I am working with individuals with Parkinson's and Alzheimer's disease, and my IRB suggests that additional measures must be taken to ensure the capacity of individuals with memory problems to make a decision of whether or not to participate in my research. I would like to state the following:
"In addition, for participants with an Mini-mental state Exam score below 24, competency will be evaluated on an individual basis to avoid incorrect assumptions as to an individual’s ability to make decisions (45 CFR 46.111(b) and 21 CFR 56.111(b); UHCMC IRB Policies and Procedures, Appendix F): In the present study if it is believed that the prospective participant is not competent to consent for him or herself, an evaluation of the individual’s decision-making capacity and whether or not the prospective participant is competent to consent will be determined by the individual’s physician/neurologist. In the event this information cannot be obtained, the prospective participant will be asked to take a post-consent quiz to document the prospective participant’s knowledge of critical elements in the informed consent. Individuals must score 100% to participate. In some cases and in addition to the post-consent quiz, competency may be evaluated by the research team’s physician’s assistant. A determination of incompetence will be a clinical judgment that a person lacks the capacity to understand the circumstances of participating in research and to make an autonomous decision to take part."
1. Does anyone have any comments or suggestions on my approach posed here?
and
2. Does anyone have a post-consent quiz that they are willing to share? What I'm trying to get a sense of is the number of questions, how general/specific the questions are, the type of questions (true/false, multiple choice, fill in the blank, etc)
Thanks Anthony, that is very helpful. I will be working with mild to moderate dementia as well, so it will be relevant to my population. I wonder if others use a similar strategy or can share specific questions that you ask?
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