Generally, Institutional Review Boards (IRBs) require investigators clearly and accurately inform human subjects about research during the recruitment and consent process. Human subjects are defined as a living individual about whom an investigator conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information (§46.102(f) Definitions). Researchers must disclose the purpose of the study, benefits, potential risks and a description of what participants will be asked to do. Additional protection and safeguards may be needed for vulnerable populations. There are however, some instances in which deception or incomplete disclosure is allowed.
- Deception occurs when the researcher provides false information to subjects about the research.
- Incomplete disclosure is defined as the withholding of information about the purpose of the study.
The IRB considers several factors when reviewing studies using deception or incomplete disclosure. There must be a clear justification for the use of deception, why it is needed, and whether it is possible to conduct the research without it. Participants cannot be deceived about significant aspects of the research that would affect their willingness to participant or that would cause them physical or emotional harm. In most cases, a debriefing is required including a detailed description of the deception.
There are instances in which the only way the research can be conducted is with deception or incomplete disclosure. Research examining the placebo effect may use deception. The American Psychological Association provides guidelines for the use of deception in research under Standard 8.07. The use of deception in research is allowable under certain conditions and carefully considered during the IRB review.