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The University of Iowa IRB has the authority to suspend or terminate approval of human subjects research that is not being conducted in accordance with the University of Iowa IRB’s requirements or that has been associated with unexpected serious harm to subjects. The University of Iowa IRB also has the authority to suspend or terminate research being conducted under the oversight of Western Institutional Review Board. Any suspension or termination of approval includes a statement of the reasons for the IRB’s action and is reported in writing within 5 working days to the investigator, the investigator’s Departmental Executive Officer, the Office of the Vice President for Research, and the Division of Sponsored Programs/Clinical Trials Office (when the study is externally funded). Suspension or termination of a Western Institutional Review Board-approved project is reported within 5 working days to the reviewing IRB. Suspensions implemented by an IRB Chair will be reported to and reviewed by the convened IRB. The IRB may take actions, within its authority, as deemed appropriate.
When suspending or terminating IRB approval on an urgent basis, the IRB (or IRB Chair for suspensions):
- Considers actions to protect the rights and welfare of currently enrolled participants.
- Considers whether procedures for withdrawal of enrolled participants considered their rights and welfare.
- Considers whether participants should be informed of the termination or suspension.
- Requires any adverse events or outcomes to be reported to the IRB.