Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed)

The National Institutes of Health (NIH), specifically the National Institute of Mental Health (NIMH), has issued a Notice of Funding Opportunity (NOFO) titled Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed) under Funding Opportunity Number PAR-25-283. This opportunity aims to encourage innovative research projects that advance the understanding and delivery of high-quality, equitable, and scalable mental health services. The focus is on addressing NIMH strategic priorities, particularly Goal 4 of the NIMH Strategic Plan, which emphasizes strengthening the public health impact of mental health research. Applications must not propose clinical trials but can include observational, survey, epidemiological, or mixed-methods research. The NOFO supports research in several priority areas. These include identifying mutable factors that impact access, continuity, quality, and equity of mental health services; developing and testing new tools, technologies, and statistical methods; and analyzing large datasets using advanced computational approaches. Projects are encouraged to leverage existing infrastructure and partnerships to enhance the scalability and applicability of their findings. Collaborations with stakeholders such as state agencies, healthcare providers, insurers, and community organizations are highly encouraged to ensure research findings are relevant and actionable in real-world settings. Studies must focus on understanding not just whether interventions are effective, but also how, why, for whom, and under what circumstances they work. Funding is available through the R01 Research Project Grant mechanism. While there is no specified budget limit, proposed budgets must reflect the actual needs of the project. The maximum project period is five years. Applications must adhere to NIH policies on data management and sharing, with an emphasis on submitting data to the NIMH Data Archive (NDA). Researchers must ensure compliance with common data elements (CDEs) to facilitate cross-study comparisons and maximize the utility of generated data. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local and state governments, Native American tribal organizations, independent school districts, public housing authorities, and foreign organizations. Both domestic and non-domestic components of U.S. organizations are eligible to apply. Applicants must meet all registration requirements, including active registration with SAM, eRA Commons, and Grants.gov, before submission. Principal Investigators (PIs) must have an eRA Commons account and ensure compliance with NIH guidelines on diversity and inclusion. Applications must follow the standard NIH submission process and requirements, including the use of ASSIST or Grants.gov Workspace. A letter of intent is encouraged but not mandatory and should be submitted 30 days before the application due date. Applications are due on standard NIH dates: February 5, June 5, and October 5 of each year through January 8, 2028. Submissions must include a well-detailed research strategy addressing significance, innovation, approach, and feasibility, along with plans for stakeholder engagement and data sharing. Evaluation will consider three main factors: the importance of the research (significance and innovation), rigor and feasibility (approach), and expertise and resources (investigators and environment). Applications will be reviewed for scientific merit by an NIH-convened peer review group, followed by Advisory Council review, with funding decisions based on scientific merit, program priorities, and availability of funds. Key contact personnel are listed for scientific, peer review, and financial queries, and applicants are encouraged to reach out for clarification or guidance throughout the submission process.