Opportunity Information: Apply for RFA DK 13 010
Apply for RFA DK 13 010
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Type 1 Diabetes TrialNet Clinical Centers (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on Jun 18, 2013 and posted on Jun 18, 2013.
- Applicants must submit their applications by Nov 27, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $6,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: Small businesses Private institutions of higher education Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education State governments Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) 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 City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments For profit organizations other than small businesses County governments Independent school districts.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Only Non domestic (non U.S.) Entities (Foreign Institutions) located in North America are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Only foreign components, as defined in the NIH Grants Policy Statement, that are located in North America are allowed.
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Opportunity Summary:
The Type 1 Diabetes TrialNet Clinical Centers (U01) funding opportunity (RFA-DK-13-010) is a National Institutes of Health cooperative agreement designed to keep the Type 1 Diabetes TrialNet research network running effectively at the clinical site level. TrialNet is an international consortium focused on delaying or preventing type 1 diabetes (T1D) by conducting clinical studies and trials that identify at-risk individuals, test interventions, and closely monitor outcomes over time. Rather than funding a single standalone research project, this mechanism is meant to provide the operational and clinical infrastructure that allows participating centers to reliably carry out TrialNet protocols, enroll and manage participants, and generate high-quality, standardized clinical data across many locations.
A central purpose of the award is to support TrialNet Clinical Centers in the core activities required for network trials: recruiting eligible participants, conducting screening and enrollment, delivering study interventions or treatments as required by TrialNet protocols, and following participants longitudinally for outcomes and safety. These centers function as the on-the-ground clinical engines of the consortium, ensuring that studies can be executed consistently and that participants receive appropriate study-related care and monitoring. Because TrialNet studies often involve complex logistics (for example, screening relatives or other at-risk populations, coordinating specimen collection, and maintaining consistent follow-up schedules), the emphasis is on enabling dependable site capacity and readiness rather than on one-off, investigator-initiated experimentation.
The opportunity also explicitly provides support for Clinical Centers to manage and support Affiliate Sites. In practice, this means a funded Clinical Center is expected to extend TrialNet activities beyond its main institution by partnering with additional clinical locations that can help with screening, recruitment, and possibly elements of participant follow-up. This hub-and-spoke structure is intended to broaden geographic reach, make it easier for potential participants to access screening and trial opportunities, and increase overall enrollment efficiency across the network. The Clinical Center plays a coordinating role for its affiliates, helping ensure that the affiliates meet TrialNet standards for protocol implementation, regulatory compliance, and data and specimen handling.
In parallel with these Clinical Center awards, NIH noted that a separate new TrialNet unit was planned: the Clinical Network Hub (CNH). While the Clinical Centers focus on executing trials and following participants, the CNH is described as concentrating on coordinating and enhancing screening and recruiting activities across the network. In other words, the CNH was envisioned as a network-level catalyst for bringing more participants into the TrialNet pipeline, improving consistency and performance of recruitment strategies, and strengthening the overall screening enterprise that feeds TrialNet prevention and delay trials.
From an administrative and funding standpoint, the award uses a cooperative agreement (U01) mechanism. Cooperative agreements typically involve substantial federal programmatic involvement compared with standard research grants, reflecting the reality that large multicenter clinical networks require close coordination, shared governance, and consistent adherence to common protocols. The opportunity was issued under NIH with the CFDA listing 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). It was categorized within a health-related activity area and is clearly aligned with clinical research operations rather than basic science.
The total estimated funding level listed for the opportunity was $6,500,000, with an award ceiling of $200,000 per award (as stated in the source data). There was no cost sharing or matching requirement. The opportunity was posted on June 18, 2013, with an original and current closing date of November 27, 2013, and an archive date of December 28, 2013, indicating it is a past cycle announcement rather than an open solicitation.
Eligibility was broad and included many common applicant types such as public and private institutions of higher education, nonprofit organizations (with and without 501(c)(3) status), state and local governments, tribal governments and tribal organizations, public housing authorities/Indian housing authorities, independent school districts, special district governments, small businesses, and other for-profit organizations (other than small businesses). The eligibility notes also highlighted inclusion of faith-based and community-based organizations and a wide range of minority-serving institutions (for example HBCUs, Hispanic-serving institutions, AANAPISIS, TCCUs, Alaska Native and Native Hawaiian-serving institutions). Foreign participation was limited: non-U.S. entities and foreign institutions were eligible only if located in North America, and non-domestic components of U.S. organizations were not eligible. Only foreign components as defined by the NIH Grants Policy Statement and located in North America were allowed, underscoring NIH's intent to maintain a tightly coordinated regional footprint for this network component.
