Subject: Investigator, Study Personnel, IRB Committee Members and Staff Training

Procedure:

1. Investigator Responsibilities.
   1. Initial Training. The Investigator and key study personnel shall complete and pass Mayo Clinic’s Training Program (MTP) before being eligible to participate in any human subjects research.
   2. Biennial Training. The Investigator and key study personnel shall complete and pass the MTP every two years.
   3. The Investigator and key study personnel shall review the IRB’s website for current IRB Policies and Procedures and be familiar with Federal regulations, especially those applicable to their area of research.
2. IRB Committee Member Responsibilities.
   1. Initial Training. IRB Committee Members will complete and pass Mayo Clinic’s Training Program (MTP) before being eligible to participate in any human subjects research review and approval process.
   2. Biennial Training. IRB Committee Members complete and pass the MTP every two years.
   3. IRB Committee Members will attend annual training (IRB Education Days).
   4. IRB Committee Members will review the IRB’s website for current IRB Policies and Procedures and be familiar with Federal Regulations, especially those applicable to the research project they are assigned to review.
3. IRB Staff Responsibilities.
   1. All new IRB Staff will complete a role-specific competency and assessment tool within three months of their start date in the IRB.
   2. Initial Training and Orientation.
      1. Mayo Clinic requires all newly hired Mayo Clinic employees attend a general orientation program conducted by Mayo Clinic’s Human Resource department.
      2. New IRB Staff will complete a role-specific orientation and corresponding checklist.
      3. IRB staff will complete the Collaborative Initiative Training Initiative Training (CITI) Basic Course for Biomedical and Social/Behavioral Research within their orientation period.
   3. Yearly Training.
      1. IRB Staff will attend Monthly IRB Education Meetings.
      2. IRB Staff will complete CITI Refresher Course every year.
      3. IRB Staff will attend annual training (IRB Education Days).
   4. Documentation of Training
      Documentation of all required training will be maintained in the IRB office in a secure file.