Documentation of informed consent.

§ 26.1117 Documentation of informed consent. (a) Informed consent shall be documented by the use of a written consent form approved by the IRB and signed (including in an electronic format) by the subject. A written copy shall be given to the subject. (b) The informed consent form may be either of the following: (1) A written informed consent form that meets the requirements of § 26.1116. The investigator shall give the subject adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject. (2) A short form written informed consent form stating that the elements of informed consent required by § 26.1116 have been presented orally to the subject, and that the key information required by § 26.1116(a)(5)(i) 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. 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. 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 must be given to the subject, in addition to a copy of the short form.