Use of deception and incomplete disclosure generally goes against a basic principle of human subjects research: to treat individuals as autonomous agents by disclosing complete and truthful information about a study. However, the IRB recognizes it can be a useful tool, especially in behavioral and social research. The information below provides guidance on the appropriate use of deception and outlines the special responsibilities investigators have when using the technique.
What is Deception and Incomplete Disclosure?
Deception occurs when one or more elements of the research study is intentionally misrepresented or disguised by providing participants with misleading or false information.
- Example: To induce stress, participants are told they are being video recorded acting out social situations and the recording will be observed and rated when the sessions are not actually recorded.
Incomplete disclosure involves the intentional withholding of information about the true purpose or nature of the research study.
- Example: Participants are told they will complete a survey, but not told the true purpose of the study is to assess how cell phone usage affects an individual’s concentration and task performance.
When is Deception / Incomplete Disclosure Acceptable?
In some instances, being told the true nature of the study can cause participants to change how they would normally respond, challenging the scientific validity of the study. Deception is acceptable when revealing the true nature of the study will influence participants and bias their responses.
Deception or incomplete disclosure in research cannot be approved if:
- Non-deceptive alternatives are available;
- The deception is intended as a ploy to get people to participate in a study they would not otherwise want to; and/or
- It introduces unmitigated financial, physical, legal, psychological, or social risk to participants.
Consent / Debrief Process
The informed consent form is intended to provide the prospective participant all the information about a study in easy-to-understand terms so they can determine whether or not to enroll in a research project. When deception or incomplete disclosure is used, the participant is not able to consider all elements of the study and prospectively provide fully informed consent. Therefore, investigators should employ the following items to preserve the autonomy of research participants.
- Acknowledge the Deception. Including a statement in the consent document to inform participants the study involves deception or incomplete disclosure allows participants to determine whether or not they are comfortable enrolling in the study on these terms.
- Sample consent form language: For scientific reasons, this consent form does not include complete information about the study hypotheses and the research questions being tested. You will be fully debriefed following your participation in the research.
- Debrief Participants. After study procedures are complete, participants are provided with information about the use of deception or incomplete disclosure, called a debrief. Debriefing sessions can mitigate any harm of deception by explaining the scientific need to use the technique. Participants should be given simple, clear and informative explanation and should have the opportunity to ask questions. The IRB may require investigators allow participants to sign the debriefing form and also have the option to exclude their data from analysis.
Deception and Exempt Studies
The 2018 Common Rule allows for use of deception in studies that are determined to be Exempt by the IRB. In order to qualify as exempt, the research must fall into one of the established exemption categories and participants must prescriptively agree to the use of deception.
- Deception Qualifying for Exempt Review (45 CFR 46.104(3, Ciii))
- General Requirements for Informed Consent: (45 CFR 46.116)