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Brief Instrument For Evaluating Decisional Capacity
Brief Instrument For Evaluating Decisional Capacity
1. What is the purpose of the study that was just described to you?
Response (Study dependent) Score
0
1
8. Please describe 2 ways that people might benefit if they participate in this
study.
Response (1 = Societal and/or personal benefits - partly Score
study dependent)
0
1
9. Is it possible that being in this study won’t have any benefit to you?
Response (1 = Yes) Score
0
1
10. Who will pay for your medical care if you are injured as a direct result
of participating in this study?
Response (1 = The institution or hospital) Score
0
1
11. Where can people find the phone numbers of the people to contact if
they have questions?
Response (1 = In the consent form) Score
0
1
Notes:
(1) Prior to the initiation of the study, the PI must prepare a list of
answers for her or his specific study that will receive a score of 1 on
each item. A deviation from such an answer will be scored as 0. It is,
therefore, important to be as detailed as possible in describing correct
responses. The local IRB will need to approve the PI’s list of answers.
If a subject does not get a score of 11 even after 3 trials, s/he may be
asked to return for another visit one or more days later, and the same
procedure repeated. Alternatively, the subject may be given consent
information using an enhanced procedure (such as PowerPoint slide
presentation or a multimedia video presentation) on those occasions.
(3) For research purposes, the scoring system may be modified so that
each item can be scored on a 0-to-2 scale. The PI must then
determine, prior to initiation of the study, the responses that would
receive scores of 0, 1, or 2 on each item.