Guidelines for Human Pluripotent Stem Cell Research: Frequently Asked Questions

CIHR, NSERC and SSHRC ("the Agencies") are committed to promoting and ensuring an understanding of the guidelines for stem cell research as outlined in the document Updated Guidelines for Human Pluripotent Stem Cell Research ("the Guidelines"). The Guidelines became effective when they were publicly announced on March 4, 2002. Please note: these Updated Guidelines for Human Pluripotent Stem Cell Research supersede the March 2002 version.

To facilitate an understanding of the Guidelines by the research community, a bank of Frequently Asked Questions (FAQs) has been created. These FAQs will be updated as necessary to include new relevant information.

It should be noted that the Assisted Human Reproduction Act became law March 29, 2004 and applies to human embryo research including research to derive stem cells from human 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 at stemcell@cihr-irsc.gc.ca. 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 the Guidelines

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 the Guidelines and that have been approved by peer review committees, for conformity with the Guidelines (see the document entitled "Policy Highlights" and FAQs below 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 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. How is 'pluripotent' defined as it relates to the Guidelines?

The Final Report of the ad hoc Working Group on Stem Cell Research defines a pluripotent stem cell as "a stem cell with the capacity to differentiate into cells of all germ layers (endoderm, ectoderm, and mesoderm). These are usually derived from early embryos or embryonic germ cells."

This includes human embryonic stem cells (hESC) and human induced pluripotent stem (iPS) cells.

Procedures

3. How do I submit my human pluripotent stem cell research application to SCOC?

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

4. How often does SCOC meet to review human pluripotent stem cell research application?

SCOC has face-to-face meetings twice a year, in spring and fall, which coincide with most competition funding cycles. SCOC may review any application to use human pluripotent stem cell lines at face-to face meetings. Applications for research to derive new human embryonic stem cell lines (hESC) or use hESC lines that have not yet been approved may only be reviewed at face-to-face meetings.

As necessary, SCOC will review applications by teleconference once a month as needed, except in months that SCOC meets face-to-face. During teleconferences, the Committee may consider applications for the use of SCOC-approved hESC lines and applications involving the engraftment of induced human pluripotent stem (iPS) cells, or the derivatives of these cells. This process allows SCOC to review most applications within 30 business days of receipt of a complete application for funding.

Proposals to use SCOC-approved hESC in vitro, minor amendments to approved proposals, trainee (student, fellow) scholarship or studentship proposals that are wholly subsidiary to a SCOC-approved project and minor extensions to approved research proposals may be eligible for a process of delegated SCOC review. This process allows the Chair plus one (or more) member(s) of SCOC to review on the Committee's behalf.

Human iPS cell research involving grafting experiments that are limited to in vivo experiments to test teratoma formation is exempt from SCOC review, provided that the investigators notify SCOC in writing that the animals will not be used for reproductive purposes.

5. Does SCOC ethics 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.

6. What will happen if I don't follow the Guidelines?

The Agencies will receive complaints of non-conformity with the Guidelines, as they do with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). In the case of CIHR, allegations of non-conformity should be directed to the Ethics Policy Officer (research.integrity@cihr-irsc.gc.ca). These complaints will be handled according to the process set out in Schedule 8 of the Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards.

7. I am a researcher with Agency funding and/or working for an institution that receives Agency funding. I am transferring my SCOC-approved research programs to another institution. How should I proceed?

SCOC should be notified in writing of the transfer of approved projects. The notification should confirm that the successor institution acknowledges that human pluripotent stem cells will be used in these programs, and that these projects will be conducted in a manner that conforms to the Guidelines. The notification should also:

  • list the funded programs that, following SCOC review, were found to conform to the Guidelines for Human Pluripotent Stem Cell Research;
  • list the human pluripotent stem cell lines that are being used;
  • acknowledge that local REB approvals will be obtained for all work; and
  • be signed by the appropriate institutional officials (President or Principal of Institution, Head of Department, and Dean of Faculty or Director of Institution)
    Institutional signatures are required only from the institution of the Nominated Principal Applicant. If the Nominated Principal Applicant is normally the signing authority for the faculty, another senior official must sign instead. The signatures of the Principal Applicant and of institutional officials must be original signatures. If the Principal Applicant's primary appointment is at an institution that has a university affiliation, the Dean of the appropriate Faculty at the university must sign the application.

