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This Notice encourages eligible awardees in the BRAIN Initiative community to apply for administrative supplements in response to PA-21-071, Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed). The NIH has a strong interest in the diversity of the NIH-funded workforce (see NOT-OD-18-210) and encourages institutions to diversify their populations by enhancing the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral, and social sciences.

Gastrointestinal (GI) complications in children and adults with neurodevelopmental disorders have drawn attention to gaps in understanding their causes and treatment. GI dysfunction is particularly common in individuals with neurodevelopmental disorders such as autism, Fragile X syndrome, and Rett syndrome, as well as chromosomal disorders such as Down syndrome. GI disorders in these conditions can include gut malformations present at birth (such as pyloric stenosis or Hirschsprung disease) but also functional issues such as feeding problems, gastro-esophageal reflux disease (GERD), cyclic vomiting, delayed gastric emptying, diarrhea, bloating, celiac disease, irritable bowel symptoms, and constipation leading to encopresis, incontinence, and stool impaction. These GI issues may be associated with severe nutritional deficiencies, weight loss, and failure to thrive. GI symptoms are reported in between 23-70% of individuals with autism, a rate ~ 8 times higher than in the general population, with similar rates in individuals with other less common forms of intellectual and developmental disabilities (IDD) (Holingue et al., Autism Res 2018:11:24-36). Unfortunately, mechanisms to accurately diagnose GI conditions in this population are limited, and tailored treatments to address them are almost nonexistent, particularly since clinical trials for IDD populations are rare.

This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm).

This Notice encourages eligible awardees in the HEAL Initiative community to apply for administrative supplements in response to PA-20-222, Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed). The NIH has a strong interest in the diversity of the NIH-funded workforce (see NOT-OD-20-031) and encourages institutions to diversify their populations by enhancing the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral, and social sciences.

The NIH Research Project Grant supports a discrete, specified, circumscribed project in areas representing the specific interests and competencies of the investigator(s). The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions. This Funding Opportunity Announcement does not accept applications proposing clinical trial(s).

The NIH Research Project Grant supports a discrete, specified, circumscribed project in areas representing the specific interests and competencies of the investigator(s). This Parent Funding Opportunity Announcement requires that at least 1 clinical trial be proposed. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions. Applicants should note that some ICs (see Related Notices) only accept applications proposing mechanistic studies that meet NIH's definition of a clinical trial through this funding opportunity announcement.

The NIH Research Project Grant supports a discrete, specified, circumscribed project in areas representing the specific interests and competencies of the investigator(s). This Parent Funding Opportunity Announcement is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the appropriate Clinical Trials Required or Clinical Trial Optional FOA. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.