Annals of Internal Medicine
March 2021 Volume 174, Issue 3
Ideas and Opinions
Waivers and Alterations of Research Informed Consent During the COVID-19 Pandemic
Emily A. Largent, JD, PhD, RN, Scott D. Halpern, MD, PhD, Holly Fernandez Lynch, JD, MBE
… As seen in the cases discussed below, studies that were or would have been eligible for consent exceptions before the pandemic may now have heightened risks, rendering exceptions no longer appropriate. Alternatively, studies previously ineligible for consent exceptions may now qualify because the pandemic has rendered what counts as minimal risk more expansive or because COVID-19 limits the practicability of doing research using traditional consent processes. Guidance is needed about how the circumstances of a pandemic influence the applicability of regulatory standards for consent exceptions….