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Deception or incomplete disclosure in research
Deception or incomplete disclosure in research
- Guidance Contact:
IU Human Research Protection Program (HRPP)
Research studies occasionally require researchers to deceive subjects or for researchers to withhold specific study details from study participants. Such procedures can be effective tools for the conduct of research; however, they also raise ethical concerns regarding subject autonomy and respect for persons, and regulatory issues regarding informed consent requirements.
The purpose of this guidance is to help researchers differentiate between these two techniques, plan for their use in research, and understand what does not constitute deception or incomplete disclosure.
Definitions and examples
Deception involves intentionally providing inaccurate or false information to subjects. Examples include:
- In order to induce stress, study personnel tell subjects that they will give a speech that evaluators will observe on video, when the subjects’ speeches will not actually be recorded or observed.
- Study personnel tell subjects that they will be engaged in a cooperative task with other subjects, but instead subjects will actually be interacting with study personnel.
- Study personnel tell subjects that they will play a competitive game involving financial rewards based on their performance. In fact, the game is rigged and rewards are not based on performance.
Incomplete disclosure involves withholding information about the study purpose and/or reason for procedures, in order to prevent biasing the results. Examples include:
- In order to examine how race and gender impact people’s perception of conflicts between individuals, subjects review several hypothetical scenarios describing confrontations between various characters, which include stock photos to represent the individuals involved, and then are asked to complete questions regarding their perception of each of the individuals involved. The subjects are not informed that the race and gender of the characters are manipulated by the researchers but subjects will know that the scenarios are hypothetical.
- To further understanding of how representations of same sex couples depicted in commercials influence consumer behavior, subjects are exposed to advertisements featuring gay couples and straight couples while their heart rate, facial muscle movement, and sweat responses are recorded. Subjects are informed that their reactions to the commercials are being studied, but not that the researchers are examining if the sexual orientation of characters in commercials influences them.
Limits on Incomplete disclosure:
- Incomplete disclosure does not extend to withholding information from subjects about what they will be asked to do. A protocol that informs subjects that they will be asked to complete one 60-minute session but provides no information about the contents of this session would not be considered incomplete disclosure.
- Protocols that involve manipulating an individual’s environment, without that person’s prospective agreement to participate in research, are not considered incomplete disclosure. In such cases disclosure to subjects is entirely absent, not merely incomplete.
Disclosed concealment involves the withholding of certain information from subjects in cases where subjects consent specifically to the lack of disclosure. An example is a double-blind, placebo-controlled trial in which subjects will have information regarding their assignment to a particular study arm withheld; however, subjects are informed of the study arms and that their assignment will not be disclosed. Disclosed concealment is considered neither deception nor incomplete disclosure.
Deception in Exempt Research
Protocols that include incomplete disclosure are eligible for exemption, assuming they would otherwise be eligible.
Protocols that involve deception are not eligible for exemption unless subjects are informed, before they agree to participate, that the study procedures include deception.
Points to consider
- Use of deception or incomplete disclosure must be justified by its impact on the potential scientific value to the research. Researchers should clearly state that the study involves deception and/or incomplete disclosure and provide a justification for the study design in the IRB application.
- Deception or incomplete disclosure should only be used when no reasonably effective, alternative methods are available to achieve the goals of the research.
- Only study procedures that involve minimal risks (as determined by the IRB) can include deception or incomplete disclosure.
- Researchers must debrief subjects at the conclusion of their participation unless an acceptable explanation for why the debriefing cannot practicably be conducted is provided. Debriefing must include the rationale for the study design, the study purpose, and a description of the information that was false or incomplete.
- In cases where deception involves a description of study activities to subjects, the description of the risks may not understate the actual risks.
- Whenever possible, subjects should be informed that the description of the study includes inaccurate or incomplete information, and that they will be provided with complete and accurate information when they have completed their study participation. Examples of such language include:
- Due to the nature of the study, we are not able to disclose the purpose of this research at this time. However, we will hold a debriefing session to answer questions and tell you about the study after your participation.
- The full purpose of this research cannot be disclosed before you participate, but will be told to you at the end.
- The purpose of this research project is to examine how decisions are made in negotiation. We are not able to provide you all details about the study at the beginning of the study, but we will provide more information during/after your participation.