Definition
Deception is the intentional misleading of subjects or the withholding of full information about the nature of the experiment. Investigators may mislead or omit information about the purpose of the research, the role of the researcher, or what procedures in the study are actually experimental. Deception increases ethical concerns because it interferes with the ability of the subject to give informed consent. Deception may be necessary in certain types of research so that results are not biased.
Regulations
Federal regulations permit deception, but there are established limitations on the use of deception. The investigator must provide scientific and ethical justification for deceptive procedures for the IRB review and approval. The deceptive practice or information should not increase the risks of the study, and subjects must be fully debriefed. Subjects must have the opportunity to ask questions about the new information and be given the opportunity to withdraw from the study and have their data removed. Deception may not be utilized to obtain enrollments in the study.
Some research can be conducted only without the full knowledge of the research subjects. The use of deception in research raises special ethical concern. One consideration is whether the deception is necessary. An investigator proposing to use deception should justify its use. Present federal rules prohibit the use of deceptive techniques which place subjects at more than minimal risk. The U.S. Office of Human Research Protections (OHRP) provided guidance on the use of deception requiring that the IRB determines and documents the following:
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration of the consent 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.
Debriefing
51³Ô¹ÏºÚÁÏ IRBs require investigators to debrief subjects who have been deceived during participation in research activities. The debriefing should include a detailed description of the ways in which deception was used. The investigator is responsible for ensuring that the subject leaves the research setting with an accurate understanding of the deception. The debriefing process, including any written materials, should be explained to the IRB as a part of submitted protocols.