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2002
Comparative Primordial Stem Cell Regulation: Canadian Policy Options
Comparative Primordial Stem Cell Regulation:
Canadian Policy Options
A paper commissioned by the Canadian Biotechnology Advisory Committee
January 11, 2001
Lori P. Knowles LLB BCL MA LLM
Associate for Law & Bioethics
Director, Education and Outreach
The Hastings Center
knowlesl@thehastingscenter.org
Human stem cells can be derived from a number of sources and offer fertile areas of scientific
research that hold great medical potential. Some stem cells are found in human umbilical cord blood,1
some in placental tissue and recent research has focused on the medical potential of somatic or "adult" stem
cells.2 However, by far the most controversial of human stem cells are primordial stem cells, known as
human embryonic stem (ES) and germ cells (EG). ES and EG cell research offers the potential of great
medical benefit, in particular, the potential to provide an endless supply of transplantable tissue. The
source of these cells, being human embryos and aborted foetuses respectively, raises difficult ethical issues
and complicates policy development.
With respect to the policy dimensions of primordial stem cell oversight, a number of existing
regulatory schemes may provide partial or adequate regulation. These include human subjects research
regulation, embryo research regulation, foetal tissue research and use regulation, research funding
legislation and guidelines, practice guidelines for use of human biological materials, health and safety
legislation and criminal law, among others.3
There has been considerable interest in the use of stem cells for therapy in the international
community.4 This paper will canvass the responses, conclusions and recommendations of various
governmental and non-governmental bodies to the issue of stem cell research. Particular emphasis will be
placed on the responses of the United States and the United Kingdom, with reference to the response of the
ethics advisory group to the European Commission and statements by Germany and the Vatican. Primary
focus will be placed on the use of ES and EG cells as a source of stem cell research. Existing Canadian
regulations will be examined to determine whether Canadian policy is sufficient to deal with research and
use of primordial stem cells or whether new policy is needed.
Background
At the end of 1998, almost simultaneously, one team of researchers announced that it had isolated
human embryonic stem (ES) cells 5 and another announced that it had isolated human embryonic germ (EG)
cells.6 Embryonic stem cells are derived from five-to-seven day old embryos known as blastocysts. If
implanted, the outer layer of the blastocyst is destined to become the placenta. The remainder of the
blastocyst, called the inner cell mass, is destined to become the foetus. Embryonic stem cells are isolated
from this inner cell mass and the derivation of these cells necessarily involves the destruction of the
embryo. Embryonic germ cells are derived from immature aborted foetuses. They are derived from a small
set of stem cells that were set aside in the embryo and prevented from differentiating. They are referred to
as embryonic germ cells because they were destined to give rise to the eggs or sperm of the next
generation.7 EG cells are not, however, the same thing as foetal eggs, they are the precursors to the cells
that might eventually become foetal eggs if the foetus was female and proceeded to term.
Why are primordial stem cells relevant?
ES and EG cells have two noteworthy properties. First, the cells are thought to divide indefinitely
when cultured in cell lines, which makes them excellent tools for manipulation by researchers. 8 Second,
they are said to be pluripotent.9 Other cells in the human body are differentiated to some degree, which
means that they have turned into a specific type of cell, such as blood, nerve or skin cells. By contrast, ES
and EG cells can turn into many cell types. As of yet, researchers have not been able to successfully direct
their differentiation to an extent that would be clinically useful, however, the hope is that someday soon
these cells will be used to generate specific, transplantable tissues.
What are the ethical issues that generate the controversy about ES and EG cell research?
Despite the potential for medical benefit offered by ES and EG cells, the origin of these cells
raises policy and ethical concerns. The policy issues primarily concern the use of existing legislative and
regulatory schemes to govern research using ES cells and the sources of funding for research involving
human embryos and foetal tissue. The ethical concerns are primarily related to the moral status of the
embryo and the aborted foetus.
How one evaluates the act of deriving ES cells depends on whether one believes the human
embryo is a person, a mass of human cells, or something in between which requires special respect.10
Science cannot answer this question for us. Currently, many western countries permit embryo research for
specific purposes and within certain strict limits.11 They proceed from the view that embryos have neither
the moral status of persons nor that of mere cells; because of their special connection with the human
community they enjoy an intermediate position that requires that they be treated with special respect.12
The use of foetal tissue to isolate EG cells is less problematic than the similar use of human
embryos for three reasons. First, the removal of EG cells from foetal tissue does not occasion the
destruction of a live foetus. Secondly, there is no question of creating foetal tissue specifically for research.
