XIII. TERMINATION AND SUSPENSION
13.1 Automatic Suspension
Pursuant to Federal regulations, any research protocol that has not been subjected to ongoing review and approval by the end of its Approval Period is automatically suspended and all research activity must cease. The protocol will automatically be terminated if an application for reinstatement is not filed within (90) days of this automatic suspension. (45 CFR 46.109 (e))
13.2 Board Suspension and/or Termination
The IRB has the authority to suspend or terminate research that is not being conducted in accordance with the requirements of the IRB or that has been associated with unexpected serious harm to any subject. Any suspension or termination shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, the sponsor (if any), appropriate institutional officials, and the appropriate government regulators required by law. (45 CFR 46.113)
13.3 Activities During Suspension or Termination
In the event a research project or protocol is suspended or terminated, all research activities must cease. This includes, not only suspending enrollment of new subjects, but also the administration of the research drug, device and/or therapy, and any use of data in which a subject identifies is attached.
13.4 Research Involving Therapeutic Treatments
In the event that a research project or protocol that involves the therapeutic treatment is suspended or terminated and interrupting that treatment in the opinion of the treating physician would be detrimental to that subject, the research may apply to continue treatment under the humanitarian exception provided in Section 6.4.
13.5 Re-instatement
Reinstatement and approval of a protocol requires that the IRB review and approve the following at a convened meeting:
13.5.1 Request for Project Review Form
Submission of a full annual review application, including submission of all amendments and adjustments that may be required by the IRB where suspension was imposed by the IRB.
13.5.2 Supporting Memorandum
The principle investigator must also submit a supporting memorandum providing the following information: (a) an explanation of the circumstances that led to the failure to submit the application at the appropriate time or to otherwise fail to comply with the instructions of the IRB; (b) a statement indicating whether patients were enrolled during the period that the project was not approved; and (c) a statement indicating the number of patients maintained on a therapeutic intervention after suspension and why cessation of that therapy would have been detrimental to each patient's health.
