A Consortium for Gut-Brain Communication in Parkinsons Disease (U24 Clinical Trial not allowed) | RFA DK 23 001

Opportunity Information: Apply for RFA DK 23 001

This NIH funding opportunity (RFA-DK-23-001) supports the creation of a Gut Brain Parkinsons Disease Consortium focused on understanding how gastrointestinal dysfunction and gut-brain communication relate to Parkinsons disease. The scientific premise behind the program is that Parkinsons is not only a movement disorder; gastrointestinal complaints are extremely common in people who go on to develop Parkinsons and can show up years before classic motor symptoms. Because these early GI symptoms may reflect underlying disease processes, the gut is being treated here as a potentially valuable window for earlier diagnosis, better tracking of disease progression, and ultimately new therapeutic targets.

The award mechanism is a U24 cooperative agreement, which means the NIH expects to be actively involved in steering and oversight rather than simply issuing funds and stepping back. Clinical trials are not allowed under this announcement, so the center being proposed should be designed around observational clinical research infrastructure, standardized data and biospecimen collection, and consortium-enabled analyses rather than interventional testing. The project being solicited is specifically the Consortiums Data Coordinating Center (DCC), which will serve as the operational and analytic hub for multiple participating research sites known as Gastroenterology Neurology Research Centers (GNRCs) that are being funded under a companion FOA (RFA-DK-22-036).

The core mission of the DCC is to make a multicenter program run smoothly and produce high-quality, harmonized datasets and biospecimen resources that can answer questions about etiology and pathogenesis. In practical terms, the DCC is expected to coordinate collaboration across the GNRC sites, support and monitor participant enrollment across the network, and manage standardized submission of data and biological materials into central repositories. That includes organizing the flow of clinical data, cellular and molecular measurements, and associated metadata into central databases, along with coordinating biospecimen processing workflows so that samples collected at different sites remain comparable and usable for downstream analyses. The DCC is also expected to conduct and/or coordinate data analysis for the consortium, which implies leadership in data standards, quality control, integration across modalities, and cross-site analytic planning.

A major operational responsibility is governance: the DCC will run the Steering Committee and other committees needed to operate the consortium. This typically includes scheduling and supporting meetings, maintaining documentation, tracking decisions and action items, managing protocol and manual-of-operations updates, and ensuring consistent implementation across sites. The DCC is also charged with providing the infrastructure required for efficient multicenter study conduct, which commonly covers data management systems, common data elements, case report forms, data dictionaries, regulatory coordination support, reporting, and the day-to-day project management functions that keep timelines and deliverables on track. Another key deliverable is establishing and maintaining a repository of patient samples intended to support ancillary studies, meaning the consortium is designed not just for immediate analyses but also to build a durable resource that other approved projects can use to rapidly explore new hypotheses about how the gut and nervous system interact in Parkinsons.

In addition to supporting the main study operations, the DCC will coordinate development of pilot projects that allow consortium members to quickly follow up on emerging findings. These pilots are meant to accelerate the science by enabling rapid testing of promising leads, leveraging the shared infrastructure, standardized measures, and access to well-characterized participants and specimens across multiple sites.

Eligibility is broad and includes many types of U.S.-based organizations: state, county, city, and special district 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. The FOA also explicitly highlights additional applicant categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions, along with faith-based or community-based organizations and eligible federal agencies. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible; however, foreign components as defined by the NIH Grants Policy Statement are allowed, meaning limited, well-justified international involvement can be included under NIH rules even though the applicant organization must be domestic.

Administrative details provided include an original closing date of November 15, 2023, an award ceiling of $400,000, and an expected number of awards that is not specified in the provided text. The activity aligns with NIH program areas in health and related biomedical research (CFDA 93.847). Overall, the opportunity is aimed at building the coordinating backbone for a national, multicenter effort that treats GI dysfunction and gut-derived biology as central to understanding Parkinsons, with an emphasis on high-quality shared data, shared specimens, and rapid collaborative science rather than interventional clinical trials.

• 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 (U24 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 $400,000.00 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.

Apply for RFA DK 23 001

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