Opportunity Information: Apply for RFA DK 18 007
The National Institutes of Health (NIH), through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), released this funding opportunity (RFA-DK-18-007) to support a planning-phase cooperative agreement (U34) for a future national, multi-site observational cohort study focused on pediatric type 1 diabetes (T1D). The scientific aim is to prospectively clarify which factors increase risk for, or protect against, neurocognitive complications in children who develop T1D in roughly the 5 to 10 year age range, alongside an appropriate comparison group without T1D (or otherwise suitable comparators as justified by the study). Because this is a planning award, it is not intended to fund the full cohort itself; it funds the groundwork needed to launch a large, coordinated cohort that can reliably answer these questions over time. The FOA is explicitly labeled "Clinical Trial Not Allowed," meaning applicants are expected to propose observational research planning and infrastructure rather than interventional clinical trials.
This U34 mechanism is structured around three core purposes. First, it allows early peer review of the rationale for the proposed cohort study, so reviewers can weigh in on whether the central questions are compelling and whether the approach is likely to produce interpretable, high-impact findings. Second, it supports rigorous assessment of the proposed study design, including key design choices that can make or break an observational cohort, such as eligibility criteria, recruitment sources, timing and frequency of follow-up, choice of neurocognitive outcomes, exposure and covariate measurement strategies (for example, glycemic metrics, hypoglycemia and hyperglycemia exposure, psychosocial factors, sleep, comorbidities, socioeconomic context), and the structure of the comparison sample. Third, it provides resources to develop the essential operational elements needed for a large multi-site effort, including the study protocol and manual of procedures, standardization across sites, data management and quality control systems, and the analysis and governance plans required to manage and interpret complex longitudinal data.
A major emphasis of the opportunity is readiness-building for a national, collaborative cohort. In practical terms, the planning period is meant to produce the concrete deliverables that would allow a subsequent full-scale cohort application or launch to proceed efficiently and consistently across many clinical and community settings. This includes building consensus on core neurocognitive and behavioral assessments, aligning biospecimen or clinical data collection plans if relevant, designing participant retention strategies suitable for children and families over years of follow-up, and putting in place clear policies for data sharing, publication, privacy protections, and cross-site coordination. The cooperative agreement format also signals substantial NIH programmatic involvement, so awardees should expect an active partnership with NIDDK staff as the plans are refined.
The FOA strongly encourages applicants to consult with NIDDK scientific staff before submitting an application. That is a practical signal that NIDDK expects prospective applicants to discuss feasibility, scope, alignment with institute priorities, and how the proposed planning activities will translate into a viable national cohort effort. Early contact can also help applicants understand expectations around study organization, multi-site leadership, and how to handle common cohort challenges such as harmonization of measures, minimizing bias, and ensuring the cohort reflects the diversity of children affected by T1D.
Eligibility is broad and includes many government, academic, nonprofit, and private-sector entities. Eligible applicants listed include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; federally recognized Native American tribal governments and other tribal organizations; and public housing authorities/Indian housing authorities. The FOA also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and non-U.S. (foreign) entities. This breadth reflects the reality that successful pediatric cohort studies often require partnerships spanning pediatric diabetes clinics, schools, community organizations, and institutions with strong ties to diverse populations.
From an administrative standpoint, this is a discretionary grant opportunity using the cooperative agreement funding instrument, categorized under Food and Nutrition/Health with CFDA number 93.847. The posting indicates an award ceiling of $225,000. The original closing date was 2019-04-11, and the FOA was created on 2019-01-23. While the notice does not specify the number of expected awards in the provided text, the intent is clearly to seed the planning work needed for a later, larger-scale national observational cohort.
In summary, this opportunity is best understood as a structured planning grant to design a high-quality, multi-site, longitudinal observational cohort study examining how pediatric-onset T1D relates to neurocognitive outcomes, with careful attention to both risk factors and protective factors. The U34 supports the up-front scientific and operational work required to launch a coordinated national effort, emphasizing standardized methods, robust data infrastructure, and early engagement with NIDDK to ensure the proposed cohort is feasible, rigorous, and positioned to generate actionable evidence about neurocognitive complications in children with T1D.Apply for RFA DK 18 007
- The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Establishing a Cohort to Clarify Risk and Protective Factors for Neurocognitive Complications of Pediatric Type 1 Diabetes (T1D) - Planning Cooperative Agreements (U34 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 2019-01-23.
- Applicants must submit their applications by 2019-04-11. (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 $225,000.00 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 this funding opportunity?
This opportunity is an NIH/NIDDK funding opportunity announcement (FOA) RFA-DK-18-007 that supports a planning-phase cooperative agreement using the U34 mechanism. The purpose is to fund the planning and build-out work needed to launch a future national, multi-site observational cohort study in pediatric type 1 diabetes (T1D), with a focus on neurocognitive complications.
Which NIH institute is sponsoring it?
The FOA is issued by the National Institutes of Health (NIH) through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
What is the main scientific goal of the planned cohort study?
The planned cohort is intended to prospectively clarify which factors increase risk for, or protect against, neurocognitive complications in children who develop type 1 diabetes, particularly when onset occurs in roughly the 5 to 10 year age range. The design also includes an appropriate comparison group without T1D (or other suitable comparators, as justified).
Is this award meant to fund the full national cohort study?
