June 16, 2021
New Guidance for Basic Experimental Studies Involving Humans. On April 28, the Office of Extramural Research (OER) released a new webpage that provides additional guidance to investigators conducting Basic Experimental Studies with Humans (BESH). The NIH definition of a clinical trial includes basic research manipulating an independent variable, resulting in some basic research studies being subject to NIH clinical trials policies.
Based on prior feedback from the research community, NIH provided temporary leniency to basic research applications subject to the clinical trials policies to allow flexibility on the platform used for registration and results reporting and on applications submitted to an incorrect FOA based on the study-type designation (NOT-OD-18-212). Soon after this notice, the NIH issued parent FOAs on Basic Experimental Studies With Humans (e.g., PA-19-091), and only submissions to these BESH FOAs have the continued registration and reporting leniency that now extends through September 24, 2023 (NOT-OD-21-088).
Findings from Recently Published Research
When given quiet moments, a person’s mind often wanders to future events such as tomorrow’s plans, to-do list items, or an upcoming trip. During these instances, the brain network called the default mode network (DMN) is being activated, but researchers have never fully understood how it functioned. In a study funded by NIDA, researchers evaluated brain activity in independent regions and found that the DMN uses two complimentary networks to create the imagined event (the “constructive” function) and assess whether this constructed event is positive or negative (the “evaluative” function). Using fMRI, the research team examined the brain activity of 24 subjects (13 female, 11 male) in response to different prompts to imagine a future event.
Disparities in COVID-19 testing and positivity rates found in rural Black communities and areas with food insecurity
The novel coronavirus, SARS-CoV-2, has had a major impact on vulnerable communities. While measures to mitigate risk of infection have been undertaken, many communities still face higher risk of poor outcomes. Higher risk in minority communities is associated with lower socioeconomic status and inability to practice mitigation efforts due to societal constraints. Location can pose even more risk with rural communities facing unique challenges due to historically lower access to healthcare. Research funded by NIGMS sought to identify factors related to low levels of COVID-19 testing among rural communities to provide testing insights and pinpoint where testing needs can be improved in rural minority populations.
Atypical eye gazing is a well-studied early symptom of toddlers/children with Autism Spectrum Disorder (ASD). However, current eye-tracking methods require special equipment and the process can be cost prohibitive. Is it possible to develop a low-cost software application ('app') that can be used on mobile phones or tablets to help diagnose abnormal eye gazing patterns of toddlers with ASD? If so, can this software produce reliable results that can be used by clinicians in a cost-effective manner? A study sponsored by the NICHD and the NIMH pursued these questions by assessing the effectiveness of an app that analyzes vision on an iPhone or iPad to discern and quantify differences in eye gaze patters of toddlers with ASD versus typical development.
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