Opportunity Information: Apply for RFA DK 22 036
The NIH funding opportunity RFA-DK-22-036 supports the creation of a coordinated, multi-site research consortium focused on how gastrointestinal (GI) symptoms and gut-brain communication may contribute to the earliest stages and underlying biology of Parkinsons disease (PD). Using the U01 cooperative agreement mechanism (clinical trial not allowed), the program is designed to bring multiple clinical research projects together with a central Coordinating Center so that participating sites operate as a single, standardized network rather than as isolated studies. The overall aim is to speed up progress on GI-related pathways in PD and translate that progress into practical, early-phase diagnostic approaches and biomarkers that are grounded in GI biology and gut-brain signaling.
At the heart of the initiative is a push for well-powered, harmonized clinical research. The consortium is expected to recruit enough participants across sites to enable meaningful comparisons and robust analyses, while using shared protocols for collecting clinical data and biospecimens that matter to both neurology and gastroenterology research. The research centers will function as enrollment and sampling sites for several key groups: people with Parkinsons disease who do and do not have GI symptoms, individuals who have GI symptoms thought to place them at higher risk for developing PD, and healthy age-matched control participants. Samples and clinical information gathered from these groups are intended to support laboratory-based investigations that clarify mechanisms, identify measurable biological signals, and strengthen or refute proposed gut-brain links in PD initiation and progression.
A major expectation is broad sharing and public availability of what the consortium generates. Beyond typical publication, the program emphasizes that data, biomaterials, models, reagents, resources, and methods should be shared among consortium projects and then made accessible to the wider scientific community through the Coordinating Center. In practice, this means the consortium is expected to operate with a strong team-science mindset: common data elements, standardized biospecimen handling, consistent clinical phenotyping, and coordinated governance that enables rapid internal exchange and eventual external dissemination. The goal is to create resources that other investigators can reuse and build on, reducing duplication and making findings easier to validate across cohorts and settings.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is a key NIH institute behind the effort, reflecting the strong GI component and the need to integrate digestive health expertise with movement-disorders neurology. The FOA also highlights NIH priorities around inclusive and representative research. Applicants are strongly encouraged to incorporate research on sex and gender differences, sexual and gender minority-related research, and race and ethnic diversity, aligning with NIDDK guidance (referenced as NOT-DK-22-003). This emphasis signals that the consortium should be designed to capture variation in PD presentation and GI symptoms across populations, and to ensure that any resulting diagnostic tools or biomarkers are more likely to generalize and avoid widening existing health disparities.
From an administrative standpoint, this is a discretionary NIH opportunity using the cooperative agreement model, which typically involves substantial NIH scientific and programmatic involvement compared with standard investigator-initiated grants. The activity sits broadly within health and nutrition-related categories and is associated with CFDA number 93.847. The posted award ceiling is $300,000, with an original closing date of 2023-11-15 and a creation date of 2023-07-31. Because it is labeled "Clinical Trial Not Allowed," applications should focus on clinical research and human participant studies that do not meet NIH’s definition of a clinical trial (for example, they should not prospectively assign participants to interventions to evaluate health-related outcomes), while still allowing rigorous observational, mechanistic, and biomarker-focused work in clinically characterized cohorts.
Eligibility is broad and includes many domestic organization types such as state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities. The FOA also explicitly calls out categories of organizations that are encouraged or included as eligible applicants, such as HBCUs, Hispanic-serving institutions, AANAPISIs, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, the opportunity limits foreign participation: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S.-led application may still include certain allowable foreign elements when justified and compliant with NIH policy.
Overall, the opportunity is best understood as an NIH-driven effort to unify clinical cohort building, GI and neurologic phenotyping, biospecimen collection, and open-resource generation around a specific hypothesis space: that PD may be initiated or shaped by GI dysfunction and altered gut-brain communication, and that these signals could be leveraged for earlier detection and better biomarkers. The consortium structure is intended to make studies larger, more comparable, and more reusable than typical single-site projects, while accelerating the field through coordinated operations and required data and resource sharing.Apply for RFA DK 22 036
- The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "A Consortium for Gut-Brain Communication in Parkinsons Disease (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 2023-07-31.
- Applicants must submit their applications by 2023-11-15. (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 $300,000.00 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) - NIH RFA-DK-22-036
1) What is RFA-DK-22-036 trying to fund?
RFA-DK-22-036 supports the creation of a coordinated, multi-site research consortium focused on how gastrointestinal (GI) symptoms and gut-brain communication may contribute to the earliest stages and underlying biology of Parkinsons disease (PD). The intent is to unify clinical cohort building, GI and neurologic phenotyping, biospecimen collection, and shared resource generation around GI-related pathways in PD, with the goal of accelerating early-phase diagnostic approaches and GI-grounded biomarkers.
2) What kind of grant mechanism is used?
The opportunity uses the NIH U01 cooperative agreement mechanism. A cooperative agreement generally indicates substantial NIH scientific and programmatic involvement compared with standard investigator-initiated awards.
3) Are clinical trials allowed under this FOA?
No. The FOA is labeled "Clinical Trial Not Allowed." Applications should be designed around clinical research and human participant studies that do not meet the NIH definition of a clinical trial, meaning they should not prospectively assign participants to interventions to evaluate health-related outcomes. Observational, mechanistic, and biomarker-focused studies in clinically characterized cohorts are aligned with the description provided.
4) What is the overall structure expected for funded projects?
