Research which requires deception regarding the purpose of the research or any other necessary element of consent is permissible when justified by prospective scientific, educational, or applied value, when effective non-deceptive alternative procedures are not feasible and only with study components that involve minimal risk (as determined by the IRB). Please note, the omission of information about the known risks of a research intervention is not an acceptable case of deception.

Whenever feasible, researchers must debrief subjects (or their legally authorized representative) about the use of deception. Generally, subjects should be debriefed immediately following their participation. There may be situations where debriefing the subjects immediately is not possible, such as when it could compromise study results. If that is the case, subjects may be debriefed following the completion of all study interventions for all subjects.

You must provide a prompt opportunity for participants to obtain appropriate information about the specifics about the deception that was used, the rationale for the deception, and a corrected account of the information that was false or incomplete, and then take reasonable steps to correct any misconceptions that participants may have. If a participant in a study involving deception chooses to withdraw consent following the debriefing, the data collected in that case may not be included in the analysis of the study. When the deception involved in a study includes audio or video recording subjects without their knowledge, the IRB will generally require that subjects are given the opportunity to withdraw from the study.

There may be situations where debriefing subjects would be inappropriate, such as when the debriefing could cause more harm to the subject than the deception itself. Such cases are expected to be rare, and would require a strong justification be provided for IRB evaluation.

Deception is a form of alteration of the consent process and alteration of the consent documentation. You should review HRP 410-CHECKLIST-Waiver or Alteration of Consent Process to ensure that you have provided sufficient information regarding the need for a waiver or alteration of the consent process.