Status Definition

Revision with Subcommittee Review

The Principal Investigator must make the changes requested by the Committee. The changes are minor in nature, but call on special expertise due to a complex study. A Subcommittee of the IRB, generally 2 or 3 members review these changes. If the changes are judged to be responsive to the requests of the Committee, the members of the Subcommittee will recommend the protocol for approval and an approval letter will be issued.

The protocol is then classified as Approved and subjects may be enrolled upon receipt of the approval notice and date stamped consent form.