Subject: Development, Approval, and Maintenance of Policies and Procedures

Procedure:

1. IRB Policy and Procedure Committee Responsibilities.
   1. The IRB Policy and Procedure Committee will develop and maintain IRB Policies and Procedures as directed by the Medical Director and Administrator of Mayo Clinic’s Office for Human Research Protection – IRB. The committee may also receive guidance on necessary revisions of Policies and Procedures from the Executive Committee and or Medical Director
   2. The Committee will review IRB Policies and Procedures at least every two years or more frequently as necessary.
   3. Policies are subject to review and approval by IRB Executive Committee, Mayo Clinic’s Institutional Official and Mayo Clinic’s Board of Governors.
   4. Procedures are subject to review and approval by the Medical Director.
   5. The Committee will routinely view OHRP and FDA websites for issuance of guidance documents, changes in regulations, and determination letters.
   6. All approved Policies, Procedures will be included in the IRB Policy and Procedure Manual and updated on the IRB website.
2. IRB Administration Responsibilities
   1. The Responsible Officer will determine the need for and type of Work Instructions required in the IRB. Appropriate staff members will be appointed to review and/or develop the required work instructions.
   2. The responsible officer will ensure that the Work Instructions are in sync with the Policies and Procedures.
   3. The responsible officer will review IRB Work Instructions at least once every two years or more frequently as necessary.
   4. IRB Work Instructions must be endorsed by the Quality Team and approved by the Administrator of the IRB.
   5. All approved Work Instructions will be included in the IRB Master Index and will be updated whenever a revision is approved. Every IRB employee must have access to this manual.
   6. The Administrator will designate appropriate personnel to manage the documentation, archiving and publishing of the IRB Policies and Procedures.