§ 26.1117 - Documentation of informed consent.

§ 26.1117 Documentation of informed consent.

(a) Informed consent must 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 document form that embodies meets the elements requirements of informed consent required by § 26.1116. This form may be read to the subject, but in any event, the investigator must The investigator shall give the subject adequate opportunity to read it the informed consent form before it is signed; or alternatively, this form may be read to the subject.

(2) A short form written informed consent document form stating that the elements of informed consent required by § 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 , 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 must shall sign both the short form and a copy of the summary, and the person actually obtaining consent must 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.

[78 FR 10543, Feb. 14, 2013]