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Deception and Incomplete Disclosure

Sometimes, particularly in behavioral research, investigators plan to withhold information about the real purpose of the research or even give subjects false information about some aspect of the research.  This means that the subject's consent may not be fully informed.  When the IRB reviews research involving incomplete disclosure or outright deception it must decide whether the information to be withheld would influence the decision of prospective subjects about participating in the research.

The IRB will consider the risks to which subjects will be exposed and then decide whether to waive or alter consent requirements.  To receive a waiver of consent requirements, the study must present no more than minimal risk and the waiver must not adversely affect the rights and welfare of subjects, and must be essential to the ability to carry out the research.

Whenever appropriate, subjects should be given additional pertinent information after they have participated in such a study. The IRB will determine if a debriefing form is necessary and will guide the Investigator in what information should be disclosed.

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