Does my research require SCOC review?

8. 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.

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

Yes.

10. 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?

Your new protocols require ethics review by SCOC, your local REB and, where appropriate, the ACC in conformity with the categories of ethics review outlined in the Policy Highlights document.

11. I am a student or postdoctoral fellow applying for a traineeship from an Agency to do research on human pluripotent stem cells. Is my traineeship subject to the Guidelines? 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 Guidelines and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) [ PDF (610 KB) - external link ]. Any research that you undertake that is within the scope of the Guidelines must receive approval from the appropriate ethics review body (SCOC, your REB, and/or the ACC in accordance with the information in the document Policy Highlights).

12. 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 the Guidelines?

Yes. Any research conducted under the auspices of an institution that receives Agency funding must conform to the Guidelines and be reviewed by SCOC to ensure conformity (see Policy Highlights document for more details). In addition, many provincial and not-for-profit organizations have explicitly endorsed the Guidelines and indicated that they would voluntarily abide by them. SCOC reviews these applications by agreement with these agencies.

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

Researchers who do not receive funding from the Agencies and who work for institutions or companies that do not receive any funding from the Agencies are not formally subject to the Guidelines or the TCPS unless their funder so requires. However, the Guidelines provide 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 stem cell research protocols that fall outside the scope of obligatory SCOC review.

14. I am a researcher with Agency funding and/or working for an institution that receives Agency funding. Do the Guidelines apply to the use of a human embryonic stem cell line that has been created outside of Canada and imported for research purposes?

Yes. Research on 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 the Guidelines.

15. 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 the Guidelines?

Yes, you may only participate in research that conforms to the Guidelines and that has received SCOC approval.

Considerations/Interpretations

16. How does the Assisted Human Reproduction Act (the AHR Act) that received Royal Assent on March 29, 2004 affect research using human pluripotent stem cells?

The AHR Act establishes a legislative and regulatory framework for the use of the in vitro human embryo in research. Assisted Human Reproduction Canada (AHRC) oversees aspects of AHR and related research that are governed by the AHR Act. Among several essential functions, AHRC will issue, renew, amend, suspend or revoke licences for controlled activities (sections 10-13), including licenses for research involving the in vitro embryo. Researchers intending to use an in vitro embryo in their research will be required to satisfy AHRC that they have undertaken certain steps, as specified in the Act or in future regulations, before being issued a licence to proceed.

The regulations which will govern the use of an in vitro embryo for research purposes are currently under development. In the interim period, until the regulatory and licensing scheme is in place, persons who would like to undertake research involving an in vitro embryo may do so in accordance with section 71 of the AHR Act (the "grandfathering" clause). Section 71 provides that any person who undertook a controlled activity at least once during the year prior to the coming into force of sections 10-13 may continue to perform that activity without a licence until a date fixed by the regulations. Sections 10-13 (except section 12) and section 71 came into force on April 22, 2004.

It should be noted that the AHR Act does not address research involving cells already derived from an in vitro embryo (e.g., pre-existing embryonic stem cell lines) and does not apply to research on other pluripotent stem cell lines.

Two sections of the AHR Act specifically refer to the CIHR Stem Cell Guidelines.

Section 3 of the AHR Act states:

"consent" means fully informed and freely given consent that is given in accordance with the applicable law governing consent and that conforms to the provisions of the Human Pluripotent Stem Cell Research Guidelines released by the Canadian Institutes of Health Research in March, 2002, as detailed in the Regulations.

Subsection 40(3.1) of the AHR Act states:

The Agency shall not issue a licence under subsection (1) for embryonic stem cell research unless it has received the written consent of the original gamete providers and the embryo provider in accordance with the Human Pluripotent Stem Cell Research Guidelines released by the Canadian Institutes of Health Research in March, 2002, as specified in the regulations.

For more information on the requirements of the AHR Act respecting the use of an in vitro embyro in research, please consult the full text of the AHR Act, which can be found on the Department of Justice Canada website.

More information respecting the AHR Act can be found on the Health Canada website.

17. 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 provision 8.3.2 of the Guidelines)?

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

18. 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 the Guidelines?

The Guidelines apply to all human pluripotent stem cell research conducted under the auspices of an institution receiving Agency funds. The Guidelines do not specifically preclude this type of research, nor the use of cells derived in this manner; however, such projects would require SCOC review.