- Last updated:
- 01/19/2021
Deception or incomplete disclosure in research
- Guidance Contact:
IU Human Research Protection Program (HRPP)
irb@iu.edu
IU Human Research Protection Program (HRPP)
irb@iu.edu
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.
Deception involves intentionally providing inaccurate or false information to subjects. Examples include:
Incomplete disclosure involves withholding information about the study purpose and/or reason for procedures, in order to prevent biasing the results. Examples include:
Limits on Incomplete disclosure:
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.
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.