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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
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18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
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23. Vulnerable Populations
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Basic Folder Information

10.2 Continuing Studies - Expedited


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

March 31, 2006

Revised: August 17, 2011

 



10.2 Continuing Studies - Expedited

Those studies recommended for review under the expedited criteria are made available to the IRB Chair or designee of the Chair who shall be a member of the IRB.  IRB Chairs and designees shall conduct reviews of studies that fit within the expedited criteria on behalf of the IRB.  IRB chairs/IRB-designees may determine that studies recommended for expedited review require "Convened Board Review".  The IRB may determine that studies recommended for Convened Board Review require exempt or expedited review.

Investigators are urged to consult with HSRO regulatory staff before making their recommendations to the HSRO and the IRB regarding the review category.

Studies initially approved via expedited review are eligible for expedited review at the time of their IRB-defined continuing review; if, during the course of the study, the risks of these studies has not increased and the investigator is not proposing changes that affect the "minimal risk" designation.  Such changes, or other information presented during an approved period or with the submission of a continuing review application, may impact the review category and disqualify the study from being approved on an expedited basis.  In this case, the IRB Chair or designee shall determine the appropriate review category and the study may be forwarded to the convened IRB for full review.

Even if the submission fulfills the criteria for expedited review according to the regulations, the Chair or designee shall use his/her discretion as to whether the study should be expedited or referred for convened IRB review.  The Chair or designee shall review all materials related to the assigned study, conduct informal queries of the Principal Investigator and/or other experts as necessary to provide a thorough review and present clear and concise requirements/recommendations for changes and/or questions in written form (by ePROST, email or otherwise) for communication to the Principal Investigator.  The Chair or designee may request minor revisions and/or clarifications before approval is granted.  The Chair or designee may request a second reviewer and/or may seek recommendations from an expert consultant(s) for issues which require expertise beyond, or in addition to, that available on the IRB.

If previously met criteria for expedited review have not changed since the most recent IRB review and approval, continuing review may be conducted under the same expedited review category(ies).  Studies that were previously reviewed by the convened IRB may receive expedited review if the IRB has documented its decision that the study involves "minimal risk" and is eligible for future expedited review or if the IRB Chair or designee concludes that the study meets the following criteria:

Option 1:

1)  The research is permanently closed to the enrollment of new participants; AND

2)  All enrolled participants have completed all study-related procedures and interventions; AND

3)  The research remains active only for long-term follow-up of participants.

Option 2:

No participants have ever been  enrolled at this site and no additional risks have been identified.

Option 3:

The remaining research activities are limited to data analysis.

Notification of approvals of expedited continuing reviews shall be made in a timely manner to the convened IRB.  If the Chair/designee cannot approve a continuing study, the review shall be deferred to the convened IRB and the Principal Investigator shall be informed of the reasons and may provide additional or clarifying information to the convened IRB.



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