There are times, especially in behavioral research, when investigators plan to withhold information about the real purpose of the study or purposely give subjects false information about some aspect of the research. The use of deception or incomplete disclosure imposes special responsibilities on the investigator and the IRB.

The IRB will NOT approve a study that presents more than minimal risk where subjects are deceived or not given complete information that they would consider material to the decision to participate. However, minor deception, such as withholding specific points to prevent a bias in the results, can be acceptable, provided the subject is fully debriefed after participation. Risks stemming from major deception must be clearly counterbalanced by the benefits of the research. The IRB may require debriefing when it contributes to the subject’s welfare to more fully disclose the purpose of the study, correct misconceptions, or reduce anxiety.

Investigators should justify, in detail, in the protocol, the reasons for deceiving or withholding information from subjects, including an explanation of: a) the necessity for deceiving subjects; b) how the potential benefits of the research justify the use of deception; and c) how the investigators will conduct the debriefing.

More information can be found at Rutgers Research Regulatory Affairs Informed Consent Process