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Betwixt and between human stem cell guidelines and legislation.


On March 4, 2002, the Canadian Institutes of Health Research released its guidelines Human Pluripotent Stem Cell Research: Guidelinesfor CIHR-Funded Research. (1) The CIHR is Canada's major federal funding agency for health research and the new research guidelines (in tandem with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2) set out the conditions under which CIHR will fund human stem cell research. The stem cell guidelines also carefully outline those types of research that are not eligible for CIHR funding. In very general terms, research to derive and study human stem cell lines from embryos, fetal tissue, amniotic fluid, the umbilical cord, placenta, and other body tissues (either from persons or cadavers) is eligible for CIHR funding. Research not eligible for CIHR funding includes research involving the creation of human embryos for research purposes, the use of somatic cell nuclear transfer to develop stem cell lines, the mixing of human or non-human stem cells wit h a human embryo or fetus, and the mixing of human stem cells with a non-human embryo or fetus.

Two months later, on May 9, 2002, the federal government released Bill C-56, An Act respecting assisted human reproduction. (3) The proposed legislation and regulatory framework is the government's most recent attempt to regulate various aspects of infertility treatment. Since many of the new reproductive technologies involve the creation and manipulation of in vitro human embryos, the bill necessarily includes a number of provisions that apply directly to embryo research. These provisions overlap with some of the CIHR guidelines for stem cell research. Among these provisions is the requirement that embryo research only be permitted on in vitro embryos discarded by infertility clinics, and only when the licensing Agency is "satisfied that the use is necessary for the purpose of the proposed research." (4) Some believe these proposed legislative requirements are a significant barrier to promising embryo research, while others believe this limit to be morally required.

More recently, on September 16, 2002 Parliament was prorogued. With the prorogation of Parliament, all bills on the Order Paper (i.e., bills under consideration that have not received Royal Assent) are considered dead. (5) This included Bill C-56. Significantly, this is not the first time the federal government has tried to introduce comprehensive legislation on assisted human reproduction only to have the bill die on the Order Paper. In 1996, the government introduced Bill C47, the Human Reproductive and Genetic Technologies Act. (6) This bill also died on the Order Paper in the spring of 1997 when a federal election was called before the legislative process was complete. Fortunately, however, Bill C-S6 has not shared the same fate as Bill C-47. On October 9, 2002, Bill C-S6 was introduced in the House of Commons and reinstated at the same stage in the legislative process, as prior to prorogation. (7) The reinstatement of the bill reflects the fact that much has changed since 1997 when the previous bill died . For many it is now imperative that some kind of regulatory framework for infertility treatment and human embryo research be put in place.

Among the significant changes that have occurred since the original bill on reproductive technologies died on the Order Paper is the growing interest in stem cell research, on the part of both scientists and the general public. In November 1998, there were three dramatic announcements of successful privately-funded research in the United States on the derivation of human stem cells. James Thomson and colleagues announced that they had isolated human embryonic stem cells from embryos remaining after infertility treatment. (8) John Gearhart and colleagues announced that they had isolated human embryonic germ cells using aborted fetal tissue. (9) And finally, Advanced Cell Technology disclosed that it had created a hybrid embryo by fusing human nuclei with enucleated cow oocytes, and that cells resembling human embryonic stem cells had been isolated. (10) Since then, scientists around the world have been working aggressively in this area of research, while governments, and quasi-governmental and professional org anizations, have been scrambling to draft relevant legislation and guidelines.

At present, in Canada, there is considerable uncertainty as regards the future of human stem cell research. The uncertainty stems from the fact that while there is much in common between the CIHR stem cell guidelines as they currently apply to embryonic stem cell research, and the proposed legislation on assisted human reproduction as it would apply to embryonic stem cell research, there are also very significant structural and substantive differences. Some of these differences are briefly summarized below to highlight more clearly why it matters so very much whether Bill C-13 (previously Bill C-56) (11) is enacted in its present form, in a revised form, or not at all.

Structural Issues


CIHR is a federal funding agency. Its mandate is to promote excellence in health research and it uses a peer-review process to identify research projects worthy of financial support.

