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How to Terminate an IRB Protocol

Teachers College Institutional Review Board, Columbia University

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When to Terminate a Protocol...

Protocol Terminations: A study 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).

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MyTC has moved!

Please navigate to https://my.tc.columbia.edu/ and click the Student Resources tab.

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Navigating to Mentor IRB

Head to the Applications section and head to the Mentor IRB icon.

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Navigating to Mentor IRB

Head to the Applications section and head to the Mentor IRB icon.

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Navigating to Your Protocol

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Navigate to My Protocols found on the left hand sidebar of TC Mentor IRB.

Choose the study you would like to terminate.

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Choose Terminate Protocol on top of your protocol page. You will be prompted to set the date the protocol closed. Upon submission, the protocol will be listed as terminated under My Protocols.

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You will be prompted to complete the following questionnaire. Make sure the appropriate Continuation Status, “Terminate Protocol” is selected. Fill out all relevant information.

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Terminating a Protocol

Continue filling out the questionnaire as it pertains to your study.

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Terminating a Protocol

  • All of your findings should be summarized in this section. Please include the overall findings.
  • Upload all relevant documents, including the two most recent signed consent forms.

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Terminating a Protocol

  • After uploading the two signed consent documents, click the ‘Submit Report’ button at the bottom of the form.
  • An email will automatically be sent to the IRB.
  • Upon review, they will acknowledge the closure/termination.
  • Your protocol will remain archived in Mentor.

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Investigator-Initiated Voluntary Protocol Suspension or Termination

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:

  • The project is complete, and the investigators are no longer engaging in human subjects research
  • Unanticipated problem(s) involving risk to participants or others
  • Incident of serious and continuing non-compliance

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.

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IRB Protocol Administrative Closure

IRB staff may close a research protocol administratively for the following reasons:

  • If an investigator has failed to submit the required continuing review materials
  • The investigators are no longer engaging in human subjects research and are unable for some unforeseeable reason (e.g., illness, injury, etc.) to terminate the protocol on their own
  • Unanticipated problem(s) involving risk to participants or others
  • Incident of serious and continuing non-compliance

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.

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If you have questions or concerns about the rights of a research subject, you should contact the Institutional Review Board (IRB) (the human research ethics committee) at 212-678-4105 or email IRB@tc.edu or you can write to the IRB at Teachers College, Columbia University, 525 W. 120th Street, New York, NY 10027, Box 151. The IRB is the committee that oversees human research protection for Teachers College, Columbia University.