Prospective Observational Comparative Effectiveness Research in Clinical Neurosciences (UG3/UH3 Clinical Trial Not Allowed) | PAR 25 048

Opportunity Information: Apply for PAR 25 048

The National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health, is soliciting applications for investigator-initiated prospective observational comparative effectiveness research (CER) in the clinical neurosciences under a cooperative agreement mechanism. The opportunity is titled "Prospective Observational Comparative Effectiveness Research in Clinical Neurosciences (UG3/UH3 Clinical Trial Not Allowed)" and is published as PAR-25-048. Its core aim is to support real-world, forward-looking (prospective) observational studies that compare the effectiveness of different clinical approaches in neurology and related neurosciences, with an emphasis on producing evidence that can inform and improve current clinical practice.

A key point is that this funding is for observational CER rather than clinical trials, meaning the work should not involve assigning participants to interventions as part of the study design. Instead, researchers are expected to observe and analyze outcomes associated with preventive strategies, diagnostic approaches, and interventions that patients and clinicians are already receiving or choosing in routine care. The scope of what may be evaluated is broad and can include drugs, biologics, medical devices, surgical approaches, behavioral treatments, and rehabilitation therapies, as long as the central questions align with the NINDS mission and research priorities (as described on the NINDS website). The announcement also signals a practical orientation: proposed studies should be a cost-effective way to collect data that has a meaningful bearing on real clinical decisions, rather than being primarily exploratory or detached from everyday care.

The award structure uses a two-phase UG3/UH3 model and must be submitted as a single, integrated application that covers both phases. The first phase (UG3) is a milestone-driven planning period of up to two years. This stage is designed to reduce risk and ensure feasibility before the full observational study is launched. During UG3, applicants can conduct scientific planning activities such as small-scale data collection to test whether key elements of the study are feasible and acceptable, including data collection methods, data storage processes, and the planned analytic approach. The UG3 phase also requires substantial operational planning, including the development of recruitment and retention strategies, creation of case report forms, and building or refining the data management system and other tools needed for data and quality management. Transition to the second phase is not automatic; only projects that meet the predefined scientific milestones and feasibility requirements are eligible to move forward.

The second phase (UH3) can provide up to five years of support to conduct the full-scale prospective observational study. This is the execution phase where enrollment, follow-up, data capture, and the primary analyses occur, guided by the infrastructure and protocols established during UG3. Because this is a cooperative agreement, awardees should expect a more substantial level of programmatic involvement from NIH/NINDS compared with a standard research grant, particularly around milestones, progress oversight, and adherence to agreed-upon plans for study conduct and data quality.

Eligibility is broad and includes many types of domestic and non-domestic organizations. Applicants may include state, county, city, township, and special district governments; independent school districts; public housing authorities; public and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized governments; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); small businesses; and other entities. The announcement also explicitly highlights eligibility for a range of community-based and historically underrepresented institution types, including 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, U.S. territories or possessions, and non-U.S. (foreign) organizations.

Administratively, the opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument. The CFDA/assistance listing number associated with this program area is 93.853. The original closing date listed is 2025-09-07, and the opportunity record indicates a creation date of 2025-01-08. The posted summary does not specify an award ceiling or expected number of awards, which typically means applicants should consult the full funding opportunity announcement and related NIH guidance for budget expectations, institute-specific constraints, and any additional review or submission requirements.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Prospective Observational Comparative Effectiveness Research in Clinical Neurosciences (UG3/UH3 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 2025-01-08.
• Applicants must submit their applications by 2025-09-07. (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 25 048

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