In contrast, while the federal government funds research through its granting Councils (including CIHR), it is not a funding agency per se. The federal government's primary responsibility in the area of health research (in concert with provincial and territorial governments) is to protect the health, safety and privacy of its citizens.

The Public--Private Divide

The CIHR guidelines Human Pluripotent Stem Cell Research: Guidelines for CIHR-Funded Research and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans apply to research funded by CIHR and research conducted at institutions that receive any CIHR funding. To be precise, these guidelines apply to a subset of publicly-funded stem cell research and do not apply to privately-funded research conducted at Canadian research institutions that do not receive any CIHR funding. For now, a number of provincial research funding organizations and health charities have aligned themselves with the CIHR stem cell guidelines, but this is not required. Indeed, the decision to do so is at the discretion of these organizations and is therefore subject to change.

If Bill C-13 (or a version thereof) is enacted, the rules for human embryo research as entrenched in the new legislation and regulatory framework would supersede the CIHR stem cell funding guidelines and the TCPS where they overlap. Notably, the legislation would apply equally to research in both the private and public sectors. The benefits of a consistent national approach to human embryo research would be considerable. Researchers would be governed by one set of rules, not two or more depending upon the source of funding. There would be a level playing field for Canadian researchers, and no built-in incentive for researchers to move their research to the private sector. A common set of 'Canadian' social values (including values other than those associated with the marketplace) could direct human embryonic stem cell research.


The stem cell guidelines issued by CIHR are limited in scope insofar as they only set out the conditions under which certain research projects are eligible or ineligible for new and continued funding. For projects that receive CIHR funding, the sanction for non-compliance is loss of funding; institutions or all or any faculty not in compliance with the TCPS and the CIHR stem cell guidelines may be ineligible to continue receiving research funds.

Significantly, most of the embryonic stem cell research activities ineligible for CIHR funding are also prohibited in Bill C-13. In an effort to safeguard the interests of those who use assisted human reproduction and those who are born of these technologies, Bill C-13 prohibits creating a human clone, genetically altering the germ-line, maintaining an embryo outside of the woman's body beyond 14 days of development, creating human embryos solely for research purposes, and creating animal-human hybrids for reproductive purposes. A researcher found guilty of any of the above could be fined as much as $500,000, imprisoned for as many as 10 years, or both.

For some, these legal sanctions are excessive; dedicated scientists ought not to be at risk of heavy fines or lengthy jail terms. Others, however, bemoan the fact that CIHR (and its predecessor, the Medical Research Council of Canada (MRC)) have never exercised their authority to withdraw research funds for non-compliance with their guidelines for research involving humans. It is thought that severe sanctions will help ensure that scientists take care in proceeding with human embryonic stem cell research and related activities.

Excellence and Other Values

Excellence in research can be difficult to define in the abstract and, on occasion, difficult to identify in practice (and not only because of weaknesses with the peer-review system). Nonetheless, CIHR is firmly committed to funding excellent research that is in compliance with its research guidelines.

The federal government is also committed to research excellence (which, in Canadian fashion, it sometimes tries to balance with considerations of distributive justice). Not all excellent research involving human embryos, however, is permitted under Bill C-13. Embryo research is a controlled activity for which a license is required. The proposed legislation stipulates that "A license authorizing the use of an in vitro embryo for the purpose of research may be issued only if the Agency is satisfied that the use is necessary for the purpose of the proposed research." (12) It follows that if the Agency is persuaded that the proposed research could be done using stem cells from adults or from other sources, it can refuse to grant a license for embryonic stem cell research. This is a novel development in research review in Canada (welcomed by some, criticized by others) where the social and scientific value (as contrasted with the scientific validity) of proposed research may be scrutinized and ultimately may deter mine whether proposed research is allowed to proceed: "Not all paths to a worthy end are themselves worthy."

