Under the Federal Policy for the Protection of Human Subjects (the "Common Rule"), the IRB may approve an informed consent process that waives some or all of the elements of consent or waive the requirement for written consent.
Waiver of Informed Consent (45 CFR 46.116)
For research that is no more than minimal risk the IRB may approve a request to waive of some or all of the required elements of informed consent under specific circumstances. Waivers of informed consent are primarily requested for projects involving the secondary analysis of existing data or in projects involving deception.
Under the 2018 Common Rule, to waive in total or to alter informed consent elements, the IRB must determine that:
- The research involves minimal risk to subjects;
- The research could not be carried out practicably without the waiver or alteration;
- If the research involves identifiable private information or identifiable biospecimens, this research could not be carried out practicably without using the information/specimen in an identifiable form;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and,
- Where appropriate, the subjects will be provided with additional information about their participation.
Investigators will be prompted to justify the request for a waiver or alteration of consent in their submission, and the IRB will document that the requirements are met and convey the decision in the determination letter.
Waiver of Documentation of Informed Consent (45 CFR 46.117)
For some research projects, the IRB may approve a request to waive the documentation of informed consent. This means that the study team must provide a subject with the required consent information, but the study team is not required to obtain the subject's signature on the informed consent document.
Subjects should be offered a copy of the consent information for their records even when a signed document is not required for the project.
For studies subject to the 2018 Common Rule, the IRB may approve waiver of written consent when:
- The signature on the informed consent document would be the only record linking the
subject to the research and the principal risk of harm to the subject would be a breach
of confidentiality;
- In this scenario, each participant must be asked whether they would like to sign a consent document. If the participant declines to sign, but voices consent verbally, they can still be in the study.
- The research presents minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context, or
- The participants are members of a cultural group in which signing forms is not a normal/acceptable
practice.
- In this case there must be an appropriate alternative mechanism for documenting that informed consent was obtained.
For research that is FDA-regulated, a waiver of documentation of consent may be granted only when:
- the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context.
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Examples
Examples of studies that may be eligible for requesting a waiver of documentation of consent include:
- A minimal risk study involving phone interviews or data collection via a web-based portal.
- A study that seeks to collect information about a sensitive topic such as illicit drug use or immigration status where having participant name linked to participation in the study might pose a risk.
- A minimal risk study that involves focus groups in a community where the cultural norm is that individuals affirm agreement via handshake. Requesting a signature is seen as a symbol of distrust and would deter participation in the research.