Waivers and Alterations of Research Informed Consent During the COVID-19 Pandemic

Waivers and Alterations of Research Informed Consent During the COVID-19 Pandemic
Ideas and Opinions
Emily A. Largent, Scott D. Halpern, Holly Fernandez Lynch
Annals of Internal Medicine, March 2021
Open Access
Excerpt
A foundational requirement of ethical research is that persons provide informed consent. Yet, there are exceptions that promote valuable research without unduly compromising participants’ interests. Applicable regulations for federally funded research permit waiver or alteration of consent requirements when certain conditions are met, including that the research poses no more than minimal risk to participants and that it would be impracticable to do without waiver or alteration (1). Determining whether these regulatory standards are met has become increasingly challenging during the coronavirus disease 2019 (COVID-19) pandemic…