Once oversight of a study has been ceded to the Reviewing IRB under the SMART IRB Agreement, can an institution take back IRB oversight?
Yes. The expectation is that when review of a research study is ceded under the Agreement, the study will remain under the Reviewing IRB’s oversight authority for as long as IRB oversight is required. However, for a particular study, if a Relying Institution determines that it must change IRB oversight of the study (e.g., the Relying Institution wants to take back review of the study to its home IRB), the Relying Institution’s Point of Contact (POC) should contact the Overall PI of the study, requesting that the institution be removed as a Relying Institution. The Overall PI for the study will remove the site by submitting an amendment to the Reviewing IRB in accordance with the SMART IRB SOP on “Protocol Amendment Submission and Review Process.” The Overall PI and Site Investigator for the Relying Institution should work together to ensure that appropriate alternate review and approval are in place for this institution.
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