ARCHIVED – Guidelines for Human Pluripotent Stem Cell Research, June 28, 2006
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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.
2.0 Canadian Institutes of Health Research and Ethics in Research
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.
3.0 Development and evolution of the Guidelines
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.
4.0 Guiding principles
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:
Research undertaken should have potential health benefits for Canadians;
Free and informed consent, provided voluntarily and with full disclosure of all information relevant to the consent;
Respect for privacy and confidentiality;
No direct or indirect payment for tissues collected for stem cell research and no financial incentives;
No creation of embryos for research purposes;
Respect individual and community notions of human dignity and physical, spiritual and cultural integrity
5.0 Oversight of human pluripotent stem cell research
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.
6.0 Creating a national registry
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.
7.0 Application of the Guidelines
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).
8.0 Guidelines for Human Pluripotent Stem Cell Research
8.1 Research that would conform with the Guidelines
The types of research that conform with the Guidelines include:
Research to derive and study human embryonic stem (ES) cell lines or other cell lines of a pluripotent nature from human embryos, provided that:
The embryos used, whether fresh or frozen, were originally created for reproductive purposes and are no longer required for such purposes; and
There was free and informed consent from the persons for whom the embryos were originally created for reproductive purposes. Where third party donor gametes were used to create the embryo, the third party gamete donor(s) must have given at the time of donation free and informed consent to the unrestricted research use of any embryos created, when these embryos are no longer required for reproductive purposes; and
Neither the ova nor the sperm from which the embryos were created, nor the embryos themselves, were obtained through commercial transactions, i.e., were acquired by payment of money in excess of costs actually incurred or in exchange for healthcare services.
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:
The proposed research does not compromise the pregnant woman's decision on whether to continue her pregnancy. To ensure that such compromise does not occur, the stem cell researcher shall provide SCOC with satisfactory evidence that the pregnant woman's decision to discontinue the pregnancy was made prior to any request made to her to participate in the research; and
There was free and informed consent from the pregnant woman for the use of her fetal tissue in research.
Research to derive and study human stem cell lines of a pluripotent nature from the umbilical cord and placenta, provided that:
There was free and informed consent from the mother, or from both parents of the newborn if there are two people committed to parenting. If there is disagreement between the parents, the umbilical cord and placenta cannot be used for research.
Research to derive and study human stem cell lines of a pluripotent nature from human somatic tissues, provided that:
When the tissue is from a legally competent person, there was free and informed consent from the prospective research participant; or
When the tissue is from a legally incompetent person,
the tissue has been obtained from a surgical, diagnostic or other legitimate practice not including research, and
an appropriate legally competent third party has authorized its availability for research, and
the donation is in accordance with applicable consent law in the province where the donation takes place; or
When the tissue is from a cadaver, there is a legally appropriate advance directive that appropriately specifies the use of tissue for stem cell research, or there is authorization from an appropriate legally competent third party.
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:
Those created in Canada were developed in accordance with the Guidelines. It is incumbent on the recipient of such cell lines to ensure that they were derived in a manner consistent with the Guidelines. The recipient must provide satisfactory evidence to the local REB and the Stem Cell Oversight Committee that the cell lines fulfill the informed consent provisions before research can begin.
The recipient of stem cell lines created in a country other than Canada provides the Stem Cell Oversight Committee with satisfactory evidence that the manner in which the stem cell lines were created in the country of origin, including embryo donors' informed consent, satisfy the laws and policies of that country. Should the Stem Cell Oversight Committee find that the manner of creation of these stem cell lines and the informed consent provisions vary significantly from the Guidelines, 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 ES 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 free and informed consent to the use of their embryos for ES cell research, or insufficient information is available to make this determination;
The embryos used to create ES cell lines were obtained through commercial transactions, or insufficient information is available to make this determination;
The pregnant woman from whom fetal tissue was obtained for deriving EG cell lines did not make the decision to donate that tissue after the decision to discontinue the pregnancy, or insufficient information is available to make this determination;
The pregnant woman from whom fetal tissue was obtained did not give free and informed consent to the use of that tissue for research; or insufficient information is available to make this determination.
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:
The research is designed to reconstitute a specific tissue or organ to derive a pre-clinical model, and
These non-human animals grafted with human stem cells will not be used for reproductive purposes.
Research involving the grafting of human stem cells or other human cells that are likely to be pluripotent into legally competent humans, provided that:
There is overwhelming evidence from pre-clinical models for safety and efficacy, and
The research is carried out in well-designed clinical trials, and
There is free and informed consent from the prospective research participants.
8.2 Research that would not conform with the Guidelines
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.
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.
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.
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.
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.
Research in which human ES cells, EG cells or other cells that are likely to be pluripotent are combined with a non-human embryo.
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 Consent, privacy and confidentiality provisions
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.
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.
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:
An explanation that the cell line(s) will be anonymized (i.e. that no personal identifiers of those who donated embryos from which ES cell lines were derived for research will be provided to stem cell investigators), except if the research involves autologous donation;
An assurance that prospective research participants are free not to participate and have the right to withdraw at any time before an anonymized cell line is created;
An explanation that the research could result in the production of a stem cell line that could be maintained for many years, distributed to other parts of the world, and used for various research purposes;
An explanation that the research participants will not benefit directly financially from any future commercialization of cell lines; nor will there be any personal benefit in terms of dispositional authority over any cell lines created (i.e., there will be no directed donation of the cells or cell lines to particular individuals), except if the research involves autologous donation.
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.
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 188.8.131.52), except if the research involves autologous donation.
All researchers who make stem cell lines available to other academics, will ensure that the cell lines are anonymized.
Physicians responsible for fertility treatment and physicians responsible for termination of pregnancy will not be part of a stem cell research team.
8.4 Commercial interest
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.
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.
Effective June 28, 2006