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© Office of Research Support, Duke University 2003-2009
Federal regulations require that protocols be renewed no less frequently than annually.
The IRB is required to decide when a protocol needs continuing review
at the time of the original approval and of each subsequent renewal.
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Timing the |
If an investigator would like to retain the original approval date, the request must be submitted and approved within 30 days prior to the expiration date. A request submitted prior to the 30 day period will receive a new approval date. The IRB office cannot hold requests to renew protocols if they are submitted prior to the 30 day period and the investigator would like to retain the initial approval date. There is no grace period. If a protocol is not approved prior to its expiration date, all activities associated with the protocol, including the analysis of identifiable data, must be suspended until the renewal is approved. |
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Process |
IRB staff will review the request, provide feedback if needed, and make a determination about what type of review, expedited or full, is required. |
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Expedited or Full Review? |
Expedited review may be used if: The original protocol was expedited and there are no proposed changes or if proposed changes are minor.
The original protocol required full IRB review, but
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Anticipated Approval Time |
Requests will be approved prior to the current expiration date of the protocol. |
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International Research |
Researchers who will not be in the United States when a protocol is due to expire must make arrangements for the protocol to be renewed. |