National Review

With the release of the stem cell guidelines, CIHR took the unprecedented step of establishing a National Stem Cell Oversight Committee to provide national research ethics review of all stem cell research. National review of similarly novel and controversial areas of research had been proposed before by the MRC Working Group on Somatic Cell Gene Therapy (1990)(13) and by the Royal Commission on New Reproductive Technologies (1993); (14) but for various reasons these recommendations were never acted upon. This time, however, the CIHR Ad Hoc Working Group on Stem Cell Research argued persuasively that a national committee would:

1. Provide a greater degree of accountability than currently exists with the local research ethics review system and thereby foster public confidence;

2. Ensure greater access to appropriate experts with the background and knowledge to review the research;

3. Minimize the potential for conflict of interest, as the reviewers can be completely at arms-length from the research proposals; and

4. Set the stage for a truly national review system that can be implemented as part of the AHR legislation and apply to both private and public sector research. (15)

These arguments were developed with an understanding that the forthcoming legislation on reproductive technologies likely would include some kind of national regulatory body, similar to the Human Fertilisation and Embryology Authority in the United Kingdom. (16) Indeed, Bill C-13 establishes the Assisted Human Reproduction Agency of Canada whose mandate includes issuing licences for research involving in vitro human embryos.

Significantly, while the CIHR guidelines foresaw (and planned for) the eventual creation of a legislated national regulatory body, the proposed legislation makes no reference to the CIHR national research ethics review process. This is perhaps not surprising, but it is nonetheless problematic in so far as no direction is provided as to how these two national committees might work together effectively if the legislation is passed and the Agency is created.

The CIHR Stem Cell Oversight Committee has a mandate to review all human stem cell research and will be operational (though perhaps with an amended mandate) regardless of whether Bill C-13 (or a version thereof) is enacted. If the legislation fails, the CIHR guidelines and the Stem Cell Oversight Committee will be authoritative in all matters concerning stem cell research. In the alternative, if legislation is enacted, the law will supercede the CIHR guidelines where there is overlap concerning embryonic stem cell research. With respect to the specific role of the Oversight Committee, in the short-term, embryonic stem cell researchers will be faced with uncertainty. Will they need to obtain an embryo research licence: i) before or after scientific peer review; ii) before or after local review by the Research Ethics Board; or iii) before or after national review by the CIHR Stem Cell Oversight Committee or some other national research ethics review body? (17)

Substantive Issues

In addition to these structural differences, there are important substantive differences between the CIHR stem cell funding guidelines and Bill C-13, notwithstanding claims to the contrary by Health Canada. In media releases available at the time Bill C-S6 (now Bill C-13) was announced, Health Canada affirmed that "The proposed Act respecting assisted human reproduction and the CIHR guidelines are consistent." (8) To be sure, in large measure the two documents are compatible. There are, however, inconsistencies that are not inconsequential.

Consent from Embryo Donors

At the outset, the TCPS stipulates that research involving humans may only begin if

...prospective subjects, or authorized third parties, have been given the opportunity to give free and informed consent about participation... (Article 2.1)

Later, in the section on research involving human gametes, embryos or fetuses, it is further explained that embryo research may only begin if the researchers have obtained free and informed consent from the individuals whose gametes (ova and sperm) were used to form the embryo (Article 9.1). This requirement is straightforward and seems obviously right when the gamete providers are using their genetic material in pursuit of their own reproductive project.

In some instances, however, the persons whose gametes are used to create embryos for reproductive purposes are not the same persons as those with the reproductive project, as when an infertile couple consents to the creation of embryos using donor ova, donor sperm or both. Recognizing this, the CIHR guidelines on stem cell research expand on the consent requirement for embryonic stem cell research. This consent must be obtained from:

...the persons for whom the embryos were originally created for reproductive purposes. Additionally, where 'donor' gametes have been used to create the embryos, the gamete providers must have originally given free and informed consent to the unrestricted research use of any embryos created when these embryos were no longer required for reproductive purposes. (Article 7.1.1)

That is, consent to embryonic stem cell research must be provided by the original gamete providers and the embryo providers (i.e., persons with the reproductive project). Sometimes these will be the same persons, sometimes not. Significantly, these consent requirements do not appear in Bill C-13.

One of the fundamental principles of Bill C-13 is free and informed consent:

The Parliament of Canada recognizes and declares that ...

s. 2(d) the principle of free and informed consent must be promoted and applied as a fundamental condition of the use of human reproductive technologies.

Indeed, there are several provisions in the bill on the use of human reproductive material and in vitro embryos without consent. Consider, for example,

s. 8(1) No person shall make use of human reproductive material for the purpose of creating an embryo unless the donor of the material has given written consent, in accordance with the regulations, to its use for that purpose.

