61 - Definition Analysis of Deception in Human Subjects Research

Background:  IRBs often have website guidance about research that involves deception. IRBs approve either a waiver or alteration of informed consent for research using deception. However, federal regulations and guidance include little information about what constitutes deception, and IRBs rely on institution-specific policies or guidance.

Methods:  Definitions of "deception" in research were selected from publicly available IRB websites from institutions in the United States. A definition analysis was performed to identify common themes across the definitions, including whether incomplete disclosure is included or considered a separate concept. Major differences between definitions were also identified.

Conclusion:  There is no uniform definition of "deception" in human subjects research across institutions in the United States. As a result, there is a lack of consistency between institutions regarding if deception includes incomplete disclosure. Some institutions discuss the concepts of deception and incomplete disclosure interchangeably, whereas others differentiate between these concepts. Additionally, it may depend on the specific details of a project to determine whether incomplete disclosure constitutes deception. For example, if details are left out with the intent to mislead participants, then incomplete disclosure may be a form of deception. However, if participants are prospectively made aware that details will be left out without being told what is being left out, participants may not view this as being deceived. Federal regulations specifically discuss deception in relation to studies qualifying for exemption under 45 CFR 46.104(d)(3) for benign behavioral interventions. OHRP guidance mentions that an alteration of consent may be granted if subjects must be left unaware of the particular purpose of the research but it does not use the terms “deception” or “incomplete disclosure.” Therefore, institutions in the United States have no federal definition of "deception" to rely upon.

Limitations: What constitutes deception may differ between academic disciplines. Additionally, an exhaustive review of peer-reviewed journal articles and institutional IRB websites was not conducted, meaning some perspectives may have been inadvertently overlooked. Since only institutions in the United States were analyzed, the results do not address the concept of deception in other countries.

Discussion:  Deception is a concept that IRBs are familiar with; however, it may not be straightforward to know if deception is viewed the same across institutions. For research requiring single IRB oversight, it is important for participating institutions to understand how the IRB of Record interprets the concept of deception. Especially if the research proposes withholding information, since there may be conflicting interpretations as to whether incomplete disclosure is a form of deception. It may also be beneficial if federal guidance is created that defines deception and discusses whether incomplete disclosure is a form of deception or a distinct concept.