Frequently Asked Questions
For foreign clinical studies conducted under an IND, how can an investigator sign the 1572 when the investigator knows he/she cannot commit to all of the requirements on the form, specifically IRB membership?
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.