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 4th 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 and all questions requiring policy interpretation will be referred to the Stem Cell Oversight Committee (SCOC).
1. What is SCOC's role?
SCOC is a standing committee of CIHR's Governing Council. The membership of SCOC was approved by the Executive Committee of Governing Council in October 2003. 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 Details" for information on whether or not your research needs to be reviewed by SCOC). In addition, it will review stem cell research proposals not falling under the auspices of an Agency-funded institution by mutual agreement between CIHR and other funders. The 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.
2. How do I submit my human pluripotent stem cell research application to SCOC?
The SCOC application form will soon be found on the CIHR website. When the Guidelines apply to your research (see Policy Details document for details) you must enclose the SCOC application form with your application to the funding organization. Applicants submitting to NSERC may include the SCOC application form with their NSERC application. Do not submit the application directly to SCOC at this time. The funding organization will forward it to SCOC if your application is approved for funding.
3. When will SCOC review my human pluripotent stem cell research application after it is recommended for approval by the scientific peer review panel?
SCOC has face-to-face meetings twice a year, in March and September. While these dates are timed to coincide with the CIHR open competition funding cycle, in order to provide flexibility to other organizations, SCOC will review applications by teleconference whenever possible. Applications received by CIHR in September will be reviewed by SCOC in March and those received in March will be reviewed by SCOC in September. Applications received by CIHR from other organizations by early March or early September will be reviewed in March or September respectively. Applicants can expect to hear back from SCOC within six weeks of the meeting. Applications received at other times may be reviewed on an ad hoc basis by SCOC between face-to-face meetings if they are straightforward.
4. I am a researcher with Agency funding and/or working for an institution that receives Agency funding and I currently have funding approved prior to March 2002 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 re-review (by the funding organization, SCOC, or the local REB), or can I simply redirect my Agency funds to this research provided the research adheres to the Guidelines?
Your new protocols require ethics review by SCOC, your local REB and, where appropriate, the Animal Care Committee (ACC) in conformity with the categories of ethics review outlined in the Policy Details document on the CIHR website.
5. I am a doctoral or postdoctoral student 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). 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 Details and question #2).
6. I work for an institution that receives Agency funding, but my own research is funded by a not-for-profit organization. Do I need to comply with the Guidelines?
Yes. Any research conducted under the auspices of an institution that receives Agency funding must conform with the Guidelines and be reviewed by SCOC to ensure conformity (see Policy Details document on the CIHR website 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.
7. 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 and 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 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.
8. Does SCOC ethics review happen before or after the REB (and where appropriate 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 ethics review by SCOC.
9. I am a researcher currently receiving Agency funding. Prior to March 4th 2002 I started research with human pluripotent stem cell lines that I would like to publish. Neither my research protocols nor the derivation procedure for the stem cell lines were in conformity with the Guidelines released March 4th, 2002. Would publication of this work jeopardize future funding of my research by the Agency?
No, provided that you had proper REB approval prior to the March 4th 2002 announcement of the Guidelines and provided that your data collection was terminated on March 4th, or if it continued that it was subsequently brought into conformity with the Guidelines.
10. What will happen if I don't follow the Guidelines?
The Agencies will receive complaints of non-conformity with the Guidelines, as with the TCPS. In the case of CIHR, allegations of non-conformity should be directed to the Ethics Policy Officer. 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.
11. 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. The Assisted Human Reproduction Agency of Canada, which will be established pursuant to the Act, will oversee aspects of AHR and related research that are governed by the AHR Act. Among several essential functions, the Agency 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 the Agency 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 undertakes 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 (eg. 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 at http://www.parl.gc.ca/PDF/37/3/parlbus/chambus/house/bills/government/C-6_3.pdf
More information respecting the AHR Act can be found at:
www.healthcanada.gc.ca/reproduction
12. 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.
13. 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?
You may only participate in research that conforms to the Guidelines.
14. 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."
15. 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 successive 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:
