___ Conducted the informed consent and/or authorization discussion in private, or only in the presence of those people that the potential subject wanted to hear the discussion. ___ N/A
___ Noted that the potential subject is fluent in English or that the subject (check all that apply):
___ Signed form written in own language: __________________.
___ Was assisted by study personnel fluent in _______________.
___ Was assisted by a professional medical interpreter.
___ Was not enrolled because refused offer of professional medical interpreter.
___ Was not enrolled because study restricted to those fluent in English.
___ Read the Informed Consent and/or the Authorization Document with subjects who do not choose to read the document on their own. ___ N/A
___ Verified an adequate level of comprehension by:
- Asking the potential research subject to restate his/her understanding of the research.
___ Goal of the Research and Protocol
- "Tell me in your own words about the goal of this research and what will happen to you if you agree to be in this study."
- "What do you expect to gain by taking part in this research?"
- "What risks would you be taking if you joined this study?"
- "What do you think will happen to you if you refuse to be in this study?"
- "What should you do if you agree to be in the study but later change your mind?"
- "What will happen to information already gathered if you change your mind?"
- "Who will be able to see the information you give us?"
- "What should you do if you have any questions or concerns about this study?"
- Reviewed any misinformation (e.g., "Let's talk about the goal of the study again because I think I have not explained the project clearly.").
- Asked the potential research subject to restate concepts not clearly understood.
- Repeated this process until the potential research subject was able to exhibit comprehension.
___ Encouraged the potential research subject to ask questions.
___ Provided a copy of the Informed Consent and/or Authorization Document.
___ If all above items are not checked, note exceptions here:
___ Adequate level of Comprehension Confirmed ___ Not eligible due to lack of comprehension
* This form is designed for minimal risk, noninterventional research only.