§50.27. Documentation of informed consent. — Inbound Citations

21 C.F.R. § 50.27

Statutory Authority

Cited by 3 regulations in release Current.

21 C.F.R. § 50.55(f)

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(f) Permission by parents or guardians must be documented in accordance with and to the extent required by § 50.27.
21 C.F.R. § 56.109(c)

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(c) An IRB shall require documentation of informed consent in accordance with § 50.27 of this chapter, except as follows:

(1) The IRB may, for some or all subjects, waive the requirement that the subject, or the subject's legally authorized representative, sign a written consent form if it finds that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context; or

(2) The IRB may, for some or all subjects, find that the requirements in § 50.24 of this chapter for an exception from informed consent for emergency research are met.
21 C.F.R. § 56.111(a)(5)

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(5) Informed consent will be appropriately documented, in accordance with and to the extent required by § 50.27.