Human Pluripotent Stem Cell Research: Frequently Asked Questions

Human stem cell research must conform to the Assisted Human Reproduction Act, which applies to human embryo creation and research. This Act prohibits ten activities relating to human genome alterations, the creation of embryos, and the maintenance of embryos. Subject to this law, SCOC reviews for compliance with Chapter 12, Section F of TCPS 2, research involving human pluripotent stem cells that have been derived from an embryonic source, and/or will be transferred into humans or non-human animals.

Types of pluripotent stem cell research that require SCOC review:

1. all research to derive or study human pluripotent or human totipotent stem cell lines from human embryos;
2. all research on anonymized human stem cell lines derived from human embryos created in Canada or created elsewhere and imported for research purposes;
3. all research involving the grafting of human pluripotent stem cell lines into non-human animals from birth to adulthood;
4. 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;
5. all research involving the grafting of human pluripotent stem cell lines into humans;
6. all research using imported cell lines differentiated from human pluripotent or human totipotent stem cells derived from human embryos. 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 TCPS 2; and
7. 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 pluripotent stem cell research that require the submission of notification to SCOC:

1. 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:

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 that are not likely to be pluripotent from human somatic tissues;
3. all research to derive human pluripotent stem cell lines from human somatic tissues;
4. all research on anonymized human stem cell lines from non-embryonic sources created in Canada or created elsewhere and imported for research purposes and not involving grafting;
5. research using products (e.g. RNA), not including cells, derived from human pluripotent stem cells;
6. research using only histologically fixed human pluripotent stem cells; and
7. grafting of non-pluripotent human stem cells, not including non-pluripotent human cells derived from pluripotent cells, into animals after birth.

Local ethics review from your Research Ethics Board (REB) and, where appropriate, Animal Care Committee (ACC) is essential, but it can follow or precede review by SCOC. Researchers should consult with their institutional ethics advisors. At any time the local REB or ACC may refer a human pluripotent stem cell research proposal to SCOC for review if it considers the research to be within SCOC's purview. Please visit Does the Stem Cell Oversight Committee need to review my research proposal? for more information.

Please visit Does the Stem Cell Oversight Committee need to review my research proposal? to determine the review requirements for your proposed research, and Submitting Stem Cell Research Applications to the Stem Cell Oversight Committee for information on how to submit proposals to SCOC.

Local ethics review from your Research Ethics Board and, where appropriate, Animal Care Committee is essential, but it can follow or precede review by SCOC. Researchers should consult with their institutional ethics advisors.

Approval is effective for the duration of funding of the research project, as originally specified when submitted to SCOC. The duration of approval is provided in all SCOC approval letters issued after April 2021.

Local ethics review from your REB and, where appropriate, ACC is essential but it can follow or precede review by SCOC. Researchers should consult with their institutional ethics advisors. For more information on how SCOC, REB and ACC reviews intersect, see Does the Stem Cell Oversight Committee need to review my research proposal?

Yes. Compliance with TCPS 2 is required when conducting research under the auspices or within the jurisdiction of institutions eligible to administer Agency funds.

The Tri-Agency Framework: Responsible Conduct of Research sets out the responsibilities of institutions, Researchers and the Agencies in respect of the responsible conduct of research, including the procedures to be followed in the event of a breach of an Agency requirement, or an allegation thereof.

Yes.

Yes. Your new protocols require review by SCOC, your local Research Ethics Board and, where appropriate, the Animal Care Committee.

If you are conducting human pluripotent or human totipotent stem cell research that falls under SCOC’s purview (e.g., using human embryonic stem cells or using human induced pluripotent stem cells in vivo), then the funding that you receive within the Canada Research Chair program requires SCOC approval.

However, if the Canada Research Chair funding will be used to solely supplement SCOC-approved projects, then you need not repeat the process in full. Should this be the case, please submit a written attestation that no new research is proposed under the Canada Research Chair, indicating the title and date of approval of the project it is subsidiary to. This obviates the need for additional review by SCOC.

Yes. The research that you do as a trainee with Agency funds (whether inside or outside Canada) or while working for an institution that receives Agency funding, must conform to the TCPS 2. Any research that you undertake that is within the scope of Chapter 12, Section F must receive local ethics review approval from your REB and, where appropriate, ACC.

Please use the application form for SCOC review. Indicate by checking the box that you are a trainee and list your supervisor(s).

Yes. Any human pluripotent or human totipotent stem cell research conducted under the auspices or within the jurisdiction of an institution eligible to receive Agency funding must conform to TCPS 2 and be reviewed by SCOC to ensure conformity.

Researchers who do not receive funding from the Agencies and who work for institutions or companies that are not eligible to receive any funding from the Agencies are not formally subject to the TCPS 2 unless their funder so requires. However, Chapter 12, Section F of TCPS 2 provides a carefully thought-out ethical framework for research that can protect the interests of researchers in both private and public sectors, as well as the general public. Accordingly, upon agreement between CIHR and the other funders, SCOC may provide ethical review of human pluripotent stem cell research protocols that fall outside the scope of obligatory SCOC review.

Yes, you may only participate in human pluripotent stem cell research that conforms to Chapter 12, Section F of TCPS 2 and that has received SCOC approval.

The members of the health team treating and/or counselling a patient(s) are in a position of power which might allow them to unduly influence the disposition of embryos that are surplus to the reproductive needs of the patient(s). For more information on the risks of undue influence and the importance of managing the dual roles of clinician and researchers, please refer to the Application of Article 3.1 and to Chapter 7, Section D of TCPS 2.

Article 12.20 of TCPS 2 requires that "Copies of contracts between researchers, institutions and industry sponsors and any relevant budgetary information shall be provided to SCOC and the Research Ethics Board to examine and evaluate any potential or actual conflicts of interest and to ensure the right to publish in a timely manner without undue restriction."

In implementing the policy, SCOC understands that given current publication timelines and patent submission requirements, “in a timely manner” would generally mean that the researcher may submit a manuscript for publication within approximately 90 days. Additional time may be justifiable, and may be clarified in the application to SCOC or by letter if necessary.

Chapter 12, Section F of TCPS 2 applies to all human pluripotent or human totipotent stem cell research conducted under the auspices or within the jurisdiction of an institution eligible to receive Agency funds. Chapter 12, Section F does not specifically preclude this type of research, nor the use of cells derived in this manner; however, such projects would require review and approval by SCOC and a Research Ethics Board. Types of stem cell research that are not permitted under Canadian legislation and shall not be conducted at all are listed in the Application of Article 12.10.

The TCPS 2 has replaced the former CIHR Guidelines for Human Pluripotent Stem Cell Research as the official human research ethics policy of the Agencies. Archived information is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. For previous versions of the 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), please contact stemcell-cellulesouche@cihr-irsc.gc.ca.