May 12, 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
Long-term exposure to traffic-related noise or air pollution further increases risk for cognitive decline in people with metabolic dysfunction
Cognitive impairment has been separately linked to traffic-related air pollution and noise exposure as well as to metabolic syndromes, but the interaction of these two vulnerabilities is not well understood. In a study funded by the NIEHS, NIA, and NIDDK, researchers used 10-year longitudinal data from Mexican American participants to examine whether the presence of metabolic dysfunction modifies associations between air pollution or noise exposures and cognitive impairment, with or without dementia.
An important concern during the COVID-19 pandemic has been whether reopening schools for in-person visits would increase the risk of COVID-19 infections, leading to a resurgence. Recently published research funded by the NIA and the Conrad N. Hilton Foundation sought to answer this question because children across the nation have been impacted by COVID-19 through altered access to education, food, social services, and their peers. To address this question, the researchers leveraged two large sources of national data: mobile phone tracking data and medical insurance claims data from the first 46 weeks of 2020.
Depression is a common disease with limited effective treatments for the greater population with therapeutics being effective in only small groups of individuals. In a study funded by the NIA, NINDS, NIMH, Veterans Affairs, and others, researchers hypothesized that specific genetic variants influence depression by altering brain protein expression levels. The researchers used a study design which combined genome-wide association studies (GWAS) and human brain proteomic data to determine if variations in genes altered brain protein levels and could explain some of the inherited risk for depression.
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