AHRQ toolkit provides examples of 'teach-back'
AHRQ toolkit provides examples of 'teach-back'
Teach-back helps ensure understanding
"The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research," published in September, 2009, provides very concrete examples of ways investigators and IRBs can improve the informed consent process.
Here are the toolkit's examples of how to use teach-back to ensure potential participants fully understand what they've heard and read during informed consent:
Teach-Back: Part I
Start with phrases such as:
• "I want to make sure we have the same understanding about this research. Can you tell me what this project is about in your own words?"
• "It's my job to explain things clearly. To make sure I did this I would like to hear your understanding of the research project."
Teach-Back: Part 2
Make sure that the potential research subject has understood all the important elements of the study. Allow the potential research subject to consult the document when answering the questions. The purpose is to check comprehension, not memory. Listen for simple parroting; probe further if a potential research subject uses technical terms. Ask open-ended questions, such as the following:
• 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?"
• Benefit 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
- "Will anything 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?"
Teach-Back: Part 3
Correct any misinformation until potential research subjects indicate that they have understood by correctly answering all the questions. Make clear that the need to repeat is due to the complexity of the material rather than the "fault" of the potential research subject.
For example, you could say, "Let's talk about the purpose of the study again because I think I may have not explained it clearly."
• Potential research subjects should not be enrolled if they cannot comprehend the study protocol, despite repeated attempts to explain the details.
• Document completion of the teach-back process on the Researcher's Certification of Consent and Authorization.
• Ask the potential research subjects what questions they still have.
- Avoid yes or no questions, such as, "Do you have any questions?" and "Do you understand?"
- Ask instead, "What questions do you still have?" and "What would you like to hear more about?"
• If the potential research subject signs the document (unless written consent and authorization have been waived), make a copy for him or her. Alternatively, have two copies and give one to the subject.
- Emphasize that subjects should keep the document since it has important phone numbers in case they have any questions or concerns later.
• Complete and sign the Researcher's Certification of Consent and Authorization.
"The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research," published in September, 2009, provides very concrete examples of ways investigators and IRBs can improve the informed consent process.Subscribe Now for Access
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