Thirdly, the use of foetal tissue to develop therapies for people unrelated to reproduction has been raised
before in the context of foetal tissue transplantation, and therefore a number of laws and policies exist
regarding this use. Consequently, EG cell researchers and funders should be aware of safeguards and
guidelines regarding the use of foetal tissue in research.13
International policy recommendations for ES and EG cells research
The United States
EG cell research:
Human foetal tissue has been used in research aimed at developing therapies for disorders, such as
Parkinson´s disease, by transplanting that tissue into afflicted people. Prior to 1993, laws in the United
States prohibited the use of federal funds for this research since the tissue used is obtained from aborted
foetuses. In 1993 President Clinton lifted that ban. A number of restrictions exist to ensure that foetal tissue
for research is obtained in a manner that respects the women from whom it is taken, and that such research
does not encourage abortion.14 These restrictions can and should apply to EG cell research.
Limitations of the use of foetal tissue in transplantation include three main restrictions. First, the
physician is required to obtain the woman´s informed consent to use foetal tissue removed from her body.
Second, to ensure that the possibility of donating tissue to benefit medical science does not influence a
woman´s decision, the donation of foetal tissue can only be discussed following a decision to terminate the
pregnancy. Finally, restrictions mandate that a woman cannot direct that her foetal tissue be used to benefit
a particular person. Both the National Bioethics Advisory Commission and the National Institutes of
Health indicated that these guidelines should be expanded to apply to EG cell research.15 Changes to the
informed consent required to use foetal tissue would mirror those indicated below with respect to the use of
donated embryos, including specific consent to the use of the tissue for stem cell research.16
In the United States, existing federal law prohibits federal funding of research using human
embryos.17 The law limits the ability to conduct research on embryos that would lead to the discard or
destruction of the embryo, in which case only interventions intended to benefit the embryo and conducted
on embryos intended for implantation would be permissible. Consequently, private corporations have
taken the lead in this research and have, as mentioned above, isolated the first human ES cells. In
November 1998 President Clinton appealed for guidance to the National Bioethics Advisory Commission
(NBAC).18 In January 1999 the Director of the National Institutes of Health (NIH) issued a moratorium on
NIH-funded research using human pluripotent stem cells derived from human embryos and foetal tissue
pending examination of the law. That same month the NIH received a legal opinion that the current law can
be interpreted so that it is legal to fund research on human ES cells so long as federal funds are not used to
support the derivation of those cells.19
Although this legal interpretation may be technically sound, it places the American government in
the paradoxical position of withholding funds from research to derive ES cells but permitting funds for
research on ES cells once they have been derived using private funds, or once they have been imported
from countries without restrictions on embryo research. This paradox is explicitly acknowledged by the
French National Commission: "We are approaching a paradoxical situation as a result of legislation: ...
experimentation or therapeutic research on [stem cells] from embryos in vitro are banned, but it is possible
to import cells from collections established without any observance of specific ethical law applicable in
France to embryonic cells".20 The same situation applies in Australia where research on ES cells is being
conducted on cell lines created in Singapore.21 Despite the foregoing, the NIH guidelines, discussed below,
are based on that legal opinion.
National Bioethics Advisory Commission
In response to the President´s letter of November 1998, NBAC was charged with the task of
analyzing the ethical implications of primordial stem cell research and recommending directions for future
regulation of this research. NBAC published its report Ethical Issues in Human Stem Cell Research in
September 1999. With respect to EG cells, NBAC endorsed the use of foetal tissue for the derivation and
use of these cells provided the restrictions in the foetal tissue transplantation laws already in effect were
followed. NBAC also specifically recommended that changes are needed to make it explicit that the
restrictions on the use of tissue from aborted foetuses for transplantation should apply to the research on
EG cells from that tissue.22
NBAC debated the ethics of ES and EG research and, convinced that the promise of primordial
stem cell research was great, recommended a partial lifting of the embryo research law so that embryo
research, both deriving stem cells and using derived stem cells, could be eligible for federal funding.23 Of
particular importance was the finding that a distinction between the derivation of ES cells and the use of
those cells was not morally relevant.24 In addition, NBAC stated that relying on cell lines derived
exclusively by privately-funded researchers could severely limit scientific and clinical progress, and would
diminish the scientific value of the activities receiving federal support. NBAC gave the following reasons
in support of their assertion:
-
Researchers using ES cell lines will derive substantial scientific benefits from a detailed
understanding of the process of ES cell derivation
-
Significant basic research needs to be conducted regarding the process of ES cell derivation before
cell-based therapies can be realized, and this work must be pursued in a wide variety of settings
including those exclusively devoted to basic academic research
-
ES cells are not indefinitely stable in culture, therefore it is especially important in the first few
years of ES cell research to be able to repeatedly derive ES cells in order to ensure that the
properties of the cells that are being studied have not changed.
