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CMAJ News Clinical trials: the balance between protecting participants and promoting drug and product development T hey have been called bureau- cratic, cumbersome, a liability to the drug and research indus- tries, and even harmful to patients. In fact, so maligned have research ethics boards been in Canada that they have spurred demands for the introduction of national accreditation centralized re- view for clinical drug trials involving multiple sites. The purpose is straightforward — to protect human research subjects (as de- fined by granting council guidelines). Research ethics boards are groups of volunteers — doctors, lawyers, scientists, community mem- bers — that review clini- cal trial protocols to deter- mine whether the risks of Photos.com a study are “reasonable” and whether there’s “undue” pressure on individuals to participate. Research ethics boards exist to protect patients in clinical trials, but some researchers Because of the growth of clinical trials claim they actually harm more patients than they help by delaying novel projects that in Canada, research ethics boards seem to could lead to life-saving discoveries. be proliferating across the nation. Busy teaching hospitals have created multiple boards to streamline and professionalize deride research ethics boards for their Another time she abandoned a trial af- the process, as well as teams of research lack of scientific expertise and com- ter waiting nearly 2 years for approval staff to support their work. Smaller hos- plain of waiting up to 2 years to win from several hospitals, while watch- pitals, however, typically cannot afford approvals for multisite clinical trials. ing from afar as a European group such efficiencies. Meanwhile, the pharmaceutical indus- nearly completed its study. “That was Of late, though, research ethics try takes trials to other countries, in part just so painful.” boards have increasingly come under to avoid delays in ethics review. To cut through the red tape, a fire for delaying the process by which Health Canada-sponsored group, the new drugs are tested for human use. Review delays Experts Committee for Human Re- Critics even say the system of boards There’s little question that delays have search Participant Protection in and committees that now protects indi- become altogether common. Canada, recently asked the federal viduals who volunteer for scientific re- Dr. Laurie Morrison, a University government to create a new council to search actually harms more patients of Toronto, Ontario, professor who accredit research ethics boards that than it helps — by delaying novel proj- runs resuscitation trials funded by the meet a set standard of performance. ects that could lead to life-saving dis- US National Institutes of Health and Alberta, Quebec and Newfoundland coveries, and by clogging the system the Canadian Institutes of Health Re- and Labrador have gone further, man- by approving studies that have already search (CIHR), has become accus- dating centralized ethics reviews for all been done. tomed to waiting more than 18 months human research. A recent draft of a re- As Sir Iain Chalmers, a United for sign-off from research ethics vised version of the Tri-Council Policy Kingdom clinical trials expert, wrote in boards at the 40 or more hospitals in- Statement: Ethical Conduct for Re- 2007, research ethics boards contribute volved in her trials. search Involving Humans includes a to “the avoidable suffering and deaths “One of my studies never got off new section recognizing the role of of millions.” the ground because a European coun- specialized or multi-institutional boards Frustrated Canadian scientists often try could move faster,” Morrison says. for collaborative research. CMAJ • MARCH 17, 2009 • 180(6) 603 © 2009 Canadian Medical Association or its licensors News But researchers in most provinces Koski recommends that clinicians section of the survey that asked for still must approach each hospital sepa- who do research receive extra training, comments, the scientists wrote of “con- rately for approval of a multisite proj- which would eventually lead to better flicting recommendations from differ- ect, respond separately to each research research ethics applications. But he ac- ent REBs at different hospitals” and ethics board’s questions, and provide knowledges that ethics boards also need “nit-picky details for consent forms that each with ongoing reports about to become
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