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Guidelines for Human Pluripotent Stem Cell Research: Policy Details

Scope of application of the Guidelines

New or ongoing human stem cell research that is:

  1. funded by the Agencies; or
  2. conducted under the auspices of an institution that receives any Agency funding, whether on site or off site; or
  3. conducted elsewhere with any source of funding, by faculty, staff or students from an institution that receives Agency funding,

must be in conformity with the Guidelines as of March 4th 2002. Please note that the 2002 Guidelines have been superseded by the Updated Guidelines for Human Pluripotent Stem Cell Research as of June 29, 2007. 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 Question #4).

Types of stem cell research that require SCOC review

SCOC, local REB and, where appropriate, ACC approval is required for:

  1. all research to derive and study human embryonic stem (ES) cell lines or other cell lines of a pluripotent nature from human embryos;
  2. all research to derive and study human embryonic germ (EG) cell lines or other pluripotent stem cell lines from human fetal tissue or amniotic fluid;
  3. all research on anonymized human ES or EG cell lines created in Canada or created elsewhere and imported for research purposes;
  4. all research involving the grafting of human ES cell lines, EG cell lines or other human cells that are likely to be pluripotent into non-human animals from birth to adulthood;
  5. all research involving the grafting of human pluripotent stem cell lines into legally competent human adults;
  6. all research using imported cell lines differentiated from human pluripotent stem cells. 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; and
  7. all research involving the grafting of cells differentitated from human pluripotent stem cells, into both human and non-human animals, from both domestic and imported sources.

Types of stem cell research that do not require SCOC review

  1. all research to derive and study human stem cell lines from the umbilical cord and placenta;
  2. all research to derive and study human stem cell lines from human somatic tissues;
  3. 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;
  4. research using products (e.g. RNA), not including cells, derived from human pluripotent stem cells;
  5. research using histologically fixed human pluripotent stem cells; and
  6. 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, where appropriate, ACC approval, is required for i-iii above.

At any time the local REB or ACC may refer a human stem cell research proposal to SCOC for ethics review if it considers the research to be within SCOC's purview, according to the above criteria.

Human pluripotent stem cell lines that have been approved by SCOC

The following human embryonic stem cell lines have been reviewed by SCOC, found to be in conformity with 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.

Cell Line Source
H1, H7, H9 WiCell
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

Amendments to applications previously approved by SCOC

Note that if researchers wish to introduce major changes in direction in a research plan previously approved by SCOC (e.g. if they wish to use additional human pluripotent stem cell lines not previously approved by SCOC), they must submit a new application to SCOC describing the changes in the research plan.

Researchers who wish to use additional SCOC-approved stem cell lines not described in the original research application without major changes in the research plan should notify SCOC in writing, providing details of the original application and specifying the names of the new cell lines.

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 submitted to SCOC.

Process SCOC will follow to review contracts relevant to human pluripotent stem cell research 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:

Lynne Cayer
Ethics Policy Advisor
Canadian Institutes of Health Research
Telephone: 613-952-4264
Email: stemcell@cihr-irsc.gc.ca


Modified: 2007-06-29
Reviewed: 2006-06-28
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