Background

Health research is not just one of many factors contributing to societal progress, it is a necessity. It is through research that we are able to gain understanding about disease and to constantly work to improve the health and well-being of individuals and the population as a whole.

Yet, however great the benefits stemming from health research, certain activities cannot be justified, especially those that fail to respect human dignity or meet minimum standards of scientific rigour.

In many countries, as in Québec, this notion has become one of the fundamental principles of "research ethics". Concretely, it has given rise to bodies of standards, rules and legislation defining what is socially and legally acceptable or unacceptable.

Acknowledgement that "ethics" and "scientific integrity" are inextricably linked is a sign of the maturity of research communities and their stakeholders. Indeed, these investigators view the promotion of these two basic values and their application (best practices) as an additional guarantee of the quality of their work and of their reputation.

Canada and Québec - examples...

In recent years, federal and provincial government departments and agencies have published action plans, laws, tools and frameworks to guide research stakeholders.

It is noteworthy that the standards set out in these documents have become a criteria for receiving grants from public sources, i.e. government departments and public granting agencies.

... in Canada

Canada's three granting councils – the Medical Research Council of Canada (MRC), now the Canadian Institutes of Health Research (CIHR); the Natural Sciences and Engineering Research Council (NSERC); and the Social Sciences and Humanities Research Council (SSHRC) – were established to promote, facilitate, support and sustain research projects in their respective fields.

The three councils together have adopted a series of ethical rules (Tri Council Policy Statement, 1998) that provide rigorous guidelines for the support and funding of research involving human subjects.

Since that blueprint document does not address every aspect of research, the CIHR has expanded on those guidelines in the wake of debate over human pluripotent stem cell research.

Draft bill C-13, currently under study in the House of Commons, seeks chiefly to provide a framework for research into assisted reproduction.

... in Québec

Since 1998, these issues have been discussed by the Québec government departments and agencies that provide financial assistance for research, including Québec’s three granting agencies (Fonds de recherche du Québec - Nature et technologies, Fonds de recherche du Québec - Société et culture, and the FRQS). That discussion intensified with the adoption of Quebec’s Policy on Science and Innovation, which redefined the roles of the granting agencies. It was at this time that the FRQS was mandated to establish research standards and oversee the quality of health research conducted in Québec.

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FRQS Mandate and Specific Actions

The FRQS is a pioneer and champion in the field of ethics, integrity and best practices. Indeed, Québec’s minister of health and social services (Ministère de la Santé et des Services sociaux) has entrusted the FRQS with the establishment and enforcement of research standards in Québec (Guide d'éthique et d'intégrité scientifique de la recherche, published in 2001 and revised in 2003).

The FRQS has established a comprehensive quality assurance system complete with standards and monitoring procedures to ensure the highest norms in matters of science, research supervision and research ethics.

In collaboration with the boards of directors of university-affiliated healthcare institutions and their research centres, the FRQS has adopted a regulatory framework of best research practices to govern the conduct of research within those institutions.

Each board of directors is accountable for the ethical nature of the research conducted within its institution. Each board must appoint a research ethics board (REB) whose mandate is to review research protocols and to enforce the regulatory framework and relevant legislation. The FRQS conducts periodic on-site visits to ensure that standards are being respected and that the institution is fulfilling its obligations to conduct reviews and monitor the research projects carried out within its walls.

The FRQS recognizes the capital importance of respecting the dignity of human research subjects. We also encourage transparent, impartial relationships between researchers, research subjects and research administrators (the host institutions and their boards).

The FRQS’s formal position is that respect for ethics and integrity, and the enforcement of those values, is primarily the responsibility of individuals. No set of rules, however perfect, can ever replace the careful thinking and behaviour inspired by honesty and a respect for human dignity. In the same breath, the FRQS wishes to reaffirm its confidence in all Québec health research investigators.

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