About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

IRB review and approval are required prior to start of a clinical study under IND (21 CFR 56.103(a)). FDA may waive the IRB requirements for certain research activities, but only when alternative provisions are available to ensure protection of the rights and welfare of human subject. The most common case for which the FDA receives a waiver request is for foreign clinical studies under an IND. In such cases, Independent Ethics Committee (IEC) reviews the case instead of a U.S. IRB. An IEC may not meet all IRB requirements contained in 21 CFR 56.

An IRB waiver request for foreign studies must include the alternative methods for assuring human subject protection. It is generally acceptable to include the intention to use an IEC that complies with GCP (e.g. ICH E6) instead of an IRB (that complies with 21 CFR 56) in the waiver request.

The sponsor must submit the request to the IND under which the study will be conducted. The IND will be reviewed by Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER). Then the respected agency will inform the sponsor in a writing regarding the approval or denial of the waiver request. Upon approval, the investigators must attach a copy of the wavier approval letter to the signed 1572 in the investigator’s record.

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