Overall, this opportunity can be understood as NIH support for the clinical operations backbone of TrialNet. The goal is to sustain and strengthen the clinical capacity needed to identify people at risk of T1D, enroll them efficiently into prevention or delay studies, implement TrialNet protocols consistently across multiple sites, and follow participants over time, while also extending reach through Affiliate Sites and complementing network-wide recruitment improvements anticipated through the separate Clinical Network Hub.
For the full announcement details, NIH referenced: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-13-010.html, and provided NIH OER webmaster contacts for access or linking issues (FBOWebmaster@OD.NIH.GOV).
Frequently Asked Questions (FAQs)
What is the Type 1 Diabetes TrialNet Clinical Centers (U01) funding opportunity?
It is an NIH cooperative agreement (U01) intended to keep the Type 1 Diabetes TrialNet research network running effectively at the clinical site level. Rather than funding a single standalone research project, it supports the operational and clinical infrastructure needed for participating centers to carry out TrialNet protocols consistently and generate standardized clinical data across multiple locations.
What is the funding opportunity number and title?
The opportunity is titled "Type 1 Diabetes TrialNet Clinical Centers (U01)" and is identified as RFA-DK-13-010.
Which federal agency is offering this opportunity?
The opportunity is offered by the National Institutes of Health (NIH).
What is TrialNet?
TrialNet is an international consortium focused on delaying or preventing type 1 diabetes (T1D). It conducts clinical studies and trials that identify at-risk individuals, test interventions, and monitor outcomes over time.
What is the main purpose of funding TrialNet Clinical Centers?
The main purpose is to support the core clinical and operational activities required for network trials, including participant recruitment, screening and enrollment, delivery of study interventions or treatments per TrialNet protocols, and longitudinal follow-up for outcomes and safety.
Is this award meant to fund a single research project?
No. This mechanism is designed to provide site-level operational and clinical infrastructure so centers can reliably execute TrialNet protocols. The emphasis is on dependable site capacity and readiness rather than one-off, investigator-initiated experimentation.
What kinds of activities are TrialNet Clinical Centers expected to perform?
Based on the description provided, expected activities include recruiting eligible participants, conducting screening and enrollment, coordinating specimen collection logistics, delivering study interventions or treatments required by TrialNet protocols, and following participants longitudinally for both outcomes and safety.
Why does the opportunity emphasize standardized, high-quality clinical data?
Because TrialNet is a multicenter network operating across many locations, it depends on consistent protocol execution and standardized data collection to ensure that results are comparable and reliable across sites.
Does this opportunity support management of Affiliate Sites?
Yes. The opportunity explicitly supports Clinical Centers in managing and supporting Affiliate Sites. A funded Clinical Center is expected to extend TrialNet activities beyond its main institution by partnering with additional clinical locations.
What is the purpose of using Affiliate Sites?
Affiliate Sites broaden geographic reach, make screening and trial access easier for potential participants, and increase overall enrollment efficiency across the network.
What role does a funded Clinical Center play for its Affiliate Sites?
The Clinical Center serves as a coordinating hub for its affiliates, helping ensure TrialNet standards are met for protocol implementation, regulatory compliance, and data and specimen handling.
What is the NIH funding mechanism used here, and what does it imply?
The mechanism is a cooperative agreement (U01). Cooperative agreements typically involve substantial federal programmatic involvement compared with standard research grants, reflecting the coordination needs of large multicenter clinical networks with shared governance and common protocols.
What is the CFDA number associated with this opportunity?
The CFDA listing provided is 93.847, described as "Diabetes, Digestive, and Kidney Diseases Extramural Research."
What is the total estimated funding level for the opportunity?
The total estimated funding level listed is $6,500,000.
What is the award ceiling per award?
The source data states an award ceiling of $200,000 per award.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
When was the opportunity posted, and what were the key dates?
The opportunity was posted on June 18, 2013. The original and current closing date was November 27, 2013, and the archive date was December 28, 2013.
Is this an open opportunity right now?
No. The listing indicates it is a past cycle announcement (it has a closing date in 2013 and an archive date in 2013), not an open solicitation.
What applicant organizations were eligible to apply?
Eligibility was broad and included: public and private institutions of higher education; nonprofit organizations (with and without 501(c)(3) status); state and local governments; tribal governments and tribal organizations; public housing authorities/Indian housing authorities; independent school districts; special district governments; small businesses; and other for-profit organizations (other than small businesses).
Were faith-based and community-based organizations included in eligibility?
Yes. The eligibility notes highlighted inclusion of faith-based and community-based organizations.
Were minority-serving institutions included in eligibility?
Yes. The eligibility notes highlighted a wide range of minority-serving institutions, including (as examples provided) HBCUs, Hispanic-serving institutions, AANAPISIS, TCCUs, and Alaska Native and Native Hawaiian-serving institutions.
