§46.117. Documentation of informed consent. — Inbound Citations

(2) Research that is neither conducted nor supported by a federal department or agency but is subject to regulation as defined in § 46.102(e) must be reviewed and approved, in compliance with § 46.101, § 46.102, and § 46.107 through § 46.117 of this policy, by an institutional review board (IRB) that operates in accordance with the pertinent requirements of this policy.

(c) An IRB shall require documentation of informed consent or may waive documentation in accordance with § 46.117.

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by § 46.117.