Consequently, NBAC recommended that provisions be enacted applicable to funding by all federal
agencies that would carve out a narrow exception for funding of research to use or to derive human ES cells
from embryos that are being discarded by infertility treatment programmes.25
In reaching this conclusion NBAC recommended the following limitations to ES cell
research:
In addition, the Commission stated that voluntary compliance with the recommendations by the private
sector should be encouraged.
National Institutes of Health
The NIH published draft guidelines on the use of human pluripotent stem cells on December 2,
1999. NIH received over 50,000 comments from various groups, members of congress and private citizens
in the 90-day public comment period. On August 25, 2000 the NIH published and brought into effect
National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells (NIH
Guidelines). These Guidelines lifted the January 1999 moratorium on research using human pluripotent
stem cells. The NIH Guidelines apply to human pluripotent stem cells derived from foetal tissue or from
embryos that are the result of IVF, are in excess of clinical need, and have not reached the stage at which
the mesoderm is formed. They do not impose requirements on federal funding of research involving stem
cells from human adults, umbilical cords, or placentas.
The NIH Guidelines endorsing ES and EG cell research are based on the conclusion that no single
source of stem cells may be best or even suitable for all therapies. The Guidelines further highlight the
importance of research comparing the potential of adult stem cells with primordial stem cells derived from
embryos and foetuses in order to determine the best source for the specialized cells and tissues needed for
new treatments. In addition, the Guidelines note that adult stem cells may be more limited in potential and
in availability than primordial stem cells, and may be more prone to genetic defects.27
The Guidelines state that funds may be used to derive human pluripotent stem cells from human
foetal tissue, but may not be used to derive human primordial stem cells from human embryos. Unlike the
NBAC recommendations, the NIH Guidelines draw a distinction between the derivation and the use of ES
cells; the former is not eligible for funding while the latter is. With respect to ES cells the Guidelines are
similar to NBAC´s recommendations in that NIH funds may be used for research on stem cells only if they
were derived from embryos left over from infertility treatment. NIH-funded researchers may not use ES
cells derived from embryos created by SCNT nor embryos created specifically for research by any means.
The result of these Guidelines is that derivation of ES cells will be funded with private money.
The Guidelines distinguish between materials required to apply for NIH funding, conditions
required for funding eligibility and research that is not eligible for NIH funding. Required in application for
funds are assurances that EG cells were derived following the conditions and restrictions set out in the
Foetal Tissue Transplantation laws.28 With respect to ES cells, required in application for funds are
assurances that ES cells were derived from human embryos in accordance with certain conditions and that
the institution will maintain documentation in support of those assurances. Researchers seeking funding
must provide the NIH not only with the research protocol proposing to use primordial stem cells but also
documentation of IRB approval of the stem cell derivation protocol.
The following conditions must be fulfilled for ES funding eligibility:
-
Only embryos created for purposes of fertility treatment and remaining in excess of the
clinical need of the individuals seeking fertility treatment may be used in research
-
No inducements, monetary or otherwise, can be offered for the donation of human embryos
for research purposes
-
Fertility clinics and labs should have specific written policies and practices to ensure no
such inducements are made
-
There must be a clear separation between the decision to create embryos for fertility treatment
and the decision to donate human embryos for stem cell research
-
To allow adequate time between decisions only frozen human embryos should be used
for stem cell research
-
The decision to donate embryos for stem cell research must be free from influence of
researchers
-
The attending physician responsible for the fertility treatment and the researcher/investigator
deriving and/or proposing to utilize human pluripotent stem cells should not be the same person
-
Fertility patients are to be approached about a donation decision only when they are deciding
about the disposition of excess embryos
-
No directed donation of embryonic tissue or stem cells derived from that tissue is permitted
by the donors 29
-
IRB approval is required with respect to the research protocols for the derivation of both ES
and EG cells
With respect to achieving the informed consent of the embryonic tissue donors the following conditions
must be satisfied:
-
Researchers must specify to the tissue donor whether information that could reveal his or her
identity will be retained
-
Donors must be informed of possible commercial benefit resulting from research on donated
stem cells and that the donor will not have access to that commercial benefit 30
-
Donors must be informed that no medical benefit will be accruing to the donor
With respect to the oversight of primordial stem cell research, the NIH Guidelines echo the
recommendation in NBAC´s report by providing for the creation of the NIH Human Pluripotent Stem Cell
Review Group. This working group would review documentation of compliance with the guidelines for
funding requests and provide a yearly report on research funded and protocols submitted.
