Guidance: Using Deception and Incomplete Disclosure in Research

Purpose: To inform researchers about expectations for human subjects research methods that involve deception. 

Scope: This guidance applies to human subjects research conducted under the auspices of Ohio University, where the protocol involves deception or incomplete disclosure.

 

Definitions used at Ohio University: 

Deception involves intentionally providing inaccurate or false information to research participants to deceive the subjects about the nature or purposes of the research.

Incomplete disclosure involves withholding information about the true study purpose and/or reason for procedures. 

Disclosed concealment involves informing participants up front that they will not know certain details or receive certain information (for example, in placebo-controlled trials). 

 

Introduction: 

According to the Belmont Report, “respect for persons demands that subjects enter into the research voluntarily and with adequate information.” Informed consent is a central component of ensuring research participants have adequate information to make an informed decision about whether to participate in a research study. 45 CFR 46.116(b) lists specific elements of informed consent that must be provided to prospective participants. 

However, the regulations allow an alteration of consent, or, withholding certain details about the research or even deceiving potential subjects, if this can be justified. In rare circumstances where the study design requires omission of details that might introduce bias or influence the research participants’ responses or behavior in the research, certain information about the study or study activities can be withheld until after their participation. 

 

Guidance:

Studies involving deception and incomplete disclosure may be approved if they have scientific value and would not be otherwise feasible. Researchers should be prepared to provide a strong justification to the IRB for the use of deception or incomplete disclosure, as well as plan additional safeguards for protecting the rights and welfare of research participants.

Deception or incomplete disclosure in research cannot be approved if:

  • The research involves more than minimal risk;
  • The research could be conducted without the deception or incomplete disclosure;
  • The purpose of the deception is to recruit individuals who would otherwise not choose to participate if they knew all the details;
  • The research places participants at significant financial, physical, legal, psychological, or social risk;
  • The research is regulated by the U.S. Food and Drug Administration. 

Research involving deception that is subject to the General Data Protection Regulation (GDPR) in European Union countries, European Economic Area (EEA) countries, or in the United Kingdom may require stronger scientific justification for the use of deception and require additional reviews. 

Studies that involve deception or incomplete disclosure should include a debriefing at the end of participation where the participant is informed of the full details of the study and given the opportunity to withdraw their participation and their data, unless the research team can justify that such disclosure of the full details would be more harmful to participants than beneficial. 

Sample Debriefing Statement (adapted with permission from guidance information from the University of Kentucky's Office of Research Integrity): 

Thank you for your participation in this research!  It was important for this study that [I/we] [withhold some information from you/provide you with incorrect information] about the research. Now that you have finished the study procedures, [I/we] will explain:

  • what you were not told at the beginning when you agreed to participate, 
  • why it was important not to tell you; and 
  • how you can still decide whether you agree to have your data/information included in this study. 

[I/we] will also answer any questions you may have.

What you should know about this study

(1) Provide a detailed description of the deception or omitted information.  (2) Explain why the deception/omission of information was necessary. Giving you full information in advance could have influenced your participation and/or your responses, which can result in invalid data.   

Please do not reveal the research procedures and/or full purpose of this study to anyone who might participate in the future. It could affect the results of the study. A crucial aspect of the study is that each participant has the same experience as everyone else from the beginning.

PERMISSION TO USE YOUR DATA/INFORMATION

Right to withdraw data 

You may choose to withdraw the data/information you provided for the study now that you know the full purpose of the research. You can do so without penalty or loss of any benefits to which you are otherwise entitled.  [If applicable] You will still receive [insert incentive/payment amount] for your participation, even if you decide to withdraw your data/information.

Can the study team still use your data/information as part of the research?

  • Yes, I give permission for the data/information collected from or about me to be included in the research study.

  • I DO NOT give permission for the data/information collected from or about me to be included in the research study. 

     

Additional Information: 

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

Protocols that involve deception are not eligible for exemption unless subjects are informed before they agree to participate that the study procedures include deception.

Expedited and full board submissions involving deception should include a request for an alteration of the informed consent process.