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Waiver of Documentation for Informed Consent Form

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Waiver of Documentation for Informed Consent Form

Use this form if consent is given, but there is no signature. A waiver of 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 two 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) OR
  • 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)

PLEASE NOTE: The IRB will take into consideration the risks and potential harms involved in the research and consent process before granting a waiver of documentation of informed consent.