Opportunity Information: Apply for RFA DK 08 011
Apply for RFA DK 08 011
- The National Institutes of Health in the food and nutrition health income security and social services 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): 93.213 Research and Training in Complementary and Integrative Health 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research 93.855 Allergy, Immunology and Transplantation Research 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Dec 24, 2008 and posted on Dec 29, 2008.
- Applicants must submit their applications by Mar 10, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $5,400,000.00 to eligible and selected applicants.
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Non domestic (non U.S.) Entities (Foreign Organizations) Tribally Controlled Colleges and Universities (TCCUs) .
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Opportunity Summary:
The Type 1 Diabetes TrialNet Clinical Centers (U01) funding opportunity (RFA DK-08-011) is a National Institutes of Health (NIH) cooperative agreement designed to support clinical centers that will operate as part of the TrialNet clinical research network. The participating NIH components include the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Allergy and Infectious Diseases (NIAID), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Center for Complementary and Alternative Medicine (NCCAM). The central objective is to build and sustain a coordinated set of clinical sites capable of carrying out studies that prevent or delay the onset of type 1 diabetes (T1D), slow disease progression, and improve the overall quality and efficiency of T1D prevention-focused clinical research.
TrialNet is explicitly oriented toward intervening early in the disease process, often before clinical diabetes is diagnosed. A major emphasis is on screening and identifying individuals at elevated risk for T1D, improving understanding of the disease natural history, and running clinical trials that test promising therapies that may interrupt the autoimmune process that leads to beta cell loss. A key point in the announcement is that TrialNet prioritizes evaluation of new therapies, particularly immunotherapies, in at-risk individuals, including children, who have not yet developed clinical disease. This prevention-first focus means the supported clinical centers must be equipped not only to conduct interventional trials, but also to manage the operational and ethical complexities of research in people who may be asymptomatic yet biologically at risk.
In addition to prevention trials, the network also supports studies in people with newly diagnosed (recent-onset) T1D to generate safety and efficacy data that can inform prevention strategies and future trial design. These recent-onset studies typically aim to reduce ongoing beta cell destruction and/or enhance beta cell survival or regeneration, especially in individuals who still have residual beta cell function. In practical terms, this positions the clinical centers to contribute across a continuum that includes pre-symptomatic risk identification, early-intervention prevention studies, and carefully selected trials in newly diagnosed patients where preserving remaining insulin-producing capacity is still feasible.
Beyond testing therapies, the FOA highlights a methodological and mechanistic mission. TrialNet clinical centers are expected to participate in efforts to improve how trials are conducted and interpreted, such as developing or validating outcome assessment approaches, evaluating surrogate markers, and performing mechanistic studies that clarify underlying pathophysiology. These mechanistic and biomarker-oriented components are meant to strengthen the scientific foundation for future clinical trials by improving measurement tools, sharpening hypotheses about disease pathways, and helping determine which interventions are most likely to work and why. In effect, the clinical centers are not only treatment-testing sites; they are also engines for refining clinical trial methods and generating biologically informative data that can accelerate progress across the field.
Administratively, this opportunity uses the U01 cooperative agreement mechanism, which generally indicates substantial NIH programmatic involvement compared with a typical research project grant. Under a cooperative agreement, awardees typically work in a more coordinated and standardized way across the network, aligning protocols, data collection, regulatory processes, and performance expectations with TrialNet governance and NIH oversight. The goal is a harmonized, multi-site clinical infrastructure capable of enrolling participants efficiently, following shared protocols, and producing comparable, high-quality data across centers.
Key dates and funding details in the posted announcement include a Posted Date of December 29, 2008, with an Original and Current Closing Date of March 10, 2009, and an Archive Date of April 10, 2009. The estimated total funding listed is $5,400,000, and there is no cost sharing or matching requirement. The opportunity is categorized as discretionary funding and appears under multiple CFDA numbers reflecting the multi-institute nature of the initiative, including 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), 93.855 (Allergy, Immunology and Transplantation Research), 93.865 (Child Health and Human Development Extramural Research), and 93.213 (Research and Training in Complementary and Integrative Health).
Eligibility is broad and includes a range of domestic and non-domestic organizational types capable of conducting high-quality clinical research. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with or without 501(c)(3) status, and other entities as described in the FOA. The eligibility language specifically calls out several categories of institutions and organizations, including Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and foreign organizations (non-U.S. entities). This breadth reflects the network’s interest in robust clinical capacity and potentially diverse participant access, while still requiring applicants to demonstrate the infrastructure and expertise needed for complex, regulated, multi-site trials that may include pediatric populations and pre-symptomatic individuals.
Overall, the grant supports clinical centers that can function as reliable TrialNet nodes: sites that can help find and follow at-risk individuals, enroll participants into prevention and early-intervention trials, conduct studies in recent-onset T1D to inform the prevention pipeline, and contribute to biomarker, outcome-measure, and mechanistic work that strengthens the next generation of clinical trials. The full announcement is linked through NIH at http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-08-011.html, and the NIH Office of Extramural Research (OER) webmaster contact is provided for access or linking issues.
Frequently Asked Questions (FAQs)
What is the Type 1 Diabetes TrialNet Clinical Centers (U01) funding opportunity?
It is an NIH cooperative agreement (U01) funding opportunity titled "Type 1 Diabetes TrialNet Clinical Centers (U01)" under RFA DK-08-011. It supports clinical centers that will operate as part of the TrialNet clinical research network focused on type 1 diabetes (T1D) prevention-focused clinical research.
What is TrialNet and what is the network trying to accomplish?
