Stem cell research holds great potential to treat human disease and prevent suffering. Stem cells have the potential to provide treatments for a host of debilitating diseases including Alzheimer's, Parkinson's, diabetes, multiple sclerosis, and heart disease. Few other areas of science have generated as much excitement, scrutiny and controversy. At the same time, their derivation and use raise ethical, social issues and legal concerns of interest to Canadians.
Until March 2002, Canada had no laws to govern stem cell research, nor were there any guidelines for researchers, research ethics boards, or funding agencies on how stem cells may be derived and used. Recognizing the urgent need for clear guidelines that would allow for response to rapidly evolving science and shifting public opinion, and to ensure ethical and scientific oversight, the Canadian Institutes of Health Research (CIHR) announced guidelines for human pluripotent stem cell research in March 2002. The federal granting agencies, the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council (NSERC) and the Social Sciences and Humanities Research Council (SSHRC) ("the Agencies") subsequently adopted interim Tri-Agency stem cell measures, agreeing that no research with human pluripotent stem cells would be funded without the prior review and approval of the Stem Cell Oversight Committee (SCOC) in conformity with the CIHR guidelines. The measures incorporate adherence to the Guidelines as a condition of Agency-funded research, and were adopted to afford time to integrate the Guidelines into the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, in a manner consistent with the developing federal regulatory regime for human embryonic stem cell research.
While CIHR was working on the development and implementation of its Guidelines, the federal government was working on legislation on assisted human reproduction, including the use of human embryos for research. In March 2004, Bill C-6: an Act Respecting Assisted Human Reproduction and Related Research, became law. The Act applies to the derivation of stem cells from human embryos, but does not apply to research using human embryonic stem cell lines that have already been derived. However, the Guidelines do apply to both types of research.
Canadian researchers have been pioneers in the area of stem cell research and continue to lead the way using animal models. With the introduction of these Guidelines, Canadian researchers are now able to move forward and remain at the forefront of their field while conducting their research according to explicit ethical standards. Funding agencies, Research Ethics Boards, and universities now have a framework to guide their evaluation and approval decisions. Canadians can be assured that the research made possible by federal public funds will be undertaken within a well-defined ethical and legal framework.
CIHR thanks the members of the ad hoc Working Group on Stem Cell Research for their significant contribution to the development of these guidelines and Canadians for their thoughtful input, and looks forward with great anticipation to the discoveries that lie ahead and the potential health benefits they will bring to Canadians and the world.
CIHR was established by the Government of Canada in 2000 as the federal funding agency for health research in Canada. CIHR funds a broad spectrum of health research, including biomedical research, clinical science research, health systems and services research, and population health research. CIHR has a duty to ensure that research carried out under its auspices involving humans or human biological material meets the highest ethical standards. The ethical principles governing research involving humans including tissues, biological fluids, embryos and fetuses are laid out in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). The TCPS applies to all research funded by the Agencies and all research conducted at institutions that receive any Agency funding.
Given the research potential and the ethical concerns inherent in human pluripotent stem cell research, CIHR convened an ad hoc Working Group on stem cell research, consisting of scientists, clinicians, philosophers and a lawyer, with national and international expertise in human reproductive technologies and stem cell research. The Working Group was asked to provide guidance to CIHR as to whether human embryonic stem cell research should be considered eligible for CIHR funding, in the light of existing guidelines for human embryo research in Canada and the evolving international situation. While research on human adult stem cells was not included in the Working Group's mandate, recent scientific research has raised the possibility of isolating adult stem cells with properties similar to embryonic stem cells. Although the source of adult stem cells does not raise unique ethical concerns, ethical issues about the experimental use of pluripotent stem cells would apply to such cells whether derived from the embryo or the adult. Thus the Working Group considered its mandate to cover all human pluripotent cells, whatever their source and the final guidelines are worded with that consideration in mind.
An initial Discussion Paper with preliminary recommendations was released in March 2001 as the basis for public consultation with interested individuals and organizations. This input was incorporated into the development of the Working Group's final report. Their recommendations were adopted by the Governing Council of CIHR in January 2002.
The Guidelines were intended to be an interpretation and extension of the Tri-Council Policy Statement (TCPS) and as such will be incorporated into the TCPS, which applies to all research conducted under the auspices of the granting Agencies. Accordingly, NSERC and SSHRC joined CIHR in agreeing to a Tri-Agency approach requiring adherence to the Guidelines as a condition for Agency funding of research. This will apply until the Guidelines are formally incorporated into the TCPS.
The Agencies will review the field of human stem cell research on an ongoing basis to revise ethical guidelines for eligible funding as needed and, when appropriate, to broaden or narrow the scope of permitted research. This review process will also examine the Guidelines and the role of SCOC in light of the evolving federal regulatory regime.
The guidelines are based on the provisions of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). Therefore, the guidelines are based on several guiding principles, such as:
Because of the complex ethical issues and public concern in this area, a Stem Cell Oversight Committee (SCOC) has been created to conduct ethical review of all human pluripotent stem cell research proposals recommended for approval by the Agencies' scientific peer review panels, or conducted under the auspices of institutions receiving Agency funding. All such research proposals falling within the scope of these Guidelines now require approval from SCOC, as well as from the local Research Ethics Board (REB), and, where appropriate, the Animal Care Committee (ACC), before funds can be released to the researcher. SCOC's members include experts in biology, assisted human reproduction, ethics, law, and social sciences, as well as representatives of the general public. SCOC can also, on request, provide ethical review of human pluripotent stem cell research proposals submitted by other public or private granting agencies or by industrial sponsors of research. It will also provide advice to investigators and local REBs on the application of the Guidelines.
