Subject: Administrative Hold, Suspension or Termination of IRB Approval

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – that all currently approved research is subject to modification or change in approval status, as deemed necessary by the Mayo Clinic IRB. The IRB may ask the Investigator to place research on administrative hold to gather information or the IRB may suspend or terminate research due to cause for research not being conducted in accordance with the IRB's requirements or the Federal regulations or if it has been associated with unanticipated problems/events involving risk to subjects or others. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and will be reported promptly to the investigator, appropriate institutional officials, OHRP and other applicable agencies. ^[1], ^[2], ^[3]

Examples of a suspension for cause might include:

1. Inappropriate involvement of human subjects in research;
2. Violation of the rights or welfare of subjects or others;
3. Serious or continuing non-compliance with Federal regulations or IRB policies; or
4. New information regarding increased risk to human subjects or others.

^[1] 45 CFR 46.113

^[2] 21 CFR 56.113

^[3] IRB Policy II.C