Subject: Reporting Unanticipated Problems Involving Risk to Subjects or Others (UPIRTSO)

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to require that Investigators promptly report any unanticipated problems involving risk to subjects or others (UPIRTSO). Once reported, Mayo Clinic's IRB will determine what constitutes an unanticipated problem involving risks to subjects or others (UPIRTSO) and will report to appropriate institutional officials, OHRP, and other relevant Federal agencies as set forth in IRB Policy II.C. ^[1], ^[2], ^[3]

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

^[2] 21 CFR 56.108 (b)(1)

^[3] IRB Policy II.C