Submit a study
Click on the list below to get the forms you need to start a new study:
Full Board Review
Full Board Review is required for initial review, continuing reviews and when modifications require a voting quorum. Once reviewed, Copernicus Group IRB will notify the Principal Investigator of the Board’s action, in a timely manner. Usually this notification is accomplished by mailing documentation to the investigator within 72 hours of the review meeting. The review will result in one of the following 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 Principal Investigator/Institution’s IRB Liaison 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 days of the board meeting the initial contact should be followed by notification in writing. The Principal Investigator has the right to appeal the Board’s decision, in writing, at which time he or she may make changes and resubmit the proposal to the IRB for another review.
An Expedited Review is available for modifications to the study that require no more than minimal risk to study subjects, including previously approved research, and for other categories as specified in the regulations. The IRB makes the determination as to whether an item qualifies for expedited review. The IRB 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.