Author Affiliation: Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland.
Regulations stipulate that, to provide valid consent for research, potential participants must be competent, understand the essential elements of consent, and make a voluntary decision.1 According to European Union guidelines, valid consent requires that the decision to enroll is “taken freely” by a “person capable of giving consent.”2 In contrast, regulations provide almost no guidance on what steps investigators should take to determine whether participants provide valid consent before enrolling them. When this issue is addressed at all, investigators typically are directed to adopt a uniform approach of “ensuring” that the conditions for valid consent have been satisfied. According to the Declaration of Helsinki, investigators should enroll participants only after “ensuring that they have understood”3; guidance on US regulations similarly maintains that investigators “should ensure” that participants understand.4
Wendler D. How to Enroll Participants in Research Ethically. JAMA. 2011;305(15):1587-1588. doi:10.1001/jama.2011.421