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.Apply for PAR 22 055
- 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.
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Frequently Asked Questions (FAQs)
What is this NIH funding opportunity?
This opportunity is a National Institutes of Health (NIH) Notice of Funding Opportunity (NOFO) titled "Data Harmonization, Curation and Secondary Analysis of Existing Clinical Datasets (R61/R33 Clinical Trial Not Allowed)" (PAR-22-055; CFDA 93.853). It supports projects that increase scientific value from existing clinical research datasets by harmonizing and curating them across studies and then conducting secondary analyses tied to neurological disorders and conditions within the mission of the National Institute of Neurological Disorders and Stroke (NINDS).
What is the main purpose of the program?
The program is designed to support multidisciplinary teams that can (1) systematically harmonize and curate data from multiple clinical research projects and (2) use the resulting integrated datasets to test well-defined scientific and clinical hypotheses relevant to NINDS-focused neurological disorders and conditions.
Does this program fund new clinical trials?
No. The NOFO is explicitly a secondary analysis mechanism and states "Clinical Trial Not Allowed." The work must rely on existing clinical datasets rather than initiating a new clinical trial.
How many datasets or projects must be included?
Applications are expected to combine and rework data from at least two separate multi-site clinical research projects.
What does "multi-site" mean in this context?
Based on the NOFO summary, the datasets should come from clinical research projects conducted across multiple sites, which is one reason harmonization is needed (differences in measurement, coding, and implementation across sites can limit direct pooling without careful curation).
What kinds of research questions are encouraged?
The NOFO emphasizes hypothesis-driven secondary analyses that address neurological disorders and conditions aligned with the mission of NINDS. The intent is to enable cross-study analyses that may reveal patterns and answers that single studies are often underpowered or too narrow to detect.
What is the R61/R33 phased structure?
This NOFO uses a phased award mechanism:
- R61 phase: systematic, comprehensive cross-project data harmonization and curation.
- R33 phase: secondary analyses using the curated, harmonized datasets to test the proposed hypotheses.
The phased structure is intended to reduce risk by ensuring the foundational data work is strong before substantial hypothesis testing begins.
What is expected during the R61 phase?
During R61, applicants are expected to carry out cross-project data harmonization and curation. The summary describes work such as aligning variables and definitions across studies, standardizing formats and coding schemes, documenting provenance and data transformations, and ensuring datasets can be meaningfully combined or compared.
What determines whether a project moves from R61 to R33?
Progression from R61 to R33 depends on meeting pre-specified Go/No-go data-quality metrics. Applicants are expected to define objective criteria up front for what is considered "good enough to analyze" and then demonstrate those criteria are met before entering the main analysis phase.
What are examples of Go/No-go data-quality metrics mentioned in the summary?
The summary provides examples such as completeness thresholds, concordance checks across sites, reliability of key measures, and validation of harmonization rules. The NOFO expectation is that applicants define these criteria in advance and use them to justify readiness for hypothesis testing.
What happens in the R33 phase?
The R33 phase supports the actual secondary analyses of the curated, harmonized datasets to answer the proposed neurological research questions and test the proposed hypotheses.
What types of expertise does NIH/NINDS appear to be looking for?
The summary emphasizes multidisciplinary teams capable of both (1) informatics-heavy harmonization/curation work and (2) rigorous statistical and clinical interpretation for credible secondary analyses.
What does "data harmonization" mean here?
In this context, harmonization refers to making data from different studies meaningfully comparable or combinable. The summary highlights aligning variables and definitions, standardizing formats and coding schemes, documenting provenance and transformations, and validating that harmonization rules work as intended.
What does "data curation" mean here?
Based on the summary, curation includes systematic organization and documentation of the datasets, including provenance and transformation records, to produce a high-quality integrated resource that can support robust secondary analysis and future reuse.
Does the program expect outputs beyond statistical results?
Yes. The NOFO emphasizes that harmonization and curation are core scientific products. It also emphasizes documenting and sharing the methods, pipelines, and decision rules that enable cross-study integration.
How does the NOFO address FAIR data principles?
The summary states strong alignment with FAIR principles: findable, accessible, interoperable, and reusable. Applicants are expected to use open-source cataloging of the processes and tools used for harmonization, curation, and analysis, so the work can be reproduced or extended by others.
Does FAIR mean the curated datasets must be publicly downloadable by anyone?
Not necessarily. The summary anticipates that, because these are clinical datasets with potentially sensitive participant information, the curated datasets may require controlled access rather than unrestricted public release.
What does "controlled access" imply for these clinical datasets?
The summary indicates controlled access generally implies formal governance such as data use agreements, data access committees, or repository-controlled permissions. The goal is broad scientific reuse while protecting privacy and respecting consent and regulatory requirements.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organization types, including (as listed in the summary):
- 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)
- Small businesses
Are there additional eligible applicant categories highlighted?
Yes. The summary also highlights Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
Can a foreign institution apply as the main applicant?
No. The summary states that foreign institutions (non-U.S. entities) are not eligible to apply as the applicant organization.
Can international collaborators still participate?
Yes, with important distinctions noted in the summary: non-domestic components of U.S. organizations are eligible, and foreign components (as NIH defines them in the NIH Grants Policy Statement) are allowed. This supports including international collaborators or conducting parts of the work abroad while keeping the applicant institution U.S.-based.
What is the administrative nature of this program?
The summary describes it as a discretionary grant program under NIH.
What are the key dates mentioned?
The summary lists an original closing date of 2023-03-22 and states the FOA was created on 2021-11-16.
Is an award ceiling or number of awards specified in the provided information?
No. The summary explicitly notes that it does not specify an award ceiling or expected number of awards, and suggests applicants consult the full FOA text and related NINDS/NIH budget guidance for likely funding range, allowable costs, and project period expectations for each phase.
Why is NIH/NINDS emphasizing harmonization and curation so heavily?
The summary frames a common bottleneck: valuable clinical datasets exist, but differences in study design, outcome measurement, and data recording often prevent straightforward pooled analyses. The NOFO treats rigorous harmonization and curation as central deliverables and uses a phased mechanism with Go/No-go gates to ensure the integrated datasets are validated and reusable before deeper hypothesis testing proceeds.
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