The program is designed to bring multiple clinical research projects together with a central Coordinating Center. Participating sites are expected to operate as one standardized network rather than as isolated studies, using shared protocols and harmonized operations across the consortium.
5) What role does a Coordinating Center play?
Based on the FOA description, the Coordinating Center is expected to enable consortium-wide coordination and standardization, and to support broad sharing and public availability of what the consortium generates. This includes organizing common data elements, standardized biospecimen handling, consistent clinical phenotyping, coordinated governance, and dissemination of data and resources to the broader scientific community.
6) What participant groups is the consortium expected to enroll?
The consortium is expected to recruit and collect data/samples from several key groups across sites, including:
- People with Parkinsons disease who have GI symptoms
- People with Parkinsons disease who do not have GI symptoms
- Individuals with GI symptoms thought to place them at higher risk for developing PD
- Healthy age-matched control participants
7) Why does the FOA emphasize multi-site recruitment and large sample sizes?
The initiative highlights "well-powered, harmonized clinical research." Multi-site recruitment is intended to help the consortium enroll enough participants to enable meaningful comparisons and robust analyses, while also improving the generalizability and validation potential of findings through standardized, comparable methods.
8) What types of data and samples are expected to be collected?
The FOA emphasizes shared protocols for collecting clinical data and biospecimens relevant to both neurology and gastroenterology research. The specific sample types are not enumerated in the provided description, but the intent is clear: collect clinically meaningful information and biospecimens that support mechanistic and biomarker investigations related to GI biology and gut-brain signaling in PD.
9) What is meant by "gut-brain communication" in the context of this consortium?
Within this opportunity, gut-brain communication refers to biological signaling and interactions between the gastrointestinal system and the nervous system that may contribute to PD initiation and progression. The consortium is intended to generate human clinical data and biospecimens that can be used to clarify mechanisms and identify measurable biological signals that support or challenge proposed gut-brain links.
10) What are the intended scientific outputs of the consortium?
The FOA is oriented toward outputs that can accelerate the field, including early-phase diagnostic approaches and biomarkers grounded in GI biology and gut-brain signaling. In addition, it emphasizes generation of broadly usable resources such as datasets, biomaterials, models, reagents, resources, and methods.
11) How important is standardization across sites?
Standardization is a central expectation. The consortium is intended to operate as a single, standardized network with common data elements, standardized biospecimen handling, and consistent clinical phenotyping. This is meant to reduce duplication, make results easier to compare, and improve the ability of others to validate findings across cohorts and settings.
12) What does the FOA require or encourage about data and resource sharing?
The program places major emphasis on broad sharing and public availability. Beyond publishing results, the consortium is expected to share data, biomaterials, models, reagents, resources, and methods among consortium projects and then make them accessible to the wider scientific community through the Coordinating Center.
13) Is this initiative focused more on neurology or gastroenterology?
It is intentionally integrated across both. The FOA focuses on GI symptoms and digestive-system biology as they relate to PD, while also requiring clinically meaningful characterization relevant to neurology. The presence of NIDDK as a key NIH institute behind the effort underscores the GI component and the need to integrate digestive health expertise with movement-disorders neurology.
14) Which NIH institute is specifically highlighted in the opportunity?
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is highlighted as a key NIH institute behind the effort.
15) What does the FOA say about inclusion and representativeness in research design?
The FOA highlights NIH priorities around inclusive and representative research. Applicants are strongly encouraged to incorporate research on sex and gender differences, sexual and gender minority-related research, and race and ethnic diversity, aligning with NIDDK guidance referenced as NOT-DK-22-003. The intent is to capture variation in PD presentation and GI symptoms across populations and to reduce the risk that resulting tools or biomarkers fail to generalize or worsen disparities.
16) What is the award ceiling listed for this opportunity?
The posted award ceiling is $300,000.
17) What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.847.
18) What are the key dates mentioned for this funding opportunity?
The creation date is 2023-07-31, and the original closing date is 2023-11-15.
19) What types of organizations are eligible to apply?
Eligibility is broad and includes many domestic organization types, such as:
- State, county, and local governments
- Public and private institutions of higher education
- Federally recognized tribal governments and other tribal organizations
- Public housing authorities
- Nonprofits (with or without 501(c)(3) status)
- For-profit organizations (other than small businesses) and small businesses
- Other eligible entities listed in the FOA description
20) Are any specific institution types called out as eligible or encouraged?
Yes. The FOA explicitly calls out categories of organizations that are encouraged or included as eligible applicants, including HBCUs, Hispanic-serving institutions, AANAPISIs, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.
21) Can foreign institutions apply as the main applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply.
22) Can a U.S. organization include work performed outside the United States?
The FOA states that non-domestic components of U.S. organizations are not eligible to apply. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S.-led application may include certain allowable foreign elements when justified and compliant with NIH policy.
23) What is the practical reason the FOA emphasizes open sharing and public availability?
The stated purpose is to create reusable resources that other investigators can build on, reducing duplication and making findings easier to validate across cohorts and settings. The expectation is that coordinated operations plus sharing will accelerate progress more than isolated studies.
24) What is the main hypothesis area this consortium is meant to investigate?
The opportunity is centered on the idea that PD may be initiated or shaped by GI dysfunction and altered gut-brain communication, and that these signals could be leveraged for earlier detection and better biomarkers. The consortium is intended to generate harmonized human clinical evidence to strengthen or refute proposed gut-brain links in PD initiation and progression.
25) What research category is this opportunity associated with?
The activity sits broadly within health and nutrition-related categories, consistent with the GI and systemic biology focus described.
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