In some studies an element of deception or incomplete disclosure is necessary, because prior knowledge of the full purpose of the study may alter the subject’s responses, making the study impossible to conduct. Investigators must always refrain from unnecessary or unjustified deception and fully disclose the study purpose and procedures whenever possible. Deception may be defined as taking an action to cause the subject to believe something that the investigator, or perhaps his or her confederate or an actor, does not believe or knows is false. Incomplete disclosure means that the subject is not fully informed about the purpose or some other aspect of the study. Deception or, more commonly, incomplete disclosure, is primarily utilized in behavioral and social sciences studies in which some aspect of human behavior is being studied. The following are examples of incomplete disclosure: (a) misrepresentation of identity on the part of an investigator or use of a confederate (in a situation in which the investigator may covertly arrange or manipulate experiences), (b) covert observation of the subject by the investigator, and (c) obtaining information from third parties without the subject’s knowledge. An example of deception is the misrepresentation of the purpose or source of documents whose real purpose is to evoke a response in the subject. According to the American Psychological Association, considerations that may make the use of deception more acceptable in a study include the following: (a) the research objective is of great importance and cannot be achieved without the use of deception; (b) on being fully informed later, the subjects are expected to find the procedures reasonable and to suffer no loss of confidence in the investigator; (c) research participants are allowed to withdraw from the study at any time; (d) research participants are free to withdraw their data when the concealment or misrepresentation is revealed; and (e) investigators take full responsibility for detecting and removing stressful aftereffects of the experience.
In clinical research, it may be necessary to withhold information regarding certain procedures or the purpose of the study, because disclosing the information would invalidate the results. All other elements necessary for the subject to make a decision about participation should be disclosed. In addition, the investigator should offer to disclose this “withheld” information at the conclusion of the study. Therefore, the consent form should specify that some information is being withheld and explain the plan for later disclosure. The nondisclosure of information is justified if, upon learning the purpose for withholding the information, most “reasonable persons” would have agreed to participate if they knew then what they know now.
An example of deception in clinical research is a trial in which there is monitoring for compliance or adherence with therapy, but the participant is unaware of this monitoring. Prospective subjects may be told that certain procedures will be performed, but they will not be informed of their purpose until the research is completed. The participant should be informed of the amount of risk (usually none) and the amount of inconvenience that this nondisclosure presents. Another method would be to inform potential subjects that there will be compliance monitoring and explain the purpose of this monitoring. In this case, the information provided should emphasize that the exact nature of the monitoring activities will be kept secret and a general explanation for this secrecy provided (e.g., identification of individuals who are complying completely, production of generalizable results of the trial, maximization of each subject’s chance of having a therapeutic response, as applicable to the study).
The National Commission’s report on Institutional Review Boards stated that incomplete disclosure or deception could be permitted if it was not likely to be harmful to the subject and if sufficient information could be disclosed to give the subject an opportunity to make a reasonable decision regarding participation. It also stated that the IRB should consider whether the research could be done without the deception. The commission also stated that when research subjects have been deceived, it is desirable that they be debriefed as soon as possible after their participation.
The American Psychological Association’s Ethical Principles in the Conduct of Research with Human Participants also addresses deception. It requires investigators and IRBs to evaluate any deceptive techniques with regard to the following: the scientific value and validity of the research, the efficacy of alternative procedures that do not use concealment or deception, the degree of certainty that deception does not influence participants’ willingness to participate, the possibility of experimentally induced harm and the ability of the proposed procedures to remove such harm through debriefing (as soon as possible once participation is complete), and the potential of deception to facilitate unwanted and inappropriate invasions of privacy.
Deception is recognized as necessary for the proper conduct of a select group of studies in the behavioral and social sciences. The investigator must fully justify the need for deception to the IRB. The IRB, in turn, must make specific findings in approving a study that involves deception. This, of course, involves the waiver of one or more elements of consent. The investigator must also state how the deception will be disclosed to subjects following the study. In addition, it is imperative that the consent itself avoid deception and that the information provided be as truthful as possible without compromising the study (including, where possible, the fact that some information must be withheld from the participant). It is also recommended that the investigator include his or her plan for debriefing subjects.