FULL BOARD REVIEW

Full Board Review is required for initial review, continuing reviews, and when modifications require a voting quorum. Once reviewed, CGIRB will notify the Principal Investigator (PI) of the Board's action in a timely manner. Usually this notification is accomplished by mailing documentation to the PI within 72 hours of the Board meeting. The review will result in one of the following Board actions:

• Unconditional Approval - Approved as submitted.
• Conditional Approval - The research meets regulatory criteria for approval if certain conditions are met (satisfied).
• Deferral - Significant changes are required or outstanding issues need resolution prior to a decision being made.
• Disapproved* - CGIRB Board decides that the research fails to meet regulatory criteria for approval.

*The PI/Sponsor will be contacted stating the reasons the Board disapproved the research study. The reasons for the disapproval may be initially given verbally; however, usually within 10 business days of the CGIRB Board meeting the initial contact should be followed by notification in writing. The PI has the right to appeal CGIRB's decision, in writing, at which time he or she may make changes and resubmit the proposal to the CGIRB for another review.

EXPEDITED REVIEW

An Expedited Review is available for modifications to the CGIRB-approved research study that require no more than minimal risk to research study subjects, including previously approved research, and for other categories as specified in the regulations. The CGIRB Board Chairperson makes the determination as to whether an item qualifies for expedited review. The CGIRB Board Chairperson or designee will review proposed changes and determine an action. The decision will then be presented to the full Board at the next regularly scheduled meeting.