Deception in human subjects research means deliberately misleading subjects about the nature of a study. Concealment means deliberately withholding certain information.
Studies involving deception or concealment must meet all criteria for a waiver or alteration of informed consent. The study must pose no more than minimal risk to subjects, and the waiver or alteration must not adversely affect subjects’ rights and welfare. The nature of the study must necessitate use of deception or concealment and, therefore, the waiver or alteration.
