NEIRB vice president, James Saunders, described this to Outsourcing-Pharma as “a one-stop shopping arrangement for clients”, allowing NEIRB to “meet client requests” by permitting them to have their protocol reviewed just once.
“We are pleased to collaborate with NEIRB” said Janice Parente, founder and president of ethica Clinical Research Inc/Veritas IRB. “Veritas IRB will work in concert with NEIRB to fulfill a combined role for sponsors of North American research.”
Citing a recent article by Jerry Menikoff in the New England Journal of Medicine, entitled “The Paradoxical Problem with Multiple-IRB Review”, James Saunders outlines the need to find an alternative to multiple-IRB review which can have a negative impact on efficiency of research conduct. Regulations for IRBs are said to have been written at a time when multisite trials were rare.
Sanders added that the “confusion of responsibility” which ensues when protocol for multi-site research is reviewed by more than one IRB can mean “no one IRB feels empowered to say the protocol might need to be modified” and therefore “the review process might be flawed”.
IRB effectiveness
Much discussion has taken place recently concerning the effectiveness of IRBs in protecting research participants. It has been argued that expansive bureaucracy stifles research productivity and is not in the interest of the participants it intends to protect.
While the US Government Accountability Office (GAO)’s delivered testimony on the ease of setting up a fake IRB and getting an actual IRB to approve a fictitious protocol for human subjects research in 2009, concerns have come to light this year regarding the overall efficacy of the work of IRBs.
Sanders says that the “sting operation” by the GAO emphasises the importance of IRB accreditation which is a “relatively new phenomenon and difficult to attain”, providing a means for sponsors to “feel assured that the IRB is of good quality and not subject to undue influence”.
Both IRBs have highlighted that the partnership will not dramatically affect the way their clients work with them, with NEIRB clients continuing to communicate with a dedicated IRB study administrator who will have team support bridging both IRBs. Parente, of Veritas IRB, added “Canadian research participants can be assured that their rights and welfare will be protected by a group of individuals who understand local language, culture and laws, at both the federal and provincial levels”.
While NEIRB was founded in 1988 to act as a national, central IRB; Veritas IRB was founded 8 years later as a non-profit division of the contract research organisation (CRO), ethica Clinical Research Inc.