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What documentation is needed to permit non-local IRB review?

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About the Author
Proxima CRO Team
Stephanie Mull
Director of Project Management
Stephanie has over 20 years of clinical research experience working from the site, CRO, and sponsor perspectives.

When non-local IRB review takes place, the reviewing IRB must document its role and responsibility. A written agreement should be executed between the performance site where the research is to be conducted (e.g. private practitioner's office, clinic, etc.) and the IRB or its institution. The agreement should confirm the authority of the IRB to oversee the study. While the IRB assumes responsibility for oversight and continuing review, the clinical investigator and the research site retain the responsibility for the conduct of the study.

When an institution has a local IRB, the written procedures of that IRB or of the institution should define the scope of studies subject to review by that IRB. A non-local IRB may not become the IRB of record for studies within that defined scope unless the local IRB or the administration of the institution agree. Any agreement to allow review by a non-local IRB should be in writing.

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