We’ve linked to the FDA’s Guidance on Clinical Trials of Medical Products During the COVID-19 Pandemic on at least two other blog items, but we like this updated version of the guidance so much that we think it merits its own blog entry.
Strictly speaking, it applies to FDA-regulated clinical trials, of course. However, it has a lot of good ideas about adapting informed consent and study procedures to minimize COVID-19-related risks for any kind of study. There’s also a helpful FAQ section at the end. Question 10 directly addresses the issue of obtaining informed consent from a COVID-19 patient. The information here will be helpful to anyone who needs to seek consent from someone who may have COVID-19.