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 in the IRB-1 Protocol Application
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 its use in the IRB-1 protocol application. Address the following when preparing the IRB-1:
- In the procedures section, justify use of deception and explain why deception is necessary to achieve the goals of the study. Explain if alternative methods not involving use of deception were considered and why these methods are not being used (Sloan & Hull, 2006).
- In the procedures section, explain the process to debrief participants. Explain when participants will be debriefed and who will debrief them. Provide copies of the debriefing statement that will be given to participants and the script that will be used by the researchers to orally explain the study (see below for guidance regarding the debriefing).
- In the risk section, explain if use of deception is likely to cause the participant psychological discomfort (i.e., stress, loss of self-esteem, embarrassment) while the deception is taking place. Explain how this risk will be minimized during the experiment and after the experiment is complete (i.e. full debriefing) (Sloan & Hull, 2006).
- Complete the waiver of consent section. 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.). See below for additional information.
Informed Consent Requirements with Use of Deception in Research
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. Address the following when preparing the consent form/information sheet:
- In the “Why is this study being done?” section, 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.
- Include the following statement in the “What will I be asked to do?” section, “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.” Please note: the last sentence can be further customized to say, “We will give you a full explanation as soon as you complete the study.”
Debriefing Requirements for Use of Deception in Research
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 (see below).
The Federal Debriefing Requirement
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 research could not practicably be carried out without the requested waiver or alteration;
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
- the waiver or alteration will not adversely affect the rights and welfare of the participants; and
- whenever appropriate, the participants will be provided with additional pertinent information after participation.
As indicated above, the debriefing must occur “when appropriate.” It may be inappropriate when: Debriefing regarding the deception may cause more harm than the deception itself. For example, if a student is selected for participation in a study based upon certain physical characteristics (i.e., weight), it might not be appropriate for the debriefing to describe that aspect of the selection process.
The timing of the debriefing is also an important consideration. Generally, the IRB expects that participants will be debriefed immediately following their participation in the study. However, it is possible that an immediate debriefing may compromise study results. Participants who have completed the study might tell others about it. If they have been debriefed and have been debriefed may share that information with prospective participants, thus compromising the scientific validity of the study. The IRB recommends the use of the following strategies to handle this situation.
If participant names and contact information are collected as part of study procedures, debriefing information can be sent when the study is completed via mail, email or by phone.
If participant names and contact information are not collected researchers can:
- Give participants a URL where they can get debriefing information and a date upon which it will be available.
- Have each participant address an envelope to themselves before they leave the study session and send them debriefing information when the research is completed.
In most cases, the IRB expects that participants will be given a debriefing statement to take with them after the study is complete and after participants have been given an oral debriefing (script) immediately following completion of the study. Both the debriefing statement and the debriefing script must be reviewed and approved by the IRB.
The process to debrief participants must be explained in the IRB-1 protocol. Address the following elements:
- Indicate who will debrief participants. The IRB expects that this person is a member of the research team, someone knowledgeable about the research and the deception. If the research is student directed (i.e. related to graduate studies, master’s thesis or doctoral dissertation), the IRB expects that the student researcher will debrief participants.
- Indicate when participants will be debriefed. Again, 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 include the following:
- Label the form as “Debriefing Statement”
- Study title
- PI name and contact information for follow-up questions
- Student researcher’s name and contact information, if applicable, for follow-up questions.
- Thank participants for taking the time to participate in the study
- Explain what was being studied (i.e., purpose, hypothesis, aim). Use lay terms and avoid use of jargon.
- Explain how participants were deceived
- Explain why deception was necessary in order to carry out the research
- Explain how the results of the deception will be evaluated
- If the study involves use of audio or video-recording an individual participant, give the participant an opportunity to withdraw his/her consent for use of the recordings 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 for whom participants should contact regarding their withdrawal from the study. This option must be given to participants even if they were video or audio-recorded 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 audio recording.
Consider adding the following, additional elements, to the debriefing statement:
- Provide references/website for further reading on the topic
- Emphasize that it was the not the gullibility of the participant but rather the skill of the experimenter that is responsible for the success of the deception (Sloan & Hull, 2006).
- If the study did not involve use of audio or video recording but involves sensitive topics, it may be appropriate to give participants an opportunity to withdraw their consent to participate.
In addition to the elements included in the debriefing statement, consider adding the following elements to the oral debriefing that takes place after the participant has completed the study:
- Relate the research to something participants may have learned in class (methods or theory)
- Explain anticipated or observed results so far
- Offer to provide them with the study results
Debriefing as an Educational Tool
Finally, the IRB suggests that the debriefing also be used as an educational tool, even when the study does not involve use of deception. Participants should be given a simple, clear and informative explanation of the rationale for the design of the study and the methods used. Ask for and answer participant’s questions.
Sloan, L and Hull, J. 2006. Deception of Research Subjects 2nd Edition. In E. A Bankert and R. J. Amdur (Eds.), Institutional Review Board Management and Function (210-215). Sudbury, Massachusetts: Jones and Bartlett Publishers.
Source material for this policy guidance was provided by the Duke University IRB and the Stanford University Psychology Department. The UConn IRB gratefully acknowledges this support.
January 2009