Waiver or Alteration of Informed Consent Process
Waiver or Alteration of Informed Consent
The Institutional Review Board (IRB) may consider a waiver or alteration of the requirement for obtaining informed consent if all the conditions are met. To request a waiver, the research description should address each of the criteria listed below.
The research involves minimal risk to subjects
This condition is satisfied if either the likelihood or the magnitude of harm/discomfort is no greater than what the subjects would ordinarily encounter in daily life or during routine clinical care.
The waiver or alteration will not adversely affect the rights and welfare of the subjects
The IRB will assess whether the subjects' rights, such as the "right to privacy", would be violated if the consent were waived. For example, in the case of "right to privacy", the IRB will consider the safeguards for minimizing the potential invasion of privacy and will consider the potential benefits of participation.
The research could not practicably be carried out without the requested waiver or alteration
For example, obtaining informed consent would not be practicable if the investigator will have no direct contact with subjects and will not know their identities.
The research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format
For example, a record review where an investigator securely retains an identifier in order to compare the same records at two points in time.
Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after they have participated in the study
In social science research involving deception, it is common practice to debrief the subjects at the conclusion of the study. In other studies, however, it would not be appropriate to require debriefing. For example, if the research proposed collection of tissue without identifiers, it would not be possible for the investigator to provide additional information since the identities of the subjects would be unknown.
Waiver of Consent vs. Waiver of Signatures
Deception and Debriefing
Researchers may decide to use deception in research to minimize bias. Or they may wish to create a controlled environment to study social and/or behavioral characteristics. Generally, deception research can be categorized in two different ways:
Passive Deception or Incomplete Disclosure: A research study that intentionally withholds information from participants. In this type of research, the researcher might choose to be ambiguous about the study design or the study purpose. For example:
- Survey Research: A survey that asks participants to read a series of news stories pulled from different platforms and different time periods.
- Purpose: Participants are told the purpose of the study is to compare the style, accuracy, and trustworthiness of the news sources.
- Incomplete Disclosure: Participants are not told that the research purpose also includes an age variable to compare how different generations respond to different news outlets.
Deception: A research study that deliberately includes false information. The researcher may choose to include incorrect feedback or create a staged environment to measure the response of participants. For example:
- Placebo Effect Research: An intervention study on pain management in the testing stage of a new drug.
- Purpose: Participants are told they will be randomly placed in the group that will receive the new drug or in the group that receives the placebo.
- Deception: Both groups will receive the placebo because the true purpose is to measure pain perception and the placebo effect.
Debriefing: Passive deception and deception research should also include a plan for debriefing. Debriefing should:
- Include full disclosure of the deception
- Explain the purpose of using deception in the study in plain language
- Provide the opportunity for participants to ask questions
- Allow the participant to decide whether their collected data can be included in the study (see the Deception Debriefing and Permission to Use Data Form/Script below)
Passive deception and deception research should address all the criteria for a waiver or alteration of informed consent in the protocol application. The Institutional Review Board (IRB) will consider a waiver or alteration of informed consent for research that involves incomplete disclosure or deception if all the above criteria are met.
Even if all of the above conditions are met, the IRB is authorized to require an investigator to obtain informed consent. For example, the IRB may determine that the knowledge being sought is not important enough to justify the use of unaware subjects.
To request this waiver, check the box for "Request for Waiver of Informed Consent Process" under the Informed Consent section of the E-IRB application, and answer the questions as prompted.