Report slams UBC ethics

The University of British Columbia (UBC) had "indefensible" deficiencies with reviews of 523 research projects approved before mid 2001 by an "overwhelmed" and underfunded ethics panel that resulted in the university "more or less" allowing investigators "to do their own ethics review," according to a review made partially available last week. Such problems with oversight, two ethics experts said, are likely widespread right across the country.The UBC report, which has not yet been made public, was ordered later that year by its vice president of research, Indira Samarasekera. Portions of the report were released after media demands under the province's Freedom of Information Act and after requests from the province's information and privacy commissioner about why the university was withholding the information in the first place.The problems at UBC—recently ranked third among Canadian universities in sponsored research income by Research Infosource—arose when it was learned the university had been approving projects using only summaries of project protocols rather than full details. It had also failed to adequately inform some patients in clinical trials of potential risks. In all, 523 research projects were under scrutiny. One multicenter trial funded by the US National Institutes of Health resulted in a critical 11-page letter from the Office for Human Research Protections in the US Department of Health and Social Services.When she ordered the review of the university's Clinical Research Ethics Board (CREB), Samarasekera told the Canadian University Press in March it was due to concerns over inadequate administration and not a reaction to concerns about patient safety.There was criticism over the fact that UBC did not notify Health Canada about the problem until March of 2002, "until we received the official report," Samarasekera said. This delay prompted a threat from Health Canada in May 2002 that it would freeze funds for some projects unless the university remedied the situation. The Canadian Institutes of Health Research and the National Sciences and Engineering Research Council of Canada also expressed concerned to UBC over 44 projects they were funding.UBC spokesman Scott Macrae told The Scientist that UBC had declined to release portions of the report because it was concerned over "harm to the financial interests of itself and other public bodies and undue invasion of personal privacy." He did say that the report said that "even with the best intentioned applicant, the opportunities this process presents for investigator bias, conflict of interest, and the overlooking of some central elements and dangers are evident."As to the central criticism of the review—that UBC had fallen out of compliance with granting agency requirements— Macrae said, "UBC immediately began requiring that the full report of risks be given to the CREB, and the university re-reviewed all the trials. All were re-certified, and none needed to be shut down," although some consent forms were amended. Macrae said that the ethics board had since hired three new employees, as there was just one previously. An associate director of ethics was appointed, he said, and "a variety of ethics educational programs targeted at the research community were put in place as well as a new Research Ethics Policy and procedures, and a new electronic system for handing research ethics reviews."In 2003, the National Council on Ethics in Human Research reported that UBC's CREB was "clearly effective in its reviews in the protection of human research participants." But Jocelyn Downie, the director of the Health Law Institute, said problems with ethics reviews are widespread. Downie had told a local reporter in February that "the system is broken." "There is no comprehensive set of standards that applies to all health research conducted in Canada." The standards that are in place, Downie told The Scientist, "may best be described as a 'patchwork quilt with holes.'" "There is some evidence," said Downie, the Canada Research Chair in Health Law and Policy at Dalhousie University in Halifax, "that non-compliance is not being discovered—who is looking for it, after all?—and, even when it is discovered, is not being dealt with adequately. The system has [as well] inherent conflicts of interest that I no longer believe can be managed."UBC ethics professor Michael McDonald, who wrote in the first comprehensive and in-depth study of Canadian governance for health research involving human subjects in the late 1990s that "serious reform is clearly in order," declined comment on the specifics of the controversy surrounding the UBC ethics review "for reasons of confidentiality." However, he told The Scientist, "What we lack in Canada is an evidence-based, demonstrably effective, and transparently accountable system of oversight for human research protection." "The bottom line is that no one knows how generalizable the situation is at Canadian institutions that have been in the news in regard to research ethics issues or whether there are major unreported issues," McDonald said. "It surely would be in the best collective interests of all parties—Canadian researchers, research institutions, research sponsors, and most of all research subjects—to remedy this situation."

Report slams UBC ethics

Canadian university says review problems are fixed, but others say problems are national

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