(3) No person shall make use of an in vitro embryo for any purposes unless the donor has given written consent, in accordance with the regulations, to its use for that purpose.

Significantly, however, while the donors of reproductive material are defined in the legislation as the persons from whose bodies the material is obtained, the embryo donors are not defined. The definition of embryo donor is deferred to the regulations. This is odd and some might even argue irresponsible. Certainly it is difficult to reconcile the opening declaration of a commitment to the principle of free and informed consent with subsequent failure to clearly define in legislation from whom such consent should be obtained. The persons who might qualify as donors comprise a finite list, so why defer the decision? (19) Will the law require consent to embryo research only from the gamete providers, as per the TCPS? Alternatively, will the law require consent to embryo research from both the gamete providers and those with the reproductive project for whom the embryos were originally created, as per the CIHR stem cell guidelines? Or, will others be identified as embryo donors?

Clarity on this point is required in a timely fashion in order for in vitro fertilization clinics to appropriately amend their consent for embryo research forms. Presuming Bill C-13 (or a version thereof) is enacted, uncertainty on this point serves only to entrench delays in proceeding with whatever embryo research is permitted.

Creating Animal-Human Chimeras

Research that involves the genetic alteration of human gametes or embryos (Article 9.4), the formation of animal/human hybrids, or the transfer of embryos between humans and other species (Article 9.5) is precluded in the TCPS. Consistent with the spirit of these prohibitions, the CLHR stem cell guidelines stipulate that the following research is ineligible for CIHR funding:

7.4.4 Research in which human or non-human ES cells, EG cells or other cells of a pluripotent nature are combined with a human embryo.

7.4.5 Research in which human or non-human ES cells, EG cells or other cells of a pluripotent nature are grafted to a human fetus.

7.4.6 Research in which human ES cells, EG cells or other cells of a pluripotent nature are combined with a non-human embryo.

7.4.7 Research in which human ES cells, EG cells or other cells of a pluripotent nature are grafted to a non-human ferns.

At first glance, it might appear that the proposed legislation and the CIHR stem cell guidelines are consistent on this point since the creation of chimeras followed by transplantation into a human or a non-human are among the prohibited activities in the legislation:

s. 5(1) No person shall knowingly

(i) create a chimera, or transplant a chimera into either a human being or a non-human life form.

But to properly understand and appreciate the scope of this prohibition, one needs to pay close attention to the definitions provided for chimera and embryo. In the legislation,

"chimera" means:

1. an embryo into which a cell of any non-human life form has been introduced; or

2. an embryo that consists of cells of more than one embryo, foetus or human being.

And, in the legislation, an embryo is not an embryo of any species. It is solely an embryo of the species Homo sapiens. Embryo is defined in s. 3 of the bill as:

"embryo" means a human organism during the first 56 days of its development following fertilization or creation, excluding any time during which its development has been suspended, and includes any cell derived from such an organism that is used for the purpose of creating a human being.

It follows that s. 5(l)(i) prohibits the creation of an animal-to-human chimera (where non-human genetic or cellular material is added to a human embryo), and the creation of a human-to-human chimera (where human genetic or cellular material is added to a human embryo). (20) These prohibitions correspond to Article 7.4.4 of the CIHR stem cell guidelines. Notably, the creation of a human-to-animal chimera (where human genetic or cellular material is added to an animal embryo), and the creation of an animal-to-animal chimera (where non-human genetic or cellular material is added to a non-human embryo) are not prohibited in the bill. In contrast, the first of these creations (viz., a human-to-animal chimera) is explicitly prohibited in the CIHR guidelines (Article 7.4.6).

In some sense it is not surprising that research involving the insertion of human genetic or cellular material into animal embryos is not prohibited in the bill given the scope of the legislation. Bill C-13 is designed to regulate infertility treatment and not genetic technologies per se. This explains the narrow focus on the manipulation and disposition of human embryos. But this narrow focus is problematic given the multiple ways in which the bill intersects with a range of embryonic stem cell research activities. Moreover, failure to address all possible combinations of human and non-human genetic material makes for a very significant difference between the proposed legislation and the CIHR stem cell guidelines. While the CIHR guidelines prohibit all manner of chimera-making involving human cellular and genetic material, the bill only explicitly prohibits the insertion of human or non-human DNA into human embryos. To be precise, the insertion of human stem cells into animal embryos is not prohibited in the bill. What remains to be seen, however, is whether this type of research is outside the legislation, or whether it might be a controlled activity requiring a license.

