Enhancing Understanding During the Consent Process

To enhance understanding during the enrollment process, consider ways to improve verbal and complementary communication.

  • Speak slowly and use clear, simple language.
  • Discuss specific behaviors (what the participant will do).
  • Consider using pictures, flow charts, or other graphics to supplement verbal conversations.
  • Use translated forms, when applicable.

Create a shame-free environment.

  • Look for clues of low literacy and react non-judgmentally.
  • Offer help with paperwork.
  • Read materials aloud.
  • Encourage participants to ask questions.

Use available resources.

  • Offer the opportunity for family and friends to be with participants during discussions.
  • Consider language needs and use interpreters.

The following sample scripts may help assess a participant’s comprehension and understanding. (Source: S. Titus et al., “Do you understand? An ethical assessment of researchers’ description of the consenting process,” J Clin Ethics 7 (1996): 60-8)

I want to make sure I explained everything clearly. If you were trying to explain what you’re doing in this study to a family member, what would you say?

What questions do you have?

Tell me in your own words what this study is all about.

Tell me what you think will happen to you in this study.

What do you expect to gain by taking part in this research?

What risks might you experience by participating in the research?

What are your alternatives (other choices or options to participating in this research)?

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This page last reviewed on September 9, 2016