Compliance Review Selection and Process

Selection Criteria

Studies under the purview of the University of Minnesota's IRB are subject to review.

Studies may be chosen for a compliance review in more than one manner:

1. Higher risk studies such as gene therapy or novel therapies
2. Studies involving IND's/IDE's, especially investigator-held IND/IDE
3. Studies enrolling vulnerable populations
4. Studies requiring more than annual review by the IRB
5. "For Cause" requests based on:
• Subject's complaint
• Employee's complaint
• Whistle blower
• IRB request
6. Methodological selection from the entire database

Compliance Review Process

How are Principal Investigators notified that their protocol has been chosen for review?
An email notice will be sent to the PI notifying him/her that their study has been selected. Attached to this email message will be the formal compliance review notification letter, which outlines the information that will be reviewed during the compliance review. The PI or research staff can then contact the Compliance Officer to ask any questions and schedule the compliance review.

How long does the compliance review take?
The amount of time needed for a compliance review varies greatly. Generally, the Compliance Officer would like to meet with the PI for about 20-30 minutes either before, during of after the review of the study documents. The time needed to review the study documents depends on the amount of material and the number of subjects.

How is compliance determined?
Compliance reviews are done to check compliance with:

• IRBapproval and regulations
• University Policy
• Federal and state policies and regulations
• ICH-Good Clinical Practice guidelines
• Other applicable policies and regulations

What is reviewed?
Please refer to Materials reviewed in the compliance review for the list of documents that are reviewed.

After the Compliance Review
When the compliance review is complete, the Compliance Officer will:

• Meet with the PI/study coordinator if necessary to discuss the findings
• Write a report of the findings from the compliance review
• Send a copy of the report to the PI, the Assistant VP of Regulatory Affairs, the IRB and Fairview's Legal Counsel and Chief Compliance Officer (if applicable).

Follow Up Follow up on the findings from the compliance review includes:

• The IRB to follow up with major issues
• Regulatory Affairs to follow-up with minor issues
• No follow up needed