(a) Informed consent must be documented by the use of a written consent form approved by the IRB and signed by the subject. A copy shall be given to the subject.
(b) The consent form may be either of the following:
(1) A written consent document that embodies the elements of informed consent required by Sec. 26.1116. This form may be read to the subject, but in any event, the investigator must give the subject adequate opportunity to read it before it is signed; or
(2) A short form written consent document stating that the elements of informed consent required by Sec. 26.1116 have been presented orally to the subject. When this method is used, there must be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject. Only the short form itself is to be signed by the subject. However, the witness must sign both the short form and a copy of the summary, and the person actually obtaining consent must 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. [78 FR 10543, Feb. 14, 2013] Secs. 26.1118-26.1122 [Reserved]