Subject: Reporting to the Appropriate Institutional Officials, and the Department or Agency Head(s)

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to report the items described below according to the Federal regulations and Mayo Clinic IRB policy.

1. The following items shall be reported to appropriate Institutional Officials, the Office for Human Research Protections, ^[1], ^[2] the Food and Drug Administration ^[3], ^[4] (if applicable) and the head of any Department or Agency that provides support for the study:
   1. Any unanticipated problem/event involving risk to subjects or others (UPIRTSO); in accordance with IRB Policy III.J ^[5] and
   2. Any serious or continuing non-compliance with Federal regulations, IRB policy or the requirements or determinations of the IRB; and
   3. Any suspension or termination of IRB approval.

^[1] 45 CFR 46.103(b)(5)

^[2] 45 CFR 46.113

^[3] 21 CFR 56.108(b)

^[4] 21 CFR 56.113

^[5] IRB Policy III.J