Deception in Research Guidance

Version Date: October 13, 2016

Research studies occasionally involve the deception of subjects. Subject deception is typically used to promote scientific validity, with subjects provided with false or incomplete information about the research in order to obtain unbiased data with respect to the subjects’ attitudes and behavior when complete or truthful disclosure is expected to produce biased results. While deception can be an effective tool for the conduct of research, it also raises ethical concerns with subject autonomy and respect for persons, as well as regulatory issues with informed consent requirements. The purpose of this guidance is to help researchers identify and plan for the use of deception in research.

Defining Deception
Points to Consider When Using Deception in Research
Deception and Informed Consent
Deception and Consent Documents
Debriefing Requirements
Deception Involving Audio or Video Recordings
Preparing an IRB Application Involving Deception

Defining Deception

For the purposes of this document, deception means the use of deliberately misleading communication with subjects about research purposes or activities. Types of deception are defined as follows:

Related activities that do not constitute deception under this guidance:

Points to Consider When Using Deception in Research

Deception and Informed Consent

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. An alteration of the required elements of consent must be requested 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).

Deception and Consent Documents

Even though the IRB may agree to alter the required elements of consent, a consent process is required. The consent document or script must provide a truthful description of the study to the extent possible. Generally, subjects should also be informed that the description of the study includes inaccurate or incomplete information, and that they will be provided with complete and accurate information when they have completed their participation. Examples of appropriate consent form language include:

Debriefing Requirements

Researchers must debrief subjects (or their legally authorized representatives) about the use of deception whenever feasible. 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. 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. Debriefing plans should address the following:

Deception Involving Audio or Video Recordings

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. This information should be included in the debriefing statement and, if the subject withdraws, any audio or video recording must be edited to remove the subject or destroyed.

Preparing an IRB Application Involving Deception

When filling out an IRB application for a study that involves deception, the following steps should be taken:

  1. In the “Special Procedures” section, select the ‘Deception’ box. This will open a section of the application in which to describe the justification for the use of deception and the debriefing plan.
  2. In the “Research Design” section, describe deception as part of the study procedures.
  3. In the “Risks” section, describe the potential risks of the deception, how the risks will be minimized, and why the deception involves no more than minimal risk to the subject population.
  4. In the “Consent: General” section, select the “Alteration of the required Elements of Informed Consent” box. This will open a section in which to describe how the required elements of consent will be altered as a result of deception (e.g., false or omitted information regarding procedures). This section should also provide reasons for the alteration, including why the study could not be practicably carried out without the use of deception.
  5. In the “Supplemental Information” section of the application, upload a copy of the debriefing document.

See Also: