1. HRPP Coordinator Meeting May 19, 2017
Deception Research
HRPP Coordinator Meeting
May 19, 2017

2. What is Deception?
Deception is when researchers are intentionally misleading participants by providing them with overt misdirection or false information about some aspect of the research, whether it is in the procedures or purpose of the research.
Incomplete Disclosure is when researchers withhold information about some aspect of the research whether it is in procedures or purpose of research. Examples of this would be participants being informed about the purpose of the study in general terms that are true but not detailed enough to reveal the true objectives of the study.
Though some IRBs distinguish between deception and incomplete disclosure both interfere with a participant’s ability to provide informed consent. CUNY does not distinguish between deception and incomplete disclosure.
Deception can occur in Exempt Research as well. This issue will become more important if and when the new federal regulations are approved and new exemption categories (in particular exemption category 3) are adopted as authorized deception will be required.

3. When is Deception Allowed in Research?
Some research can only be carried out when a participant is unaware of certain aspects of the study. This is to prevent bias from the participant, as they may act a particular way knowing that a specific phenomenon is going to be measured, particularly when that thought or behavior is socially unacceptable (racism, prejudice, cheating, stealing, etc.)
Examples
Providing a false statement on the study’s purpose
Withholding information that the study is actually about racism.
Informing participants that they received a certain result on a survey or test to see how they respond
Telling participants that they did poorly on the test, even if they actually performed well.
Study “confederates”
A research assistant pretends to be another participant and starts openly cheating to see how you will respond.

4. Use of Deception in Research
In general, the IRB must consider:
Is the use of deception scientifically and ethically justified?
Would the information being withheld from the subjects influence their decision to participate in the research?
Is it permissible to alter and/or the exclude a required element of informed consent?
Is it appropriate to debrief participants?
All deception research must be justified – why is it necessary to deceive participants or withhold information from them? Could the study be carried out otherwise? This must be clear in the application.
If the study is not research a participant would want to partake in otherwise, deception tactics should not be used to fool them into participating.

5. Consent in Deception (Consent Alteration/Waiver)
45 CFR 46 allow for waivers/alterations of consent, which are commonly used to allow deception.
Waiver/Alteration of one or more elements of informed consent:
No more than minimal risk
Waiver or alteration will not adversely affect the rights or welfare of subjects
Research cannot not be practicably carried out without the waiver or alterations
Whenever appropriate, subjects will be provided with additional pertinent information after participation
Researchers may also obtain a preliminary quasi-consent or engage in “authorized deception”, meaning that they tell the subject upfront that only parts of the study can be revealed before participation or that some parts of the study will be deceptive, respectively.
Please see our “Suggested Language for Informed Consent Documents” document for recommended deception language that should be included in consent documents.

6. Debriefing
Debriefing provides participants with a full explanation of the hypothesis being tested, the procedures used 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.
Whenever possible, participants should be debriefed as soon as the study design allows (right after participation is complete or the study is complete), unless debriefing would cause an unreasonable risk of harm that would not be outweighed by the benefit. A delayed debriefing might be reasonable if revealing the true purpose of the study to participants immediately could jeopardize the results by possibly alerting other potential participants.
Debriefing allows the investigator to apologize for the deception, explain why deception was necessary, and reveal all necessary information about the study to the participant. It allows the participant to work through distress caused by the research, and gives the participant the opportunity to ask any questions in light of the new information.
It also gives the participant the opportunity to withdraw their participation.

7. Additional Notes
Deception, especially for sensitive topics that involve socially unacceptable behaviors/attitudes by the participants, may cause some participants to feel distressed, upset, ashamed, or embarrassed afterwards. This is why debriefing is so important. Researchers should be prepared for potential reactions from participants and do everything they can to minimize the severity and amount of deception used.
Deception can erode trust in research.
Deception research can be approved under exempt categories if the research meets exempt criteria. If the project meets exempt criteria it does not need to go to expedited review or the full board.
In an FDA regulated study, it is also acceptable to withhold certain information in the initial consent process if the withholding is essential to ensure blinding.  This would not be considered deception, just as blinding is not considered deception.  However, it would usually be appropriate to disclose the withheld information to the subject at such point as it is no longer necessary for the blinding.

8. Determining Deception in Research
Researchers may not be aware that they are utilizing deception in their studies. It is important that HRPP Coordinators review the IRB application and associated materials to ensure that researchers are not misleading or providing incomplete disclosure. Some ways to ensure this are the following:
Comparing the consent form with the IRB application to ensure that all research procedures and purposes are being accurately described. For those projects requiring IRB review ensuring that all elements of consent are present unless a consent waiver or alteration has been requested.
Reviewing research procedures to ensure that investigators are not misleading subjects.
Reviewing research materials to ensure that participants are receiving accurate information.

9. Deception Resources
incomplete-disclosure-guidance.pdf