It is important to note that the question of funding for ES cells is far from settled. The selection of
the President will likely have a profound impact on the Guidelines. Given his stance on abortion, Governor
Bush is unlikely to be in favour of government funding for embryo research, whereas Vice-President Gore
has indicated he is supportive of ES cell research.31 In addition, there are a number of bills currently before
Congress and the Senate both expanding and restricting the use of government funding of ES cell
research.32
The United Kingdom 33
There is no specific legislation currently in force in the UK to regulate research on stem cells once
extracted from embryos or research aimed at deriving stem cells from other, non-embryonic sources such
as an aborted foetus or adult cells. However, the United Kingdom has one of the most respected and
comprehensive models of ART regulation. Within that framework it is possible to accommodate scientific
developments and adapt the legislation with minimal disruption of the system. This is discussed below in
the context of ES cell research.
A Code of Practice laid down by the Polkinghorne Committee in 1989 governs the use of foetal
tissue, while guidance from professional and research bodies and from the Department of Health governs
research more generally. The code laid down in the Polkinghorne Report is similar in its restrictions on the
use of foetal tissue to that of the United States mentioned above. These restrictions should apply to EG cell
research in the United Kingdom.
The Warnock Report issued in 1984 canvassed the ethical and policy issues with respect to
assisted reproductive technologies and recommended regulatory authority and guidelines with respect to
embryo research.34 In 1990 the Human Fertilisation and Embryology Act 1990 (HFEA) was passed. In
addition to setting out limits and prohibitions on embryo research, the HFEA created a regulatory authority,
the Human Fertilisation and Embryology Authority (HFE Authority), endowed with exclusive power to
grant licenses necessary to conduct embryo research in the UK. Only purposes specified under the Act are
eligible for licensing.
The HFEA, arguably one of the most liberal embryo research acts, makes no explicit provision for
research such as stem cell research aimed at replacement of diseased or damaged tissues. However the
HFEA provided a mechanism to add research purposes not currently available for licensing through
amendment of the regulations to the Act. In light of the announcement of the discovery of primordial stem
cells, the Human Genetics Advisory Commission and the HFE Authority (HGAC/HFEA Statement) issued
a joint report including the following statement in December 1998:
[W]hen the 1990 HFE Act was passed, the beneficial therapeutic consequences that could
potentially result from human embryo research were not envisaged. We therefore recommend that the
Secretary of State should consider specifying in regulations two further purposes to be added to the list
[of approved purposes], being:
-
Developing methods of therapy for mitochondrial diseases
-
Developing methods of therapy for diseased or damaged tissues or organs.35
In addition, the HGAC/HFEA Statement specifically recommended permitting research of this
sort, advising that it would be unwise to rule out research using cloning techniques (called Cell Nucleus
Replacement [CNR] in the United Kingdom) involving embryos "that might prove of therapeutic value."36
The Nuffield Council on Bioethics endorsed this recommendation by the HFEA/HGAC.37 Rather
than adopting the HGAC/HFEA recommendations however, the British government responded to the report
by setting up an expert advisory group to further study the need for, benefits and risks of therapeutic
cloning in humans.38 That panel, headed by chief medical officer Liam Donaldson, issued a report to the
government in May 2000 which was published August 16, 2000 entitled Stem Cell Research: Medical
Progress with Responsibility. Among its primarily recommendations was the modification of the HFEA to
permit stem cell research for the aims outlined by the HFEA/HGAC Statement above.
The following conclusions were established in the report and provide the basis for the Expert
Groups´ recommendations:
At the same time as it released the Expert Group´s report, the British Government published a
response to the report endorsing all of its recommendations.39 The government subsequently drafted
legislation implementing the recommendations and placed this legislation before the British Parliament for
a free vote. The proposed expansion of ES cell research was passed by a vote of 366 to 174 on December
19, 2000. 40 The British government has also promised new legislation explicitly outlawing the reproductive
cloning of human beings a procedure currently prohibited under the regulations, but thought to require
additional explicit condemnation. In response to the UK report and government response the Vatican
condemned the proposed changes.41 The Vatican position articulates an unambiguous condemnation of ES
cell research as well as EG research which cannot be morally condoned because by using tissue from
aborted foetuses it requires complicity in abortion, a practice condemned by the Catholic Church.
