Intervention Research to Improve Native American Health (R34 Clinical Trial Optional)

The Intervention Research to Improve Native American Health (R34 Clinical Trial Optional), reissued under funding opportunity number PAR-25-378, is a planning grant from the National Institutes of Health (NIH). This initiative is part of the broader Intervention Research to Improve Native American Health (IRINAH) initiative and is managed in collaboration with several NIH Institutes and Centers, including NIDA, NIA, NIAAA, NICHD, NIDCR, NIEHS, NIMH, NINR, and NCCIH. Additional support may be provided by NIH offices such as the Office of Disease Prevention, Office of Behavioral and Social Sciences Research, Office of Research on Women's Health, and the Tribal Health Research Office. The primary purpose of this grant is to support preparatory research activities—such as pilot studies or feasibility research—that will inform future intervention trials aimed at improving health outcomes in Native American communities. Proposed projects must incorporate community engagement and cultural appropriateness, involving tribal partners throughout the research process. The studies funded by this opportunity should ultimately aim to address health promotion, disease prevention, treatment, recovery, or services delivery and are not limited to substance use or addiction research. Eligible applicants include a wide range of U.S.-based institutions such as higher education institutions, nonprofits, local and state governments, tribal organizations, and others. Foreign entities and non-U.S. components of U.S. organizations are ineligible. Applicants may request up to $450,000 in direct costs over a maximum of three years, with no more than $225,000 allowed in any single year. Matching funds are not required. Applicants must clearly define specific milestones and study targets that will justify the progression to a full clinical trial. Applications are due annually on October 21 for both AIDS and non-AIDS projects, starting in 2025, with scientific reviews in March, advisory council reviews in May, and earliest start dates in July of the following year. Applications open on September 21, 2025, and the funding opportunity expires on January 8, 2027. The application process mandates adherence to NIH’s Research (R) Application Guide and includes requirements such as a two-page Milestone and Study Target Plan and letters of support from tribal or community partners. Applicants are encouraged to adopt culturally responsive and community-engaged research methods, such as Community-Based Participatory Research (CBPR), and to include traditional health and cultural practices in their interventions where appropriate. Projects must demonstrate the potential to be scaled and sustained in Native communities, and investigators are expected to participate in regular IRINAH initiative meetings. Questions regarding the grant should be directed to scientific contacts listed in Section VII of the notice, which includes contacts from each participating NIH institute. For financial inquiries, grants management officials are also listed. Applications must be submitted electronically via ASSIST, Grants.gov Workspace, or institutional system-to-system platforms, and all NIH and HHS policies, including those on data sharing and cybersecurity, must be followed.

Engage with NIH program officers before submission Include tribal resolutions or equivalent documentation Ensure cultural and community engagement Use CBPR methods when appropriate