Timing the
Request

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.

Process

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

• The research has not begun.
• The IRB^* determined during the full review that there was no more than minimal risk to subjects, and no new risks have been identified.
• Enrollment is closed and no additional risks have been identified.
• The remaining activities are limited to data analysis.

Anticipated Approval Time

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.