Little is known about the views of mothers when their children are invited to participate in randomized clinical trials (RCTs) investigating medicines and/or invasive procedures. Our goal was to understand mothers’ perceptions of the processes of informed consent and randomization in a RCT that divided uncooperative children into three intervention groups (physical restraint, sedation, and general anesthesia) for dental rehabilitation.

To promote research subjects' comprehension of study information, experts recommend simplifying consent documents, providing verbal information and visual aids, and asking patients to "teach-back" main points. We implemented these guidelines for enrollment in a clinical trial. We examined the independent effect of literacy on subject comprehension, determining whether subjects could correctly teach back eight key concepts on the first attempt. Approximately 40% were able to teach back the eight items initially; those with higher literacy levels did much better. Despite the (...) use of simplified consent procedures, this study found that literacy remains an independent predictor of comprehension. Additional measures will be necessary to promote informed consent among low-literacy subjects. (shrink)