Deception and Incomplete Disclosure - Office of Research Compliance

Deception & Incomplete Disclosure in Human Subjects Research Guidance

Overview

The UMaine Institutional Review Board for the Protection of Human Subjects (IRB) recognizes that research studies involving human subjects may sometimes necessitate the use of deception and incomplete disclosure to prevent participant biases or test a hypothesis that requires the misdirection of participants. The regulations (45 CFR 46.116) require the full disclosure of all elements in the research to ensure that participants’ consent in the research is given voluntarily and with adequate information. Thus, the use of deception and/or incomplete disclosure in research with human subjects places additional requirements on researchers including the provision of scientific justification and added study procedures designed to preserve participant autonomy and respect for persons. Researchers must demonstrate that the use of such methodology is required by the research, not merely that it would be inconvenient to carry out the study without the deception and/or incomplete disclosure.

Definitions

Deception

Deception is the intentional communication of misleading or false information to participants through the study procedures or study purpose. Examples include:

Participants take a quiz and are inaccurately told that they did poorly.
A confederate (an undisclosed member of the research team) is used in interactions with the participant before and/or during expected study procedures.

Incomplete Disclosure

Incomplete disclosure applies when the true purpose or nature, or some other aspect of the research, is deliberately withheld or concealed from the participant. Examples include:

Participants are asked to take a quiz for research, but they are not told that the research question involves how background noise affects their ability to concentrate.
Participants are informed about the purpose of the study in general terms (e.g., “levels of satisfaction of participant’s experience using AI [Artificial Intelligence]”) but are not provided with enough details that reveal the true objectives of the study (e.g., “correlation of participant’s reported experience with AI in relation to the AI platform used”).

Investigator Responsibilities/Protocol Preparation

The IRB will consider the following when reviewing research involving the use of deception or incomplete disclosure:

The study must generally not involve more than minimal risk to the subjects;
The use of deception or incomplete disclosure must be justified in the application by the study’s significant prospective scientific, educational, or applied value;
The use of deception or incomplete disclosure must be justified in the protocol to show that the research cannot be performed in the absence of deception or incomplete disclosure and that the benefits of the research will sufficiently outweigh any risks that deception or incomplete disclosure may create;
The application demonstrates that the investigators are aware of, seeking to minimize, and have a plan to address the possible negative impacts on participants;
The application includes a description of post study debriefing and debriefing materials that includes (when required) offering the participant the option to withdraw their data from the study; and
Research participants cannot be deceived about significant aspects of the research such that it would affect their willingness to participate or cause them significant physical or emotional harm.

The IRB may choose to not approve research that entails more than minimal risk where participants are deceived or not given complete information that they would consider material to the decision to participate in the study.

Exempt IRB Review Requirements for Deception Only

The 2018 Revised Common Rule regulations allow for deception to be approved as exempt if participants authorize the deception through a prospective agreement to participate in research and the research otherwise falls into one or more exempt research categories. Debriefing may still be required in these deception studies as determined by the IRB.

When research of this type involves deceiving participants about the purpose or nature of the study or activities, the deception disclosure must be agreed to by the subject as a part of the consent process. If an investigator chooses not to disclose deception within the consent, the level of IRB review will be raised to expedited and the standard debriefing requirements will still apply.

Note: This applies only to the use of deception (i.e., incomplete disclosure does not require prospective agreement to be considered exempt).

Sample language for authorized deception:

“For scientific reasons, this consent form does not include complete information about the research questions or topics being tested.”

“We cannot tell you every detail of this study ahead of time, but if you are willing to participate under these conditions, we will explain the procedure to you fully after your participation, and you will have the right to withdraw your consent at that time. If you withdraw your consent, your data will be deleted.”

Debriefing

When an investigator uses deception or incomplete disclosure, regulations require that participants be debriefed at the end of the study, unless otherwise deemed unnecessary or inappropriate by the IRB (for example, when debriefing regarding the deception may cause more harm than the deception itself). The debriefing aims to mitigate any harm to the subject and to restore the informed consent obtained from subjects to an unaltered, fully informed consent process as required by the regulations.

The debriefing provides participants with:

A full explanation of the hypothesis being tested;
The procedures involved to deceive participants or not disclose the full purpose of the study;
The reason(s) why it was necessary to do so; and
Other relevant background information, if appropriate, pertaining to the study.

Debriefing sessions and materials should mitigate the potential harm of deception or incomplete disclosure by explaining the rationale for the use of such methodologies. Participants should be given a simple, clear, and informative explanation of the study and should have the opportunity to ask questions. Debriefing can occur via email, in-person, virtually over Zoom, etc., depending on which format aligns with the methods and risks of the research.

Debrief Timing

Participants should be debriefed as early as feasible. However, in some cases, immediately debriefing a participant after study participation would compromise study results (e.g., the study is ongoing and early participants might tell others about it, making it impossible for the researchers to obtain valid/unbiased results from later participants). Under such circumstances, the IRB may approve a delayed debriefing process, such as sending debriefing information to participants via email or giving participants a website URL where they can retrieve debriefing information at a specified date when the study has concluded.

Conversely, some studies may cause subjects to feel a range of emotions at different intervals about being deceived. In these instances, the IRB may require a process for continuous or staged debriefing; however, this is generally only done for greater than minimal risk (or full board) studies.

Option for Participant Withdrawal

The IRB may require that the debriefing includes an option for participants to withdraw their data from the study after they are told the true nature of the research. If the deception or incomplete disclosure could have materially influenced the participant’s decision about study participation, and/or the deception or incomplete disclosure would likely be perceived by participants as an invasion of privacy (e.g., videotaping without prior consent), the IRB may require reconsent for the use of data as part of the debriefing process. In cases where the IRB requires that the investigator provide participants with the option to withdraw their data upon being debriefed, the research team will need to keep sufficient identifiers or links to identifiers for participants to exercise this option.

Sample Debriefing Language

Sample language for debriefing on use of incomplete disclosure in online survey:

“Thank you for participating in this research! As stated in the consent form, the purpose of this research is to [insert explanation of study purpose given to participants in the informed consent]. More specifically, we are interested in [insert information about the study purpose or procedures that were withheld]. We were unable to articulate this specific research question in the consent form because awareness of this question might bias participants’ responses. To protect the integrity of this research, we ask that you do not discuss the study with others. If you have any questions about this research (or wish to withdraw your data from use in this research [if option to withdraw is required]), please contact the principal investigator at [insert PI’s email and phone number]. If you have any questions about your rights as a research participant, please contact the UMaine Office of Research Compliance at 207-581-2657 or email umric@maine.edu, We thank you again for participating in our research!”

Sample language for debriefing on use of deception in-person:

“We would like to thank you for participating in this research! Now that you have participated in the study, we would like to discuss in greater detail with you the purpose of the study. As stated in the consent form, the purpose of this research is to [explanation of study purpose given to participants in the informed consent]. More specifically, we are interested in [explanation of information about the study purpose or procedures that were withheld]. During the study, we used [explain the deception] because [explain the scientific rationale]. We were unable to reveal this information to you in the consent form because awareness of these details could bias participants’ responses. Now that you are aware of the deception used in this study, do you still wish to include your confidential data in this research? Do you have any questions at this time about the methods used in the study? To protect the integrity of this research, we ask that you do not discuss with others the details of this study that we just revealed to you. If you have any additional questions about this research, you may contact the principal investigator at [insert PI’s email and phone number]. If you have any questions about your rights as a research participant, please contact the UMaine Office of Research Compliance at 207-581-2657 or email umric@maine.edu. We thank you again for participating in our research!”

Office of Research Compliance