How do I provide informed consent when deception is required for the study technique?

When a study uses deception, fully informed consent cannot be obtained from subjects because they are not provided with enough information to make an informed decision. A waiver form to request an alteration of the required elements of consent must be included in the IRB application to waive the element of consent associated with the deception (e.g., waive the requirement to provide an accurate description of a procedure).

1. The alteration to the consent must provide a truthful description of the study to the extent possible.

2. Either the consent should state that the description of the study includes inaccurate or incomplete information and they will be provided with a full explanation including the reason for withholding the information at the end of the study or the application must include a justification for why this statement would impede the research.

3. The study must include a debriefing at the end, including an opportunity for the subject to withdraw and have their data deleted from the data set if they wish. The debriefing should include when the debrief will be done, who will be responsible for the debriefing and how it will be done.

Last updated: 2/21/2023