What is the difference between full board review, expedited review and exempt?
Review procedures for expedited review and full review are similar in several ways: . The review criteria are the same. . Both types of review are documented communication processes between investigators and reviewers. . Expediting reviewers and the full IRB can request modifications to submissions and can approve protocols, continuing reviews, and amendments to approved protocols. . Expediting reviewers and the IRB will specify when a protocol must be reviewed again. By regulation it must be within twelve months, but shorter review periods may be required. A key difference between the two processes is that expedited reviewers cannot disapprove a protocol. They must refer protocols they cannot approve to the full IRB. All IRB members must be advised about protocols, continuing reviews, and amendments approved through expedited review procedures. Any member of the IRB may request that such approvals be reconsidered by the full IRB. Exempt research does not have to be reviewed by the HSR