The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is inviting applications for the NICHD Small Research Grant Program (R03 Clinical Trial Required). This grant supports small-scale clinical trials that align with NICHD's mission, which focuses on human development, reproductive health, pregnancy, childhood and adolescent development, intellectual and developmental disabilities, and rehabilitation medicine. The R03 mechanism is designed for discrete, well-defined projects that can be completed within a limited timeframe and with modest resources. Eligible activities include pilot and feasibility studies, secondary data analysis, development of research methodology, small self-contained research projects, and innovative technology development. Applications must propose at least one NIH-defined clinical trial, and early consultation with NICHD program staff is strongly encouraged to ensure alignment with institute priorities.

The funding opportunity specifically targets clinical trials that address NICHD's scientific mission areas, including contraception, childbirth, pediatric health, and intellectual disabilities. Projects should fall within the scope of the NICHD Division of Extramural Research (DER) or the National Center for Medical Rehabilitation Research (NCMRR). Applicants are encouraged to review NICHD’s high-priority research areas to ensure their proposal aligns with strategic objectives. Research topics may include prevention, diagnosis, treatment, or management of health conditions relevant to NICHD's goals. The program is intended to support innovative ideas and approaches with the potential to generate data or findings that can lead to larger studies or broader scientific contributions.

Applicants may request up to $50,000 in direct costs per year for a maximum project period of two years. Applications should reflect the scope and feasibility of the proposed research within these budget and timeline constraints. While preliminary data are not required, applicants must provide a strong rationale, well-defined research objectives, and a clear plan for execution and analysis. Applications that exceed these budgetary or temporal limits will not be considered for funding. Projects must comply with NIH policies regarding clinical trials, including study design, monitoring, and reporting requirements.

Eligibility for this grant is broad and includes higher education institutions, nonprofits, for-profit organizations, small businesses, government agencies, and certain foreign entities. Both domestic and foreign organizations are eligible to apply, and non-domestic components of U.S. organizations may also participate. Applicants must complete required registrations, including those with SAM.gov, eRA Commons, and Grants.gov. Program Directors/Principal Investigators (PDs/PIs) must have an active eRA Commons account, and applications must be submitted electronically following NIH's standard submission guidelines.

Applications will be evaluated based on scientific merit through NIH’s peer review process. Review criteria include the significance and innovation of the research, the rigor and feasibility of the proposed approach, and the expertise and resources of the investigator and institution. Additional considerations include the protection of human subjects, inclusion plans for diverse populations, and data and safety monitoring plans. Applications will undergo scientific peer review, followed by a second-level review by the National Advisory Child Health and Human Development (NACHHD) Council. Final funding decisions will consider scientific merit, program priorities, and the availability of funds.

The first application submission date is February 16, 2025, with subsequent cycles following NIH standard due dates. The final application deadline is January 8, 2028. Applicants are encouraged to submit early to address any technical or administrative issues before the deadline. Detailed submission instructions are available in the NIH Application Guide, and program-specific guidance can be obtained from NICHD scientific, peer review, and grants management contacts listed in the funding announcement.