The purpose of this study is to evaluate prospectively the comprehension of a specific, detailed and fully informative consent in a standardized manner using a validated tool. The Deaconess Informed Consent Comprehension Test, a set of standardized questions related to eight domains of informed consent was used to survey nearly one hundred patients in a randomized controlled trial (RCT) over a year. The results of our survey demonstrate the lack of comprehension of respondents regarding most of the domains of “informed” consent. This study highlights the limitations of informed consent and the need of alternative concepts, such as entrustment/valid consent.

The purpose of this study was to evaluate prospectively the comprehension of a specific, detailed and fully informative consent in a standardized manner using a validated tool.

The results of our survey clearly demonstrate the lack of comprehension of the respondents regarding most of the domains of the “informed” consent. We are therefore concerned about the moral value of such consent.

This study highlights the importance of discussing the limitations of informed consent and the need of alternative concepts, such as entrustment and valid consent.

We surveyed nearly one hundred patients enrolled in a randomized controlled trial (RCT) over a year. All received their own copy of a specific, detailed, fully informative explanatory letter, the consent form and a patient’s guide to medical research. The Deaconess Informed Consent Comprehension Test, a set of standardized questions related to eight domains of informed consent, was used to evaluate the comprehension of research participants. Although over half of the research participants had retained a copy of the explanatory letter, the consent form and the guide, nearly 40% did not understand the purpose of the RCT. An overwhelming majority (greater than 90%) failed to identify the risks/discomforts associated with the study, while almost 60% of respondents could not identify potential benefits of their participation in the RCT. A mere 56% could provide a clear explanation of randomization. However, over 75% could identify the appropriate persons/process in case they had queries or concerns about the study.