Are foreign institutions eligible to apply?
Foreign participation was limited. Non-U.S. entities and foreign institutions were eligible only if located in North America.
Are non-domestic components of U.S. organizations eligible?
No. The description states that non-domestic components of U.S. organizations were not eligible.
What foreign components are allowed under this opportunity?
Only foreign components as defined by the NIH Grants Policy Statement and located in North America were allowed, reflecting an intent to maintain a tightly coordinated regional footprint for this network component.
How does this opportunity relate to the planned TrialNet Clinical Network Hub (CNH)?
NIH noted that a separate new TrialNet unit was planned: the Clinical Network Hub (CNH). While Clinical Centers focus on executing trials and following participants, the CNH was described as concentrating on coordinating and enhancing screening and recruiting activities across the network.
What is the difference between a TrialNet Clinical Center and the Clinical Network Hub (CNH)?
Based on the description provided: Clinical Centers are the on-the-ground clinical engines that implement TrialNet protocols, enroll and manage participants, and conduct follow-up. The CNH was envisioned as a network-level catalyst focused on improving screening and recruitment coordination and performance across the network.
What general area does NIH categorize this opportunity under?
It is categorized within a health-related activity area and is aligned with clinical research operations rather than basic science.
Where can applicants find the full announcement details?
NIH referenced the full announcement at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-13-010.html
Who was listed as a contact for access or linking issues?
The information provided lists NIH OER webmaster contacts for access or linking issues: FBOWebmaster@OD.NIH.GOV
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Applicants who have applied for this opportunity (RFA DK 13 010) also looked into and applied for these:
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|---|
| NIDDK Program Projects (P01) Apply for PAR 13 266 Funding Number: PAR 13 266 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| NIDDK Multi Center Clinical Study Implementation Planning Cooperative Agreements (U34) Apply for PAR 13 268 Funding Number: PAR 13 268 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $225,000 |
| Limited Competition for the Continuation of a National Endoscopic Database (U01) Apply for RFA DK 13 504 Funding Number: RFA DK 13 504 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Diabetes Research Centers (P30) Apply for RFA DK 13 004 Funding Number: RFA DK 13 004 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Continuation of ChiLDReN, the Childhood Liver Disease Research Network (U01) Apply for RFA DK 13 011 Funding Number: RFA DK 13 011 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Limited Competition Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN)(U01) Apply for RFA DK 13 503 Funding Number: RFA DK 13 503 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Gut Microbiota Derived Factors in the Integrated Physiology and Pathophysiology of Diseases within NIDDKs Mission (R01) Apply for PAR 13 293 Funding Number: PAR 13 293 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Limited Competition Chronic Kidney Disease (CKD) Biomarkers Consortium Data Coordinating Center (U01) Apply for RFA DK 13 506 Funding Number: RFA DK 13 506 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Collaborative Interdisciplinary Team Science in NIDDK Research Areas (R24) Apply for PAR 13 305 Funding Number: PAR 13 305 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Improving Diabetes Management in Young Children with Type 1 Diabetes (DP3) Apply for RFA DK 13 022 Funding Number: RFA DK 13 022 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $1,400,000 |
| Understanding Barriers and Facilitators to Type 1 Diabetes Management in Adults (DP3) Apply for RFA DK 13 023 Funding Number: RFA DK 13 023 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $5,000,000 |
| Limited Competition of the MAPP Research Network(U01) Apply for RFA DK 13 507 Funding Number: RFA DK 13 507 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Expansion of the MAPP Research Network (U01) Apply for RFA DK 13 025 Funding Number: RFA DK 13 025 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $250,000 |
| Developmental Centers for Interdisciplinary Research in Benign Urology (P20) Apply for RFA DK 13 019 Funding Number: RFA DK 13 019 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Translational Research to Improve Diabetes and Obesity Outcomes (R01) Apply for PA 13 352 Funding Number: PA 13 352 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Harvesting the Neuroimaging Cornucopia for Pancreatic Islet Imaging Reagents for Diabetes Research (DP3) Apply for RFA DK 13 024 Funding Number: RFA DK 13 024 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $300,000 |
| Human Islet Research Network Coordinating Center (U01) Apply for RFA DK 13 013 Funding Number: RFA DK 13 013 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $1,000,000 |
| Human Islet Research Network Bioinformatics Center (U01) Apply for RFA DK 13 014 Funding Number: RFA DK 13 014 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $333,000 |
| Consortium on Targeting And Regeneration (CTAR) HIRN (UC4) Apply for RFA DK 13 015 Funding Number: RFA DK 13 015 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $600,000 |
| Consortium on Human Islet Biomimetics (CHIB) HIRN (UC4) Apply for RFA DK 13 016 Funding Number: RFA DK 13 016 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $1,200,000 |
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