If you have not responded in time to renew the protocol before it lapses, the protocol is considered no longer approved. If this occurs, you will receive notice that the protocol approval has expired. Any research activity conducted under an expired protocol is in violation of the regulations, and jeopardizes the entire University's privilege to conduct human research. Occasionally a researcher will ask to have an expired protocol such as this reinstated. For reinstatement, the protocol must undergo HRC review again, as a new project.
Timely renewal avoids approval lapses.
The H-101 form may also be used for closing a protocol. A project needs to be kept open while it is active, including through data analysis. An HRC approval needs to be closed in an orderly manner, with reporting about the past approval period. When RCO receives an H-101 marked for project closure, the project will be closed on RCO records. No printed notice of project closure is sent to the investigator.