Ethics Context

: : Origins
: : Development of Canadian Guidelines
: : Continuing Vigilance

The modern history of research ethics began in the aftermath of World War II. In 1947, the Nuremberg Military Tribunals condemned the experiments performed by Nazi researchers on prison camp inmates during World War II as "crimes against humanity." A section of the judges' verdict became known as the Nuremberg Code. The Nuremberg Code brought the issue of human experimentation to the forefront of public debate and influenced a series of international documents created to ensure that all countries respect adequate standards of human dignity. These documents include the Universal Declaration of Human Rights (1948), the Declaration of Helsinki (first adopted by the World Medical Association in 1964, and regularly amended), the International Covenant on Civil and Political Rights (1966), and the Belmont Report (1979).

Despite the Nuremberg Code and other human rights protections in place at the time, some research undertaken after World War II, such as the Tuskegee Syphilis Study and the Willowbrook Studies, raised ethical concerns. Controversial research put at risk the trust relationships between research subjects and researchers, research sponsors, institutions, their professional bodies, and society. As a consequence, research ethics guidelines, codes and regulations were further developed in many countries, including Canada.

In the 1970s, the Medical Research Council of Canada (MRC) (Canadian Institutes of Health Research [CIHR] as of 2000) and the Canada Council developed guidelines for research involving human subjects. In 1978, when the Social Sciences and Humanities Research Council was created, they adopted the Canada Council Guidelines. In 1987, the MRC revised its guidelines and, in 1990, produced Guidelines on Somatic Cell Gene Therapy. The Canadian guidelines were influenced by international codes of ethics, as well as professional association codes of ethics. Canada began the practice of formulating official research ethics policies as funding agency guidelines. Given that the Natural Sciences and Engineering Research Council (NSERC) did not have its own guidelines, research involving humans funded by NSERC was subject to either SSHRC or MRC guidelines (whichever was most appropriate). In 1998, MRC, SSHRC and NSERC jointly published the TCPS as a single Canadian standard to replace their previous guidelines. The agencies have committed to keeping it a living or "evolving" document in order to respond to new developments and identified gaps.

Unfortunately, ethical controversies in research involving humans have not ceased. Most unethical behaviour results from a lack of awareness of ethical concerns and/or various pressures on researchers, Research Ethics Boards (REBs), and institutions. The insights gained from historical and more recent ethical controversies demonstrate why vigilant ethics review is necessary and appropriate. Research ethics policy must continue to evolve to protect research subjects and maintain trust between researchers and society as a whole.

Protection of research subjects is a central concern for Canada. Key to an effective ethics review system are mechanisms for education and training for all people involved in research. Education in research ethics engenders public trust in institutions, researchers and the research process. Education also promotes a culture of research ethics.

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