A waiver for documentation of informed consent is a request whereby a signed consent document is not required. Examples include online, verbal, and implied consent. Consent will still be obtained from participants; however, they will not be required to sign the consent form. There are only three circumstances when the IRB may waive the requirement to obtain a signed consent form:
- The only record linking the research participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (participant must be asked if he/she want documentation);
- The research presents no more than minimal risk of harm to participants and involves no procedure for which written consent is normally required outside of the research context (for example, no risk surveys or interviews); OR
- The subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm and the research presents no more than minimal risk of harm to subjects.