Federal regulations state that
The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as… individuals with impaired decision-making capacity….” 1
Many people are at risk of impaired decision-making capacity, and researchers often overestimate how well participants understand and appreciate informed consent information.2 To address these challenges, researchers can assess participant’s understanding and appreciation using a reliable and valid assessment instrument.
In this section, we provide you with guidance on how to administer a short validated assessment of consent understanding. Specifically, we provide guidance on:
We additionally provide:
A validated assessment instrument, with instructions on how to administer and score it.
Sample language and references you could incorporate into an IRB application to explain why you have adopted this practice.
2. Montalvo W, Larson E. Participant comprehension of research for which they volunteer: a systematic review. J Nurs Scholarsh. 2014;46(6):423-431.