CIHR will establish an electronically accessible national registry of human embryonic stem cell lines generated in Canada. This registry will minimize the need to generate large numbers of cell lines, which should decrease the need for donation of large numbers of embryos.
All human embryonic stem cell lines generated using CIHR funds will be listed with the registry and made available by the researcher to other researchers, subject to reasonable cost-recovery charges. Participation in this registry will be a prerequisite for obtaining CIHR funding for human pluripotent stem cell research.
These guidelines apply to all research involving human pluripotent stem cells that is funded by the Agencies, or is conducted under the auspices of an Institution that receives any Agency funding (see Frequently Asked Questions for details).
The types of research that conform with the Guidelines include:
8.1.1
Research to derive and study human embryonic stem (ES) cell lines or other cell lines of a pluripotent nature from human embryos, provided that:
8.1.2
Research to derive and study human embryonic germ cell (EG) lines, or other cell lines of a pluripotent nature from human fetal tissue or amniotic fluid, provided that:
8.1.3
Research to derive and study human stem cell lines of a pluripotent nature from the umbilical cord and placenta, provided that:
8.1.4
Research to derive and study human stem cell lines of a pluripotent nature from human somatic tissues, provided that:
8.1.5
Research on anonymized human embryonic stem cell lines, embryonic germ cell lines or other cell lines of a pluripotent nature that have been created in Canada, or created elsewhere and imported for research purposes, provided that:
8.1.6
Research involving the grafting of human ES cells, EG cells or other human cells that are likely to be pluripotent into non-human animals, from birth to adulthood, provided that:
8.1.7
Research involving the grafting of human stem cells or other human cells that are likely to be pluripotent into legally competent humans, provided that:
The types of research that do not conform with the Guidelines include:
Research involving the creation of human embryos specifically to derive stem cell lines or other cell lines of a pluripotent nature.
8.2.2
Research involving somatic cell nuclear transfer into human oocytes (cloning) or involving stimulation of an unfertilized egg to produce a human embryo (parthenogenesis) for the purposes of developing human embryonic stem cell lines or other cell lines of a pluripotent nature.
8.2.3
Research involving the directed donation of stem cell lines or, other human cells or cell lines of a pluripotent nature to particular individuals, unless the research involves autologous donation.
8.2.4
Research in which human or non-human ES cells, EG cells or other cells that are likely to be pluripotent are combined with a human embryo.
8.2.5
Research in which human or non-human ES cells, EG cells or other cells that are likely to be pluripotent are grafted to a human fetus.
8.2.6
Research in which human ES cells, EG cells or other cells that are likely to be pluripotent are combined with a non-human embryo.
8.2.7
Research in which human ES cells, EG cells or other cells that are likely to be pluripotent are grafted to a non-human fetus.
8.3.1
Embryos no longer wanted for reproductive purposes may be donated to another couple, used for research (including research to derive and study human ES cells), or discarded. These options should be discussed with the gamete providers (and the embryo providers if these are different individuals), and a decision regarding the eventual disposition of unwanted embryos should be made prior to the collection of gametes and the creation of embryos for reproductive purposes.
8.3.2
At the time when the embryos are to be used for research to derive and study ES cells (and other human cells or cell lines of a pluripotent nature), consent of the embryo providers must be reiterated. This requirement affirms the right to withdraw and is necessary because of the possible lengthy delay between the time at which the original consent is given and the time at which the embryos are utilized for research purposes. Members of the health team treating and/or counselling the client should not be the persons to obtain consent from the embryo provider at the time of re-consent. A renewal of the consent provided by the gamete providers (if the gamete providers are not the same individuals as the embryo providers), is not required provided that appropriate consent for the unrestricted research use of the embryos was given at the time of gamete donation.
8.3.3
For the purpose of obtaining free and informed consent to human stem cell research, at a minimum, researchers shall provide to prospective research participants, in addition to the usual information given:
8.3.4
Researchers must not ask, encourage, induce or coerce members of the fertility treatment team to generate more embryos than necessary for the optimum chance of reproductive success; this is tantamount to creating embryos for research.
8.3.5
All human stem cell lines, other human cells or cell lines of a pluripotent nature from human embryos, fetuses or adults, must be anonymized (i.e. no personal identifiers - see 8.3.3.1), except if the research involves autologous donation.
8.3.6
All researchers who make stem cell lines available to other academics, will ensure that the cell lines are anonymized.
8.3.7
Physicians responsible for fertility treatment and physicians responsible for termination of pregnancy will not be part of a stem cell research team.
8.4.1
When researchers or their institutions have or acquire financial interests in the outcome of the stem cell research, including, but not limited to, income from commercial firms supporting their research, stock holdings in corporations supporting their research, or patents in products produced through their research, they must disclose this information to the Stem Cell Oversight Committee, the REB and prospective research participants. In some instances, disclosure may not be a sufficient response to concerns about actual, perceived or potential conflicts of interest and researchers and/or their institutions may be asked to remedy any possible distortion of proper procedures attributable to such conflicts.
8.4.2
Copies of contracts between researchers, institutions and industry sponsors and any relevant budgetary information must be provided to the Stem Cell Oversight Committee and the local REB, to examine and evaluate any potential or actual conflict of interest and to ensure the right to publish freely after a modest interval.
