Waivers of Informed Consent Guidance

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)

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;
• 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. 

Under the 2018 Common Rule, there is an additional requirement for the IRB approval of an informed consent waiver request:  

• 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.

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.

A waiver of documentation is permissible 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; or
• The research presents minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context. 

Under the 2018 Common Rule, there is an additional circumstance in which the IRB may approve waiver of written consent:  

• Where the participants are members of a cultural group in which signing forms is not a normal/acceptable practice.

• 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.