Extending a Study / Continuing Review

All research protocols approved by the IRB as a full review shall be reviewed annually. The interval between consecutive reviews may be less than twelve months if the IRB determines that the level of risk warrants more frequent reviews. Once a research project no longer involves human subjects (i.e., once the investigators have finished obtaining data through interaction or intervention with subjects or obtaining identifiable private information about the subjects), the protocol file may be closed rather than extended.

A notification, including instructions and forms for extending the protocol, will be sent to investigators 30-45 days prior to the expiration of the protocol approval date. However, investigators are responsible for ensuring that their IRB approval is current so if this notification is not received, investigators should contact the IRB for instructions on extending studies. It's imperative to follow the timeline specified in the instructions in order for the extension to be processed before the approval expires.

If the study is not complete and an extension is needed, a request for an extension must be submitted using the Extension Request FormPlease note that studies still enrolling subjects require the consent form to be updated to comply with the new Common Rule requirements as indicated in the blue highlighted sections of the IRB Guide to Writing a Consent Form.

 

Page last updated 5:51 PM, January 29, 2019