Waivers of Informed Consent Guidelines

Under the Federal Policy for the Protection of Human Subjects (a.k.a. the "Common Rule"), the IRB may approve an informed consent process that:

• Waives the requirement to obtain informed consent, or
• Alters some or all of the elements of informed consent, or
• Waives the requirement to document informed consent (i.e., to obtain a signature)

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.

To waive in total or to alter informed consent elements, the IRB must determine that:

• The research involves no more than 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.
  • Note: The intent of this waiver criteron is to require debriefing for participants in deception research

  

  Under the 2018 Common Rule, there is an addtional 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. For example, for research on sensitive topics, such as domestic violence or illegal activities; OR
  • The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context. For example, minimal risk research that invovles surveys/interviews conducted via telephone or online.

  

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

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

  It is not appropriate to request a waiver of documentation of informed consent for human subject projects that collect biospecimens.