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Researcher's Certification of Consent and Authorization

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:

_________________________________________________________________________

_________________________________________________________________________

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

_______________________________
Signature
_______________________________
Date
_______________________________
Name (Print)
_______________________________
Title

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

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Page last reviewed September 2009
Internet Citation: Researcher's Certification of Consent and Authorization: The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research. September 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/funding/policies/informedconsent/icform4.html