On June 30, the Canadian Institutes of Health Research (CIHR) released updated Guidelines for Human Pluripotent Stem Cell Research. The Guidelines apply to all research involving human pluripotent stem cells conducted with funding from, or under the auspices of institutions receiving funding from the three federal granting agencies, known as the Tri-Council: CIHR, Natural Sciences and Engineering Research Council (NSERC) and Social Sciences and Humanities Research Council (SSHRC). First created in 2002 and last updated in 2007, the Guidelines complement the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans and provide the basis for ethical oversight of all Tri-Council supported human pluripotent stem cell research. The Guidelines also guide the deliberations and activities of the Stem Cell Oversight Committee (SCOC), the national research ethics review committee that provides ethical oversight of all human stem cell research protocols to be conducted with or under the auspices of institutions receiving Tri-Council funds. The Guidelines apply to both to derivation of new stem cell lines and use of existing ones.
The updates consist mainly of editorial revisions aimed at clarifying the content of the Guidelines. The only substantive revisions address the treatment of induced pluripotent stem (iPS) cells, which were already covered but not specifically mentioned in the Guidelines. In general, the Guidelines were designed to cover all human pluripotent stem cells regardless of the derivation source. The revisions relating to iPS cells include the following:
- iPS cell lines are exempt from the requirement for mandatory listing in the publicly accessible National Registry of Human Embryonic Stem Cell Lines, as they are not derived from embryonic sources.
- With the exception of research aimed at combining iPS cells with a human or non-human embryo, or engrafting the same into a human or non-human fetus, all iPS cell research can be undertaken with Tri-Council support, provided that the research is SCOC-approved and conforms to the Guidelines. The former kinds of research cannot be undertaken with Tri-Council funds or in institutions receiving Tri-Council funds.
The notes accompanying the update announcement state that human iPS cell research involving in vivo grafting experiments to test teratoma formation are exempt from SCOC review, provided that the investigators notify SCOC in writing that the animals will not be used for reproductive purposes.
Lastly, a significant editorial revision is the deletion of the word “great” from the following statement contained in the Foreward to the Guidelines: “Stem cell research holds great potential to treat human disease and prevent suffering.” This is a welcome revision that responds to calls from bioethicists and biotechnology law experts for responsible promotion of stem cell research. A lot has been written about biotechnology hype, and it is refreshing to see some acknowledgment of that literature in policymaking.
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