Any modification to your research (exempt, expedited, or full board) requires HSC review and approval prior to implementation. Modifications that do not pose any new or additional risks to participants are typically handled via expedited review procedures. Modifications that are substantive in nature and increase risk to the subjects are reviewed by the full board at a convened HSC meeting. Some examples of modifications are:
If you need to modify your protocol, click here for instructions.
Exempt submissions are approved indefinitely and do not need to be renewed. Expedited and full board submissions must be renewed and approved annually prior to its expiration date for ongoing studies to avoid any lapses in protocol approval.
You will receive an email reminder 60, 30, and 14 days before your protocol expires. If you have not submitted a renewal by the protocol’s expiration date, you will receive an expiration notice and all research must cease until the renewal has been approved by the HSC.
Protocols should be renewed when any of the following activities are still ongoing:
If you need to renew your protocol, click here for instructions.
If you are not sure if you can close your protocol, see the guidance on Closing a Project.
Yes, you have 180 days from the date of expiration to renew an expired protocol. After 180 days, the project will be automatically closed and the UCOP records retention period starts. If you would like to renew a protocol that has expired and been closed, you may base a new protocol off the closed protocol, but it will be reviewed as a new submission.
If you have been conducting research on an expired protocol, cease all activities and contact the HSC immediately.