This article seeks to inform sponsors preparing for study start-up and enrollment by providing a brief review of the requirements of 21 CFR 56.106. While institutional review board (IRB) registration with Office for Human Research Protections (OHRP) has been a requirement for federally-funded projects since 2000 under the Federal Wide Assurance (FWA) system, registration of US investigational new drug (IND) studies has only been required since 2009, and remains voluntary for non-IND studies. Some sponsors, intending to rely on non-IND, non-US studies to support NDAs, are actively encouraging non-US Ethics Committees to complete this registration step. MEDIOIMAGES/PHOTODISC/GETTY IMAGES In practical terms, depending on company or CRO set-up and size, the regulatory affairs, clinical operations, or clinical compliance group responsible for reviewing "the regulatory packet" routinely verify that the IRB named on the form FDA 1572 is registered and, based on their internal guidances and SOPs, may preclude drug shipment to these sites until they have documentation that the IRB is registered. While this is an appropriate step, it should be noted that registration of an IRB does not provide any guarantees of the accuracy of the registered information, or represent accreditation of that IRB. For non-US ethics committees, there seems to be less consistency across sponsors, since IRB registration is voluntary. Given the Office of the Inspector General's (OIG) previously expressed concern about the ability of sponsors to assure an equivalent level of human protection in clinical studies of FDA-regulated products conducted outside of the United States,1 the considerable FDA, sponsor, and investigational site resources required to coordinate an overseas regulatory agency inspection, and the trend towards generation of clinical data outside the United States, some sponsors are choosing to drive for a harmonized approach in the absence of an absolute regulatory requirement, in an effort to prevent costly delays or temporary confusion at the final NDA approval stage.
Applied Clinical Trials, Jun 1, 2011