Human Pluripotent Stem Cell Research: Frequently Asked Questions
This list of Frequently Asked Questions (FAQs) was created to facilitate an understanding of the review requirements, as set out in Chapter 12, Section F of Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2), for human pluripotent or human totipotent stem cell research funded by the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC) and the Social Sciences and Humanities Research Council of Canada (SSHRC) or conducted under the auspices of an institution eligible to receive such funding.
Details about the Stem Cell Oversight Committee (SCOC) are contained in its Terms of Reference.
If you do not find the answer to your question below, please contact us at stemcell-cellulesouche@cihr-irsc.gc.ca.
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What type of pluripotent stem cell research falls within SCOC’s mandate?
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:
- all research to derive or study human pluripotent or human totipotent stem cell lines from human embryos;
- all research on anonymized human stem cell lines derived from human embryos created in Canada or created elsewhere and imported for research purposes;
- all research involving the grafting of human pluripotent stem cell lines 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;
- all research involving the grafting of human pluripotent stem cell lines into humans;
- 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
- 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:
- 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 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.
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.
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When and how do I submit my human pluripotent or human totipotent stem cell research application to SCOC?
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.
Full committee review Committee delegated review (the Chair plus one (or more) member(s) of SCOC to review on the Committee’s behalf) Administrative review (CIHR Ethics Office plus SCOC Chair) Proposed research - engraftment of SCOC-approved hESC, human iPSC and derivatives of these cells into humansFootnote *
- derive new hESC linesFootnote **
- use hESC lines not yet approvedFootnote **
- most uses of SCOC-approved hESC in vitro
- most engraftments of SCOC-approved hESC, human iPSC and derivatives of these cells into non-human animals, where animals will not be used for reproductive purposes
- substantive amendments to SCOC-approved proposal
- use additional SCOC-approved hESC lines not described in the original application, without major changes in the research plan
- human pluripotent stem cell teratoma assays in non-human animals, where the animals will not be used for reproductive purposes
- minor extensions
- trainee proposals wholly subsidiary to SCOC-approved project
Frequency of review Up to once a month As needed Continuous Service standard 30 business days 30 business days hESC: human embryonic stem cell; iPSC: induced pluripotent stem cell
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How long is SCOC approval valid?
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.
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Does SCOC review happen before or after the Research Ethics Board (REB) and where appropriate, Animal Care Committee (ACC) review?
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?
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Is following TCPS 2 mandatory?
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.
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Does TCPS 2 apply to my research involving human stem cells, thereby requiring SCOC review?
TCPS 2 applies to all research conducted within the jurisdiction or under the auspices of any institution that has been deemed eligible to receive and administer research funds from any of the three Federal research funding Agencies (the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada) – also known as an eligible institution. This means that TCPS 2 applies to all research that takes place within the jurisdiction or under the auspices of the eligible institution, irrespective of where the research is conducted and/or whether it is unfunded, funded by one or more of the three Federal research funding Agencies and/or funded by another organization. Accordingly, TCPS 2 applies to research that is funded (in whole or in part) by industry that is conducted within the jurisdiction or under the auspices of eligible institutions.
Therefore, researchers affiliated with an eligible institution are subject to TCPS 2, and their research using human pluripotent or human totipotent stem cells that have been derived from an embryonic source, and/or that will be grafted or transferred in any other form into humans or non-human animals requires review and approval by SCOC and a Research Ethics Board. For more information on the scope of the TCPS 2, see the Panel on Research Ethics TCPS Interpretations.
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Do I need SCOC approval to use human pluripotent stem cells to generate preliminary data?
Yes.
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I want to refocus some of my research to include studies involving human pluripotent or human totipotent stem cells not originally described in the funding proposal. Do the changes have to be submitted for SCOC review?
Yes. Your new protocols require review by SCOC, your local Research Ethics Board and, where appropriate, the Animal Care Committee.
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I have been nominated for a Canada Research Chair. Does the research to be conducted require SCOC approval?
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.
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I am a student or postdoctoral fellow applying for a stipend from an Agency to do research on human pluripotent stem cells. Is my stipend subject to Chapter 12, Section F of TCPS 2? Do I need approval from the SCOC, my local Research Ethics Board (REB) and, where appropriate, the Animal Care Committee (ACC)?
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).
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I work for an institution that receives Agency funding, but my own research is funded by a not-for-profit organization. Does my research need to conform to TCPS 2?
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.
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Does SCOC review private sector research proposals?
SCOC does not review Canadian private sector research proposals (i.e., research that is not conducted under the auspices of institutions eligible for Agency funding).
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I work for, or am a student at, an institution that receives Agency funding, but I am currently working/studying at a foreign institution that does not receive any Agency funding. Does my research need to conform to Chapter 12, Section F of TCPS 2?
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.
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Why should members of the health team treating and/or counselling the client not be the persons to obtain consent from the embryo provider at the time of re-consent (as stated in Article 12.12 of TCPS 2)?
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.
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What process does SCOC follow to review contracts relevant to human pluripotent stem cell research that are submitted for review?
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.
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Does the transfer of the nucleus of a human cell, or the contents of a human cell, including the nucleus, into a non-human ovum for the purpose of research conform to TCPS 2?
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.
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Where can I find the former CIHR Guidelines for Human Pluripotent Stem Cell Research?
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.
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