A waiver of the requirement for documentation of informed consent may be granted under specific conditions defined by regulations such as 45 CFR 46.117. The waiver allows the research team to provide consent information to the subject without requiring the subject's signature on the consent document. This type of waiver is typically permissible when:

• The only record linking the subject and the research would be the consent document, and the principal risk of harm would be a breach of confidentiality. This is common in research involving sensitive topics like domestic violence or illegal activities.
• 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 instance, minimal risk survey or interview research.
• In some cases, when the research subjects belong to a cultural group in which signing forms is not a usual practice, and the research is minimal risk with adequate alternative consent documentation mechanisms.

In these scenarios, subjects should still be offered a copy of the consent information, and the IRB may require researchers to provide a written statement regarding the research even without a signature requirement.