The Development of Guidance for Human Pluripotent Stem Cell Research in Canada

Stem cell research has the potential to provide treatments for a host of debilitating diseases including Alzheimer's, Parkinson's, diabetes, multiple sclerosis, heart disease, and spinal cord injury. Few other areas of science have generated as much excitement, scrutiny and controversy. At the same time, the derivation and use of human pluripotent stem cells raise ethical and social issues and legal concerns of interest to Canadians.

In recognition of this and because of the complex ethical issues that it raises, the President of CIHR convened the Ad Hoc Working Group on Stem Cell Research in the fall of 2000. Its mandate was to advise CIHR as to whether human embryonic stem cell and human embryonic germ cell research should be considered eligible for CIHR funding. While research on human adult stem cells was not included in the Working Group's mandate, recent scientific research has confirmed the possibility of generating human pluripotent stem cells with properties similar to embryonic stem cells from adult cells (e.g., induced pluripotent stem cells). Although the source of induced pluripotent stem cells does not raise unique ethical concerns, there are other ethical issues around related to the experimental use of human pluripotent stem cells whether they are derived from embryos or adults. Indeed the Working Group considered its mandate to cover all human pluripotent cells, whatever their source, and the final guidelines were worded with that consideration in mind.

In January 2002, after a year of discussion and consultation, the group produced a report to CIHR's Governing Council, which was unanimously accepted and formed the basis of human pluripotent stem cell research guidelines that were publicly announced in March 2002. Until then, Canada had no laws to govern human pluripotent stem cell research, nor were there any guidelines for researchers, research ethics boards, or funding agencies on how human pluripotent stem cells may be derived and used. The guidelines provided for the review of human stem cell research applications by a Stem Cell Oversight Committee (SCOC).

In March 2004, an Act Respecting Assisted Human Reproduction and Related Research, became law. The Act applies to the derivation of human pluripotent stem cells from human embryos, but does not apply to research using human embryonic stem cell lines that have already been derived. The Act also prohibits certain activities such as cloning humans or creating chimeras.

In 2014, the guidelines were integrated into the 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2). The Agencies recognize that considerations around the ethical conduct of such research are complex and continually evolving, and welcome comments and discussion, and commit to the continued evolution of TCPS 2.

Contact information

The former CIHR Guidelines for Human Pluripotent Stem Cell Research (2002, 2005, 2006, 2007, and 2010), the Report of the ad hoc working group (2002) and Discussion paper (2001) are available in electronic format on request. Please contact:

Joëlle Gregoire-Gauthier
Analyst, Research Excellence and Ethics

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