Guidelines for Human Pluripotent Stem Cell Research: Policy Highlights
Scope of application of the Guidelines
New or ongoing human stem cell research that is:
- funded by the Agencies (CIHR, NSERC, SSHRC); or
- conducted under the auspices of an institution that receives any Agency funding, whether on site or off site; or
- conducted elsewhere with any source of funding, by faculty, staff or students from an institution that receives Agency funding,
must conform to the Updated Guidelines for Human Pluripotent Stem Cell Research, which supersede the Guidelines of March 4, 2002. As well, all such research must be in conformity with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS).
Note that, according to the TCPS "An institution is responsible for the ethical conduct of research undertaken by its faculty, staff or students regardless of the location where the research is conducted. Thus, review of research by that institution's REB is required in addition to review by any agency having jurisdiction over the site of research."
Review and approval of applications by the Stem Cell Oversight Committee (SCOC), the local REB and, where appropriate, the Animal Care Committee (ACC) may be required (see Frequently Asked Questions).
Types of stem cell research that require SCOC review
SCOC approval is required for:
- all research to derive or study human pluripotent stem cell lines from human embryos;
- all research to derive or study human pluripotent stem cell lines from human fetal tissue or amniotic fluid;
- all research on anonymized human pluripotent stem cell lines derived from human embryos, fetal tissue, or amniotic fluid created in Canada or created elsewhere and imported for research purposes;
- all research involving the grafting of human pluripotent stem cell lines derived from human embryos into non-human animals from birth to adulthood;
- all research involving the grafting of human induced pluripotent stem cell lines into non-human animals from birth to adulthood for purposes other than testing teratoma formation;
- vi. all research involving the grafting of human pluripotent stem cell lines into humans;
- all research using imported cell lines differentiated from human pluripotent stem cells derived from human embryos, fetal tissue, or amniotic fluid. If the progenitor lines are not among those that have been approved by SCOC, then SCOC will review the derivation of the progenitor cell line for conformity to the Guidelines; and
- all research involving the grafting of cells differentiated from human pluripotent stem cells, into both humans and non-human animals, from both domestic and imported sources.
Types of stem cell research that require the submission of notification to SCOC
- research to graft human induced pluripotent stem cells into non-human animals solely to test teratoma formation, provided that the investigators notify SCOC in writing that the animals will not be used for reproductive purposes.
Types of stem cell research that do not require SCOC review or notification
- all research to derive and study human stem cell lines from the umbilical cord and placenta;
- all research to derive and study human stem cell lines that are not likely to be pluripotent from human somatic tissues;
- all research to derive human pluripotent stem cell lines from human somatic tissues;
- all research on anonymized human stem cell lines from non-embryonic and non-fetal sources created in Canada or created elsewhere and imported for research purposes and not involving grafting;
- research using products (e.g. RNA), not including cells, derived from human pluripotent stem cells;
- research using only histologically fixed human pluripotent stem cells; and
- grafting of non-pluripotent human stem cells, not including non-pluripotent human cells derived from pluripotent cells, into animals after birth.
Note that REB and ACC approval may be required.
At any time the local REB or ACC may refer a human stem cell research proposal to SCOC for review if it considers the research to be within SCOC's purview.
Human embryonic stem cell lines that have been approved by SCOC
The following human embryonic stem cell lines have been reviewed by SCOC, found to conform to the Guidelines, and approved by CIHR's Governing Council. Note that research projects that use these cell lines still need to be reviewed and approved by SCOC before the work can commence.
|hES1, hES2, hES3, hES4, hES5, hES6||ES Cell International|
|I3, I6||Technion-Israel Institute of Technology|
|HSF-6||University of California, San Francisco|
|CA1, CA2||Dr. Andras Nagy, Mt. Sinai Hospital, Toronto|
|HUES 1-28||Dr. Douglas Melton, Harvard University|
|CC1, CC3||Dr. Derrick Rancourt, University of Calgary|
|ES2, ES3, ES4, ES5, ES6||Centre for Regenerative Medicine of Barcelona|
|CyT49||CyThera, Inc., San Diego, California|
|KCL-003-CF1||King's College, London, UK|
Duration of SCOC approval
Provided there are no substantive changes in the research plan described in the application to SCOC, approval will be effective for the duration of funding of the research project, as originally specified when submitted to SCOC.
Process SCOC will follow to review contracts relevant to human pluripotent stem cell research that are submitted for review
The Guidelines state in Section 8.4.2 that "Copies of contracts between researchers, institutions and industry sponsors and any relevant budgetary information must be provided to the Stem Cell Oversight Committee and the local REB, to examine and evaluate any potential or actual conflict of interest and to ensure the right to publish freely after a modest interval."
SCOC will identify any concerns it may have with a contract, communicate these to the researcher and to the VP Research at the relevant institution, and request assurance that these issues have been resolved to the satisfaction of the VP Research.
If you are uncertain about whether or not your research should be reviewed by SCOC, please contact:
Ethics Policy Advisor – Stem Cells
Canadian Institutes of Health Research