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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

7.4 Approval Duration


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

March 14, 2006

Revised: May 24, 2011

 



7.4 Approval Duration

The following shall apply almost exclusively to studies approved under the convened IRB category since studies approved under the expedited category should involve no greater than minimal risk to human subjects and will likely require continuing review only on an annual basis. However, IRB chairs or chair-designees may impose shorter continuing review durations for expedited studies if appropriate.

Federal regulations [45 CFR 46.109(e) and 21 CFR 56.109(f)] require that continuing review of research be conducted by the IRB at intervals appropriate to the degree of risk and not less than once per year. Pursuant to regulations, the IRB shall define the duration of approval of each study with the requirement that all studies, no matter whether previously approved under the expedited or convened IRB review category, shall be subject to continuing review at intervals appropriate to the degree of risk and not less than once per year.  Regulations make no provision for any grace period extending the conduct of the study beyond the expiration date of IRB approval.

For studies reviewed and approved by the IRB chair or designee within the "expedited" category, the length of approval shall be calculated from the date that the IRB chair or designee finalized his/her approval.  For studies that did not fit within the expedited category and therefore require review by the convened IRB, the length of approval shall be calculated from the date of the convened IRB review at which approval was given.  Additionally, where the convened IRB specifies conditions for approval of a study and defers approval until the satisfaction of its conditions are verified by the IRB chair or designee, continuing review must occur no more than one year after the date the study was reviewed by the convened IRB, not on the anniversary of the date on which the IRB chair or designee verifies that IRB-specified conditions for approval have been satisfied.

The approval duration shall be based on evaluations as to whether the risks are of a sufficient magnitude that annual review is inadequate.  Although the magnitude of the risks is in part determined by the study procedures, other factors that pertain to the study (e.g., age of participants) may also be considered.

Among the factors that the IRB shall consider in determine whether a study requires continuing review by the IRB more frequently than annually are:

1)  If the study involves experimental therapies or procedures in which a clear potential for significant adverse experiences has been identified at the time of review

2)  The nature, probability and magnitude of anticipated risks to subjects

3)  Likely medical or psychological condition of the proposed subjects

4)  Qualifications of the PI and other members of the research team

5)  Nature and frequency of adverse events observed in similar research

6)  Vulnerability of the population being studied including familiarity with the language on consent forms and other documents

7)  Other facts the IRB deems relevant



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