342. Informed Consent and Incomplete Disclosure or Deception
Updated July 1, 2019
The IRB recognizes that incomplete disclosure/deception is sometimes necessary for human research.
- Incomplete disclosure applies when information about the real purpose or nature of the research is withheld from participants.
- Deception in the context of human research refers to providing false information to prospective participants.
Incomplete disclosure/deception may NOT be used in greater than minimal risk research.
Investigators using incomplete disclosure/deception must provide sufficient information in the IRB application to make it clear that the incomplete disclosure/deception
- is necessary for the conduct of the research, and
- does not increase risks beyond what participants would agree to had they been fully informed about all aspects of the research.
When Research May Require Use of Incomplete Disclosure or Deception
Incomplete disclosure/deception may be used when the study purpose is to measure behaviors or responses that are likely to be different if participants were fully informed about the project.
Examples of Incomplete Disclosure
- Participants are given general information about the study purpose but the information is not detailed enough to reveal the researcher's main or specific objective.
- Participants are given truthful information about a study procedure but are not fully informed about the expected findings.
Examples of Deception
- Participants are given a cover story that provides a feasible but slightly inaccurate account of the study purpose.
- The study includes a confederate: an individual who is working on behalf of the research but poses as a participant. The confederate's actions are components of the experimental design.
Informed Consent in Studies Involving Incomplete Disclosure or Deception
Investigators may be vague as to the purposes of the study or omit information in consent materials in order to maintain the incomplete disclosure or deception necessary for the research.
Rarely, it is necessary to continue the deception by providing false or misleading information in consent materials. Investigators must justify the inclusion of false/misleading information in consent materials. The IRB will evaluate the effects of the continued deception on participant risk, and will determine if continuing the deception in the consent materials is warranted.
The use of incomplete disclosure/deception means one or more of the basic elements for informed consent are being withheld or distorted. Consequently the use of incomplete disclosure/deception requires the IRB to approve an alteration of informed consent.
Requirements for IRB approval of an Alteration of Consent for Incomplete Disclosure/Deception
- The research involves no more than minimal risk to participants.
Investigators and the IRB must insure incomplete disclosure/deception are only used in minimal risk research and do not increase risks beyond what participants would agree to had they been fully informed about the research.
- The waiver or alteration will not adversely affect the rights and welfare of participants.
Investigators and the IRB must insure incomplete disclosure/deception do not compromise participants' privacy, interests, or well-being.
- The research could not practicably be carried out without the waiver or alteration.
Investigators must provide sufficient information for the IRB to determine that the research questions could not be answered without the use of incomplete disclosure/deception.
- Whenever appropriate, participants are to be provided with additional pertinent information after participation.
This criterion generally applies to research involving incomplete disclosure/deception. Participants should be debriefed after participation unless doing so would harm them. In the latter case, the investigator must explain why it would not be appropriate to provide additional information after participation. The IRB must weigh the harms that may result from debriefing with the ethical concerns of not fully informing participants about the research after their participation.
Sample Language for Consent Materials:
Ideally and when feasible, investigators include a statement in the consent materials to let participants know that some information about the research is being withheld and they will be debriefed after their participation has concluded. When such information may affect the research results (i.e., may influence participant behavior), it may be omitted but the omission must be justified.
We have described the general nature of what you will be asked to do but the full intent of the study will not be explained to you until after [your participation] [the completion of the study]. At that time, we will give you more information about the study and give you an opportunity to ask questions.
Debriefing Participants in Studies Involving Incomplete Disclosure/Deception
When researchers use incomplete disclosure/deception, they must include a process for informing participants about the incomplete disclosure/deception, unless a debriefing process is not possible or would cause unacceptable risk to the participants.
The debriefing process should
- inform participants that incomplete disclosure/deception was used,specify what information was withheld or falsified,
- explain why it was necessary to use incomplete disclosure/deception, and
- provide participants the opportunity to ask questions about the new information.
After the debriefing, researchers may ask participants to refrain from talking to others about the incomplete disclosure/deception to minimize the possibility that results may be skewed if subsequent participants knew in advance that incomplete disclosure/deception was being used in the study.
Providing Participants the Option to Withdraw Their Data Post-Debriefing
Although not a requirement, researchers may wish to allow individual participants to withdraw their data after learning of the incomplete disclosure/deception, and the true purpose/goals of the research.
This may be a reasonable option when participant data contain personal identifiers or codes that are linked to a master key, or the debriefing and option to withdraw are provided before a participant submits her/his data. This option is not feasible when data are collected without participant identifiers or links to identifiers.
Investigators wishing to exercise this option should provide clear instructions for participants to withdraw their data.
IRB Approval of Research Involving Incomplete Disclosure/Deception
For the IRB to approve incomplete disclosure/deception, the use
- must be scientifically necessary,
- must be ethically justified, and
- may NOT adversely affect participants' rights and welfare.
IRB Approval of an Alteration of Informed Consent
The nature of incomplete disclosure/deception mean that the consent process/materials do not include the eight basic elements required for informed consent. Consequently, the IRB must determine if the research meets the criteria for IRB approval of an alteration of the consent process.
Documentation of the IRB's Determinations
Review worksheets are used to document the IRB's review and determinations, including approval of waiver/alteration of informed consent or waiver of signed consent. Completed worksheets are added to the related submissions in IRBNet.