Full Review

Full reviews are conducted by a quorum of the Institutional Review Board.

Federal Regulations	A protocol that poses more than minimal risk to the subjects must be reviewed by an Institutional Review Board.
Duke Requirements	Duke policy requires full review of a protocol if the research: Involves significant deception. Uses the researcher's subjects or employees as research subjects. Has been reviewed by an expediting reviewer who wishes to refer the protocol to the full IRB.
Submission Deadlines	Protocols that need full review should be submitted two weeks prior to IRB meetings.
Review Process	A staff member will conduct a pre-review of the protocol, using the Reviewer Checklist and the Consent Form Checklist and may suggest revisions. A primary reviewer will present the protocol to the IRB. The primary reviewer may contact the researcher before the meeting to request clarification or additional material. The IRB may: Approve a protocol as submitted. Approve a protocol with minor modifications. Minor modifications are those for which the IRB can propose specific language, such as a change in wording in a consent form. If the investigator chooses to incorporate the changes as suggested, the protocol can be approved by the primary reviewer. Although the research cannot begin without the approval, the approval period begins on the date the IRB reviewed the protocol. Defer a protocol. Deferrals occur when the IRB cannot recommend specific changes but needs to engage in dialog with the researcher.
Approximate Review Time	Three to six weeks.

Forms