HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R21 Basic Experimental Studies with Humans Required)
The NIH Exploratory/Developmental Grant supports exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research. This Funding Opportunity Announcement (FOA) invites Exploratory/Developmental Grant applications to study the impact of opioids, alone or in combination with other substances of misuse, on placenta function and neurodevelopment during pregnancy and in the first year of life using experimental designs that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical and/or behavioral outcomes in humans to understand fundamental aspects of phenomena related to opioid exposure during pregnancy. NIH considers such studies as Basic Experimental Studies with Humans (BESH), or prospective basic science studies involving human participants that meet the NIH definition of basic research and fall within the NIH definition of clinical trials (see, e.g., NOT-OD-19-024). Applications should not propose a goal of clinical outcomes or products. Applications that propose studies including model animal research or observational studies involving humans should submit under the companion FOA, RFA-HD-23-031,"Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R21 Clinical Trials Not Allowed).