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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
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eProst User Guide
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About the HSRO


Basic Folder Information

13.4 Convened IRB Action


Approval Date

Review:

IRB Policy and Procedure Committee

Original Approval:

April 6, 2006

Revised:

April 30, 2012

 



13.4 Convened IRB Action

The convened IRB has the responsibility and the authority to suspend or terminate its approval of any study that it has reviewed and approved for reasons such as that the alleged practices of the study 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

Such actions shall be incorporated into the minutes of the meeting. The IRB shall consider the rights and welfare of current research subjects when suspending or terminating approval of active studies.

As part of its review and deliberations, the IRB may request an investigation by the Office of Research Support and Quality Assurance (RSQA) and/or may initiate an inquiry by requesting specific information from the Principal Investigator. Suspension or termination of a study by IRB action 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, the reasons for the suspension or termination and any required steps for corrective action and/or closure.

The IRB has the authority to take actions other than suspension and termination to ensure subject safety (c.f. Policy 3.1). Actions that the IRB may take include, but are not limited to:

  1. Requiring more frequent than annual review of a protocol
  2. Imposing a probationary period for an investigator
  3. Suspending an investigator's right to perform studies, pending remedial action(s)
  4. Requiring that additional educational requirements be completed by the Principal Investigator and his/her staff
  5. Transferring responsibility for the protocol to another principal investigator
  6. Arranging for additional or alternate physician follow-up
  7. Arranging for the subject to remain in the study at another institution


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