The suspension or termination of a study by expedited action may be taken if the IRB Chair or Chair-designee deems that such prompt action is necessary to ensure the safety of human subjects and that it is inappropriate to await action by the convened IRB. Such prompt action may occur if notification is received by the IRB or referred to the IRB by administration outside of a regularly scheduled IRB meeting. Reasons for expedited action may include that the alleged practices have or had the potential to:
- Cause injury or any other unanticipated problems involving risks to subjects or others; OR
- Constitute serious or continuing non-compliance with IRB determinations or federal regulations
As part of his/her review, the expediting reviewer may request an investigation by the Office of Research Support and Quality Assurance (RSQA), and/or may conduct an inquiry by requesting specific information from the Principal Investigator. Expedited 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.