CANADIAN PERSPECTIVES

Canada, by landmass the largest country in North America, is the smallest in population, at just over 32 million inhabitants. Despite this relatively small population, Canada has made a number of distinctive contributions to discussions of science, technology, and ethics. Among these is, notably, the Genomics, Ethics, Economics, Environment, Law, and Society (GE³LS, pronounced gels) program, part of Genome Canada, that has supported more than seventy investigators and as many graduate students to investigate issues related to genomics research. As the name indicates, the goal is to promote social context research and education related to new developments in genetics.

General Background

While many would argue that ethical, economic, and social aspects have always been embedded in the management of science in Canada, these have not always been present in a formal sense. In earlier years companies, governments, and scientific researchers often consulted, in an ad hoc fashion, with social scientists and humanists about the impacts of their plans. In the 1970s, however, the demand for formal review arose (e.g., in environmental assessments, which frequently considered socioeconomic impact statements) at the same time as the supply of social scientists expanded and new university research institutes and degree programs related to applied ethics, human rights, environmental economics, risk studies, and science, technology and society (STS) studies were introduced.

The professional and academic efforts to investigate, consider, and implement ethical, economic, environmental, legal, and social studies related to genomics and other life-science research in Canada evolved in tandem with related efforts in the United States. Many of the researchers now leading GE³LS teams previously participated in the Ethical, Legal, and Social Implications (ELSI) program initiated in 1990 by the Human Genome Project (HGP), which was based in the U.S. Department of Energy and the U.S. National Institutes of Health (NIH). The combined ELSI efforts constituted the largest bioethics program in the world and as such has been internationally influential, especially in Canada.

The Canadian efforts became more organized once the demand began to become more formal. Perhaps the first significant requirement for comprehensive social science analysis arose in the context of the evolving environmental legislation in the provinces and at the federal level. This culminated with the passage of the new Canadian Environmental Protection Act (CEPA) in 1992, which required assessment of any environmental effect on health, socioeconomic conditions, physical and cultural heritage, and aboriginal, historical, archaeological, paleontological, and architectural interests.

Shortly thereafter research into the human and various plant, animal, and microbial genomes accelerated. The scientific research efforts surrounding genomics is aimed at decoding all of the genetic information of an organism. This revolutionary research has given rise to a number of social, ethical, legal, and environmental issues.

Specific Initiatives

At about the same time, two independent processes arose to address the need for more social, ethical, legal, economic, and environmental review of Canadian science. One emerged from political discussions, the other from the research community.

In 1983 the federal government adopted its first Canadian Biotechnology Strategy, with an informal group of representatives from industry, consumer groups, and academia providing recommendations to the Canadian Minister of Industry. In 1998 the government concluded that if Canada were to become a leader in biotechnology research, it would need an advisory body with a wider membership base in order to examine and reflect on the changing role of science in society. This led, in 1999, to the establishment of the Canadian Biotechnology Advisory Committee (CBAC) as a part of a renewed Canadian Biotechnology Strategy. The CBAC consists of up to twenty members appointed for three-year terms, and is supported by an executive director with a small staff. Its mandate is to provide comprehensive advice on current policy issues associated with the ethical, legal, social, regulatory, economic, scientific, environmental and health aspects of biotechnology and to provide Canadians with easy-to-understand information and opportunities to voice their views. It is the CBAC that provides both a market for GE³LS studies and a conduit for promoting the results to a broader audience.

In 1998 the nation's three peer-reviewed granting councils—the Social Sciences and Humanities Research Council, the Natural Sciences and Engineering Research Council, and the Canadian Institute of Health Research—released a tri-council policy statement titled "Ethical Conduct for Research Involving Humans." This statement laid out a series of policies related to confidentiality, consent, balance between benefits and harms, and respect for human dignity and the vulnerable. Universities, public labs, and industry responded by developing internal processes to conform to these ethical standards for both new and ongoing research.

In 2001 the three councils created an Interagency Advisory Panel on Research Ethics to support the development and evolution of collaborative ethics research following the 1998 statement. The advisory panel, composed of twelve volunteer members whose backgrounds span several disciplines including the social sciences, natural sciences, law, and commerce, meets regularly to examine and recommend policies related to council practices for life-science research. Once the direction was set, most national research efforts conformed and adopted ethical and socioeconomic reviews as a formal part of their structure.

The Canadian Networks of Centers of Excellence (NCE) program, started in 1990 by Industry Canada and the three granting councils to fund long-term discovery research networks involving industry, academia, and government, initially had little or no role for socioethical review. Once the tri-council guidelines related to research ethics involving humans were developed, however, the NCE program incorporated them into their projects and, in the competition round completed in 2002, formally included a GE³LS research component and incorporated dedicated funding for GE³LS programs. For example, the Advanced Food and Materials Network that began in 2002 spends C$22.2 million and involves eighty-eight investigators; C$3.5 million of the budget goes to GE³LS studies, which fund eighteen investigators.

The single largest public investment in GE³LS has been through Genome Canada. In the first two rounds of competition (in 2001 and 2003), Genome Canada funded five GE³LS projects (one each in British Columbia, the Prairies, and Quebec and two in Ontario) and supported one GE³LS investigation in a science project (related to potatoes). Those six projects had a total budget of more than C$16 million (equal to about 8% of the total investment of more than C$600 million by Genome Canada) and involved more than seventy investigators and at least as many graduate students. In 2005 the third competition for projects was underway and Genome Canada solicited dedicated GE³LS projects and instructed all science projects to incorporate GE³LS components. A brief review of a number of science projects suggests project proponents intend to invest on average 1 to 3 percent of their total requested funds in GE³LS activities.

PETER W. B. PHILLIPS

BIBLIOGRAPHY

INTERNET RESOURCES

Canadian Biotechnology Advisory Committee (CBAC). Available from http://cbac-cccb.ca/epic/internet/incbaccccb.nsf/en/Home. The home page of the CBAC.

Interagency Advisory Panel on Research Ethics. Available from http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm. This site contains the tri-council policy statement, "Ethical Conduct for Research Involving Humans," first issued in 1998 and revised in 2000 and 2002.