Requirements for Reporting to the IRB
Federal regulations (45 CFR 46.1 03(b)(5) & 21 CFR 56.1 08(b)) require written procedures for ensuring prompt reporting of unanticipated problems to the IRB, appropriate institutional officials, any supporting department or agency head (or designee), and OHRP. The purpose of prompt reporting is to ensure that appropriate steps are taken in a timely manner to protect subjects from avoidable harm. Investigators must promptly report any Unanticipated Problem Involving Risk to Subjects or Others (UPIRSO) associated with their research study according to this procedure.
Refer to MCW Office of Research Standard Operating Procedure "Requirements for Reporting to the IRB" for more information.