The IRB recognizes that the uses of deception or incomplete disclosure in research are valuable research techniques. However, the use of such techniques raises special issues that the IRB will review closely. Deception occurs when participants are deliberately given false information about some aspect of the research. Incomplete disclosure occurs when participants are not given information about the real purpose or the nature of the research.
Justifying the Use of Deception
Federal regulations prohibit the use of deceptive techniques that place participants at greater than minimal risk. An investigator proposing to use deception or incomplete disclosure should justify the use of deception and explain why deception is necessary to achieve the goals of the study.
Informed Consent
Potential participants should be advised in the consent form that the information they are given is not complete and that they will be debriefed after the research procedures are completed. When preparing the consent form, provide a truthful and accurate explanation of the purpose of the study to the extent possible, without priming participants or by giving too much of the study away. Some examples:
- “Some research requires that the full purpose of the study not be explained before you participate. We will give you a full explanation at the end of the study.” OR
- “We will give you a full explanation as soon as you complete the study.”
Complete Waiver of Consent Form
When participants are not given complete information about the study in the consent document, the IRB must waive certain required elements of the consent process (i.e. an explanation of the purpose of the research, a description of the procedures involved, etc.).
When required elements of informed consent are waived or altered by the IRB, in accordance with criteria provided in the regulations, participants must be debriefed at the end of the study, when appropriate. When a research study involves use of deception, the IRB must find that:
- the research involves no more than minimal risk to participants;
- the waiver or alteration will not adversely affect the rights and welfare of the participants;
- the research could not practicably be carried out without the alteration or waiver; and
- when appropriate participants will be provided with additional pertinent information regarding participation.
Debriefing Requirements
The debriefing is an essential part of the informed consent process and is mandatory when the research study involves use of deception. The debriefing provides participants with a full explanation of the hypothesis being tested, procedures to deceive participants and the reason(s) why it was necessary to deceive them. It should also include other relevant background information pertaining to the study.
The process to debrief participants must be explained in the protocol application. Address the following elements:
- Indicate who will debrief participants. The IRB expects that this person is a member of the research team, has completed the CITI training, and is knowledgeable about the research and the deception.
- Indicate when participants will be debriefed. The IRB generally expects that participants will be immediately debriefed after they complete the study. Any delay in debriefing must be explained and justified.
- Provide a rationale for any elements of the deception that will not be revealed to participants.
At a minimum, the debriefing statement must be labeled as a “Debriefing Statement” and include the following:
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- Study title.
- PI name and contact information for follow-up questions.
- Statement thanking participants for taking the time to participate in the study.
- Explanation of what was being studied (i.e., purpose, hypothesis, aim). Use lay terms and avoid use of jargon.
- Explanation of how participants were deceived.
- Explanation why deception was necessary in order to carry out the research.
- Explanation of how the results of the deception will be evaluated.
If the study involves use of audio or videotaping an individual participant, give the participant an opportunity to withdraw his/her consent for use of the tapes and, potentially, withdraw from the study all together, after the true purpose of the study is revealed. The IRB suggests that participants be given at least 48 hours to make this decision and provide contact information. This option must be given to participants even if they were video or audiotaped during a focus group or during an experiment involving other participants. If a participant decides to withdraw, the PI must use video editing tools to make an individual who withdraws unidentifiable. If tools are not available, the PI cannot use the video or audiotape.
You may also consider adding the following additional elements to the debriefing statement:
- Provide references/website for further reading on the topic.
- If the study did not involve use of audio or videotaping but involves sensitive topics, it may be appropriate to give participants an opportunity to withdraw their consent to participate.
- Explain anticipated or observed results so far.
- Offer to provide them with the study results.