TrialNet is a coordinated clinical research network oriented toward intervening early in the T1D disease process, often before clinical diabetes is diagnosed. The network aims to build and sustain a set of clinical sites capable of carrying out studies that prevent or delay the onset of T1D, slow disease progression, and improve the overall quality and efficiency of T1D prevention-focused clinical research.
Which NIH components are participating in this opportunity?
The participating NIH components listed are the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Allergy and Infectious Diseases (NIAID), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Center for Complementary and Alternative Medicine (NCCAM).
What is the main objective of funding TrialNet Clinical Centers?
The central objective is to build and sustain a coordinated set of clinical sites that can run prevention and early-intervention studies, support recent-onset T1D studies that inform prevention, and contribute to methodological and mechanistic research that improves trial conduct and interpretation.
What types of studies are TrialNet Clinical Centers expected to conduct?
Clinical centers are expected to participate in studies designed to prevent or delay T1D onset, slow progression of disease processes, and improve clinical research quality and efficiency. This includes screening and identification of at-risk individuals, prevention-focused interventional trials, and selected studies in people with newly diagnosed (recent-onset) T1D.
Does the opportunity emphasize prevention over treatment?
Yes. TrialNet is explicitly oriented toward intervening early, frequently before clinical diabetes is diagnosed. A major emphasis is on screening, identifying individuals at elevated risk for T1D, and conducting trials that test therapies intended to interrupt the autoimmune process leading to beta cell loss.
Who are the intended research participants in these studies?
The announcement highlights research in individuals at elevated risk for T1D, including children, who may not yet have developed clinical disease. It also includes studies in people with newly diagnosed (recent-onset) T1D, particularly those with residual beta cell function.
What kinds of therapies does TrialNet prioritize evaluating?
The FOA prioritizes the evaluation of new therapies, particularly immunotherapies, in at-risk individuals who have not yet developed clinical disease.
Are newly diagnosed (recent-onset) T1D studies included, and why?
Yes. The network supports studies in people with newly diagnosed T1D to generate safety and efficacy data that can inform prevention strategies and future trial design. These studies often aim to reduce ongoing beta cell destruction and/or enhance beta cell survival or regeneration, especially when residual beta cell function remains.
What is meant by TrialNet focusing on the "natural history" of T1D?
In this context, it refers to improving understanding of how T1D develops over time, especially in pre-symptomatic, at-risk individuals, and using that knowledge to guide screening, risk identification, and early-intervention trial strategies.
What additional scientific missions are included beyond testing therapies?
The FOA highlights a methodological and mechanistic mission. TrialNet clinical centers are expected to contribute to improving trial conduct and interpretation by helping develop or validate outcome assessment approaches, evaluating surrogate markers, and performing mechanistic studies that clarify underlying pathophysiology.
What are "mechanistic" and "biomarker-oriented" components in this FOA?
They are research components intended to strengthen the scientific foundation for future trials by improving measurement tools, refining hypotheses about disease pathways, and helping determine which interventions are most likely to work and why, using biologically informative data (including biomarkers and surrogate markers).
What is the funding mechanism used for this opportunity?
The opportunity uses the U01 cooperative agreement mechanism, indicating substantial NIH programmatic involvement and coordination compared with a typical research project grant.
What does "cooperative agreement" imply for awardees?
Under a cooperative agreement, awardees typically work in a coordinated and standardized manner across the network, aligning protocols, data collection, regulatory processes, and performance expectations with TrialNet governance and NIH oversight. The aim is harmonized multi-site infrastructure and comparable, high-quality data across centers.
What are the key dates listed in the announcement?
The posted date is December 29, 2008. The original and current closing date is March 10, 2009. The archive date is April 10, 2009.
What is the estimated total funding amount?
The estimated total funding listed in the announcement is $5,400,000.
Is cost sharing or matching required?
No. The announcement states there is no cost sharing or matching requirement.
How is this opportunity categorized?
It is categorized as discretionary funding.
Which CFDA numbers are associated with this opportunity?
The opportunity appears under multiple CFDA numbers, including 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), 93.855 (Allergy, Immunology and Transplantation Research), 93.865 (Child Health and Human Development Extramural Research), and 93.213 (Research and Training in Complementary and Integrative Health).
Who is eligible to apply?
Eligibility is broad and includes domestic and non-domestic organizational types capable of conducting high-quality clinical research. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with or without 501(c)(3) status, and other entities as described in the FOA.
Are minority-serving institutions specifically included in the eligibility language?
Yes. The eligibility language specifically calls out Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions.
Are foreign (non-U.S.) organizations eligible to apply?
Yes. The eligibility language explicitly includes foreign organizations (non-U.S. entities).
What capabilities should a proposed TrialNet Clinical Center demonstrate?
Based on the FOA description, centers should be able to function as reliable TrialNet nodes by supporting identification and follow-up of at-risk individuals, enrolling participants into prevention and early-intervention trials, conducting selected recent-onset T1D studies, and contributing to biomarker, outcome-measure, and mechanistic work. They should also be able to operate within a regulated, standardized multi-site network that may include pediatric and pre-symptomatic participants.
Why does the FOA emphasize operational and ethical complexity?
The announcement notes that TrialNet prioritizes studies in at-risk individuals who may be asymptomatic yet biologically at risk, including children. This prevention-first approach can introduce additional operational and ethical considerations compared with studies conducted only in clinically diagnosed patients.
Where can the full announcement be found?
The full announcement is available through NIH at http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-08-011.html.
Who is the contact for access or linking issues related to the announcement?
The NIH Office of Extramural Research (OER) webmaster contact is provided in the announcement for access or linking issues.
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