No. This is a planning award. It is intended to fund the groundwork required to launch a large, coordinated national cohort later. The U34 supports planning, design finalization, and operational readiness rather than the full-scale conduct of the long-term cohort itself.
Is a clinical trial allowed under this FOA?
No. The FOA is explicitly labeled "Clinical Trial Not Allowed." Applications are expected to propose observational research planning and infrastructure activities, not interventional clinical trials.
What does "planning-phase cooperative agreement (U34)" mean in practice?
It means the award supports structured planning activities and uses a cooperative agreement funding instrument. The cooperative agreement format signals substantial NIH programmatic involvement, so awardees should expect an active partnership with NIDDK staff as study plans are refined.
What are the three core purposes of this U34 planning mechanism?
The FOA describes three major purposes: (1) early peer review of the cohort study rationale and central questions; (2) rigorous assessment of key observational study design elements that affect interpretability and impact; and (3) development of essential operational components needed for a large, multi-site, longitudinal cohort.
What kinds of study design decisions are expected to be addressed during the planning period?
The planning work is expected to address design choices such as eligibility criteria, recruitment sources, timing and frequency of follow-up, selection of neurocognitive outcomes, strategies for measuring exposures and covariates, and the structure and justification of the comparison group.
What factors or exposures does the FOA highlight as examples for measurement in the future cohort?
Examples mentioned include glycemic metrics, hypoglycemia and hyperglycemia exposure, psychosocial factors, sleep, comorbidities, and socioeconomic context. These are presented as illustrative domains for exposure and covariate measurement strategies in the cohort design.
What operational deliverables is the planning award intended to produce?
The FOA emphasizes readiness-building deliverables such as a study protocol and manual of procedures, standardized methods across sites, data management and quality control systems, and analysis and governance plans to manage and interpret complex longitudinal data.
Does the FOA emphasize standardization across multiple sites?
Yes. A major emphasis is on building the concrete operational elements that enable a coordinated national, multi-site cohort, including standardization across sites and harmonization of core assessments and procedures.
What does the FOA say about neurocognitive and behavioral assessments?
It emphasizes building consensus on core neurocognitive and behavioral assessments so that measurements can be consistent and comparable across participating sites over time.
Are biospecimen or clinical data collection plans part of this planning effort?
The FOA notes aligning biospecimen or clinical data collection plans "if relevant." This indicates such elements may be included in planning when they fit the proposed cohort approach.
How does the FOA address participant retention for a long-term pediatric cohort?
It specifically calls out the need to design participant retention strategies that are suitable for children and families over years of follow-up, reflecting the practical realities of longitudinal pediatric observational research.
What policies does the FOA expect applicants to plan for (data sharing, publications, privacy)?
The FOA indicates planning should include clear policies for data sharing, publication, privacy protections, and cross-site coordination, as part of establishing governance for a national collaborative cohort.
Is early contact with NIDDK staff recommended before applying?
Yes. The FOA strongly encourages applicants to consult with NIDDK scientific staff prior to submission to discuss feasibility, scope, alignment with NIDDK priorities, and how the proposed planning activities will translate into a viable national cohort effort.
Why does the FOA encourage consultation with NIDDK scientific staff?
Based on the FOA description, early consultation can help prospective applicants clarify expectations around study organization and multi-site leadership, and address common cohort challenges such as harmonization of measures, minimizing bias, and ensuring the cohort reflects the diversity of children affected by T1D.
Who is eligible to apply?
Eligibility is broad and includes many types of government, academic, nonprofit, and private-sector entities. Examples listed include state/county/city/township governments, special district governments, independent school districts, public and private institutions of higher education, nonprofits with or without 501(c)(3) status, for-profit organizations (including small businesses and other than small businesses), federally recognized tribal governments and other tribal organizations, and public housing authorities/Indian housing authorities.
Are minority-serving institutions and other specific organization types listed as eligible?
Yes. The FOA highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, and TCCUs, among other groups such as eligible federal agencies, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and non-U.S. (foreign) entities.
Are non-U.S. (foreign) entities eligible to apply?
Yes. The eligibility list in the provided information explicitly includes non-U.S. (foreign) entities.
What type of funding instrument is used?
This is a discretionary grant opportunity using a cooperative agreement funding instrument.
How is this opportunity categorized administratively?
It is categorized under Food and Nutrition/Health and is associated with CFDA number 93.847.
What is the award ceiling listed in the posting?
The posting indicates an award ceiling of $225,000.
What are the key dates included in the provided information?
The FOA was created on 2019-01-23, and the original closing date was 2019-04-11.
Does the provided information state the expected number of awards?
No. The provided text notes that the notice does not specify the number of expected awards.
What kind of study is being planned: observational or interventional?
The planned study is an observational cohort study (not an interventional trial). The planning award supports observational research planning and the infrastructure needed for a future longitudinal cohort.
What population is the future cohort focused on?
The focus is on children who develop type 1 diabetes in roughly the 5 to 10 year age range, with attention to neurocognitive outcomes and a comparison group without T1D (or otherwise suitable comparators as justified).
What is the overarching intent of the FOA?
The intent is to seed the planning work needed for a later, larger-scale national observational cohort by supporting strong scientific justification, robust design decisions, and operational readiness for a multi-site longitudinal study on pediatric T1D and neurocognitive complications.
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