Data Harmonization, Curation and Secondary Analysis of Existing Clinical Datasets (R61/R33 Clinical Trial Not Allowed) | RFA NS 20 007

Opportunity Information: Apply for RFA NS 20 007

The National Institutes of Health (NIH), through the National Institute of Neurological Disorders and Stroke (NINDS), offered this discretionary grant opportunity titled "Data Harmonization, Curation and Secondary Analysis of Existing Clinical Datasets (R61/R33 Clinical Trial Not Allowed)" under funding opportunity number RFA-NS-20-007 (CFDA 93.853). The focus is on getting more scientific value out of data that already exist by supporting multidisciplinary teams that can combine, standardize, and analyze datasets drawn from at least two separate multi-site clinical research projects. Rather than funding new participant enrollment or prospective trials, the program is explicitly aimed at secondary analyses that test well-justified scientific and clinical hypotheses relevant to neurological disorders and other conditions within the NINDS mission. As indicated by "Clinical Trial Not Allowed," the work should not involve initiating a clinical trial; it should center on reusing existing clinical research data.

A defining feature of this opportunity is its phased R61/R33 structure, which is designed to reduce risk and ensure that the underlying data foundation is strong before major hypothesis testing begins. In the first phase (R61), applicants are expected to carry out systematic, comprehensive cross-project data harmonization and curation. This typically means aligning variable definitions, coding schemes, data dictionaries, timepoints, outcome measures, and metadata across different studies so the datasets can be meaningfully combined or compared. Progression to the second phase (R33) depends on meeting predefined Go/No-go milestones that evaluate data quality and readiness. In practice, these milestones function as objective checks that the harmonized datasets are accurate, complete enough for the intended analyses, internally consistent, and properly documented. Only after those harmonization and curation benchmarks are achieved does the program anticipate supporting the second phase, which is where the more intensive secondary analyses would occur.

The FOA also places strong emphasis on modern data stewardship and transparency, specifically aligning expectations with the FAIR data principles: findable, accessible, interoperable, and reusable. Applicants are expected to openly catalog the processes and tools they use for harmonization, curation, and analysis, with an open-source orientation. This is meant to make the work reproducible and to let other researchers learn from, reuse, or extend the harmonization approaches rather than repeating them from scratch. At the same time, because these are clinical datasets that may contain sensitive participant information, the FOA anticipates controlled access to the curated datasets rather than unrestricted public release. In other words, the program pushes for maximum responsible sharing: detailed, transparent methods and tooling, plus curated data made available through appropriate access controls that protect privacy and comply with applicable policies.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants listed include 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; Native American tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as specified); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

There are important restrictions related to non-U.S. participation. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are stated as not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components (as defined in the NIH Grants Policy Statement) are allowed. This distinction typically means a U.S. applicant institution can include certain foreign collaborations or activities as components of the project when permitted by NIH policy, even though a foreign institution cannot serve as the primary applicant.

From a practical standpoint, a competitive project under this FOA would be expected to bring together expertise in clinical domain science (neurology and the specific disorder area), biostatistics and epidemiology, data science, informatics, and data management/governance. The team would need access to the qualifying existing datasets from two or more multi-site projects, a clear plan for how harmonization will be performed and validated, explicit Go/No-go metrics for assessing whether the curated data are fit for purpose, and a rigorous analysis plan that can answer meaningful hypotheses once the harmonized dataset is ready. Administrative details in the source information note the agency as NIH, the original closing date as March 17, 2020, and the FOA creation date as October 30, 2019. The award ceiling and expected number of awards are not specified in the provided text.

• 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 2019-10-30.
• Applicants must submit their applications by 2020-03-17. (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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