Verbal consent in biomedical research: moving toward a future standard practice?

Abstract

Properly obtaining informed consent is a core obligation for research conducted using human subjects. The traditional informed consent process involves written forms and obtaining signatures. This process remains the standard, but in various research settings, such as COVID-19 and rare disease research, verbal consent has increasingly become the norm. Although verbal consent is used in these settings, its use is still a subject of debate. This article reviews in what medical settings verbal consent is commonly seen today, various advantages and disadvantages of verbal consent, and its legislative and policy ecosystem. In doing so, this review article asserts that it is time for the debate over verbal consent to come to an end and for legislator and policymakers to acknowledge its use and to formalize the process. This will allow verbal consent to be regulated in a similar manner to written consent and will give clinician-researchers guidance on how to better implement verbal consent in their studies to addressing ongoing concerns with the consenting process as a whole.

Keywords: COVID-19; biomedical research; consent; rare disease; verbal consent.