groups » Informed Consent and Community Engagement » Informed Consent - comprehension tests to improve reliability of forms
I recently wrote a blog post regarding a seminar I'd attended on the presentation 'Expediting informed consent' (see: http://globalhealthehub.org/blog/post/Tamzin/2011/07/improving-expediting-and-tracking-informed-con/).
The author described the problems of lengthy informed consent forms which can actually hinder respondents' understanding of the study, and described his preferred process of separateing the 'informing' from the 'consenting' by using an information leaflet to inform patients about the nature of the research, then testing their comprehension.
I would be very interested to hear others' thoughts on the types of comprehension tests which could be used for this, and whether others have used comprehension tests in this way? If so, what sort of processes did you use to test respondents' comprehension and how did you validate this process?
At my site we recently started developing assessment tools for a number of clinical trials, these are developed by team members and reviewed by the Clinical Trials Support Office and sometimes by the sponsor for suitability, and are then given to participants with the option of answering either true or false to about 8-10 questions on key study information. The questions are asked after the study information has been given. And participants are usually given two attempts.
We do not have a validation process in place as yet but we are working to get this done soon.
The steps we used are as follows:
If all questions were answered correctly at the 1st attempt: ENROL
If 1st attempt was completed with:
|__| 1 error |__| 2 or more errors
If 1 error –review missed or incorrect question and ensure volunteer’s understanding of informed consent
If 2 errors – review missed and or incorrect questions and ensure volunteer’s understanding of informed consent by repeating the informed consent process
Then repeat the consent understanding assessment at the same visit and
If 0 error ENROL if 1 or more errors DO NOT ENROL