Source: https://www.govregs.com/regulations/title7_part1c_section1c.109
Timestamp: 2019-04-19 17:22:47+00:00

Document:
7 CFR 1c.109 - IRB review of research. § 1c.109 - IRB review of research.
§ 1c.109 - IRB review of research.
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under § 1c.104 for which limited IRB review is a condition of exemption (under § 1c.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7), and (8)).
(b) An IRB shall require that information given to subjects (or legally authorized representatives, when appropriate) as part of informed consent is in accordance with § 1c.116. The IRB may require that information, in addition to that specifically mentioned in § 1c.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
(c) An IRB shall require documentation of informed consent or may waive documentation in accordance with § 1c.117.
(e) An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year, except as described in § 1c.109(f).
(g) An IRB shall have authority to observe or have a third party observe the consent process and the research.

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