Released December 3rd of last year, the latest guidelines for ethical research involving humans are now being submitted to the Canadian research community for review and consultation. These stipulations apply to any institute or researcher eligible to receive funding from the community and whose research involves humans.
The updated version of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) was drafted by the federal Interagency Panel on Research Ethics on behalf of Canada’s three federal funding agencies: the Social Sciences and Humanities Research Council of Canada, the Natural Sciences and Engineering Research Council, and the Canadian Institutes of Health Research.
First published in 1998 and updated in 2000, 2002, and 2005, the TCPS has had a major overhaul to reflect the changing needs of researchers and 10 years of scientific advance.
Research ethics is a relatively new field, tracing its origins to the Nuremberg Code and the 1947 Declaration of Helsinki. While it has evolved significantly over the last few decades, there is still a long way to go. Fundamental questions, like “does the TCPS improve the ethics of research?” remain unanswered, says panel member Dr. Jim Lavery, an assistant professor at U of T’s Dalla Lana School of Public Health Sciences. “It is extremely difficult to study its impact precisely. However, the guidelines provide a crucial common starting place.”
The process has not been without its challenges. “It’s been arduous,” says Lavery. The professor adds that it has been “an astonishing policy journey.”
What makes the TCPS so unique, he says, is that it’s “a living document.” The official web-based version now allows for ongoing communication between the panel, the research community, and the public. “If a person wishes clarification on a certain issue, they can submit a query and the panel will return with an official interpretation,” Lavery explains.
This characteristic distinguishes it from the U.S. research ethics model, based on a set of regulations called the Common Rule. The U.S. regulations are essentially law, making changes “very legalistic and complex, and the result is that it is very poorly responsive or non-responsive to rapid changes in the science,” says Lavery.
The TCPS and the ethics review process have not been without their share of critics. At a recent U of T consultation session, a social science researcher complained that emphasis on consent forms in the 1998 version undermined the sense of trust between researcher and subject. Researchers, particularly in the social sciences and humanities, have noted that the ethics review process can be cumbersome, unhelpful, and at its worst, an obstacle to their work.
According to Lavery, face-to-face consultation with the people involved in, and affected by, research is fundamental. “This [consultation tour] is where we’ll hear whether we’ve gotten close to something that resonates with the communities that we’re trying to respond to,” he says.
Major changes to the TCPS include condensing the eight original guiding principles into three, and a more comprehensive section on research involving Aboriginal communities.
Lavery emphasized that this document is not a how-to manual, but is designed to guide Research Ethics Boards (REBs) as they make difficult decisions. Ideally ethical decision-making should to be a part of everyday scientific practice.
Lavery notes that accessibility and communication are the cornerstones of the document’s success. Making it available online and written in an understandable fashion will “set the tone about what [publicly funded] ethical commitments are about.”
The TCPS consultation period ends March 31, 2009. The panel will then incorporate feedback from the consultations into a final draft, presented to the agencies by the end of June 2009. It is expected that the agencies will approve the new version by November 2009.
For more information about the second draft of the TCPS document, and its contents and history, visit www.pre.ethics.gc.ca