The Pontifical Academy for Life published from Vatican City, August 25, 2000 a Declaration on
the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells. That declaration
concluded that ES cell research was in some respects not necessary given the potential for reprogramming
of adult stem cells. Nevertheless, the declaration states that even if it ES cell research could be shown to be
necessary, it is unethical on its own terms based on the understanding that from conception a "human
identity is created, which from that point begins its own coordinated, continuous and gradual development
such that at no later stage can it be considered as a simple mass of cells." Given this premise the following
reasons were given to explain why ES cell research is illicit and immoral:
-
A human individual with a right to its own life is created at conception.
Consequently, any intervention that is not in favour of the embryo is an act that violates that right
and is gravely immoral and illicit. The ends of ES cell research, although believed to be good, can
neither justify such an immoral intervention nor make right an action that in itself is wrong.
-
Every type of therapeutic cloning, which implies producing human embryos and
then destroying them in order to obtain stem cells, is illicit.
-
ES Cells and the differentiated cells obtained from them, which are supplied by
other researchers or are commercially obtainable cannot be morally used, as such a use would be
morally complicit with the immoral actions of deriving those cells.42
A similar conclusion was drawn in Germany with respect to the ability to conduct ES cell
research, but for very different reasons than those articulated by the Vatican.
Germany
The German Embryo Protection Act, 1991 is one of Europe´s strictest embryo research
laws and ostensibly protects human embryos from all harmful research. In discussing the use of ES cells,
the German government came to the conclusion that there was no need to relax the strict embryo protection
laws to permit ES research, since EG cell research is permitted under laws relating to the use of foetal
tissue.43 Since that time, discussions have continued between those in favour of liberalising the embryo
research laws to permit some ES cell research and those against all embryo research.44 These discussions
have continued in earnest since the UK recommendations were announced.45 To date no legislation has
been drafted or tabled.
The European Group on Ethics in Science and New Technologies to the European Commission (EGE)
On November 14, 2000 the EGE published Opinion No. 15 entitled Ethical Aspects of Human
Stem Cell Research and Use. EU directives currently exist which prohibit the patenting of embryos or
commercial uses of human embryos. The EGE will issue a future opinion on the ethical aspects related to
the patenting of inventions involving human stem cells, consequently Opinion 15 does not address these
issues with respect to stem cells.
With respect to EG cells, the EGE Opinion reaffirms the need to ensure that decisions to terminate
pregnancy are not influenced by the therapeutic possibilities the use of fetal tissue may occasion. As with
other regions, the need for specific consent to use foetal tissue in research is required and commercial trade
in this tissue is forbidden.
The EGE recognizes that the most promising therapeutic application of ES cells would be the
production of specific cell lines for therapeutic transplantation, while recognizing that the use of these cells
in clinical application is still well in the future. The EGE underscores the pluralism of the European Union
(EU) by briefly outlining the different approaches to embryo research in the EU member states. Some
states have embryo research legislation, some do not and some have judicial pronouncements that direct the
permissible scope of embryo research. Although at a national level stem cell research is not regulated as
such, that situation is in flux as several countries; notably the UK, the Netherlands and Belgium are in the
process of drafting legislation.46
Where embryo research is permitted for research into infertility, restrictions ensure that embryos
used in such research must be destroyed (i.e. cannot be implanted). Consequently, the EGE could find no
argument that would prohibit the expansion of permissible embryo research to include research aimed at
developing new treatments to cure severe diseases or injuries. The EGE was of the opinion that funding for
this research should be available through the EU Framework programme of research, if the research
complies with the ethical and legal requirements defined therein.
Specific funding should be allotted in the EC research programme for stem cell research based on
spare embryos, foetal tissue and adult stem cells. The creation of embryos for stem cell production,
however, was considered ethically unacceptable when spare embryos exist as an alternative source. In
addition, although the EGE noted that the creation of embryos by SCNT might be the most effective way to
derive stem cells that are histocompatible, they were not persuaded of the necessity to fund this research at
this time. Balancing the low levels of success in SCNT and the resulting remote therapeutic prospects
against considerations of trivializing the use of embryos and exerting pressure on women as a source of
oocytes (the provision of cell lines would require large numbers of oocytes), the EGE concluded that the
creation of embryos by SCNT for research on stem cell therapy would be premature given existing
alternative sources.
