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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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Basic Folder Information

13.5 Suspension and Administrative Closure of IRB-Approved Research


Approval Date

Review:

IRB Policy and Procedure Committee

Original Approval:

April 24, 2007

Revised:

April 30, 2012

 



13.5 Suspension and Administrative Closure for Lapse in IRB Approval

If a continuing review of an active study is not approved prior to the end of the previously approved duration of the study, the IRB approval shall automatically expire and the study shall be suspended in accordance with federal regulations. The HSRO may provide warning notices of study expiration to Principal Investigators prior to the study expiration date, but investigators should understand that these are a courtesy and are not required. It is the responsibility of the Principal Investigator to monitor approval periods and to ensure that continuing reports are filed in ample time to allow for IRB review.

Letters informing the Principal Investigator of a suspension for lapse in IRB approval may be sent by the HSRO but these letters are also a courtesy to Principal Investigators who are responsible for suspending study-related activity, including subject accrual and other changes, pursuant to regulations whenever IRB approval has lapsed.

Expiration of IRB approval will not be reported to OHRP. This is in contrast to the reporting that must occur pursuant to HHS regulations and OHRP guidance if a study is suspended or terminated for cause.

If a study has lapsed in IRB approval and the Principal Investigator wishes to continue the research, continuing reports should be submitted immediately but in no case should a continuing report be submitted to the HSRO later than 45 days after the lapse in IRB approval. During the suspension for lapse in IRB approval, initial (i.e. new) studies from the Principal Investigator may be submitted and the IRB may review and approve such studies, but the IRB has the authority to make implementation of the new study contingent upon approval of either a continuing report or a final report (or administrative closure) for the suspended study.

If a study suspension for lapse in IRB approval extends beyond 90 days, the study shall be administratively closed unless this closure is waived by the Associate Vice Provost for Human Subject Research. This administrative closure shall be reported to the IRB and the Chair of the Principal Investigator's academic department. If two studies from a Principal Investigator are administratively closed within a 3-year period, the IRB shall review the circumstances and make recommendations regarding corrective action.



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