In the wake of news that Trafalgar Ethics Board Inc. suddenly ceased operations last month, Institutional Review Board Services has quickly stepped in to ensure a smooth transition, bringing peace of mind to both researchers and participants currently involved in important clinical studies across the country.
“This is one of the very few first times in North America that an independent ethics board has had to voluntarily close its doors,” said IRB Services president Jack Corman, noting that it was extremely important to ensure ongoing ethical oversight for all research studies and clinical trials engaged by TEB. “Otherwise, there would be no ethics approval in place for the research which is a very serious breach of Canadian, U.S. and international clinical trial regulations and all research activity would have had to cease,” he added.
Founded in 1993, IRB Services is an independent organization accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and dedicated to protecting the rights and safety of human subjects. IRB Services operates research ethics committees in Toronto, Ontario; Montreal, Quebec; and Boca Raton, Florida, which review a wide range of both industry and publicly funded human subject research across multiple disciplines, including Health Canada, Food and Drug Administration, and US Department of Health and Human Services regulated research.
Trafalgar Ethics Board, based in Oakville, Ontario, chose IRB Services to help guide the shutting down process, relying on IRB Services’ strong reputation as the leading Canadian independent board to ensure continuity of ethics approval for vital research. Since June, IRB Services has assumed responsibility for the majority of TEB research projects, conducting thorough re-reviews and issuing re-approvals of nearly 40 studies involving approximately 200 researchers in just 17 business days. The acquired projects include urology, allergy and behavioural studies involving top pharmaceutical companies as well as independent research organizations.
“We successfully chartered new territory for the industry, demonstrating a viable course of action for board closure that established continued ethical oversight as well as continued protection for study participants,” noted Corman. “Our thorough re-review process minimized any lapse in ethical approval and gave researchers the confidence to continue to recruit new patients for their studies.”
The transition process set out by IRB Services closely mirrors draft guidance recently announced by the Federal Drug Administration (FDA) and Office for Human Rights Protection (OHRP) in the U.S. entitled: Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution. “The similarity between our approach and the joint guidance put forth by the FDA and OHRP demonstrates its validity,” said Corman.
Last year, IRB Services became the first fully independent, unaffiliated Canadian-based research ethics committee to earn accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The company strongly advocates that ethical review and approval should be kept at an arm’s length from the research organizations and companies who conduct and sponsor research. It is also actively involved in assisting Health Canada to develop standards for Canadian ethics boards and is the only independent review board to be officially recognized by the province of Saskatchewan.
Date: July 2, 2012
Source: Institutional Review Board Services
Filed Under: Drug Discovery