Canada's granting councils have issued an updated draft of ethics guidelines governing human research, including expanded sections about aboriginal and qualitative research, as well as bolstered chapters concerning genetic and human-tissue research and clinical trials.
While some researchers are praising the changes as a good response to community concerns and evolving ethical principles, others caution that they do not adequately address emerging governance problems as health research moves from research-based institutions into community settings.
“What is not covered is as important as what is covered — in particular, research conducted in the private sector or in private physicians' offices,” says Michael McDonald, who holds the Maurice Young Chair of Applied Ethics at the University of British Columbia.
Adherence to the Draft 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans is required of all researchers who receive funding from the Canadian Institutes of Health Research, the National Sciences and Engineering Research Council, and the Social Sciences and Humanities Research Council. In addition, Association of Universities and Colleges of Canada member institutions are bound by the standards under a memorandum of understanding signed with the 3 granting councils. Nongovernmental organizations and federal departments also comply, Derek Jones, an ex-official member of the Interagency Advisory Panel on Research Ethics, which drafted the guidelines, told a December 2008 news conference.
But the Tri-Council policy does not govern private-sector research. Nor does it govern work overseen by private research ethics boards or trials organized by contract research firms.
“The mandate of the committee was to revise the Tri-Council Policy Statement, but there are many outstanding research ethics issues, such as governance, monitoring and oversight,” Tim Caulfield, advisory panel member and research director of the Health Law Institute at the University of Alberta, told CMAJ in an email.
The statement, which updates the Tri-Council's 1998 policy, will not be finalized until scheduled community consultations are completed in March. It broadly articulates ethical principles, while hoping to address societal and technological trends. For example, it warns that genetic research, however important to preventing and treating disease, has the potential “to exploit or stigmatize individuals or groups, who may experience discrimination or other harms because of their genetic status.” Such work may uncover delicate “non-paternity” issues or may lead to obligations on individuals to disclose disease predisposition risks to their employers or insurers.
McDonald praises the policy's “new and useful” sections about conflict of interest, which stress the possibility of institutional conflicts, in addition to those individual researchers might have.
But he raises questions about where contract research organizations fall, particularly those hired by the pharmaceutical industry to recruit patients and run trials. “Are they regulated directly under Health Canada rules, or indirectly because they have contracts with pharmaceutical companies? It's an area that is murky.”
The new statement incorporates many attitudes that were considered radical 10 years ago, says McDonald, who wrote an influential Law Commission of Canada report on the need for stronger protections for human research subjects in 2000. “There's more recognition that research participants aren't just individuals, they are part of families and communities. What's interesting is to see the evolution of thinking around these things.”
University of Toronto Professor of Public Health Lorraine Ferris says the guidelines provide much-needed clarification, while being responsive to community concerns.
But Ferris and McDonald raise concerns that the document does not fully address institutional potential conflicts of interest. In the past, clinical trials involving drugs and medical devices usually took place in academic settings, even if a pharmaceutical company was the external sponsor of the trial. The research was then governed by the institution's Research Ethics Board.
Today, the institutions themselves sponsor clinical trials, and that could put them in a potential conflict, say Ferris and McDonald. “There needs to be more clarity around how the institution applies the rules,” Ferris says.
In addition, McDonald believes Research Ethics Boards at institutions should not report to the vice-president of research, because that job involves promoting and attracting research — and research dollars — to the institution. If a board discovers an ethical problem with research, that finding puts the vice-president into the tense situation of wondering how action regarding the problem will affect his or her ability to attract dollars.
Boards should report to another administrator, McDonald says. “There is a real conflict of roles here.”
Susan Zimmerman, executive director of the Secretariat on Research Ethics, which provides administrative support to the advisory panel, says feedback on the proposed changes has thus far been positive. “Obviously whatever the policy statement says, it is just about the conduct of research itself. How we in this country govern research is a separate issue. We have been involved in that dialogue but that is separate from the policy statement itself.” — Laura Eggertson, CMAJ
Figure. Research involving Aboriginal peoples should not be undertaken without community participation, according to revisions in granting council policy on research involving human subjects. Image by: Reuters/David Ljunggren