IRB review and approval is required before a clinical study can be initiated under an IND (21 CFR 56.103(a)). FDA may waive any of the IRB requirements for specific research activities or for classes of research activities otherwise covered by the IRB regulations (21 CFR 56.105), but FDA uses the waiver provision only when alternative mechanisms for ensuring protection of the rights and welfare of human subjects are acceptable. The most common circumstance for which FDA receives a waiver request is when a sponsor wishes to conduct a foreign clinical study under an IND. In this case, typically an
Independent Ethics Committee (IEC) that operates in accordance with Good Clinical Practice (GCP) is utilized instead of a U.S. IRB. Although its membership and functions for assuring human subject protection are comparable to an IRB, an IEC may not meet all of the IRB requirements contained in 21 CFR Part 56. For a foreign study, an IRB waiver request should contain a description of alternative mechanisms for assuring human subject protection. It would generally be acceptable for a waiver request to state the intention to use an IEC that complies with GCP (e.g., ICH E6) instead of an IRB that complies with 21 CFR Part 56.
The sponsor should submit the waiver request to the IND under which the study will be conducted. The IND will have been submitted to the appropriate review division in either the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).
The sponsor will be informed by the agency in writing whether the waiver request is denied or granted. If a waiver is granted, the sponsor should have investigators attach a copy of the letter granting the waiver to the signed 1572 in the investigator’s record.