When reviewing research involving incomplete disclosure or outright deception, the IRB needs to be satisfied that the deception is necessary and that, when appropriate, the subjects shall be debriefed.
However, debriefing may be inappropriate, for example, when the debriefing itself would present an unreasonable risk of harm without a corresponding benefit. If debriefing is inappropriate, investigators need to note this is the application.
The IRB needs to insure that the proposed subject population is suitable.
Deception is only permitted where the IRB documents that an alteration of the usual informed consent requirements is justified under the criteria present in the Common Rule.
Specifically, the IRB must find and document that all four of the following criteria have been satisfied:
- The deception presents no more than minimal risk to subjects (and the protocol itself is approved for study).
- The alteration does not adversely affect the rights and welfare of the subjects.
- The research could not practicably be carried out without the alteration, and this necessity is documented in the application.
- Where appropriate, the subjects shall be provided with additional pertinent information after participation, and the subjects have the opportunity to withdraw their consent at that time.
Note: The regulations make no provision for the use of deception in research that poses greater than minimal risks to subjects.