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Institutional Review Boards
UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
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HSRO Forms & Documents
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eProst User Guide
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Western IRB (WIRB)
About the HSRO


Basic Folder Information

13.3 Expedited Action


Approval Date

Review:

IRB Policy and Procedure Committee

Original Approval:

April 6, 2006

Revised:

April 30, 2012

 



13.3 Expedited Action

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:

  1. Cause injury or any other unanticipated problems involving risks to subjects or others; OR
  2. 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.



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