IRB Policies and Procedures
Policies & Procedures
- An Overview
- Application Process and Deadlines
- Approval of Research
- Closure or Withdrawal
- Continuing Review
- Deception or Incomplete Disclosure
- Departmental Review Boards
- Dietary Supplements
- European Union’s General Data Protection
- Exempt Review
- Expedited Review
- Full Review
- Incentives in Research
- Informed Consent, Parental Permission and Child Assent
- International Research
- IRB Administration
- IRB Review Process
- Mandatory Reporting
- Mandatory Training
- Non-English Speaking Participants
- Oral History
- Prisoner Research
- Records Retention
- Recruitment of Participants
- Reproductive Risk in Clinical Research
- Research Advisors
- Responsibilities of Investigators and Sponsors
- Revisions to Approved Research
- Separation of Principal Investigators
- Student Research
- Suspension or Termination
- Whistleblower Policy
Deception or Incomplete Disclosure
The purpose is to outline the policies and procedures for deception or incomplete disclosure used in human research.
Deception is an intentional misleading of others through misrepresentation or falsehood. In research, it may happen when an investigator provides participants with false information in order to obtain unbiased results in social or behavioral research. Some examples are:
- The investigator provides the subjects with a false description of the study's purpose.
- A member of the research team poses as a fellow participant and interacts with subjects as part of the experimental design.
Incomplete disclosure occurs when an investigator withholds information about the specific purpose or nature of the research. An example is:
The investigator presents the purpose of the study or certain procedures in general terms that are true but deliberately vague enough that they do not reveal the researcher’s specific objective.
The use of deception and/or incomplete disclosure presents challenges in the protection of human participants because it interferes with the requirements for fully informed consent and overall ethical considerations. Therefore, deception should only be utilized when there are no viable alternatives. Employment of such methods requires special consideration by the IRB. The Institutional Review Board (IRB) may find the use of deception acceptable when it is unavoidably required in order for the research to take place, when it is adequately justified, and when the benefits outweigh the risks. In general, deception is not acceptable if, in the judgment of the IRB, the participant may have declined to participate had he/she been informed of the true purpose of the research.
Deception may only be permitted where the IRB documents that an alteration of the usual informed consent requirements is justified under the criteria presented in federal regulations at 45 CFR 46.116(d). Specifically, the IRB must find and document that all four of the following criteria have been satisfied:
- The research presents no more than minimal risk to participants.
- The alteration will not adversely affect the rights and welfare of the participants.
- The research could not practicably be carried out without the alteration.
- Where appropriate, the participants will be provided with additional pertinent information (debriefing) after participation.
Subjects must not be deceived about research that could reasonably be expected to cause physical pain or severe emotional distress. When practical, subjects should be told during the informed consent process that some information is being withheld and that they will receive additional information when their participation is complete.
The debriefing process should consist of the following:
- Full disclosure of the deceptive aspects of the study and an explanation of the actual study objectives
- An explanation as to why the deception was necessary
- An opportunity for the subject to ask questions
- Whenever possible, an opportunity for the subject to withdraw his/her data from the study
Research involving deception does not qualify for exemption and therefore must be submitted to the IRB for either full or expedited review. Federal regulations prohibit the use of deceptive techniques that place participants at greater than minimal risk.
For research which poses no greater than minimal risk, the appropriate category of review will depend upon:
- The nature of the deception
- The degree of risk present
- The vulnerability of the participants
- Whether or not all activities qualify for a federal expedited category or categories
Investigators planning to employ deceptive techniques in a project must include the following information or documentation within their submission:
- Request for an Alteration of Informed Consent Form
Federal regulations require complete disclosure of the purpose and procedures of a study in the informed consent process; however, the IRB may waive some elements of consent if certain criteria are met. Please see the IRB's Forms & Instructions page for a Waiver or Alteration of Informed Consent Request Form. All four points on the form must be adequately addressed.
Justify the use of deception, explaining why it is necessary. Explain if alternative methods not involving deception were considered and why these methods are not being used. State if participants would have been less likely to participate had they known the true nature of the study.
- Description of Risk(s)
Describe any additional risk resulting from the deception. Will it upset or inflict any harm to participants? Explain how risk will be minimized during and after the experiment.
Debriefing provides participants with a full explanation of the hypothesis being tested, procedures used to deceive participants and the reason(s) why it was necessary to deceive. It should also include any other relevant background information concerning the study.
- Explain the debriefing process.
- Explain when debriefing will take place.
- Explain who will debrief participants.
- Provide the debriefing form. If applicable, provide a script to be read to orally.
- If there are any elements that will not be revealed to participants, explain and provide a rationale.
- If debriefing itself would present an unreasonable risk of harm, explain.
- Withdrawal Option
Include an option for participants to withdraw their data from the study after they learn the true nature of the research.
- Expedited Review of Research
- Full Review of Research
- Informed Consent, Parental Consent and Child Assent
11/13/2012 - Created
06/27/2013 - Format and headings updated
07/25/2013 - Format updated; added related policy
12/12/2013 - Updated procedures
06/09/2017 - Updated definitions and examples; added criteria for debriefing