Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R21 - Clinical Trial Optional)

The National Institutes of Health (NIH) invites applications for exploratory and developmental research grants under the program titled "Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R21 - Clinical Trial Optional)." This initiative is managed by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and focuses on fostering research that advances newborn screening technologies and therapeutic interventions. The program targets conditions already included in newborn screening panels as well as other potentially fatal or disabling genetic disorders that could benefit from early detection. The program seeks to support projects that introduce novel ideas or extend existing research to address critical gaps in newborn screening and treatment. Research areas include developing or optimizing screening technologies, addressing disparities in access and outcomes, conducting comparative studies of treatments, and exploring the ethical and social implications of screening methods. Innovation is a central theme, and projects should demonstrate their potential to advance screening methods or therapeutic approaches significantly. Both clinical trials and non-clinical research projects are supported under this funding opportunity. The grant provides up to $275,000 in direct costs over two years, with no more than $200,000 allocated in any single year. Eligible entities include higher education institutions, nonprofits, for-profit organizations, tribal governments, local and state governments, and foreign organizations. Researchers from diverse backgrounds, including underrepresented groups, are strongly encouraged to apply. Multiple applications from a single organization are allowed, provided each is scientifically distinct. Applications are evaluated based on significance, innovation, rigor, feasibility, investigator qualifications, and the suitability of the research environment. Projects involving human subjects or vertebrate animals must comply with ethical and safety standards. A mandatory Data Management and Sharing Plan must outline how research data will be shared and managed in compliance with NIH policies. The first submission date is January 16, 2025, with subsequent due dates in June and October. Applicants are required to register with SAM.gov, eRA Commons, and Grants.gov before submission. NIH will use its peer review process to evaluate applications for scientific merit, innovation, and alignment with program priorities. Successful applicants will receive a Notice of Award (NoA), which outlines terms and conditions, including adherence to cybersecurity and nondiscrimination regulations. Post-award, recipients must submit annual performance reports and adhere to NIH reporting requirements. The program offers a critical opportunity to influence the future of newborn screening and improve health outcomes for vulnerable populations.