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. 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: 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: 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 RequirementWhen 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:
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:
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:
At a minimum, the debriefing statement must include the following:
Consider adding the following, additional elements, to the debriefing statement:
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:
Debriefing as an Educational ToolFinally, 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 Back to Researcher’s Guide What is deception and debriefing 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.
What is the difference between debriefing and informed consent?Informed consent is when participants give permission prior to taking part in a study or experiment. The participants understand that their participation is voluntary and they accept the possible risks, benefits, or outcomes of the study. Debriefing is an interview between the researchers and the participants.
What is debriefing in research?“Debriefing” is a procedure that occurs at the conclusion of the human subject's participation in the study (although, in cases that warrant it, a full debriefing may occur at the conclusion of the study), through which the subject is provided the opportunity to discuss with the researcher the details of the research.
What happens during the debriefing stage of an experiment?Debriefing is the act of informing participants about the intentions of the study in which they just participated; during this process, researchers reveal any deceptions that occurred and explain why deception was necessary. Debriefing typically occurs at the conclusion of participants' study involvement.
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