§56.109. IRB review of research. — Inbound Citations

(a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy shall be given to the person signing the form.

(iii) Ensures that each investigator participating in an investigation of the device obtains from each subject under the investigator's care, informed consent in accordance with part 50 of this chapter.