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

Procedure:

1. IRB Committee Responsibilities.
   1. The IRB Committee, through the Chair or Vice Chair, will report to the Medical Director and/or Administrator of Mayo Clinic's Office for Human Research Protection - IRB:
      1. Any problem/event determined by the IRB to represent an Unanticipated Problem Involving Risk to Subjects or Others (UPIRTSO)
      2. Any non-compliance determined by the IRB to be serious or continuing; and
      3. Any action of the IRB to suspend or terminate its approval for cause.
2. IRB Administration Responsibilities.
   1. The Medical Director of Mayo Clinic's Office for Human Research Protection will prepare a letter that outlines (as applicable):
      1. Project Title;
      2. PI Name
      3. HHS or other Federal Support;
      4. A detailed description of the incident; and
      5. A description of any corrective actions or modifications to the research required by the IRB or the Institution, or changes in IRB Procedures.
   2. The letter is signed by the Medical Director of Mayo Clinic's Office for Human Research Protection - IRB.
   3. The Medical Director of Mayo Clinic's Office for Human Research Protection - IRB will send a copy of the letter to:
      1. The Institutional Official for Mayo Clinic
      2. OHRP
      3. FDA, if the research is subject to FDA regulation;
      4. The study sponsor, if the research was sponsored by an external entity (this includes NIH, NSF, and industry sponsors);
      5. IRB Members of the applicable Committee (as an information item in the agenda packet);
      6. Institutional officials at external sites where the research is conducted and the Mayo Clinic IRB serves as the IRB of Record;
      7. The following individuals at the discretion of the Medical Director:
         1. Institutional Leadership as appropriate;
         2. The Chair of the Research Committee and Chair of the Clinical Research Subcommittee;
         3. Appropriate Institutional Officials involving faculty, staff, or students whose primary affiliation is with non-Mayo Clinic schools and colleges;
         4. The Chair for the appropriate Mayo Clinic Research Committee(s);
         5. The Office of Grants and Contracts Management, if the research involves a grant or contract involving faculty, staff, or students whose primary affiliation is with the Mayo Clinic;
         6. The Department Chair, Supervisor, and/or Faculty Advisor of the Principal Investigator, if applicable;
         7. Legal Counsel, if appropriate.
      8. Principle Investigator
3. Specialist's Responsibilities
   1. The Specialist will provide the Administrator's Assistant the minute excerpt of the meeting and state clearly whether the notification is for UPIRTSO, Suspension, Termination, Continuing Non-compliance or Serious Non-compliance.