Data Harmonization, Curation and Secondary Analysis of Existing Clinical Datasets (R61/R33 Clinical Trial Not Allowed) | PAR 22 055

Opportunity Information: Apply for PAR 22 055

The National Institutes of Health (NIH), through a Notice of Funding Opportunity titled "Data Harmonization, Curation and Secondary Analysis of Existing Clinical Datasets (R61/R33 Clinical Trial Not Allowed)" (PAR-22-055; CFDA 93.853), is soliciting grant applications focused on getting more scientific value out of clinical research data that already exist. The central idea is to support multidisciplinary teams that can combine and rework data from at least two separate multi-site clinical research projects, then use those harmonized datasets to test well-defined scientific and clinical hypotheses tied to neurological disorders and conditions that fall within the mission of the National Institute of Neurological Disorders and Stroke (NINDS). This is explicitly a secondary analysis opportunity, meaning the work relies on existing clinical datasets rather than launching a new clinical trial, and the FOA states "Clinical Trial Not Allowed."

A key feature of this opportunity is its phased R61/R33 structure, which is designed to reduce risk and make sure the foundational data work is solid before substantial hypothesis testing begins. In the first phase (R61), applicants must carry out systematic, comprehensive cross-project data harmonization and curation. That typically includes aligning variables and definitions across studies, standardizing formats and coding schemes, documenting provenance and data transformations, and ensuring that datasets can be meaningfully combined or compared. Progression to the second phase (R33) depends on meeting pre-specified Go/No-go data-quality metrics. In practical terms, NINDS expects applicants to define objective criteria up front for what "good enough to analyze" looks like (for example, completeness thresholds, concordance checks across sites, reliability of key measures, or validation of harmonization rules), and then demonstrate that those criteria are met before moving into the main analysis phase.

The second phase (R33) supports the actual analyses of the curated, harmonized datasets to answer the proposed neurological research questions. The FOA is geared toward teams that can manage both the informatics-heavy work of harmonization and the rigorous statistical and clinical interpretation needed for credible secondary analyses. Because the datasets come from different multi-site projects, this mechanism is essentially encouraging investigators to create higher-value, cross-study resources that can reveal patterns and answers that single studies are often underpowered or too narrow to detect.

Another major expectation is strong alignment with FAIR data principles: findable, accessible, interoperable, and reusable. The FOA emphasizes open-source cataloging of the processes and tools used for harmonization, curation, and analysis. In other words, applicants are expected not only to produce results, but also to document and share the methods, pipelines, and decision rules that made the cross-study integration possible, so that others can reproduce or extend the work. At the same time, because these are clinical datasets and may involve sensitive participant information, the FOA anticipates controlled access to the curated datasets rather than unrestricted public release. This generally implies formal data access governance (such as data use agreements, data access committees, or repository-controlled permissions) that still promotes broad scientific reuse while protecting privacy and respecting participant consent and regulatory requirements.

Eligibility is broad and includes many types of U.S.-based organizations: state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply as the applicant organization, but non-domestic components of U.S. organizations are eligible, and foreign components (as NIH defines them in the NIH Grants Policy Statement) are allowed. That distinction matters for teams that want to include international collaborators or perform parts of the work abroad while keeping the applicant institution U.S.-based.

Administratively, this is a discretionary grant program under NIH. The original closing date listed is 2023-03-22, and the FOA was created on 2021-11-16. The provided summary does not specify an award ceiling or expected number of awards, so applicants typically would need to consult the full FOA text and related NINDS/NIH budget guidance to understand the likely funding range, allowable costs, and project period expectations for each phase.

Overall, this opportunity is aimed at solving a common bottleneck in neurological research: valuable clinical datasets exist, but differences in how studies were designed, how outcomes were measured, and how data were recorded often prevent straightforward pooled analyses. NINDS is signaling that rigorous harmonization and curation are not optional preliminaries but a core scientific product, and it is using the phased R61/R33 approach with Go/No-go quality gates to ensure that only well-validated, reusable integrated datasets move forward into the deeper hypothesis-driven analyses.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Data Harmonization, Curation and Secondary Analysis of Existing Clinical Datasets (R61/R33 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 2021-11-16.
• Applicants must submit their applications by 2023-03-22. (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 PAR 22 055

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: