Human Pluripotent Stem Cell Research: Frequently Asked Questions

CIHR, NSERC and SSHRC ("the Agencies") are committed to promoting and ensuring an understanding of ethics principles associated with pluripotent stem cell research. The Guidelines for Human Pluripotent Stem Cell Research have been incorporated into Chapter 12, Section F of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2), effective December 2014.

This bank of Frequently Asked Questions (FAQs) was created to facilitate an understanding of the human pluripotent stem cell research provisions, and is updated as necessary to include new relevant information.

It should be noted that the Assisted Human Reproduction Act became law March 29, 2004. This Act applies to human embryo creation and research. It prohibits ten activities relating to human genome alterations, the creation of embryos, and the maintenance of embryos.

If you have a question that is not answered by the FAQs below or if there is a question of interpretation, please contact CIHR. Straightforward questions will be answered by CIHR staff while all questions requiring policy interpretation will be referred to the Stem Cell Oversight Committee (SCOC).

The questions and answers fall into the following categories:

Scope of SCOC and Chapter 12, Section F of TCPS 2 (2014)

1. What is SCOC's role?

SCOC is a standing committee of CIHR's Governing Council. SCOC reviews applications that fall within the scope of Chapter 12, Section F of TCPS 2 (2014) for conformity with the principles therein (see FAQ #2 for information on whether or not your research needs to be reviewed by SCOC). In addition, SCOC will review stem cell research proposals not falling under the auspices or within the jurisdiction of an Agency-funded institution by mutual agreement between CIHR and other funders. SCOC review is intended to complement the ethics review undertaken by the investigator's own institute's Research Ethics Board by ensuring standard practice at a national level, and providing expertise in human pluripotent stem cells not available to many Research Ethics Boards.

2. What type of pluripotent stem cell research falls within SCOC’s mandate?

TCPS 2 defines a pluripotent stem cell as "a cell that can become all the cell types that are found in an implanted embryo, fetus, or developed organism, but not embryonic components of the trophoblast and placenta. Pluripotent stem cells include embryonic stem cells, induced pluripotent stem cells and embryonic germ cells."

Generally, SCOC reviews 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.

Specifically:

Types of pluripotent stem cell research that require SCOC review

  1. all research to derive or study human pluripotent stem cell lines from human embryos;
  2. all research on anonymized human pluripotent 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 derived from human embryos 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 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 Guidelines; 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.

Note that REB and ACC approval may be required. 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.

3. What is the purpose of integrating the Guidelines into TCPS 2 (2014), and what impact does it have on SCOC’s mandate?

Please see the additional set of Frequently Asked Questions that has been developed to explain the rationale for, and the impact of the integration of the Guidelines into TCPS 2 (2014).

Procedures

4. When and how do I submit my human pluripotent stem cell research application to SCOC?

Please visit "Submitting Stem Cell Research Applications to the Stem Cell Oversight Committee" for information on how to submit proposals to SCOC.

Type of SCOC review
Face to face Teleconference Delegated Notification
Proposed Research
  • derive new hESC lines
  • use hESC lines not yet approved

(all other applications are also eligible for review during a face-to-face meeting)

engraftment of:

  • SCOC-approved hESCs
  • human iPS cells
  • derivatives of these cells
  • use SCOC-approved hESC in vitro
  • minor amendments
  • student proposals wholly subsidiary to SCOC-approved project
  • minor extensions
  • human iPS cell teratoma assays in non-human animals, where the animals will not be used for reproductive purposes
  • use additional SCOC-approved stem cell lines not described in the original application, without major changes in the research plan
Frequency of type of SCOC review Twice a year, in spring and fall, to coincide with most competition funding cycles Up to once a month, except in months that SCOC meets face-to-face As needed: the Chair plus one (or more) member(s) of SCOC to review on the Committee's behalf Notify SCOC in writing
Is GC endorsement required? Yes No No n/a
Service standard n/a 30 business days 30 business days n/a

5. Which human embryonic stem cell lines have been reviewed by SCOC and approved?

The following human embryonic stem cell lines have been reviewed by SCOC, found to conform to TCPS 2 or, prior to December 2014, 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 ESI BIO
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, 64 HSCI iPS Core, 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
MEL1, MEL2 Millipore Corporation
WIBR1, WIBR2, WIBR3 Whitehead Institute, Cambridge, MA, USA
ESI-017, ESI-035, ESI-049, ESI-051, ESI-053 ESI BIO
HAD-C 102, HAD-C 104, HAD-C 106 Hadassah Human Embryonic Stem Cell Research Center

6. How long is SCOC approval valid?

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.

7. Does SCOC review happen before or after the Research Ethics Board (REB) (and where appropriate Animal Care Committee (ACC)) review?

You may request local REB (and where appropriate ACC) review of your grant application before submitting it to the Agency and SCOC, but this is not necessary. Local ethics review (from your REB and, where appropriate, ACC) is essential but it can follow or precede review by SCOC.

Entity Role
SCOC

SCOC reviews 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

to ensure compliance with Chapter 12, Section F of TCPS 2 (2014).

REB

As described in TCPS 2 (2014), “the following requires ethics review and approval by an REB before the research commences:

  • research involving living human participants;
  • research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.”
ACC Institutional “ACCs undertake animal use protocol review, approval and follow-up (post-approval monitoring)”.

8. 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.

Does my research require SCOC review?

9. Does research using human induced pluripotent stem (iPS) cells require SCOC review?

Research using human iPS cells requires SCOC review only if grafting experiments are proposed. Grafting experiments using iPS cells solely to test teratoma formation in non-humans are exempt from SCOC review, provided that the investigators notify SCOC in writing that the animals will not be used for reproductive purposes. See also Frequently Asked Question #2.

10. Do I need SCOC approval to use human pluripotent stem cells to generate preliminary data?

Yes.

11. I am a researcher with Agency funding and/or working for an institution that receives Agency funding and I currently have funding for research that did not originally include human pluripotent stem cell research. I want to refocus some of my research to include studies involving human pluripotent stem cells. Do the changes have to be submitted for SCOC review?

Yes. Your new protocols require review by SCOC (see Frequently Asked Question #2), your local REB and, where appropriate, the ACC (see Frequently Asked Question #7).

12. I have been nominated for a Canada Research Chair. Does the research to be conducted require SCOC approval?

If you are conducting human pluripotent 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. This obviates the need for additional review by SCOC.

13. 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 REB and, as appropriate the 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 Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2). Any research that you undertake that is within the scope of Chapter 12, Section F must receive approval from the appropriate ethics review body (see Frequently Asked Question #7).

Please use the application forms for SCOC review designed for trainees when applying for review.

14. 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 (2014)?

Yes. Any human pluripotent stem cell research conducted under the auspices or within the jurisdiction of an institution eligible to receive Agency funding must conform to TCPS 2 (2014) and be reviewed by SCOC to ensure conformity.

15. I am a researcher involved in human pluripotent stem cell research and I work exclusively for an organization that does not have any funding from the Agencies. Is my research subject to TCPS 2 (2014)? Do I need to get approval from SCOC, my local REB and, where appropriate, the ACC to continue my pluripotent stem cell research?

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 unless their funder so requires. However, Chapter 12, Section F of TCPS 2 (2014) 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.

16. I am a researcher with Agency funding and/or working for an institution that receives Agency funding. Does Chapter 12, Section F of TCPS 2 (2014) apply to the use of a human embryonic stem cell line that has been created outside of Canada and imported for research purposes?

Yes. Prior to starting, research using human embryonic stem cell lines that have been created outside of Canada and imported for research purposes must be approved by SCOC to ensure that the research conforms to Chapter 12, Section F of TCPS 2 (2014).

The recipient of human embryonic stem cell lines created in a country other than Canada must provide SCOC with satisfactory evidence that the manner in which the stem cell lines were created in the country of origin, including the embryo donors' consent, satisfies the laws and policies of that country. Should SCOC find that the manner of creation of these stem cell lines and the consent provisions vary significantly from Chapter 12, section F of TCPS 2, it may not approve the use of these cell lines in stem cell research in Canada.

Examples of significant variations include:

  • The human embryos from which the embryonic stem cell lines were derived were not created for reproductive purposes, or insufficient information is available to make this determination;
  • The embryo donors did not give consent for the use of their embryos for embryonic stem cell research, or insufficient information is available to make this determination;
  • The embryos used to create embryonic stem cell lines were obtained through commercial transactions.

17. 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 (2014)?

Yes, you may only participate in human pluripotent stem cell research that conforms to Chapter 12, Section F of TCPS 2 (2014) and that has received SCOC approval.

Considerations/Interpretations

18. 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 the health professional to unduly influence the disposition of embryos that are surplus to the reproductive needs of the patient(s).

Additional guidance on undue influence is available in Article 3.1 and on conflicts of interest is available in Chapter 7 of TCPS 2 (2014).

19. 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 REB 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.

20. 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 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 SCOC review.

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