Scientific Review (Prior to IRB Review)

Purpose: Review for content and structure
Due Date: First Monday of each month
Reviewer: Director of Research or MSIMR Program Chair
Turnaround Time: Approximately 2 weeks

IRB Submission – Full-Board Review

Purpose: Review for safety and protection of human subjects
Due Date: Second Wednesday of each month
Reviewer: 2-3 members of the IRB
Turnaround Time: Approximately 4-5 weeks total (2-3 weeks of subcommittee review, then full board review at the next monthly meeting held on the first Tuesday of each month)

IRB Submission – Exempt Review

Purpose: Review for safety and protection of human subjects
Due Date: Second Wednesday of each month
Reviewer: IRB Chair
Turnaround Time: Approximately 3-4 weeks

Protocol Revision (PRAF)

Purpose: Review study modifications for safety and protection of human subjects
Due Date: By Wednesday of each week
Reviewer: IRB Chair
Turnaround Time: Approximately 1-2 weeks

Continuing Review

Purpose: Ongoing review for safety and protection of human subjects
Due Date: Annually by 30 days prior to the anniversary of initial approval
Reviewer: IRB Chair
Turnaround Time: Approximately 1-2 weeks

Final Review

Purpose: Close out study and evaluate safety
Due Date: When study is concluded
Reviewer: IRB Chair
Turnaround Time: Approximately 1-2 weeks

Protocol Deviation

Purpose: Evaluate deviation from protocol for safety and protection of human subjects
Due Date: Immediately following protocol deviation
Reviewer: IRB Chair
Turnaround Time: Approximately 1 week or less

Serious Adverse Event

Purpose: Evaluation of serious adverse event
Due Date: Within 24 hours of investigator knowledge of event. For adverse event definitions and reporting requirements see here
Reviewer: IRB Chair
Turnaround Time: Approximately 24 business hours