Accelerating the Pace of Drug Abuse Research Using Existing Data (R21 Clinical Trial Optional)

The National Institute on Drug Abuse (NIDA) invites applications for the R21 exploratory/developmental grant, "Accelerating the Pace of Drug Abuse Research Using Existing Data," under FOA RFA-DA-24-037. This grant aims to foster innovative secondary analyses of existing social science, behavioral, neuroimaging, and administrative datasets to improve understanding of substance use disorder (SUD) and related behaviors. Funded research is expected to address the etiology and epidemiology of substance use (including alcohol, tobacco, and other substances), SUD prevention, HIV risk, and health service utilization. This FOA supports exploratory studies, including projects examining the impacts of SUD on morbidity and mortality, factors in SUD progression, and intervention effectiveness, with a focus on leveraging pre-collected data. Primary data collection is not permitted under this FOA. This FOA encourages projects that reanalyze existing data to explore SUD's biological, environmental, and social determinants, with particular interest in datasets like the Adolescent Brain Cognitive Development (ABCD) study, the Population Assessment of Tobacco and Health (PATH) study, and other public or restricted-use datasets. NIDA emphasizes studies that combine datasets, use computational models, or develop innovative statistical techniques to investigate previously unexplored research questions. By focusing on established datasets, applicants may uncover new insights on the prevention and treatment of SUDs and HIV, including the potential health impacts on specific demographic groups, such as racial and ethnic minorities, individuals with co-occurring conditions, and other vulnerable populations. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, government entities, tribal governments, and foreign institutions. Applicants may submit multiple scientifically distinct applications, although duplicate or overlapping submissions are not accepted. This FOA will fund 4-6 awards per year with a combined maximum direct cost of $275,000 for two years, not exceeding $200,000 in any single year. The maximum project period is two years, with applications accepted under new, resubmission, or revision statuses. NIDA anticipates committing $2 million annually for FY2023-FY2025. Applicants are encouraged to use NIH's ASSIST system, Grants.gov Workspace, or other institutional solutions for application submission. A letter of intent, although not required, is recommended 30 days before the application due date. Applicants must include data management and sharing plans in their proposals, especially if using the ABCD dataset, which has specific data use and sharing restrictions. All proposals should include a Resource Sharing Plan and adhere to NIH's requirements for data de-identification and repository submission as applicable. Applications will be evaluated based on significance, investigator expertise, innovation, approach, and environment. The review process will focus on each project's potential to advance SUD research, using conceptual rigor and innovative methodologies that demonstrate how findings may impact SUD treatment, policy, and health services. For clinical trial applications, reviewers will also assess the trial’s design and relevance to public health. Additional review will assess compliance with human subjects, inclusion criteria, and data handling requirements, including reporting expectations aligned with the NIH Grants Policy Statement. Successful applicants will receive a Notice of Award (NoA), and all funded projects must adhere to NIH and NIDA’s data management, sharing, and civil rights compliance policies. Recipients must meet all federal and civil rights requirements, including non-discrimination and accessibility for individuals with disabilities. NIH encourages prospective applicants to contact NIDA with any application-related questions and to ensure all registration and submission requirements are met by the listed due dates.