Skip to main content
Incomplete Disclosure & Deception
Summary
Occasionally in research, deception or incomplete disclosure is necessary to avoid bias or test a hypothesis that involves misdirection. However, the requirements for obtaining informed consent require transparent and comprehensive disclosure of the study’s purpose and procedures in order for the participant to make an “informed” decision to participate. The purpose of this guidance is to address when deception or incomplete disclosure can be used and how to ensure there is appropriate informed consent and a sufficient debriefing process.
Full Description
Definitions
Deception: Purposefully misleading or misdirecting participants to believe something untrue or false about some aspects of the research. In the context of human subjects’ research, deception refers to providing false information to prospective participants. Examples:
- Participants are told they are competing against another participant during a task, when they are playing against a computer.
- Participants are told that they are completing a study but not informed that they are being randomized into two different groups with different procedures.
Incomplete disclosure: The researchers intentionally withhold information about some aspects of the research. In the context of human subjects’ research, incomplete disclosure is when information about the real purpose or nature of the research is withheld from participants.
- Example: The subject is informed about the purpose of the study or a certain procedure in general terms that are true, but not detailed enough to reveal the researcher’s main or specific objective
Minimal risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Debriefing: a process that can be undertaken at the conclusion of any research activities, regardless of whether deception is part of the research design.
Dehoaxing: clarifying with the participant about the deception used and ensuring that they do not leave the study with false beliefs that may cause distress.
- Example: A study has participants completing a “test,” but all the participants receive the same “failing” score to measure their response to stress. At the end of the session, participants were informed that their score was false and did not reflect their actual ability.
When is deception or incomplete disclosure permitted?
Deception and disclosure may be used when:
- The study is no more than “minimal risk,” and the deception/incomplete disclosure does not increase the risk to the participants.
- The researcher demonstrates that deception is necessary to effectively conduct the study, and there are no reasonable alternative methods that would be effective.
- The deception must not cause physical pain or severe emotional distress to potential participants.
- That the eligibility criteria for participation in the research are designed in such a manner that possible participants who may not be willing to participate in the study if they knew the true purpose/nature, are excluded before consent.
- Incomplete disclosure or deception may NOT be used in greater than minimal risk research. Only study procedures that involve minimal risks (as determined by the IRB) can include deception or incomplete disclosure. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(j))
How can consent be obtained from participants?
For research activities eligible for exemption:- For studies seeking exemption, the participants must “authorize the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that they will be unaware of or misled regarding the nature or purposes of the research.” This means that for a study that includes deception or incomplete disclosure to be eligible for an exemption, the following must occur.
- Exemption Categories that allow for incomplete disclosure or deception when prospective permission is sought include:
- Category 2: use of surveys, interviews, focus groups, observations, etc.
- Category 3: implementation of a benign behavioral intervention
- Exemption Categories that allow for incomplete disclosure or deception when prospective permission is sought include:
- Studies involving deception will not be considered for exempt Category 1. Research conducted in established or commonly accepted educational settings) because deception is not a “normal educational practice.”
- Example language to include in the prospective consent used with exemptions can be found in the Appendix linked at the bottom of this page.
For non-exempt research activities:
- The use of deception or incomplete disclosure means one or more of the basic elements for informed consent are being altered. For non-exempt research, the regulations require that the IRB protocol address the waiver or alteration of the required elements of informed consent. The IRB will determine if the study is eligible for such a waiver.
- Ethical practices indicate that researchers inform participants of deception or incomplete disclosure in the consent information when possible. On a case-by-case basis, this consideration may be waived by the IRB if the researcher provides an appropriate justification. To qualify for a waiver or alteration of informed consent, the research must be considered “no more than minimal risk” and:
- ensure incomplete disclosure/deception does not increase risks beyond what participants would agree to had they been fully informed about the research.
- ensure incomplete disclosure/deception do not increase risks beyond what participants would agree to had they been fully informed about the research
- Describe how the waiver or alteration will not adversely affect the rights and welfare of participants. Investigators and the IRB must ensure incomplete disclosure/deception do not compromise participants' privacy, interests, or well-being.
- detail how research could not practically be carried out without the waiver or alteration. Investigators must provide sufficient information for the IRB to determine that the research questions cannot be answered without the use of incomplete disclosure/deception.
- and, whenever appropriate, participants are provided with additional pertinent information after participation. This is often referred to as “Debriefing”
- Example language to include in the consent or debriefing can be found in the Appendix linked at the bottom of this page.
Debriefing and Dehoaxing
- When incomplete disclosure or deception is used, the researcher must follow up with the participant once the study is completed to inform the participant of the incomplete disclosure or deception.
- If the study is done “in-person,” then the debriefing should be done at the end of their study participation. If it is online, asynchronous (e.g. survey), it can be done as the last page of the survey or a follow up email.
- Debriefing should ONLY be conducted by those on the research team that are adequately trained and qualified to approach debriefing in a manner that supports subjects in expressing any thoughts or feelings they may have about being deceived and can be appropriately responsive to their reactions.
- After the debriefing, investigators may ask participants to refrain from talking to others about the incomplete disclosure/deception to minimize the possibility that results may be skewed if subsequent participants knew in advance that incomplete disclosure/deception was being used in the study.
- If after debriefing a participant does not want their data to be used in the project, they should be able to request removal of the data.
What must be included in the IRB protocol submission?
The protocol and related documents submitted to the IRB must include:
- Description of the deception and how it will take place
- Explanation of why the deception/incomplete disclosure is necessary
- Description of whether the deception/incomplete disclosure increases the risk of the research
- A description of any previous use of deception/incomplete disclosure in similar research and a summary of any actual harms or reactions from participants to the use of deception/incomplete disclosure
- A description of alternatives to deception/incomplete disclosure that were considered and an explanation as to why these alternatives were rejected
- Indication of whether deception/incomplete disclosure would impact a participant’s willingness to participate
- Consent process and document that meets the requirement for waiver of one or more elements of consent
- Description of post study debriefing that includes offering the participant the option to withdraw their data from the study
- Description of Debriefing Procedures that include what will be shared with the participants. Debriefing must include:
- The study’s true purpose
- Explain why the use of deception/incomplete disclosure was needed and provide the rationale for the study design
- Inform participants that incomplete disclosure/deception was used
- Specify what information was withheld or falsified
- Align this information with the details about and the risks associated with the study,
- Provide participants with the opportunity to ask questions about the new information.
- Allow individual participants to withdraw their data after learning of the incomplete disclosure/deception, and the true purpose/goals of the research.
- Clear instructions regarding how to remove the individual’s data from the study must be provided to the participant during the consent process and debriefing.
- This option is not feasible when data are collected without participant identifiers or links to identifiers.
- Clear instructions regarding how to remove the individual’s data from the study must be provided to the participant during the consent process and debriefing.
Appendix Example Consent and Debriefing Language
ReferencesThe following resources were used to create this guidance document:
|
|---|