A protocol can be terminated once it is closed to recruitment (with no direct participant follow-up), and all data collection has concluded. Data analysis can continue after the protocol is terminated. Researchers can also receive existing follow-up clinical data from healthcare providers after the IRB protocol is terminated (just note this possibility in the report). There are different types of terminations and protocol suspensions.
Investigators may choose to voluntarily suspend or terminate some or all activities of an approved IRB protocol. If an investigator chooses to suspend or terminate their protocol, they should report to TC IRB and specify the reasons for suspension or termination. Reasons may include:
Once an IRB protocol has been terminated, it cannot be reopened. In most cases, investigators will be required to submit a new protocol to TC IRB for review and approval.
IRB staff may close a research protocol administratively for the following reasons:
Administrative closures occur after the IRB approval period on a protocol expires. This action is taken to ensure that investigators do not mistakenly assume that their protocols remain active. Ideally, the investigator will alert TC IRB of any study terminations or suspensions.
In order to close a protocol, log in to the MyTC portal and click the Faculty, Student, or Employee Resources tab. On the right side, you will find a link to Mentor IRB. Then click My Protocols, and select the protocol you would like to terminate. Once that page loads, scroll down to where it says Date Closed on the left side. Click Terminate Protocol. You will then be prompted to set the date the protocol closed. Upon submission, the protocol will be listed as Terminated under My Protocols. Data analysis may still continue after a protocol has been terminated.
Please review our How to Terminate A Protocol document for more detailed instructions and information on this topic.