Innovative Pilot Mental Health Services Research Not Involving Clinical Trials (R34 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), through the National Institute of Mental Health (NIMH), has announced the Innovative Pilot Mental Health Services Research Not Involving Clinical Trials (R34 Clinical Trial Not Allowed) funding opportunity under Funding Opportunity Number PAR-25-284. This program aims to support pilot research projects that generate preliminary data and establish the feasibility of future large-scale studies to improve mental health services. The focus is on addressing NIMH strategic priorities, specifically Goal 4 of the NIMH Strategic Plan, which seeks to maximize the public health impact of mental health research. Proposed studies must not include clinical trials and should instead employ methods such as natural experiments, surveys, mixed-methods research, or epidemiological approaches. The research funded under this opportunity should aim to identify mutable factors affecting access, quality, equity, scalability, and outcomes of mental health services. Projects may also focus on developing and testing new research tools, statistical methodologies, and measures or using large datasets to analyze service outcomes using computational approaches. Applicants are encouraged to leverage existing infrastructure, including research networks, electronic medical records, and community partnerships, to ensure the scalability and practical relevance of their findings. Collaborations with stakeholders such as federal and state agencies, insurers, healthcare providers, educators, and community organizations are strongly encouraged to enhance the real-world applicability of research outcomes. Funding for this R34 pilot grant is limited to $450,000 in direct costs over a three-year project period, with no more than $225,000 in direct costs allowed in any single year. Applications must demonstrate how the pilot research will generate preliminary data to support future R01-level studies. Projects must address questions such as how, why, and for whom mental health service interventions are effective and emphasize scalable and deployment-focused approaches. Research must also include plans for data sharing through the NIMH Data Archive (NDA) and adhere to NIH requirements for data management and common data element collection. Eligible applicants include public and private higher education institutions, nonprofits, small businesses, for-profit organizations, state and local governments, tribal governments and organizations, independent school districts, public housing authorities, regional organizations, and foreign organizations. Non-U.S. institutions and foreign components of U.S. institutions are also eligible. All applicants must complete required registrations with SAM.gov, Grants.gov, and eRA Commons before submission. Program Directors or Principal Investigators (PDs/PIs) must have an eRA Commons account. Applications must adhere to NIH submission guidelines, including preparing a research strategy that emphasizes significance, innovation, rigor, and feasibility. Proposals should describe plans for collaboration with stakeholders and address how the findings will inform scalable service delivery models. Additionally, researchers must include a Data Management and Sharing Plan that outlines compliance with NIH expectations for data submission to the NIMH Data Archive. Applications will be evaluated based on three main criteria: the importance of the research (significance and innovation), the rigor and feasibility of the approach, and the expertise and resources available to the investigators and their institutions. Specific emphasis will be placed on whether the pilot study has the potential to inform larger-scale research, whether it identifies mutable factors for intervention, and whether the approach leverages existing infrastructure and stakeholder partnerships effectively. Applications will be accepted on standard NIH due dates: February 16, June 16, and October 16 annually, through January 8, 2028. Applicants are encouraged to submit letters of intent 30 days before the application deadline. Scientific peer review will assess scientific merit, followed by an Advisory Council review for final funding decisions. Interested applicants are encouraged to contact NIMH program officials for guidance and clarification throughout the application process.