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

The Intervention Research to Improve Native American Health (R34 Clinical Trial Optional) funding opportunity supports planning and pilot studies aimed at improving health outcomes among Native American, Alaska Native, and Native Hawaiian populations. Administered by the National Institutes of Health (NIH) through multiple participating Institutes—including the National Institute on Drug Abuse, National Institute on Aging, National Institute on Mental Health, and others—this program funds research that strengthens community partnerships and prepares for future efficacy, effectiveness, or implementation trials. The initiative emphasizes community-engaged, culturally grounded, and scientifically rigorous approaches to health promotion, disease prevention, treatment, recovery, and services research. The goal of this Notice of Funding Opportunity (NOFO) is to enable investigators to plan and develop feasible and culturally appropriate clinical trials. Applicants are encouraged to collaborate closely with tribal governments, Native organizations, and community partners to adapt or develop interventions that align with Indigenous concepts of health and wellness, including spiritual, emotional, physical, and mental dimensions. The R34 mechanism funds preparatory research such as feasibility testing, recruitment and retention strategy evaluation, and development of culturally appropriate measures and protocols. The research must demonstrate readiness for a future full-scale trial by meeting specific milestones, such as tribal agreements, validation of instruments, and demonstration of intervention feasibility. Funding may support activities including establishing tribal partnerships, developing and adapting interventions, assessing intervention acceptability, and pilot-testing study procedures. The NOFO will not fund projects testing intervention efficacy or effectiveness, or those lacking meaningful community engagement. Applicants must demonstrate mutual commitment between research and community partners through resolutions of support or memoranda of understanding. The program places strong emphasis on Indigenous knowledge, resilience, and strengths-based approaches to health. Eligible applicants include U.S.-based public and private higher education institutions, nonprofit and for-profit organizations, tribal governments and organizations, state and local governments, and special district entities. Foreign organizations are not eligible. Applicants may request up to $450,000 in direct costs over three years, with a maximum of $225,000 per year. There is no cost-sharing or matching requirement. Budgets must include travel costs for at least one investigator to attend the annual IRINAH meeting. Applications are due annually on October 21, beginning in 2025, with reviews in March, advisory council consideration in May, and earliest start dates in July of the following year. Applications must be submitted through Grants.gov or NIH ASSIST, following the NIH “How to Apply” Application Guide. Required documents include a Milestone and Study Target Plan, letters of support from tribal or community partners, and a detailed Research Strategy describing community engagement, innovation, and justification for all planned activities. Applications will be evaluated based on significance, innovation, rigor, feasibility, investigator qualifications, and evidence of community partnership. For programmatic questions, applicants may contact scientific leads at participating NIH Institutes. The opportunity remains open through January 8, 2027, and is expected to recur annually.

Ensure authentic tribal engagement and clearly defined milestones; include tribal resolutions and culturally grounded intervention justification.