ABSTRACT
Changes to the consent form that result from protocol amendments will be handled in the same manner as the original document.
B. IRB Review of the Informed Consent Document
The IRB Secretary will transmit the appropriate materials to each of the board members at least three days before the scheduled meeting to allow thorough review of each proposal. The Primary Reviewer selected to review the research proposal will also review the accompanying consent. The Primary Reviewer will complete a Subject Information and Consent Form Checklist (See Attachment A), but all board members are required to review the materials for all studies.
