INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Research Short Course (R25 Independent Clinical Trial Not Allowed)

The National Institutes of Health (NIH) has released a funding opportunity titled "INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Research Short Course" (PAR-22-195) under the Research Education Program (R25). This initiative aims to expand and diversify the Down syndrome (DS) clinical research workforce, enhancing skills through innovative short courses. Supported by the INCLUDE Project, this program encourages the development of educational programs that can train new DS researchers in the skills necessary to improve the understanding of DS co-occurring conditions and to advance treatments that improve the health and quality of life of individuals with DS. The INCLUDE Project is a trans-NIH research initiative established to address the health challenges associated with DS across the lifespan. This funding opportunity supports education programs focused on the Project’s three components: high-risk basic science, large-scale cohort studies, and inclusive clinical trials to explore DS-related health conditions. Specifically, the R25 award will fund short-term educational courses that equip DS researchers with modern research methodologies and enhance their ability to work effectively in team-based science environments. The program supports students, medical residents, postdoctoral researchers, and early-career faculty, emphasizing diversity by encouraging participation from underrepresented backgrounds in biomedical sciences. Eligible institutions include U.S.-based public and private higher education institutions, nonprofit organizations, for-profit entities, and various levels of government. Foreign institutions are ineligible, although U.S. institutions with foreign components may apply. NIH requires applicant institutions to be registered with SAM, NCAGE, UEI, eRA Commons, and Grants.gov prior to submission, as these registrations may take six weeks or more. Each application must have a Program Director/Principal Investigator (PD/PI) who has scientific leadership experience relevant to the proposed program and who can oversee the program’s administration and evaluation. The NIH allows annual budgets up to $400,000 in direct costs for up to five years, with total project budgets reflective of programmatic needs. Funding covers faculty salaries, participant support, equipment, supplies, and other program-related costs. Participant support includes tuition assistance, per diem (if justified), and travel expenses. However, it may not support full-time participant salaries and stipends, nor does it substitute for NRSA T32 institutional training program costs. Indirect costs are capped at 8% of modified total direct costs, and proposals including foreign travel or software development must include robust justifications. Proposals are assessed on scientific merit through NIH’s peer review, with focus areas including program significance, investigator qualifications, innovative approach, and adequacy of educational environment. Applications should highlight unique institutional resources that enhance the program’s value and include a detailed diversity recruitment plan, a plan for responsible conduct of research training, an evaluation strategy, and dissemination practices for sharing findings. Following peer review, high-ranking applications undergo an advisory council review and NIH evaluation based on scientific impact, fund availability, and alignment with NIH and INCLUDE priorities. Deadlines for new applications are June 27 each year, through 2025. Applicants must submit electronically via NIH ASSIST, an institutional system-to-system solution, or Grants.gov Workspace, ensuring compliance with the SF424 Application Guide. Following submission, applications are reviewed for completeness and compliance; non-compliant submissions are excluded from review.