A researcher may request that the IRB waive the requirement to obtain a signed informed consent form for some or all subjects. For the IRB to waive this requirement, at least one of the following criteria must be met:

• The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern;
• The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
• If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.