Other recommendations of interest include provisions to ensure the safety of women involved in
infertility treatments and the need to ensure that demand for spare embryos and oocytes do not increase
clinical pressure on these women. The EGE also underlined the need for confidentiality, free and informed
consent, including specific consent to ES cell research by gamete and embryo donors, and the need to take
a precautionary approach to protect the health of persons involved in clinical trials involving stem cells.
Finally, the EGE emphasized that in the countries where it is permitted, it is crucial to place ES cell
research under strict public control by a centralized authority, patterned along the lines of the UK HFE
Authority. Authorizations to conduct ES cell research, whether carried out by the pubic or private sector,
should be awarded on a highly selective basis and based on a case-by-case approach. National or European
level licensing of stem cell imports and exports would be appropriate.
The foregoing description of international policy initiatives with respect to ES and EG cell
research is useful in recognizing what issues connected to primordial stem cell research merited separate
regulatory consideration, rather than using existing policy. The question posed is whether there exists in
Canada a regulatory infrastructure that can deal with primordial stem cell research in a manner sufficient to
handle the ethical and policy issues specific to these cells.
What policies exist in Canada that would apply to primordial stem cell research?
In the absence of comprehensive ART regulation in Canada, there are a few quasi-legal sources of
regulatory guidance that should be examined. In 1989 the Prime Minister appointed the Royal Commission
on New Reproductive Technologies (Royal Commission) to examine the social, legal and ethical
implications of developments in reproductive technology. Meetings and public consultation were held over
a period of two years and the commission issued its final report, Proceed with Care: The Final Report of
the Royal Commission on New Reproductive Technologies in November 1993. Significant guidance exists
in the Royal Commission´s report to aid in the development of ART policy, including stem cell research,
although the report has no legal force.
Drawing on the recommendations of the Commission, the Minister of Health issued a voluntary
moratorium on nine reproductive technology practices in July 1995. 47 Of interest in the context of this
paper were the inclusion of human embryo cloning and the creation of animal human hybrids. That
moratorium continues to be in force, however, its voluntary nature means that the moratorium has no legal
force per se including no means for sanctioning those not in compliance. Researchers receiving federal
funding would likely be under pressure to conform to the health minister´s call for a moratorium in order to
be seen to be practicing on the highest ethical ground. To the extent that researchers choose not to comply
with the voluntary moratorium they may be accused of breaching the highest articulated standards for
reproductive research; consequently, the moratorium may have some persuasive or moral authority in the
private as well as public research spheres. Given the lack of enforcement and sanctioning mechanisms, it is
not surprising however, that there have been suggestions that the voluntary moratorium is not working.48
Bill C-47, a federal law, was drafted in which the recommendations of the Royal Commission
were partially incorporated, including the ban of 13 reproductive technology practices. The proposed
Human Reproductive and Genetic Technologies Act, included a ban on creating embryos for research,
contrary to the recommendation of the Royal Commission. It also did not seek to establish a national
regulatory and licensing body as recommended by the Royal Commission. The Bill died on Order Paper in
April 1997. No further legislation has been tabled as of the writing of this paper.
In 1994 the three research councils responsible for funding research in the medical, natural and
social sciences began work on a joint policy on human experimentation. The Medical Research Council
(MRC),49 National Sciences and Engineering Research Council (NSERC) and the Social Sciences and
Humanities Research Council (SSHRC) formed a working group that issued three working papers for
public and academic discussion in 1994, 1996 and 1997. The Councils issued the Tri-Council Policy
Statement: Ethical Conduct for Research Involving Humans in September 1998. 50 The Tri-Council
Statement is mandatory only for those individuals and institutions applying for or receiving funding from
any of the government councils. When the controversy of the independence of researchers at the Hospital
for Sick Children in Toronto erupted, the MRC indicated that it would try and expand the policy statement
to all research involving humans regardless of funding source.51 To date this expansion has not been
effected. While this expansion may not be possible under the current articulation of the Tri-Council
Statement, it is important to note that there is clearly some desire to ensure that all researchers are explicitly
bound by the standards articulated therein. Like the voluntary moratorium, the Tri-Council Statement is
not binding on and therefore, has no legal force per se on privately funded researchers. It may, however,
have persuasive or moral force in that it articulates accepted standards for ethical practice. Nonetheless, in
the absence of a uniformly enforceable standard of conduct for both private and public researchers, the
legal situation in Canada is somewhat similar to that in the United States: existing standards relate to public
funding guidelines and the private sector acts without significant regulation or voluntarily conforms to the
public funding guidelines and moratorium.
