§56.110. Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. — Inbound Citations

(c) Except when an expedited review procedure is used (see § 56.110), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.

(1) Except as described in paragraphs (a)(2) through (a)(4) of this section, a sponsor must obtain approval of a supplemental application under § 812.30(a), and IRB approval when appropriate (see §§ 56.110 and 56.111 of this chapter), prior to implementing a change to an investigational plan. If a sponsor intends to conduct an investigation that involves an exception to informed consent under § 50.24 of this chapter, the sponsor shall submit a separate investigational device exemption (IDE) application in accordance with § 812.20(a).