Section 11 of the bill states that:

s. 11(1) No persons shall, except in accordance with the regulations and a licence, combine any part or any proportion of the human genome specified in the regulations with any part of the genome of a species spec qied in the regulations. (italics added)

According to Health Canada, this section was specifically included to allow for gene 'knock-out' and other transgenic experiments. That is, the intent was to regulate the mixing of DNA (splicing DNA into other cells), not the mixing of cells. It has been suggested that this intention will be clarified in the regulations. (21) If s. 11(1) is so clarified, then the creation of human-to-animal chimeras will be outside the ambit of the legislation, in which case the CIHR prohibition on this type of research will be in effect.

The fact is, however, that regulations clarifying this point may not be issued. Alternatively, if such regulations are issued, they may not clarify things in the manner suggested by Health Canada. Below is an alternative, plausible interpretation of how things could unfold such that creating human-to-animal chimeras would become a controlled activity.

Section 11(1) makes specific reference to "any part or any proportion of the human genome." In the legislation "'human genome' means the totality ofthe deoxyribonucleic acid sequence of the human species." Human cells contain the totality of the DNA sequence of the human species and so could be captured by this statute; claims to the contrary notwithstanding.

As well, the statute refers to combining "any part or any proportion of the human genome with a species to be specified in the regulations." To 'combine' is "to couple or join together; to cause to unite or coalesce into one body or substance." (22) On this definition of 'combine,' creating a cellular mosaic, as would happen if human stem cells were added to an animal embryo, could be captured by this statute. Indeed, only if 'combine' is interpreted narrowly to mean splice (or intertwine) would the Health Canada interpretation hold.

Finally, s. 11(1) makes explicit reference to the need for regulations to clarify the genome of the species with which the human genome (or any part or any proportion) could/could not be combined. If no species other than the species Homo sapiens is to be specified in the regulations, then it would have been more efficient to stipulate this in the legislation. Presumably the failure to do so is precisely because non-human species may be named in the regulations.

It follows that, depending upon the content of any regulations introduced pursuant to the legislation, inserting human stem cells into a non-human embryo to build a human-to-animal chimera could become a controlled activity for which a license must be obtained. Alternatively, s. 11(1) may be clarified in such a way that this type of research remains an unregulated activity, as suggested by Health Canada. In either case, this would be a substantially different position from that outlined in the current CIHR stem cell funding guidelines. These guidelines preclude funding for research involving the creation of animal-to-human, human-to-human, and human-to-animal chimeras.

In sharp contrast, only the first two of these three possibilities are prohibited in the legislation. The last activity is either unregulated (as suggested by Health Canada), or a controlled activity as suggested with the hypothetical reasoning outlined above.


Contrary to Health Canada's assurances that the proposed legislation and the CIHR guidelines are consistent, there are important structural and substantive differences. These differences should neither be ignored nor finessed. Rather, the differences should be confronted squarely, difficult policy choices should be made, and these value choices should be appropriately entrenched in the legislation.

(1.) Canadian Institutes of Health Research, Human Pluripotent Stem Cell Research: Guidelines for CIHR-Funded Research (4 March 2002), online: Canadian Institutes of Health Research < idelines_e.shtml> (date accessed: 18 September 2002) [CIHR].

(2.) Medical Research Council of Canada, National Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement on Research Involving Humans (Ottawa: Public Works and Government Services, 1998), online: Natural Sciences and Engineering Research Council of Canada <> (date accessed: 18 September 2002) [TCPS].

(3.) 1st Sess., 37th Parl., 2002(1st reading 9 May 2002), online: Parliament of Canada < chambus/house/bills/government/C-56/C-56_l/C-56_cover-E.html> (date accessed: 18 September 2002) [Bill C-56].

(4.) Ibid., s. 40(2).

(5.) Fact sheet on prorogation: < orogation-e.htm> (date accessed: 23 September 2002).

