Use of debriefing in the consent process

Most research does not require debriefing, but it is required when protocol activities involves deception or incomplete disclosure. Deception occurs when participants are deliberately given false information about some aspect of the research. Incomplete disclosure occurs when participants are not given information about the real purpose or nature of the research.

A debriefing form is typically read aloud to the participant once he or she has completed the study. Should your study require a debriefing, investigators must include a “debriefing statement” in the consent sections of the IRB application. Debriefing statements should include at least:

  • A title at the top of the document stating “Debriefing Statement”
  • Study title
  • PI name and contact information for follow-up questions
  • Contact information for the ORPC for participants to  use if they have additional questions or concerns
  • A thank you to participants for taking the time to participate
  • Explain what was being studied (i.e., purpose, hypothesis, aim).  Use lay terms and avoid use of jargon.
  • Explain how participants were deceived
  • Explain why deception was necessary in order to carry out the research
  • Explain how the results of the deception will be evaluated

If the study involves use of audio or videotaping an individual participant, give the participant an opportunity to withdraw his/her consent for use of the tapes and, potentially, withdraw from the study all together, after the true purpose of the study is revealed.

The IRB suggests providing at least 48 hours for a participant to make this decision and provide contact information for who participants should contact regarding their withdrawal from the study. This option must be given to participants even if they were video or audiotaped during a focus group or during an experiment involving other participants. If a participant decides to withdraw, the researcher must use video editing tools to make an individual who withdraws unidentifiable. If tools are not available, the researcher cannot use the video or audiotape.

return to Waivers or Alterations of Informed Consent