The National Institutes of Health (NIH) is inviting applications for the Research on Autism Spectrum Disorders (R21 Clinical Trial Optional) grant, which aims to support research into the etiology, epidemiology, diagnosis, and service delivery related to Autism Spectrum Disorders (ASD). The R21 grant mechanism is designed for exploratory, developmental research and provides funding to investigate novel ideas or directions in early-stage project development. This grant opportunity allows for clinical trials but does not require them, and no preliminary data is necessary to apply. However, applicants may include such data if available. The focus is on groundbreaking research that can lead to new discoveries or extend existing knowledge on ASD.

Research areas of interest for this opportunity include studies on the genetic and environmental epidemiology of ASD, early screening and diagnosis, brain mechanisms underlying ASD behaviors, genomic studies related to ASD, and services research to improve care delivery and coordination for individuals with ASD. The grant also encourages research on shared neurobiological mechanisms between ASD and related disorders, such as Fragile X Syndrome, and seeks to better understand cognitive and communication impairments in individuals with ASD across their lifespan. The goal is to improve both the understanding of ASD and the services provided to those affected by it.

This funding opportunity is open to a wide range of eligible applicants, including higher education institutions, nonprofits, for-profit organizations, local and state governments, and some foreign institutions. The total budget for the two-year project period cannot exceed $275,000 in direct costs, with no more than $200,000 in any given year. The maximum project period is two years. Applications can be new submissions, resubmissions, or revisions of previous applications. Importantly, all applicants must complete registrations with relevant federal systems such as SAM and Grants.gov before applying.

Applicants are required to follow NIH’s detailed application submission guidelines, ensuring compliance with all instructions in the SF424 (R&R) Application Guide. The application process includes several electronic submission options, such as using the NIH ASSIST system, institutional system-to-system solutions, or Grants.gov Workspace. Each applicant must provide a Data Management and Sharing Plan, as well as detailed plans for sharing data, especially if human subjects are involved.

The review process will evaluate the scientific merit of applications based on significance, innovation, approach, and investigator qualifications. For projects involving clinical trials, additional considerations will include the appropriateness of the study design, statistical methods, and the protection of human subjects. The NIH encourages early submission to allow time for corrections, and applicants will be notified of funding decisions after the peer review and advisory council review phases. The earliest start date for funded projects is expected to be in April 2025.

This grant opportunity reflects NIH’s commitment to advancing research on ASD and improving outcomes for individuals affected by this disorder. The research funded under this FOA is expected to make significant contributions to understanding ASD's complex nature and improving diagnosis, treatment, and service delivery.