The following articles in the Tri-Council Statement would apply to ES cell research:
-
Embryos may not be created for research purposes (Art. 9.4)
This article would seem to limit the ability of Canadian researchers to investigate the mechanisms of ES
cell formation and cell differentiation, as the only source of embryos for research would be surplus
embryos from IVF donation. It does not, however, inhibit the derivation of stem cells from embryos.
This article would seem on its face to result in the denial of funding for ES cell research involving SCNT
that might eventually lead to autologous transfer of tissues.
-
It is not ethically acceptable to undertake research that involves cloning human beings by any
means including somatic cell nuclear transfer (Art. 9.5)
It is unclear whether the wording of this article would, on its own, restrict the creation of embryos by
SCNT for therapeutic research.
Additionally, articles 9.1, 9.4 and 10.2 provide information on the informed consent process when
using human gametes, embryos and other tissues. The information that must be communicated to
prospective tissue donors includes the purposes of the research, any identifiers that might link the donor to
the tissue used in research, potential commercial uses of the tissue, and implications for donor privacy.
Policies that address the use of foetal tissue for therapy indicate consensus exists that the guiding
principles in this regulation should be respect for the woman´s dignity and integrity, and respect for human
life. The limitations on research involving foetal tissue in the Tri-Council Statement include the same
limitations articulated above in the United States regulation 52 including the need to obtain free and
informed consent to use the tissue, the need not to interfere with the woman´s decision to continue or
terminate her pregnancy, the prohibition against directed donation, and REB approval.53
In addition, the Royal Commission advocated the establishment of a regulatory and licensing
scheme to ensure that research projects using foetal tissue meet applicable ethical and scientific research
standards.54 Finally, the Commission also stated that regulations be enacted to avoid the commercialization
of foetal tissue. The Canadian Royal Commission states that the non-commercialisation of reproduction is
one of their guiding principles. They recommended that no for-profit trade be permitted in foetal tissue and
recommend that the "prohibition on commercial exchange of foetuses and foetal tissue extend to tissues
imported from other countries."55 Whether similar restrictions should apply to ES and EG cell lines is
unclear.56
How might Canadian Policy address Primordial Stem Cell Research?
The Canadian government has three broad choices for policy development with respect to
primordial stem cell research:
1. Stay with the status quo
One option open to the Canadian government is to make no changes to the current regulatory
structure. This option would leave the voluntary moratorium and the Tri-Council Statement as the primary
regulatory guidelines within which stem cell research would be addressed. It is the opinion of this author
that, as currently drafted, this regulatory structure is not sufficient to deal with the advent of stem cell
research. The conclusions of the Expert Panel from the United Kingdom articulate why stem cell research
needs to be specifically addressed in regulation.57 In addition, there is little question that currently
unanticipated uses of stem cells will be developed in the future; leaving the current framework in place to
deal with future scientific developments in this field could impede socially beneficial scientific research
and will likely create or exacerbate division between public and private funding in Canadian embryo
research for several reasons:
-
There are ambiguities in the Tri-Council Statement when applied to primordial stem cell
research.58
-
Current restrictions on the creation of embryos would apply to stem cell research. This limit
to scientific experimentation would take place without the benefit of public or scientific
dialogue balancing the medical benefits of this research, in particular the promise of
autologous transplantation, with the moral costs associated with the creation of embryos for
research purposes. Such dialogue is necessary as these concerns are multi-faceted and public
discourse indicates that opinions about the balancing of these issues are in a state of flux.
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No specific guidelines exist with respect to the importation of stem cells from other countries.
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No discussion of patenting issues with respect to stem cell lines or created embryos exists in
this context. Restrictions on commercialisation of reproductive tissue may or may not be
applicable to products of reproductive tissue.
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Given the financial potential of therapies developed from stem cell research and the influx of
biotechnology funding into Canada from multi-national corporations, it is likely that
differences between privately and publicly funded research will be created or exacerbated if
privately funded researchers are not explicitly subject to the same standards as publicly
funded-researchers. The situation in the United States, in which prohibitions in the public
sphere serve as an expedient political response to controversial moral issues, while private
research continues without similar guidelines should be avoided, especially where
considerable moral consensus exists.
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No mechanism exists for tracking the progress of stem cell protocols to determine if the
potential benefit promised is being delivered, if guidelines are being followed or whether
different research models are warranted.
Another policy option related to the "Status Quo" option exists. It may be possible to expand, amend,
and revise the current standards articulated by the voluntary moratorium and the Tri-Council Statement in
order to clarify the ambiguities and overcome the difficulties noted above. The challenge for this option,
however, is whether such an amendment process would adequately resolve these conflicts, provide the
necessary clarity with respect to primordial stem cell research and yet maintain the integrity of the
underlying documents. Nonetheless, with the influx of international biotechnology capital into Canada it
will become increasingly important that privately funded researchers are held to enforceable legal standards
of conduct in the future.
