MSU HRPP Manual Section 6-3-A

6-3-A, Incomplete Disclosure / Deception

Investigators may sometimes design a research study in such a way that subjects do not initially know the actual intent of the research i.e., incomplete disclosure/deception.

In all cases of research involving incomplete disclosure and/or deception, the research is justified only if the following conditions are met:

  1. Incomplete disclosure/deception is truly necessary to accomplish the goals of research;
  2. There are no undisclosed risks to subjects that are more than minimal, and
  3. There is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them.

When appropriate, subjects must be debriefed when their participation is complete. These debriefing procedures, including any script or written statement that will be used, must be submitted and reviewed by the Institutional Review Board (IRB) before a research study may be approved. The debriefing script should explain to the subjects 1) the incomplete disclosure/deception and 2) the true purpose of the research study.

A waiver or alteration of consent may be necessary for incomplete disclosure/deception as the true purpose of the research will not be disclosed to the subject. See the Human Research Protection Program Manual 6-4-B “Waiver or Alteration of Informed Consent” for policies and procedures on waiver or alteration of informed consent.

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.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 7-20-2011.

Related HRPP Manual Sections

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