Definition: Deception occurs as the result of investigators providing false or incomplete information to participants for the purpose of misleading research subjects.

The IRB accepts the need for certain types of studies to employ strategies that include deception. However, employment of such strategies must be justified. In general, deception is not acceptable if, in the judgment of the IRB, the participant may have declined to participate had they been informed of the true purpose of the research.

In the event that a study includes the use of deception, the investigator must provide:

• Confirmation that the study design meets all of the criteria for a waiver of consent [§46.116(d)]

• Justification for the deception

• A description of the manner of deception and how the deception will take place

• An explanation as to why deception is necessary to this protocol

• A description of whether the deception results in any increased risk to participants

• An indication of whether the deception may affect a subject’s willingness to participate in research

• A description of the post-study debriefing that includes offering the participant the option to withdraw their data from the study

• If an exception to the requirement for a debriefing is requested, the study must be reviewed by the full board

• A description of any previous use of deception in similar research and a summary of any actual harms or reactions from participants to the use of deception

• A description of alternatives to deception that were considered and an explanation as to why these alternatives were rejected

§46.116(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

• The research involves no more than minimal risk to the subjects;

• The waiver or alteration will not adversely affect the rights and welfare of the subjects;

• The research could not practicably be carried out without the waiver or alteration; and

• Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Policy approved September 2011.