2. Enact specific legislation with respect to stem cell oversight and guidance
While this option has the benefit of addressing specific issues not currently addressed in the
voluntary moratorium and the Tri-Council Statement it has significant drawbacks as a method of creating
science policy. Ad hoc legislation in the field of ART leads to inconsistencies in policy, does not make
clear the ethical commitments a society has in developing science policy, and is reactive in nature rather
that proactive. This latter quality leads to an inability to create flexible and consistent policy, which
addresses like cases alike and anticipates scientific developments within the field.59
3. Enact a broad scheme of regulation which addresses ARTs, including embryo research, and
within that framework address the scientific, ethical and social issues raised by primordial stem
cell research
This option is the preferred option, although it generally requires both a longer process and
broader vision than either of the preceding options. This was the recommendation of the Royal
Commission. In the area of embryo research, national and local regulation has several advantages over
guidelines that apply only to those institutions receiving federal money. Leaving oversight of protocols to
local REBs does not promote consistency, nor do most REBs have the time or expertise to create ethical
and scientific guidelines for this research. National regulation in an area of moral controversy requires that
the ethical commitments implicit in the decision to permit, restrict or prohibit certain research are explicit
and are uniformly applicable.60 Such transparency and consistency should be the goal of ART legislation,
including regulation of primordial stem cell research. If a practice is morally suspect or incurs such moral
costs that it should be prohibited, then there is little reason to permit such a practice in the private but not
the public spheres. A system like the British system, which requires researchers to be licensed and research
to be approved, ensures that a society´s ethical commitments are being respected uniformly.
A regulatory scheme rather than one based on the criminal law permits greater flexibility and
discussion. For example, where subcommittees are responsible for overseeing various scientific research
protocols in a given area of research, those subcommittees will develop specific expertise and can be
entrusted with discretionary authority. Mechanisms for tracking research protocols, ensuring that the
creation of embryos or use of stem cells is necessary can be part of the mandate of the responsible
authority. In addition, a regulatory scheme can be created which enables research aimed at new ends or of
a different type to be added through amendment to regulations, rather than introducing new legislation or
repealing overly restrictive legislation.
In this respect the Royal Commission remains the single greatest source of policy guidance with
respect to drafting thorough, thoughtful ART policy. Clearly the Commission´s recommendations would
have to be updated to accommodate scientific developments in primordial stem cell research. Guidance is
clearly also available in examining the approach taken in the United Kingdom. For example, the Warnock
report adopted the following recommendation strategy:
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Frame recommendations in general terms, leaving matters of detail to be worked out by
government;
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Indicate what should be matters of good practice;
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Indicate what recommendations, if accepted, would require legislation, and
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Any proposed changes apply equally through the UK.61
With respect to embryo research and stem cell derivation and use, guidance on framing the issues involved
can be found by examining the commonalities in guiding principles and recommendations strategies
outlined by other countries. In making decisions about using embryos in research or ART, most national
commissions adopted a long-term vision. This means that recommendations should be drafted in general
terms and allow for flexibility and adaptability in the face of future developments.
Although the responses of the various groups and regions examined are diverse, one can discern a
few points of emerging consensus. It seems clear that the question of ethical acceptability of EG cell
research is less controversial than ES cell research. It is also apparent that the question of the acceptability
of ES cell research is intimately bound up with the issue of embryo research. In general, where embryo
research is permitted for some purposes, the use of spare embryos for ES cell research is deemed
appropriate. There is little agreement on the acceptability of creating embryos for research and relatively
little support for the creation of embryos using SCNT at this time. Most countries express both a desire to
create policy that specifically addresses primordial stem cell research, and a desire to regulate that research
in a careful and on-going fashion so as to gage the research outcomes. Concerns about informed consent,
the health and safety of women and confidentiality are also integral to creating stem cell policy.
The Canadian government is faced with an opportunity to build upon the thoughtful work of both
the Royal Commission and the three research councils in responding to the advent of primordial stem cell
research. Should the government decide to create policy in this area, there is significant wisdom in
analyzing the response of countries with similar cultural backgrounds and legal traditions. It is to be hoped
that there will be a thoughtful and balanced response from the Canadian government that respects the
principals articulated in the Royal Commission, including respect for human life and dignity and respect for
women.
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