(6.) 2d Sess., 35th Parl., 1996(1st reading 14 June 1996) [Bill C- 47].

(7.) Generally, for a government bill to be revived in the next session of Parliament it must be reintroduced as a new bill. There is a process, however, whereby a government bill that has died on the Order Paper can be reinstated at the same stage it had reached prior to prorogation without having to begin the legislative process anew. This mechanism (which involves introduction of a motion that is debatable and votable) was used for Bill C-56 so that it could be brought back to the Standing Committee on Health where the process left off prior to prorogation. Even so, it is important to note that with the prorogation of Parliament all committee lists are cancelled and committee chairs are relieved of their duties. This means that although Bill C-56 has been reinstated as Bill C-13 and goes back to the Standing Committee on Health, it may be with a newly constituted committee and this, no doubt, would affect the pace at which the legislative process would proceed.

(8.) J.A. Thomson et al., "Embryonic Stem Cell Lines Derived from Human Blastocysts" (1998) 282 Science 1445.

(9.) M.J. Shamblott et al., "Derivation of Pluripotent Stem Cells from Cultured Human Primordial Cerm Cells" (1998) 95 Proceedings of the National Academy of Sciences USA 13726.

(10.) Nicholas Wade "Researchers Claim Embryonic Cell Mix of Human and Cow" New York Times (12 November 1998) A-1.

(11.) An Act respecting assisted human reproduction, 2d Sess., 37th Parl., 2002 1st reading 9 October 2002) online: Parliament of Canada < 13/C-13_ 1/CI3TOCE.html> (date accessed: 10 October 2002) [Bill C13]. Bill C-J3 was "Printed, pursuant to Order made October 7,2002, in the same form as Bill C-56 of the First Session of the Thirty-seventh Parliament, at date of prorogation."

(12.) Ibid., s. 40(2)[emphasis added].

(13.) Medical Research Council of Canada, Guidelines for Research on Somatic Cell Gene Therapy in Humans (Ottawa: Minister of Supply and Services Canada, 1990) at 34-35.

(14.) Canada, Royal Commission on New Reproductive Technologies, Proceed With Care. The Final Report of the Royal Commission Report on New Reproductive Technologies, vol. 1 (Ottawa: Minister of Supply and Services Canada, 1993) at 644-647.

(15.) Ad Hoc Working Group on Stem Cell Research, Human Pluripotent Stem Cell Research: Recommendations for CIHR Funded Research, January 2002, online: Canadian Institutes of Health Research < commendations_e.shtml> (date accessed: 17 September 2002).

(16.) Human Fertilisation and Emmbryology Act (U.K.), 1990, c. 37.

(17.) In the Speech from the Throne, September 30, 2002 the federal government made reference to "smart regulation" and went on to acknowledge the need "to work with provinces to implement a national system for the governance of research involving humans, including national research ethics and standards." A national system of governance might include national research ethics review.

(18.) Health Canada, Proposed Act Respecting Assisted Human Reproduction--Frequently Asked Questions, online: Health Canada <> (date accessed: 9 May 2002).

(19.) See article by Mathew Herder, "Donate a Definition" (2002) 11:1 Health L. Rev. 40.

(20.) For a fuller discussion of possible combinations and permutations regarding the creation of chimeras, see the article by Jason Robert, "Regulating the Creation of Novel Beings" (2002) 11:1 Health L. Rev. 14.

(21.) Personal communication, 9 May 2002.

(22.) The Oxford Universal Dictionary, 3rd ed., s.v. "combine."

Francoise Baylis, Professor, Departments of Bioethics and Philosophy, Dalhousie University, Halifax, Nova Scotia.

Research support is greatefully acknowledged from the Stem Cell Network, a member of the Networks of Centres of Excellence (NCE) program and the Canadian Institutes of Health Research. Sincere thanks are owed to members of the Novel Genetic Technologies Research Team at Dalhousie University, in particular Jason Robert and Matthew Herder. As well, thanks are owned to Jocelyn Downie and to Michael Vandergrift at Health Canada for comments on an earlier draft of this paper.
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Title Annotation:Canada
Author:Baylis, Francoise
Publication:Health Law Review
Date:Dec 22, 2002
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