Research on Autism Spectrum Disorders (R03 Clinical Trial Optional)

Overview

<p>The purpose of this Funding Opportunity Announcement (FOA) is to encourage research grant applications to support research designed to elucidate the etiology, epidemiology, diagnosis, and optimal means of service delivery in relation to Autism Spectrum Disorders (ASD). An R03 grant supports small, discrete, well-defined projects that can be completed in two years and that require limited resources. An R03 grant application may not contain extensive detail or discussion. R03 applications may include development of new research methodologies or technology, secondary analysis of existing data, and pilot or feasibility studies. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.</p> <p>Autism Spectrum Disorders share a cluster of impairments in social communication, as well as the presence of restricted/stereotyped behavior, interests, or activities. These complex disorders are usually of lifelong duration and affect multiple aspects of development, learning, and adaptation at home and in the community, thus representing a pressing public health need. The etiologies of these disorders are not yet understood, but may include a combination of genetic and environmental influences. Basic research into the pathophysiology of ASD, including research on brain mechanisms, is of special interest. Also of high priority are clinical and applied investigations that may lead to the development of new treatments and interventions.</p> <p class="Normal"><strong>Research Objectives</strong></p> <p class="Normal">Autism Spectrum Disorders share a cluster of impairments in social communication, as well as the presence of restricted/stereotyped behavior, interests, or activities. These complex disorders are usually of lifelong duration and affect multiple aspects of development, learning, and adaptation at home and in the community, thus representing a pressing public health need. The etiologies of these disorders are not yet understood, but may include a combination of genetic and environmental influences. Basic research into the pathophysiology of ASD, including research on brain mechanisms, is of special interest. Also of high priority are clinical and applied investigations that may lead to the development of new treatments and interventions.</p> <p class="Normal">Areas of interest include, but are not limited to, those described below:</p> <ul> <li>Epidemiology</li> <li>Screening, Early Identification, and Diagnosis</li> <li>Genomic Studies</li> <li>Brain Mechanisms</li> <li>Shared Neurobiology of ASD with Fragile X Syndrome, and Other Related Disorders</li> <li>Cognitive Science</li> <li>Communication Skills:</li> <li>Services Research</li> </ul> <p><span>This FOA will support mechanistic clinical trials, as defined by the NIH to include studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. The proposed human clinical studies will meet the NIH definition of a clinical trial (see </span><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html"><s… style="text-decoration:underline">NOT-OD-15-015</span></a><span>), but will not include studies whose purpose is to evaluate safety; clinical efficacy, effectiveness, and management; and/or implementation. Such trials will not be supported by this FOA. Applicants proposing clinical trials that are not supported by this FOA should refer to the relevant IC's clinical trial policies and FOAs.</span></p>