This page has been updated to reflect the New Rule effective January 21, 2019.
Research may require that subjects not be fully informed in advance of the intent or procedures of the study. Unless otherwise specified by COUHES, investigators are expected to use an informed consent even if the research activities include deception but should exclude information that could compromise the research.
Deception is justified only if it is clear that:
- incomplete disclosure is truly necessary to accomplish the goals of the research,
- there are no undisclosed risks to subjects that are more than minimal, and
- there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them. Debriefing should usually be in writing and should take place immediately after the subject's participation in the research.
Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects and truthful answers should always be given to direct questions about the research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator.
Subjects should be informed that some aspects of the study will not be revealed to them until the conclusion of the research before agreeing to participate. Research determine to meet the criteria for exemption that involves deception requires investigator prospectively inform participants that they will be intentionally mislead to the purpose of the research.