Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed) | PAR 25 283

Opportunity Information: Apply for PAR 25 283

The Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed) opportunity, identified as PAR-25-283, is a discretionary NIH grant program run under the National Institute of Mental Health (NIMH) within the U.S. Department of Health and Human Services. It uses the R01 research project grant mechanism and sits in the health funding activity area under CFDA 93.242. The central goal is to support innovative mental health services research that strengthens how mental health services are delivered in real-world settings, with an emphasis on building systems that can maintain high quality while also continuously improving over time. The focus is not on testing clinical interventions through clinical trials; instead, it is designed for research that generates evidence to improve service delivery, access, quality, effectiveness, and implementation at scale for people who have mental illnesses or who are at risk of developing them.

At a practical level, this NOFO is aimed at research that aligns with NIMH strategic priorities in mental health services research. That framing typically points to projects that can inform decisions made by service systems (such as clinics, hospitals, schools, community programs, justice settings, public health agencies, and other care networks), and that help those systems serve more people more effectively. The language about benefiting the greatest number of individuals signals an interest in work that can generalize, scale, and be sustained, rather than narrow studies that only apply to a small, highly controlled context. It also highlights the idea of learning systems and ongoing quality improvement, meaning research that helps services adapt, measure performance, and improve outcomes in a continuous cycle rather than as a one-time upgrade.

This announcement explicitly excludes clinical trials, so applicants are expected to propose studies that do not meet the NIH definition of a clinical trial (for example, not prospectively assigning people to interventions to evaluate health-related outcomes). Instead, strong fits often include observational or analytic studies, services research methods, evaluations of service delivery models where the project is not designed as a clinical trial, policy or financing analyses, implementation and dissemination research approaches that remain outside the clinical-trial definition, modeling and simulation work, data science approaches using existing data sources, and systems-level investigations into how to optimize care pathways and coordination. The key is that the research should produce actionable knowledge that improves mental health service delivery, quality, equity, reach, and real-world performance, without being framed as a clinical trial testing an intervention.

Eligibility is broad and includes many types of organizations that participate in mental health services or research. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; and public housing authorities or Indian housing authorities. Higher education institutions are eligible, including public/state-controlled and private institutions. Tribal eligibility includes federally recognized Native American tribal governments and Native American tribal organizations that are not federally recognized, and the NOFO also calls out Indian/Native American Tribal Governments (Other than Federally Recognized) as additional eligible applicants. Nonprofits may apply whether they have 501(c)(3) status or not (as long as they are not institutions of higher education), and for-profit organizations are eligible (other than small businesses, which are also eligible separately). The NOFO also highlights a set of additional eligible applicant categories that NIMH is explicitly welcoming, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and even non-U.S. entities (foreign organizations). That breadth suggests NIMH is interested in diverse settings, populations, and delivery systems, including work rooted in community and culturally specific contexts.

Timing details provided indicate an original closing date of January 7, 2028, with a creation date of December 30, 2024. The source information does not list an award ceiling or expected number of awards, which usually means applicants should consult the full NOFO for budget expectations, project period norms, and any institute-specific guidance about typical R01 scopes. Overall, the opportunity is best understood as support for rigorous, innovative services research that can reshape how mental health care is organized and delivered in the real world, emphasizing scalability, continuous improvement, and broad public impact, while staying clearly outside the clinical trial category.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on 2024-12-30.
• Applicants must submit their applications by 2028-01-07.
• 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 25 283

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