§56.109. IRB review of research. — Inbound Citations
21 C.F.R. § 56.109
Statutory Authority
Cited by 1 regulation in release Current.
Citations to §56.109(c)
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(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.