Death and Survival (CBDS)] (U01 - Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
- This funding opportunity was created on 2018-02-15.
- Applicants must submit their applications by 2018-05-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the goal of NIH funding opportunity RFA-DK-17-021?
The goal is to support research that identifies early, human-specific biomarkers of type 1 diabetes (T1D) within the pancreas, with a strong emphasis on understanding the biology of T1D before classic symptoms appear. The opportunity focuses on discovering molecular and cellular signals that mark the earliest stages of T1D pathogenesis and translating those findings into practical tools that could help clinicians detect, stage, and intervene earlier in at-risk or recently diagnosed individuals.
What types of research are encouraged under this announcement?
The announcement encourages projects that use human pancreatic tissue and human-relevant biology to:
- Identify and validate early biomarkers of T1D pathogenesis in the pancreas
- Clarify signaling and processing pathways driving the asymptomatic (preclinical) phase of T1D
- Develop diagnostic approaches that support early detection and staging
- Pinpoint therapeutic targets that could inform prevention strategies or early treatments aimed at preserving remaining beta cell mass
What is the main scientific emphasis of this FOA?
The main emphasis is human disease biology, specifically research grounded in studies of human pancreatic tissue. The FOA explicitly prioritizes efforts that increase understanding based on human tissues and human-relevant biology rather than relying primarily on rodent or other animal models.
Are clinical trials allowed in applications submitted to this FOA?
No. Clinical trials are not allowed under this FOA, and proposals must not include a clinical trial as part of the application. The scope is discovery and translational-enabling work rather than interventional testing in clinical trial settings.
What funding mechanism is used for awards under this opportunity?
Awards are made through a U01 cooperative agreement mechanism. This means funded projects are expected to operate in close coordination with NIH program staff and within a larger organized effort rather than as fully independent investigator-initiated grants.
What does it mean that this is a U01 cooperative agreement?
Under a U01 cooperative agreement, the funded research is carried out with substantial involvement from NIH program staff. Projects are expected to coordinate closely with NIH and align with the goals and activities of a broader collaborative effort.
Will funded applicants be part of a consortium?
Yes. Successful applicants become members of the HIRN Consortium on Beta Cell Death and Survival (CBDS).
What is the HIRN Consortium on Beta Cell Death and Survival (CBDS)?
CBDS is a consortium focused on defining mechanisms of beta cell stress, dysfunction, and destruction in humans, since these processes are central to T1D development. Its long-term goals include detecting beta cell destruction as early as possible, protecting residual beta cell mass early in the disease course, and ideally preventing progression to autoimmunity when feasible.
How does CBDS relate to HIRN?
CBDS sits under the broader Human Islet Research Network (HIRN), a collaborative translational research framework designed to accelerate understanding of how human beta cells are lost in T1D and to support innovative strategies to protect and replace functional beta cell mass.
What disease stage does this FOA focus on?
The FOA places strong emphasis on the asymptomatic (preclinical) phase of T1D, aiming to understand what is happening biologically before classic symptoms appear and to identify signals that mark the earliest stages of disease pathogenesis.
Does the FOA support work related to diagnostics?
Yes. In addition to biomarker discovery, the FOA supports translating discoveries into practical tools that could help clinicians detect and stage T1D earlier, including development of diagnostic approaches informed by human pancreatic biomarkers and mechanisms.
Does the FOA support work related to therapeutic target identification?
Yes. The FOA encourages projects that pinpoint therapeutic targets that could inform prevention strategies or early treatments designed to preserve remaining beta cell mass, particularly in people at risk or recently diagnosed.
Are animal models the primary focus of this opportunity?
No. A key constraint is the insistence on human disease biology. The FOA explicitly prioritizes studies based on human pancreatic tissues and human-relevant biology rather than relying primarily on rodent or other animal models.
What is the CFDA number and activity area for this opportunity?
The opportunity falls under the Health activity area with CFDA 93.847.
Which agency is offering this funding opportunity?
The funding opportunity is issued by the National Institutes of Health (NIH).
What is the program type for this opportunity?
It was offered as a discretionary program by NIH.
What was the original application closing date listed for this opportunity?
The original application closing date listed was May 10, 2018.
What is the stated award ceiling for this opportunity?
The stated award ceiling is $500,000.
When was this funding opportunity created?
The announcement was created on February 15, 2018.
Is the expected number of awards specified?
The provided text indicates that a set of projects is anticipated, but the expected number of awards is not clearly specified in the information provided.
Who is eligible to apply?
Eligibility is broad and includes many types of organizations, including:
- Public and private institutions of higher education
- Nonprofits (501(c)(3) and non-501(c)(3))
- For-profit organizations (other than small businesses)
- Small businesses
- State, county, city/township governments, and special district governments
- Independent school districts
- Public housing authorities/Indian housing authorities
Are minority-serving institutions and tribal entities eligible?
Yes. The FOA explicitly welcomes a wide range of eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, tribal governments, and tribal organizations (including those not federally recognized).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly listed among eligible applicants.
Are U.S. territories and possessions eligible?
Yes. U.S. territories or possessions are included among eligible applicants.
Can foreign (non-U.S.) organizations apply?
Yes. Non-U.S. entities (foreign organizations) and regional organizations are included among eligible applicants.
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are explicitly included among eligible applicants.
What is the overall intent of bringing many applicant types into this program?
The opportunity is designed to pull together a diverse set of investigators and institutions to accelerate discovery of early pancreatic biomarkers and mechanisms of T1D in humans, while building toward diagnostic and therapeutic paths that could shift detection and intervention earlier in the disease timeline.
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