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

2. What makes you want to consider participating in this study?

Response (Partly Study dependent) Score
0
1

3. Is this study designed primarily to provide you with better treatment?

Response (1 =No) Score
0
1

4. Do you have to be in this study if you don’t want to participate?

Response (1 = No) Score
0
1

5. If you decide to withdraw, will you be able to receive proper treatment?

Response (1 = Yes) Score
0
1

6. Please describe 2 things that will happen to people who decide to be in

this study.
Response (Study dependent) Score
0
1
7. Please describe 2 risks or discomforts that people may experience if they
participate in this study.
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.

(2) A subject must have a perfect score of 11 for being eligible to

participate in the study. If a subject gets a lower score, the
information on the items missed may be repeated, and the specific
question/s asked again. This may be done for a total of 3 trials.

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.

If a subject fails to obtain a score of 11 after 3 such attempts (on

different days), that subject does not have the capacity to consent, and
may be considered ineligible for participation in the protocol, or may
require proxy consent.

(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.