Accelerating the Pace of Substance Use Research Using Existing Data (R21 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA), has released a Notice of Funding Opportunity (NOFO) titled "Accelerating the Pace of Substance Use Research Using Existing Data (R21 Clinical Trial Not Allowed)." This funding opportunity supports the analysis of existing datasets to advance understanding of the etiology and epidemiology of substance use behaviors and related disorders, including their intersections with HIV. The mechanism used is the R21 Exploratory/Developmental Research Grant, which is intended for innovative projects in the early stages of development. NIDA seeks to stimulate research that leverages existing data sources to maximize the value of prior investments in social science, behavioral, administrative, and neuroimaging data collection. Applicants are encouraged to utilize datasets such as the Adolescent Brain Cognitive Development (ABCD) study, the National Addiction & HIV Data Archive Program (NAHDAP), and other publicly available or privately held datasets. Proposals must be distinct from previously funded research using the same data and cannot involve primary data collection or analysis of biospecimens without associated data. Innovative statistical methods, artificial intelligence, computational modeling, and cross-dataset harmonization are highly encouraged. Eligible applicants include a wide range of U.S.-based and foreign entities, including higher education institutions, nonprofits, local and state governments, small businesses, for-profit organizations, tribal governments, and public housing authorities. Non-domestic organizations and components of U.S. organizations located abroad are also eligible. All applicants must complete required registrations in systems such as SAM.gov, Grants.gov, and eRA Commons before submission. Program Directors/Principal Investigators must also hold active eRA Commons accounts. Applications must be submitted electronically via one of several NIH-supported submission portals. A letter of intent is encouraged but not required and should be submitted 30 days prior to the chosen application due date. The earliest open date for submission is June 17, 2025. Application due dates are scheduled semiannually: July 17 and December 3 in 2025, 2026, and 2027. The funding opportunity expires on December 4, 2027. All submissions are due by 5:00 PM local time of the applicant’s institution. Review criteria include the significance and innovation of the research, scientific rigor and feasibility, and the expertise and resources available to the research team. Applications must address human subjects protections if applicable and include a Data Management and Sharing Plan. Funding decisions will consider scientific merit, relevance to NIDA priorities, and budgetary considerations. NIDA expects to commit $4 million in FY 2026 to fund between four and eight applications in total—split evenly between general and HIV-focused research. The award budget cannot exceed $275,000 in direct costs over two years, with no more than $200,000 in any single year. For additional guidance, applicants may contact Dr. Marsha F. Lopez at marsha.lopez@nih.gov or 301-443-6504 for scientific/research-related questions. For grant submission technical support, NIH provides contacts for the eRA Service Desk, Grants.gov, and general grants info. Financial questions can be directed to the NIDA grants management email at nidagmbemail@nida.nih.gov. Comprehensive application instructions are available in the NIH Application Guide and must be followed precisely.

Applicants must pre-register statistical analysis plans when using the ABCD dataset. Follow NIH’s “How to Apply” Application Guide precisely to avoid rejection for noncompliance.