The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research

*I have:

___ 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."
  ___ Benefits and Compensation
  
  • "What do you expect to gain by taking part in this research?"
  ___ Risks
  
  • "What risks would you be taking if you joined this study?"
  ___ Voluntariness
  
  • "What do you think will happen to you if you refuse to be in this study?"
  ___ Discontinuing Participation
  
  • "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?"
  ___ Privacy
  
  • "Who will be able to see the information you give us?"
  ___ Contact Information
  
  • "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:

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    ___ Adequate level of Comprehension Confirmed              ___ Not eligible due to lack of comprehension

* This form is designed for minimal risk, noninterventional research only.

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