Subject: Documentation of Informed Consent for Human Subjects Research

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – that informed consent is documented as determined in the IRB review and approval process.

1. Except as provided below, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. ^[1], ^[2]
2. Except as provided below, the consent form may be either of the following:
   1. A written consent document that embodies the elements of Section II of IRB Policy IV.A. ^[3] This form may be read to the subject or the subject's legally authorized representative, but in any event, the Investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; ^[4], ^[5] or
   2. A short form consent document stating that the elements in IRB Policy IV.A ³ have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB will approve a written summary of what is to be said to the subject or the representative. Only the short form consent itself is to be signed by the subject or the representative. However, the witness shall sign both the short form consent and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form consent. ^[6], ^[7]
3. Verbal Consent.

   The IRB may waive the requirement for the Investigator to obtain a signed consent form for some or all subjects if it finds either:

   1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
   2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent form is normally required outside of the research context. In cases in which the documentation requirement is waived, the IRB may require the Investigator to provide subjects with a written statement regarding the research. ^[8] This waiver provision does not apply to research regulated by the FDA.

^[1] 45 CFR 46.117 (a)

^[2] 21 CFR 50.27 (a)

^[3] Section II of IRB Policy IV.A

^[4] 45 CFR 46.117 (b)(1)

^[5] 21 CFR 50.27 (b)(1)

^[6] 45 CFR 46.117 (b)(2)

^[7] 21 CFR 50.27 (b)(2)

^[8] 45 CFR 46.117 (c)