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April 7, 2020

Guidance for researchers during the COVID-19 pandemic

Resources from NIH, FDA and others related to clinical trials, research funding and registries.
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We know that the COVID-19 pandemic has significantly impacted GI researchers. AGA’s COVID-19 resource page is now updated with guidance for the research community from NIH, FDA and others. Here are some of the highlights:

FDA guidance on conduct of clinical trials of medical products during COVID-19 pandemic. For sponsors of pending or currently ongoing clinical trials, this resource provides FDA’s recommendations on working with trial investigators, institutional review boards/independent ethics committees, trial participants and FDA review divisions to address challenges resulting from COVID-19 related to safety and efficacy assessments, safety monitoring, protocol changes and statistical analysis plans among other topics.

Information for NIH applicants and recipients of NIH funding. NIH has published several guidances for potential applicants and current grantees including application and post-award policies, animal welfare, and human subjects studies. This resource also lists funding opportunities specific to COVID-19 across multiple institutes and centers.

Information for NSF applicants and recipients of NSF funding. NSF published guidance for applicants and current awardees to address application and post-award policies, deadlines, review panels, travel and new rapid funding opportunities specific to COVID-19.

Research efforts. AGA members and others in the GI community are leading registry-based studies to understand the impact of COVID-19 on various patient populations, including those with inflammatory bowel disease (IBD), cirrhosis and celiac disease.

You can find these resources on our COVID-19 page under “Research guidance”. We will add new resources as they become available.

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