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.
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:
- Active deception involves intentionally providing inaccurate or false information to subjects. Examples include:
- In order to induce stress, study personnel tell subjects that they will give a speech that evaluators will observe on video, when the subjects’ speeches will not actually be recorded or observed.
- Study personnel tell subjects that they will be engaged in a cooperative task with other subjects, but instead subjects will actually be interacting with study personnel.
- Study personnel tell subjects that they will play a competitive game involving financial rewards based on their performance. In fact, the game is rigged and rewards are not based on performance.
- Passive deception (i.e., deception by omission) involves withholding information, or incomplete disclosure of information, with the intention of misleading subjects about the research purpose or procedures. Examples include:
- The study involves covert procedures, such as subjects being observed behind a one-way mirror. The subjects’ ignorance regarding their observation is intended to affect their behavior.
- The study involves covert research, such as a staged experiment in a public place. Subjects are unaware that they are participating in a research study.
- Study personnel inform subjects about a general study goal (e.g., the study is assessing the frequency of personality traits in the general population); however, the description omits details that are intended to affect subject behavior or participation (e.g., the study specifically intends to identify individuals with antisocial personality disorder).
Related activities that do not constitute deception under this guidance:
Points to Consider When Using Deception in Research
- Disclosed concealment involves the withholding of certain information from subjects in cases where subjects consent specifically to the lack of disclosure. An example is a double-blind, placebo-controlled trial in which subjects will have information regarding their assignment to a particular study arm withheld; however, subjects are informed of the study arms and that their assignment will not be disclosed.
- Incomplete disclosure involves providing general but accurate information to subjects in order to avoid the potential for altering subject behavior such that study results are biased. For example, the particular psychological traits being studied are not disclosed, but a more general statement involving the investigation of personality traits is included in consent materials.
Deception and Informed Consent
- The use of deception must be justified by its potential scientific value to the research.
- Deception can only be used when there are no reasonably effective, alternative methods available to achieve the goals of the research.
- Deception can only be used with study components that involve minimal risks (as determined by the IRB).
- Whenever possible, researchers must debrief subjects about the deception. This should include specifics about the deception that was used, the rationale for the deception, and a corrected account of the information that was false or incomplete.
- In cases where the deception involves the description of study activities to subjects, the description of the risks may not understate the actual risks (i.e., the omission of information about the known risks of a research intervention is not an acceptable case of deception.)
- Whenever possible, subjects should 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 study participation.
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:
- “This consent form accurately describes the risks and benefits of the study. However, for the study to work, there are some things about this study that we won't tell you about until after you participate. At the end of your participation in the study, the researchers will fully explain the study, including the reasons for withholding certain information about the study.”
- “The information provided accurately describes the risks and benefits of the study. However, for the study to work, some of the information we tell you about the study will be misleading. At the end of your participation in the study, the researchers will fully explain the study, including the reasons for misleading you about certain aspects of the study.”
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
- A description of the debriefing procedures, including when debriefing will occur (i.e., after the deceptive event occurred, at the end of the subject’s participation in the study, or when all subjects’ participation in the study is complete), who will be responsible for debriefing, and how debriefing will be done.
- A debriefing document should be provided in the IRB application. If debriefing is done by mail, the document should provide contact information to allow subjects to discuss the use of deception with study personnel. The debriefing document should include the following: a) an explanation of how subjects were misinformed; b) a correct or complete account of the component about which subjects were misinformed; and c) an explanation of the reason the deception was believed to be necessary.
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:
- 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.
- In the “Research Design” section, describe deception as part of the study procedures.
- 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.
- 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.
- In the “Supplemental Information” section of the application, upload a copy of the debriefing document.