§ 812.62. IRB approval.
53 words·~1 min read·
/us/cfr/t21/s§ 812.62·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all investigations covered by this part.
(b)If no IRB exists or if FDA finds that an IRB's review is inadequate, a sponsor may submit an application to FDA. [46 FR 8957, Jan. 27, 1981]