IRB Policies for Obtaining Informed Consent from Non-English-Speaking People.

Abstract

United States regulations for the protection of human research subjects prescribe parameters for documentation of valid informed consent, which include the stipulation that the process be in a "language understandable to the subject." While significant energy has been devoted to improving the readability of consent documents, supplemental educational tools, and nuanced measurements of individual decisional capacity, there is little guidance about how to best meet the informational needs of adults with decisional capacity who do not speak English. This article reviews the institutional review board policies from the twenty-one research centers that received the most funding from the National Institutes of Health in 2018 and compares their guidelines for obtaining informed consent from non-English speakers. Inconsistent practices suggest the need for more assertive federal direction on what parameters constitute valid consent for this population. These practices also indicate a reluctance to directly engage the ethical underpinnings of consent policies for non-English speakers.