In the course of designing a research project, researchers may find it useful to include a debriefing of the study for participants at the close of the project. The debriefing process is a requirement for studies that employ deception (#1 below), however it could also be used as an educational tool (#2 below). What follows are: a) guidelines for preparing an e-protocol submission that incorporates deception and/or requires a debriefing process, and b) specific issues that should be addressed in the debriefing form.
1. Use of Debriefing for Deception Studies
Researchers may find that the use of deception, or incomplete disclosure, is a necessary tool for their study. 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.
Preparing Your E-Protocol Submission for Deception Studies.
A. Justifying the Use of Deception
An investigator proposing to use deception or incomplete disclosure should justify its use in their IRB protocol submission. Studies utilizing deception should not be submitted for Exempt Review, rather, depending on the nature of the deception the study will be reviewed under either Expedited or Full Board Review processes. Please address the following when preparing your IRB protocol submission:
- In the Study Procedures Section, justify the use of deception and explain why deception is necessary to achieve the goals of the study. Researchers may also provide prior evidence and data that such research methods and use of deception on the proposed subject population does not negatively affect subjects’ attitudes about the research.
- In the Procedures Section, explain the process to debrief participants. Explain when participants will be debriefed, who will debrief them, and how they will be debriefed (online studies may require a different debriefing process than in-lab studies – for more information read the Debriefing Requirements below and/or see our website for guidance of online research).
- 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).
- When participants are not given complete information about the study in the informed consent document, it is no longer considered an “informed” consent. In this instance the “informed” consent should merely be labeled a consent document. The IRB must waive certain required elements of the informed consent process (i.e. an explanation of the purpose of the research, a description of the procedures involved, etc.) in such instances. See below for additional information.
- Provide a copy of the debriefing statement(s) that will be given to participants and if applicable, the script that will be used by the researchers to orally explain the study (see below for guidance regarding the debriefing).
B. Debriefing Requirements and Process
The debriefing is an essential part of the consent process and is mandatory when the research study involves 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.
After participants have been debriefed immediately following completion of the study the IRB expects that participants will be given a debriefing statement to take with them. For online studies the debriefing process should occur as soon as a participant has completed the research activity. As an added measure, it may be necessary to send an email out to all participants after the study is completed to ensure that all participants (those that completed and those that may have stopped mid-way) receive a debriefing form. The debriefing statement must be reviewed and approved by the IRB.
The process to debrief participants must be explained in your IRB submission. Your submission must indicate who will debrief participants. The IRB expects that this person is a member of the research team who has knowledge about the research and the deception.
The Debriefing Form should include the following:
- Study title
- 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 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 for whom participants should contact regarding their withdrawal from the study. 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.
- Provide participants an opportunity to withdraw their consent to participate or to withdraw their data from the study.
- If applicable explain anticipated or observed results so far
- Offer to provide them with the study results
- Provide references/website for further reading on the topic
- Provide a list of resources participants can seek if they become distressed after the study. For a referral list of counseling resources to cite, please see our guidance page.
The IRB has provided a deception research debriefing form template for researchers to use. Please note that the UMass Psychology Department may have their own guidelines and specifications regarding debriefing forms used by researchers in the department. For further information on psychology department specific guidelines please see their website.
2. Use of 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 the 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. It should also ask for and answer participant’s questions. The IRB has provided a generic debriefing form template for researchers to use as an educational tool
Source material for this policy guidance was provided by the University of Connecticut IRB. The UMass IRB gratefully acknowledges this support.