The suspension or termination of a study by administrative action may be taken if it is deemed immediately necessary to ensure the safety of human subjects. Such prompt action may occur upon determinations such as (but not limited to) that an alleged practice within a study:
Has or had risks to subjects or others; OR
Constitutes serious or continuing non-compliance with IRB determinations or federal regulations
Administrative action to suspend or terminate a study may be implemented by the Executive Vice President and Provost, the Vice Provost for Research, the Associate Vice Provost for Human Subject Research or the Assistant Provost for IRB Affairs. Administrative suspension or termination of a study shall be immediately implemented upon notification to the Principal Investigator or other key personnel in the absence of the Principal Investigator. Principal Investigators shall be informed by letter from the HSRO about the action taken, its justification and any required steps for corrective action and/or closure. The action and its justification shall also be promptly reported to the convened IRB by the HSRO.