Waivers and Alterations of Research Informed Consent During the COVID-19 Pandemic
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.
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.
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bioethics covid-19 holly fernandez lynch human subjects research research