Informed Consent: Expanding from Sufficient Explanation to Consent Based on “Sufficient Comprehension”*

Abstract

Informed consent is a legal principle implemented during the 1974 Nuremberg Code and developed during subsequent medical lawsuits, and currently established as a code of conduct for subject safety and protection during medical/research experiments. Informed consent is also widely used in Korea but controversies exist on its nature and applicability. This paper determines the origin of such controversy in the absence of “comprehension” of informed consent under the Korea societal context. It starts by addressing the problem of interpreting “informed” as only the transferal of just the information itself. This paper thus (1) searches the dictionary meaning and common usage of “informed consent”; (2) evaluates international methods used to promote research participants understanding in consent processes such as Teach Back, iMedConsent, and Emmi Program; and (3) considers literature evaluating the effectiveness of the above methods. Ultimately, for the current research atmosphere in Korea that emphasizes the researcher’s “sufficient explanation” to change into that emphasizing “sufficient comprehension”, the researcher must not only inform the subject, but also check whether the subject has been sufficiently informed. Achieving this requires breaking away from conventional theory to practical research and attempts on the realistic usage of informed consent. Finally, the researcher must perceive communication with the subject as primarily important during the consent process and confirm that the subject has understood the explained information. The subject’s comprehension may differ due to demographic and social factors, and consideration of the information quantity and time spent on consent is necessary.