Canada's Regulatory Oversight of Stem Cell Research

Stem cell research in Canada is governed by the Tri-Council Statement: Ethical Conduct for Research Involving Humans (TCPS), the Assisted Human Reproduction Act (2004, c.2; AHRA) and the Canadian Institutes of Health Research (CIHR) Updated Guidelines for Human Pluripotent Stem Cell Research. These documents enshrine the principles of free and informed consent, human dignity, the health and welfare of women and children, non-commercialization of gametes and embryos, respect for privacy and confidentiality and a respect for embryos that requires limits on their use and creation.

The TCPS contains specific guidance with respect to research involving human embryos. It states that it is not ethically acceptable to create human embryos specifically for research purposes; however, surplus in vitro fertilization (IVF )embryos may be used subject to certain conditions. The AHRA established a national licensing scheme and agency to govern the use, storage and procurement of human gametes and embryos. In addition, the AHRA outlines several practices that are prohibited and subject to criminal sanctions, such as reproductive and research cloning. The CIHR Guidelines established a national stem cell protocol review board, the Stem Cell Oversight Committee (SCOC). The CIHR Guidelines apply to both the derivation of pluripotent stem cells from human embryos and other tissues and to research using human embryonic stem cell (hES) lines that have already been derived. They also cover all pluripotent stem cells regardless of their source. Any product to be used in a clinical trial must be authorized by Health Canada under Division 5 of the Food and Drug Regulations to Canada’s Food and Drugs Act. Stem cells therapies qualify as biologics – drug products derived from biological sources and, as such, are included under the Food and Drug Act.

International Regulation

Around the world countries and international groups have responded to the isolation of hES in a myriad of ways. Despite significant policy and regulatory differences, there are some issues of consensus and contention for all countries trying to create stem cell policy. Issues of relative consensus include the need for informed consent to stem cell research and conflicts of interest management. Issues of contention include the use of embryos created specifically for research, the creation of embryos using a cloning technology called somatic cell nuclear transfer, compensation for and commercialization of gametes and embryos, and the creation of human and non-human animal chimeras. The International Society for Stem Cell Research has addressed some of these issues in its Guidelines for the Conduct of Human Embryonic Stem Cell Research. The international regulations form a patchwork that continues to evolve as the science advances.

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Citation format: Knowles, Lori P. “Canada’s Regulatory Oversight of Stem Cell Research” Stem Cell Network, For the Public, Ethics and Policy, Spring 2010. http://www.stemcellnetwork.ca/uploads/File/whitepapers/Canada-Regulatory-Oversight-of-Stem-Cell-Research.pdf