Incomplete Disclosure/Deception in Research

Incomplete Disclosure and Deception in Research

Overview

Respecting an individual’s autonomy represents a foundational principle of ethical human participant research; providing all details and truthful information about a study upholds this basic principle.

Incomplete disclosure and deception compromise the integrity of the informed-consent process, because participants are unable to make a fully informed decision whether to participate. Thus, ethical practices strongly advise against using incomplete disclosure and/or deception in research.

However, for certain minimal-risk projects, especially with social and behavioral research, these methodologies might help avoid influencing participants and biasing their responses or behaviors (thus impacting the validity of a study). Approval of these projects is relatively rare.

Definitions

Incomplete Disclosure: deliberately withholding or concealing information about the study purpose, nature, or other aspect. Examples (used with permission from the University of California–Los Angeles Human Research Protection Program):

• Participants are asked to take a quiz for research but are not told that the research question involves how background noise affects their ability to concentrate.

• Participants are told they are completing a survey to evaluate customer service, when the true purpose of the study is to correlate psychological responses with patient care satisfaction.

Active Deception: intentionally providing misleading or false information about the study purpose, nature, or other aspect. Examples (used with permission from the University of California–Los Angeles Human Research Protection Program):

• Participants complete a quiz and are falsely told that they did poorly, regardless of their performance.
• Participants who don’t know they are in a research study are observed to see how they behave when they find valuables (e.g., wallet, laptop) unattended in a public location.
• An anxiety study, in which participants are told to expect mild pain during the course of the study, but no painful procedures are administered.

Passive Deception: incomplete disclosure plus deception. Researchers might use deception that omits important study information if providing full study details would impact participants’ behavior and their choice to participate. Examples:

• Researchers record participants without knowledge or consent.
• Participants believe a survey evaluates fictional job applicants, when the survey actually assesses participants’ tendencies to discriminate.

Risks of Deception/Incomplete Disclosure for Participants

Risks in such studies include:

• Participants feeling coerced/influenced to act against their will (because they would not have participated, had they known the full details).
• Participants experiencing shame, guilt, or stress upon learning embarrassing or negative information about themselves (that they did not know or want to know).
• Generating suspicion about human participant research or distrust in professional standards.

IRB Review Levels 

Federal regulations and SU policies prohibit incomplete disclosure/deception for projects involving greater than minimal risk.

Exemption Applications: Federal regulations and SU policy allow for deception in exempt studies only when the research falls into an established exemption category and consent materials inform participants in advance that they “will be unaware of or misled regarding the nature or purposes of the research.”

Expedited and Full-Board Studies: To use deception/incomplete disclosure at the expedited level, the deception/omission must be minor, and the study may not involve highly sensitive topics and/or potentially vulnerable participants. Otherwise, the full board must review the protocol at a convened board meeting.

Submission Guidance

Typically, the SU IRB will not approve the use of incomplete disclosure/deception in research. Investigators wishing to use these methods must demonstrate in their IRB protocol submission that:

• non-deceptive alternatives cannot achieve the study goal, and the benefits of the study justify the methods;
• the deception will not trick people into participating, if knowing the full information would otherwise lead them to decline;
• use of incomplete disclosure/deception does not elevate risk to participants (whether financial, physical, legal, psychological, social, or other).

The IRB will then evaluate:

• the study’s scientific value and validity, as well as reasonably expected benefits to individuals or society;
• the possibility of alternative procedures;
• possible risk mitigation through appropriate debriefing;
• the researcher’s expertise/resources to address potential participant distress.

The IRB may require the researcher to indicate incomplete disclosure/deception on the consent form, so individuals can choose whether to participate in such research. Sample language:

• “For specific study goals, this consent form does not include complete information about our study hypotheses and research questions. After you participate in the study, we will provide complete information (debriefing) about the research project.”
• “We provided general information about the research project, but we will not explain all study objectives until after you complete the study.”

Debriefing Process

For incomplete disclosure/deception studies, a critical part of the ongoing informed consent process involves post-activity debriefing, which should typically occur as soon as possible after participants complete study tasks.

Researchers should

• Explain (in writing or orally) in non-technical language the incomplete information/deception and clarify true study objectives.
• Identify reasons for deceptive methods, keeping in mind the potential for participants’ embarrassment or discomfort about being deceived.
• Allow participants to ask questions.
• If the IRB requires, allow participants to withdraw their data upon debriefing.
• If the IRB requires, actively re-consent participants for use of their data, once they fully understand all study details.

Click here for Sample Debriefing Template

Exceptions to the Debriefing Process: In rare instances, the IRB may recommend against full debriefing, if it could elevate risk to participants without a balancing benefit. For example, if a study about group behavior recruits certain individuals based on a “negative" behavior/characteristic, where learning about that individual designation could prove upsetting to participants.

Delayed Debriefing: A delay between finishing research tasks and debriefing might be necessary at times. For example, if early participants might reveal study details to later participants, thereby impacting study validity, then a delay might be added to the protocol. In such cases, the IRB may approve providing debriefing information via email or a website URL after study completion.

Debriefing as an Educational Tool: In some academic environments, researchers might provide general feedback about the study vs. explaining withheld or falsified information. Typically, the original consent will explain this plan, and the debriefing form will offer resources for students to learn more about the topic.