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Changes to the Common Rule
NEW: A new federal exemption regarding deception is scheduled to go into effect on July 19, 2018. It allows deception to be used in exempt research on benign behavioral interventions with adults as long as the participant agrees to deception ahead of time. In other words, the participant will need to acknowledge that they understand some level of deception will be used and will receive debriefing information about the nature of the deception after their participation in the study is complete.
Current Guidelines of Deception in Research
What are the parameters of using deception in research?
Sometimes research designs require that information deliberately be withheld from participants or false information be provided to them. There should be scientifically justifiable reasons for doing this.
The use of deception in research is not prohibited by either the federal regulations or The College at Brockport. However, because at some level the use of deception in research violates the trust that the participant puts in the researcher, this method should be considered carefully. Deliberate deception of participants may occur only in situations where withholding information about the nature of the study is necessary to ensure valid results, and never to get participants to do something that they would not do if the information was fully disclosed to them.
When is deception allowed?
Many research questions in social and behavioral science cannot be answered if participants are fully aware of the question being asked, since their behavior will often be changed by that knowledge. In some cases, we might not describe the procedure as active deception, so much as lack of full disclosure of the nature or purpose of what is being studied. For example, we may be interested in how a participant’s mood affects their cognitive performance, or social interactions. On the other hand, some studies may require active deception, for example by providing participants bogus feedback about their performance, attitudes or aptitudes, or by staging certain kinds of interactions between them and others who are covert confederates of the researcher.
Broadly, the regulations allow for studies that involve deception, despite the fact
it appears to go against the fundamental principle of informed consent. As with any
research, the IRB must weigh the potential benefits of any knowledge gained from the
research, against the costs and potential harm of the deception. It must be demonstrated
that the research could not be practicably carried out without the deception.
In assessing potential harm, the IRB considers the potential for stress and discomfort that the deception might involve, as well as the duration of that stress—how long is the delay before the true nature of the study is disclosed?
What should consent include?
In studies that require deception, the consent form should tell as much true information as possible about the protocol. Aspects of the protocol that are not disclosed should be omitted or be covered in larger/blanket statements. The consent form should not be an instrument of deception. A second “study information” sheet of some sort would be more appropriate for manipulations of the participant rather than the consent form itself, which still serves to tell the participant who is conducting the research, what they will be doing, how to contact the researchers and the IRB, etc.
Many descriptors of the study may be possible in the informed consent document, giving the participants some true idea of what sorts of experiences they will have in the research without exposing the manipulation of interest. Usually the consent/assent forms include something descriptive about the study. It may not use the actual title of the protocol, but may instead substitute a more vague descriptor or title.
When is debriefing necessary?
Debriefing is necessary any time that the full and true purpose of the experiment cannot be disclosed at the beginning of the study. This necessitates a full disclosure of the true manipulations taking place and the true and full purpose of the study, an opportunity for the participant to ask questions to the researchers, and a formal debriefing form explaining the manipulations. It will also contain signatures lines and an area where participants can again consent in writing to include their data in the study.
Note: Debriefing is not required in situations in which debriefing would cause more harm than good, for example, if subject selection was based on an undesirable or unflattering characteristic.
What should debriefing procedures / debriefing form include?
Debriefing must happen in a way that all participants are aware of the full true purpose of the study and all are debriefed. This most commonly means that participants are debriefed after the testing session end, but before they leave the experimenter’s presence.
Participants must then be told the purpose of the study and also be presented with
a form that explains this. The form should not only include an explanation of the
deception in the current study, but also a brief explanation about why deception must
take place in social and behavioral research more generally.
The form must contain BOTH a place where the participant signs saying that they received the debriefing and a line where they initial to say YES or NO that they will still allow their data to be used in the study now that they know the full purpose of the study. The participant then reads and signs the debriefing form to say they have read it. If they do not respond to that second question, or respond NO, then their data may NOT be included. There cannot be “passive re-consent”; if researchers do not get a definite response, they cannot use that participant’s data. An example of “re-consent” language is below:
Now that you have learned the true and full purpose of the current study and know about the actual manipulations that took place as part of this study, do you still wish to have your data to be included in this research project?
Please sign only one of the lines below:
YES, I DO want my data to be included in this study
NO, I DO NOT want my data to be included in this study
If your research involves deception, you will need to fill out Form E, Research Involving Psychological Intervention, where you will describe for the IRB the method, rationale and the process of informing participants of the purpose of the research as early as is feasible – preferably at the conclusion of an individual’s participation (but no later than at the conclusion of data collection) to permit participants to withdraw their data. Additionally, researchers should provide a justification for the deception techniques and document that there are no equally effective non-deceptive techniques available. Please refer to the American Psychological Association’s Ethical Principles of Psychologists and Code of Conduct for further guidance.
Please keep in mind the following:
- Depending on the level of deception, research involving deception may need full board review.
- Deception cannot be used in any study where there is risk to participants or where the deception itself would create risk.
- In general, no information can be withheld from participants that could significantly affect their decision to participate. When the deception involves a falsehood told, no information can be provided to participants that would have a harmful effect on them if the statement were believed. Since there is no informed consent in research involving deception, the terms "Informed Consent" or "Consent Form" should not be used. However, participants still need to be informed about the nature of the research in a way that does not invalidate the data. One possibility is to provide the participants with a "Participant Information Sheet" which contains the necessary information. Participants must be provided with sufficient information for them to decide whether to participate and must be allowed to withdraw at any time without penalty.
- The investigator should keep deception to a minimum and provide as much information as possible to the participants while still accomplishing the research goals.
- All participants must be debriefed regarding the true nature of the research after their participation. Care should be taken in the debriefing process to protect the well-being of the participants. A written text of the explanation must be submitted to the IRB, which can then serve as the basis for conducting the debriefing.