16.108—IRB functions and operations.

In order to fulfill the requirements of this policy each IRB shall:

(a) Follow written procedures in the same detail as described in § 16.103(b)(4) and, to the extent required by, § 16.103(b)(5).

(b) Except when an expedited review procedure is used (see § 16.110 ), 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.

CFR

16.108—IRB functions and operations.