Documentation of Informed Consent

(CFR 46.117 effective January 21, 2019)

1. Except as provided in paragraph (c) of this section, informed consent shall be documented by
   the use of a written informed consent form approved by the IRB and signed (including in an
   electronic format) by the subject or the subject's legally authorized representative. A written
   copy shall be given to the person signing the informed consent form.
2. Except as provided in paragraph (c) of this section, the informed consent form may be either
   of the following:
     
   1. A written informed consent form that meets the requirements of §46.116. The
      investigator shall give either the subject or the subject's legally authorized representative
      adequate opportunity to read the informed consent form before it is signed; alternatively,
      this form may be read to the subject or the subject's legally authorized representative.
   2. A short form written informed consent form stating that the elements of informed
      consent required by §46.116 have been presented orally to the subject or the subject's
      legally authorized representative, and that the key information required by §46.116 was
      presented first to the subject, before other information, if any, was provided. The IRB
      shall approve a written summary of what is to be said to the subject or the legally
      authorized representative. When this method is used, there shall be a witness to the
      oral presentation. Only the short form itself is to be signed by the subject or the subject's
      legally authorized representative. However, the witness shall sign both the short form 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 subject's legally
      authorized representative, in addition to a copy of the short form.
3. 1. An IRB may waive the requirement for the investigator to obtain a signed
      informed consent form for some or all subjects if it finds any of the following:
        
      1. That 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;
      2. That 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
      3. 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.
   2. 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.