(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all investigations covered by this part.

Ask a legal question, get an answer ASAP!
Click here to chat with a lawyer about your rights.

(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]