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Human Subjects

Policies & Guidance

Research Involving Deception or Incomplete Disclosure

Deception and incomplete disclosure can be valuable research methodologies.  In social and behavioral research especially, deception and/or incomplete disclosure are often necessary to avoid study bias or test a hypothesis that requires subjects’ misdirection; however, their use presents special challenges to ensure that research is conducted ethically.

The use of deception and/or incomplete disclosure can interfere with the ability of subjects to make fully informed decisions about whether or not to participate in research, and thus research employing these methods requires special consideration by the IRB. In addition to determining if study procedures interfere with subjects’ ability to provide informed consent, and if there is sufficient justification for the use of such measures, the IRB will also evaluate if a debriefing process is necessary, and if so, if it has been adequately developed.

Definitions and Examples

Deception involves an investigator providing false information to subjects or intentionally misleading them about some aspect of the research. Studies involving deception are not eligible for Exempt review.

Examples of deception:

  • A study includes a member of the research team posing as a fellow participant who interacts with subjects as part of the experimental design.
  • A subject is provided with a false description of the study purpose by the research team.

Incomplete disclosure occurs when an investigator withholds information about the specific purpose or nature of the research.

Example of incomplete disclosure:  Subjects are informed about the purpose of the study or certain procedures in general terms that are true but deliberately vague enough that they do not reveal the researcher’s specific objective.

Points to Consider

In order to comply with the general principles of the Belmont Report and federal regulations governing human subjects research, the IRB will consider the following points when reviewing research utilizing deception and/or incomplete disclosure. 

  • The study must not involve any more than minimal risk to the subjects.
  • The use of deception/incomplete disclosure must be justified by the study’s prospective value, and the researcher must demonstrate that the deception is necessary to conduct the study.
  • Subjects must not be deceived about research that could reasonably be expected to cause physical pain or severe emotional distress
  • When practical, subjects should be told during the informed consent process that some information is being withheld and that they will receive additional information when the research is over.
  • When appropriate, researchers should debrief subjects. The debriefing should take place as early as possible within the designs of the study, preferably at the conclusion of the subject’s participation (due to either withdrawal or completion of all procedures) but no later than the conclusion of the research.
  • The research must meet the criteria for a modification of the required elements of informed consent.

Debriefing of Subjects

Debriefing the subject is an important aspect of the informed consent process in studies involving deception or incomplete information. It gives the investigator an opportunity to explain any deception or incomplete disclosure involved as well as to help the subjects deal with any distress or discomfort occasioned by the research.

There may be instances when debriefing would be inappropriate, such as when the debriefing itself may present an unreasonable risk of harm. For example, if an individual were selected for participation in a study about group behavior based on a previously measured “negative” behavior or characteristic, it might not be appropriate for the debriefing to describe the selection process.  For example, if a student is selected for participation in a study based upon certain physical characteristics (e.g., weight), it might not be appropriate for the debriefing to describe that aspect of the selection process.

In certain studies, debriefing immediately after a subject’s participation could compromise study results (such as when the study is ongoing and early subjects might tell others about it). Under such circumstances a delayed debriefing process, such as sending debriefing information to subjects via email, or giving subjects a website where they can view debriefing information when the study has been completed, may be appropriate. In some cases, it may be sufficient to ask the subject being debriefed not to reveal such information to others.

In general, the debriefing process should consist of the following:

  • Full disclosure of the deceptive aspects of the study and an explanation of the actual study objectives.
  • An explanation as to why the deception was necessary.
  • An opportunity for the subject to ask questions.
  • When possible, an opportunity for the subject to withdraw his/her data from the study.
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