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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
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About the HSRO


Basic Folder Information

13.2 Administrative Action


Approval Date

Review:

IRB Policy and Procedure Committee

Original Approval:

April 6, 2006

Revised:

April 30, 2012

 



13.2 Administrative Action

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:

  1. Has or had risks to subjects or others; OR
  2. 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.



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