Small Vessel VCID Biomarkers Validation Consortium Coordinating Center (U24 Clinical Trial Not Allowed) | RFA NS 22 017

Opportunity Information: Apply for RFA NS 22 017

This NIH/NINDS funding opportunity (RFA-NS-22-017) supports a single Coordinating Center for the next phase of the Small Vessel Vascular Contributions to Cognitive Impairment and Dementia (VCID) Biomarkers Consortium. The consortium was originally launched under earlier RFAs (RFA-NS-16-019 and RFA-NS-16-020), and this new phase is focused on moving beyond initial biomarker development to the more demanding step of clinical validation. In practical terms, the funded Coordinating Center is expected to provide the organizational and scientific backbone that allows multiple research sites (funded separately under a companion FOA, RFA-NS-20-005) to operate as one coherent program aimed at validating small vessel disease-related biomarkers for VCID.

The core goal is to complete clinical validation of biomarkers that were developed during the first five-year cycle of the program. Validation here is about demonstrating that the biomarkers perform reliably and meaningfully in real-world, clinically relevant settings, and that they can be used for specific, well-defined purposes (often described as a "context of use"). The intent is to position these biomarkers for downstream use in future clinical trials, including large phase III studies, and to ensure they are applicable to general and diverse populations rather than narrow or highly selected samples. The broader scientific motivation is to speed progress in understanding, diagnosing, and eventually treating VCID related to small vessel disease by making the biomarker toolkit more mature, consistent, and trial-ready.

Structurally, the Coordinating Center must include two major components. First is an Administrative Core, which is responsible for the day-to-day and strategic coordination of consortium activities. That typically means organizing meetings, maintaining shared timelines and milestones, coordinating communication across participating sites, handling governance and decision-making processes, tracking progress, and generally ensuring the consortium functions efficiently and stays aligned with its validation objectives. Second is a Data Core, which has the central responsibility for coordinating data flow across the consortium. This includes receiving and managing data submissions from the sites, collecting and curating those data into usable formats, and enabling data sharing across the program. A key element explicitly mentioned is the handling and sharing of de-identified clinical data, indicating that the Data Core must be built to support privacy-protective workflows while still enabling robust multi-site analyses.

Because this is a cooperative agreement (U24), NIH expects substantial programmatic involvement, meaning the awardee will not simply execute an independent project but will collaborate closely with NIH staff and the consortium sites under a coordinated governance structure. The FOA is also labeled "Clinical Trial Not Allowed," which signals that the Coordinating Center award itself is not intended to run an interventional clinical trial; its role is infrastructure, coordination, and scientific support for biomarker validation activities rather than testing interventions in human subjects as a clinical trial.

Eligibility is broad across U.S.-based organizations, spanning state and local governments, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, independent school districts, special district governments, public housing authorities/Indian housing authorities, and federally recognized Native American tribal governments and certain tribal organizations. The FOA also highlights additional eligible applicant types such as HBCUs, Hispanic-serving institutions, AANAPISIs, Tribal Colleges and Universities, and faith-based or community-based organizations, reflecting NIH interest in inclusive participation. At the same time, there are strict limits on foreign involvement: non-U.S. entities and foreign institutions are not eligible, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.

Administratively, the opportunity is issued by the National Institutes of Health under CFDA 93.853, categorized under health research, and uses the discretionary funding mechanism. The original closing date listed is November 12, 2021, and the FOA creation date is September 10, 2021. The posted excerpt does not provide an award ceiling or expected number of awards, but the structure implies a focused competition for a single Coordinating Center that can serve as the operational hub for the consortium-wide validation effort.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Small Vessel VCID Biomarkers Validation Consortium Coordinating Center (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): 93.853.
• This funding opportunity was created on 2021-09-10.
• Applicants must submit their applications by 2021-11-12. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 NS 22 017

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