Deception and Incomplete Disclosure
Overview
This guidance is intended to help investigators understand the ethical and regulatory considerations associated with deception and incomplete information for human subjects' research.
Deception and incomplete disclosure limit a research subject’s ability to provide fully informed consent and therefore require careful ethical justification. When does deception occurs?
Deception occurs when investigators intentionally provide false or misleading information to research subjects.
Examples include:
- Providing a false description of the study purpose.
- Misrepresenting the identity of an investigator or research sponsor.
- Presenting confederates as study research subjects.
- Providing false feedback about research subject performance.
- Creating a fictitious scenario to observe research subject reactions.
When does incomplete information occurs?
Incomplete disclosure occurs when investigators intentionally withhold certain information about the study until participation is complete.
Examples include:
- Not fully revealing the study hypothesis.
- Withholding information about specific measures being collected.
- Delaying explanation of certain study procedures until after participation.
When does deception and incomplete disclosure permitted?
- When the research involves no more than minimal risk.
- The use of deception in the study is scientifically necessary to answer the research questions.
- There are no practical, non-deceptive alternative methods that can achieve the same research objectives or results.
- When withholding or altering information does not affect research subjects’ willingness to participate in a way that creates undue harm or unfairness,
- When research subjects are given clear and appropriate debriefing after participation, explaining the true purpose and deception used.
- The research subject’s rights and welfare are not adversely affected by the deception or incomplete disclosure.
- The study complies with federal regulations allowing alterations or waivers of informed consent under specific conditions (e.g., 45 CFR 46.116).
Investigator Responsibilities
The Principal Investigator is responsible for:
- Justifying the need for deception.
- Demonstrating that alternatives are inadequate.
- Minimizing the risks to research subjects.
- Ensuring that consent procedures remain ethically appropriate.
- Debriefing the research subjects according to the approved protocol.
- Monitoring research subjects when experiencing distress and responding appropriately.
IRB Application Expectations
When submitting a study involving deception and incomplete information, investigators should consider the following:
Section: Exempt Categories
Generally, studies involving deception are not eligible for exemption unless research subjects are prospectively informed that deception will occur, such as in certain benign behavioral intervention studies under Category 3.
Section: Research Procedures
Q: Provide a timeline of when the debrief will take place and how it will take place.
Debriefing should occur as soon as feasible after participation unless delayed debriefing is scientifically justified approved by the IRB.
The debriefing should explain:
- The true purpose and objectives of the study.
- The nature and rationale for any deception or incomplete disclosure used.
- Any information that was intentionally withheld or presented in a misleading manner.
- How the use of deception contributed to the scientific validity of the research.
- Available support resources, if research subjects may have caused discomfort or distress.
- Whether the research subjects have the option to withdraw their data after learning the true purpose of the study and how to do so, if applicable.
Section: Consent Documentation/ Waivers
Consent language should clearly explain:
- The purpose of the research and what participation involves.
- Expected duration and study procedures.
- Explain confidentiality protections.
- State that some information about the study cannot be fully explained before participation for scientific reasons, when applicable.
- Some information about the study may be withheld or not fully explained until participation is complete, if deception or incomplete disclosure is being used.
- The risks that could affect the research subjects’ decisions to participate, any physical pain, severe emotional distress, and any legal or financial consequences.
Section: Risks
Investigators should evaluate the probability, magnitude, duration, and reversibility of these risks based on the study design, and research subject population.
A. Psychological
Q: List the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the subjects' participation in the research. Include for the IRB's consideration a description of the probability, magnitude, duration, and reversibility of the risks.
Depending on the content and nature of the study, research subjects may experience:
- Temporary emotional discomfort, confusion, frustration, embarrassment, anxiety, guilt, or mild stress.
- Temporary reduction of trust toward the research process or investigators.
- Negative effects on self-esteem.
- Feeling of betrayal or perceive violation of autonomy due to not receiving complete information before participation.
Q: Provides the measures you will use to minimize risks and to monitor subjects for safety (e.g., asking a subject at regular intervals to rate how they are feeling from 1 to 10, or to slowly crouch in order to check their balance.)
The following are suggested risk mitigation:
- Deception or incomplete disclosure will be limited to the necessary to answer the research question.
- Research subjects will not be deceived about risks, physical discomfort, legal, financial consequences or any information that could reasonably affect their decision to participate.
- A debriefing should occur immediately after participation.
- Research subjects will be informed of the purpose of the deception.
- Research subjects will have the opportunity to ask questions.
- Option to withdraw their data after debriefing.
B. Privacy
Q: List the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the subjects' participation in the research. Include for the IRB's consideration a description of the probability, magnitude, duration, and reversibility of the risks.
Depending on the content and nature of the study, research subjects may experience:
- Loss of privacy or unauthorized access to research data.
- Concern about the collection of electronic information and personal information.
Q: Provides the measures you will use to minimize risks and to monitor subjects for safety (e.g., asking a subject at regular intervals to rate how they are feeling from 1 to 10, or to slowly crouch in order to check their balance.)
The following are suggested risk mitigation:
- Data will be stored on secure, password-protected systems accessible only to authorized research personnel.
- Identifying information will not be collected whenever possible.
- Research subjects will be informed of any information collected by the research platform and any limitations to confidentiality.
Regulatory References
- 45 CFR 46.116
- Belmont Report