Overview

Use of deception and incomplete disclosure generally goes against a basic principle of human subjects research: to treat individuals as autonomous agents by disclosing complete and truthful information about a study. However, the IRB recognizes it can be a useful tool, especially in behavioral and social research.

Definitions and Examples

Deception occurs when researchers purposely mislead research subjects by providing them with false information or misdirect them in some way about some aspect of the research procedure and/or purpose of the research.

Examples include:

• Subjects are told they are working with a group of other subjects on a task; however, the other "subjects" are confederates acting as research subjects.
• Participants are told they performed poorly on a task regardless of how they actually performed.

Incomplete disclosure occurs when the researchers withhold information about some aspect of the research from the subjects. In some instances, researchers may tell subjects the general purpose of the study but do not give them enough details to reveal the entire purpose.

Examples include:

• Subjects are told the purpose of the study is to examine how much time people spend studying for finals but they aren't told the secondary purpose which is to examine how well they performed on their finals.
• Researchers inform subjects that the study is exploring people's ability to read quickly but they do not tell subjects that a task they will complete during the research is intended to also examine their emotional responses to certain words they read.

When is Deception or incomplete disclosure acceptable?

In some instances, being told the true nature of the study can cause participants to change how they would normally respond, challenging the scientific validity of the study. Deception is acceptable when revealing the true nature of the study will influence participants and bias their responses.

For all research studies, such requests are justified only if it is clear that:

1. The study is minimal risk;
2. There are no undisclosed risks to participants;
3. The request is truly necessary to accomplish the goals of the research;
4. There is an adequate plan for debriefing participants, when appropriate, and
5. There is an adequate plan for dissemination of research results to participants.

Researchers must always answer participants truthfully when asked a direct question about the research.

It is important to distinguish between studies in which deception or incomplete disclosure would invalidate the research from studies in which deception or incomplete disclosure would simply inconvenience researchers.

For all research studies, such requests cannot be approved if:

1. The study is greater than minimal risk;
2. Any information about study-related risks are withheld;
3. Alternatives are available to accomplish the goals of the research that do not involve deception or incomplete disclosure;
4. The request is intended to unduly influence people to volunteer for a study they would not otherwise enroll into; and
5. The request places participants at financial, physical, legal, psychological, or social risk. 

Deception in Exempt Research

Protocols that include incomplete disclosure are eligible for exemption, assuming they would otherwise be eligible.

Protocols that involve deception are not eligible for exemption unless the participants are informed during the consenting process that the study procedures include deception. Prospective agreement to participate in research that includes deception may only be approved for benign behavioral interventions eligible for exemption under Exempt category 3.

Consent and Debriefing

Providing research participants with sufficient information to make an informed decision about their participation in a study is one the guiding principles of human subjects research. Research designs that use deception or incomplete disclosure do not allow participants to provide fully informed consent prospectively. Investigators should use the following measures to allow participants appropriate autonomy in the consent process for research that involves deception or incomplete disclosure:

• Authorized deception: Whenever possible, informing participants as part of the consent process that a study will not be described with complete accuracy or that some procedures will be deceptive provides an opportunity to decide whether to participate on these terms.

All research studies using deception or incomplete disclosure should have an adequate plan for debriefing participants when it is appropriate.

• Debriefing:Explaining to participants that investigators intentionally provided them with misleading information about the study or that information about the study was withheld from them.

The goal of debriefing participants is to reduce the harm of deception or incomplete disclosure. Investigators should design a respectful and thoughtful debriefing process with this goal in mind.

The investigator, in collaboration with the IRB, will determine if a debriefing process is appropriate for the participants.

The primary goals of the debriefing process include:

• Informing participants of the true goals of the research study and repair the breach of informed consent created by the deception
• Remove any confusion or defuse any tension that might have been generated by the deception
• Educate the participants about the research process and point them to relevant educational resources
• Inform participants why deception is sometimes used in research to obtain scientifically valuable data
• Dehoaxing participants with dignity and unconditional positive regard for the range of emotions participants may have experienced in response to the deception. 

The debriefing process should occur within a reasonable amount of time after the participant has completed study procedures. If a participant withdraws from the study prior to the study’s completion and the consent document does not specify that their data will be destroyed if they withdraw, they should receive the same debriefing process as the completed participants.

If debriefing participants after they complete study procedures could compromise study results, investigators may request that the process be delayed until study completion. Based on the type of study, deception, or incomplete disclosure, the debriefing process may be conducted by phone or online for a conversation between the participant and a researcher; or by mail, e-mail, or participants can be sent to a website where they can read the debriefing information at a date upon which the information will be available.

Suggestions for Debriefing a Participant:

• Provide the study title and the name(s) of the principal investigator(s).
• Explain the following:
  • Study’s true goals and purpose,
  • Why the study was developed, 
  • Any predictions/hypotheses of the study,
  • What the researcher(s) expect(s) to learn from the study
  • The research questions being studied, etc.
• Reveal any deception employed in the study and the reasons why
• Provide withdrawal procedures and information on the opportunity to withdraw
• If available, provide the participant with the results of the study thus far
• Offer resources for research participants, including:
  • Researchers’ contact information,
  • TAMUK IRB’s contact information,
  • Additional useful resources and/or support services, as needed (e.g., relevant crisis hotlines, mental health facilities, and outreach services),
  • Thank the individual for participating in the study. 

Investigator Responsibilities

When conducting research that involves deception or incomplete disclosures, investigators must submit an application for review and approval by the IRB prior to implementing any human subjects research activities.

The IRB protocol must:

1. Justify the reasons for deceiving or withholding information from participants;
2. Explain why the deception or incomplete disclosure is necessary;
3. Describe how the potential benefits of the research justify the deception or incomplete disclosure;
4. Outline the debriefing process, including (a) when, (b) how, and (c) by whom the information will be provided to participants; and
5. Include a copy of the debriefing script.

IRB Considerations

Under 45 CFR 46.116(d), the IRB may waive the requirement for obtaining informed consent or approve a consent procedure that leaves out or alters some or all of the elements of informed consent, provided that the IRB finds and documents that all of the following four criteria are met:

1. The research involves no more than minimal risk to the subjects;
   • Investigators and the IRB must ensure incomplete disclosure/deception are only used in minimal risk research and do not increase risks beyond what participants would agree to had they been fully informed about the research;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects
   • Investigators must provide sufficient information for the IRB to determine that the research questions could not be answered without the use of incomplete disclosure/deception
3. The research could not practicably be carried out without the waiver or alteration; and,
   • Investigators and the IRB must ensure incomplete disclosure/deception does not compromise participants’ privacy, interests, or well-being.
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation
   • Participants should be debriefed after participation unless doing so would harm them.  

The IRB may 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.