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Guiding ethical research
When Canada's top research agencies went looking for experts to guide them in how they ought to approach studies involving human subjects, they called in Pierre Deschamps.
A quick look at his resumé and you would be hard-pressed to find fault with the agencies for selecting Deschamps as a member of the new Panel on Research Ethics (PRE). The body will be supplying the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council with its views on how to promote and safeguard high ethical standards in research involving human subjects.
PHOTO: Claudio Calligaris
A lecturer in the Faculty of Law, Deschamps is also the associate director of research (law and health) for the faculty's Research Centre in Private and Comparative Law.
Deschamps is a member of the Canadian Human Rights Tribunal and serves on the research ethics boards at McGill's Faculty of Medicine and at the Institut de Cardiologie de Montréal.
Factor in his experience as the principal author of the Report on Control Mechanisms in Clinical Research in Quebec, widely known as the Deschamps Report, and Deschamps seems like a perfect choice for the PRE position.
A total of 11 people from an assortment of backgrounds have joined the PRE to build on research codes previously developed by Canada's Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans. Formed by NSERC, SSHRC and CIHR in 1998, the Tri-Council Statement was written to protect human rights and develop wide-ranging standards with which research institutions must comply to obtain grants.
Now the PRE's mandate is twofold, says Deschamps. "We need to develop concrete guidelines that can be applied on the front lines, while providing a governance framework once they're in place."
The mission will be massive. Already, scientists are bound by a bevy of research rules other than the Tri-Council's: the Helsinki Declaration, Health Canada regulations, Quebec government regulations and laws, not to mention institutional policies. "In setting up our guidelines, we don't want to interfere in the progress of research," says Deschamps.
The PRE also needs to set guidelines that mesh with similar research frameworks in the U.S. McGill, for example, "would need to adhere to American norms because it has built a reputation of being an international university."
Then the PRE must create rules that can be applied by smaller institutions, since a scattering of regional hospitals are increasingly becoming players in medical research. Unlike larger research centres, smaller institutions don't have investigation histories to draw upon, says Deschamps.
"That's why, despite the Tri-Council and other policies, we need to develop a new framework that can work on the local front lines," he says.
Another recent development the PRE is examining, says Deschamps, is the growing number of researchers who could benefit financially from their research should it result in commercially viable products or approaches.
"Researchers are becoming incredibly entrepreneurial," he says, referring to spin-off companies that many scientists have launched after making discoveries. "These have the potential of causing major conflicts of interest."
To avoid ethical missteps, he stresses, researchers must be provided with clear-cut regulations: "We need to design rules that are ready-to-wear, so to speak, to ensure researchers conform."
The PRE's main challenge will be to inform all Canadian scientists of its recommendations once they are ready in about two years. Deschamps hopes that these guidelines will be adopted swiftly, but "without paralyzing research initiatives."
Ideally, the PRE will establish a body of experts that will periodically visit research institutions to ensure regulations are applied across the chain of command, from scientists to administrators.
Deschamps is confident that the federal government will give the PRE all the support it needs to do its work effectively. He points to recent research scandals, including the death of a subject in a Johns Hopkins University asthma research trial and a couple of high-profile cases at the University of Toronto where pharmaceutical firms were alleged to have had too much influence, as proof that further research governance is needed.
These situations have made authorities nervous about the ethics and legal aspects of research. "We're in big trouble if we haven't learned from those experiences," he says.