By Margaret Munro CanWest News Service
Canadian doctors in every province except Alberta are buying ethics approval for clinical trials from private, for-profit ethics boards. The private boards, which charge $1,500 to $5,000 for every trial reviewed, approve thousands of drug trials run out of medical offices and clinics across Canada each year.
Alberta banned the practice years ago. And many observers say other provinces should follow Alberta’s lead and take over ethics reviews to ensure patients are fully aware of the risks involved in joining trials and not coerced into testing new drugs and treatments as part of Canada’s $1-billion clinical trial industry.
Private boards often advertise quick turnaround and approval in under two weeks. Some are said to do a good job, but insiders say others are little more than rubber-stamping operations that approve dozens of trials at once. “There are bad actors,” says Jack Corman, president of IRB Services, a company that operates private ethics boards in Toronto, Vancouver and Montreal. Corman adds, however, “the bad actors” – the less diligent review boards – “are not confined to the private sector.” He says there are also problems with academic boards approving trials at Canada’s universities. Canada’s ethics review system is “clearly inadequate” and “remarkably under-regulated,” says professor Trudo Lemmens, a lawyer specializing in bioethics at the University of Toronto. “I could set up shop tomorrow and start a research ethics board.”
Health Canada requires that clinical trials be approved by a research ethics board to protect the “rights, safety and well-being” of research subjects. The department says an ethics review board must have at least five members, and include two people with experience in science and two more knowledgeable in ethics and law.
There are no clear regulations spelling out what an ethics review must comprise, resulting in a system varying widely across Canada. At one extreme is the ethics board run by the Alberta College of Physicians and Surgeons, which has the toughest requirements in the country. Alberta physicians not covered by an ethics review board at one of the province’s universities or cancer research centres must pay $4,300 for a college review. The doctors must also provide a budget spelling out how and when they will be paid to care for patients in the trial, a protocol of what is involved, consent forms and recruiting posters, and their contract with the trial sponsor.
“There is little doubt that we’ve raised the bar in ethics approval for community- based research,” says Dr. Paul Flynne, assistant registrar of the college.
Flynne says the college’s ethics board recently turned down an industry- sponsored trial because of a lack of scientific and ethical merit. The trial, is however, going ahead at more than 100 other sites in North America including several in Canada, says Flynne, who believes a private ethics board may have approved the other trial sites at once.
The college set up the ethics board in 1998, he says. There was concern the private ethics operations – some located in the U.S., while others were established by enterprising Canadian doctors – were not rigorously reviewing the ethical and financial aspects of trials.
Medical colleges in other provinces were not keen to take on the time- consuming task of ethics review. Most, however, have guidelines stating clinical trails must be approved by an “appropriate” ethics committee. Doctors and the research companies were left to shop around for approvals, which has fed the growing ethics industry.
“I hear of new boards all the time,” says Dimitris Polygenis, an executive with Phase 4 Health Inc., a Toronto-based research company that runs trials across Canada. He is also vice-chair of a private ethics board. Polygenis says the quality of the reviews varies widely.
Some boards look at budgets to see how much doctors are paid to run trials, others do not. Some question stringent publication restrictions placed on doctors by companies sponsoring trials, while other boards don’t even look at them. Some question the scientific validity of studies, while others approve “seeding” trials which are primarily aimed at increasing sales of new medications. Still others have approved trials that allow research companies to go through people’s confidential medical records.
“It’s kind of a crap shoot,” says Dr. Muhammad Mamdani, who sits with Polygenis on the ethics review board operated by Ethica Clinical Research Inc. in Toronto. “If one ethics board won’t approve your trial, you can probably find a weaker board that will.”
There are also problems with academic ethics boards that review and approve the thousands of clinical trials run through Canadian universities and their affiliated hospitals. These boards – composed of professors and volunteers from the community – were described as “overburdened” and “stretched to the breaking point” in a 2000 Law Commission of Canada report on clinical trials.
Ethicists say many problems with the academic boards persist and have been compounded by pressure to fall in line with private boards and approve trials within two weeks – a time frame Flynne considers unreasonable. The ethics board at the Alberta college, which typically takes 80 days to approve a trial, often questions the design of trials, the budget, use of placebos and the consent forms. “In our experience the time taken to address those issues is longer than two weeks,” says Flynne.
Flynne questions the independence of academic boards. “I think universities are potentially in a huge conflict of interest,” says Flynne, noting how universities pull in hundreds of millions of research dollars a year from drug companies.
Corman, at IRB, is calling for federal standards and regulations that all ethics review boards – private, provincial and academic – would have to abide by to protect the estimated 1.8 million Canadians who volunteer for drug trials each year.
Several leading ethicists, including Lemmens, Timothy Caulfield, a lawyer at the University of Alberta, Michael McDonald, an ethicist at the University of B.C., and Dr. Douglas Kinsella, retired assistant dean of medical bioethics at the University of Calgary, say provincial medical colleges, which regulate the practice of medicine, have a legal responsibility to take on the job and should create a national system of college-based research ethics boards similar to the one in Alberta. Lemmens adds that the college reviews must be coupled with “meaningful national oversight and specific legal sanctions.”
Mamdani says he would welcome a national system of ethics review. “If the process could be standardized and taken over by an unbiased group that would be fantastic,” he says.
“The important thing is that any and all research ethics boards be held to a standard which needs to be set nationally,” says Flynne. “Our current system is very Balkanized, fragmented, with no consistent standard.”