Regulating consent to human embryo research: a critique of Health Canada's proposal.

• Author: Ram, Natalie

In March 2004, the Assisted Human Reproduction (AHR) Act received Royal Assent. (1) The law includes an explicit prohibition on the creation of human embryos for research. Consequently, the only embryos available for research use are those created, but no longer required, for reproductive purposes. This legislative requirement explicitly transforms Canadian IVF clinics into partners in the research enterprise, as they are, by law, the sole providers of human embryos for research use. A key issue for IVF providers, embryo researchers, and policy-makers in moving forward under the AHR Act is consent.

In November 2004, Health Canada, which is responsible for creating regulations under the AHR Act, issued a Consultation Document entitled, Seeking Input on a Proposed Approach for Regulations Concerning Section 8 (Consent) and the Section 3 Definition of an In Vitro Embryo Donor under the Assisted Human Reproduction Act. The Consultation Document introduced Health Canada's proposed approach to a variety of issues pertaining to consent under the AHR Act and sought public input on the efficacy and ethical acceptability of the proposed approach to regulations.

The Consultation Document outlines proposed consent regulations for the use of gametes (sperm and eggs) and embryos in three domains: for one's own reproductive use, for third party reproductive use, and for use in research. A particularly difficult consent issue concerns third party use of gametes, where gametes are used to create embryos for someone other than the person from whom the gametes were obtained. According to the Consultation Document, when gametes are donated to a third party, the consent is not only for the reproductive use of human gametes, but also for "all possible future uses." (2) With this approach, a gamete donor has no ability to direct or control the future use of her donated gametes. The gametes will originally be used for reproductive purposes, but, beyond that, the donor has no say. Specifically, the gamete donor has no choice with regard to the future use of her genetic material, including whether it is used in research and, if so, for what kinds of research.

Health Canada's proposed approach to the regulation of consent to third party use of gametes is both problematic public policy and possibly illegal. (3) The proposed regulation does not satisfy the core ethical principle of free and informed consent, which under current Canadian policy requires that a person who consents to any intervention understand and accept the "nature and goals" (4) of that intervention. The AHR Act explicitly identifies free and informed consent as one of its declared principles. (5) This paper will delineate requirements for consent to third party use of gametes in Canada, critically examine Health Canada's proposed approach to regulations under this rubric, and then critically evaluate three alternative approaches to consent to third party use of gametes.

Instruments for Regulation Evaluation: Defining the Ideal

An ideal model for consent to third party use of gametes would comply with all legal requirements, be consistent with current Canadian scholarship on consent, and impose the least burdensome requirements possible. Pragmatically, the consent process should not be so burdensome that it effectively precludes the future research use of embryos created using third party gametes. Nor should the consent process be so open-ended that it discourages potential gamete donors from making donations for infertility treatment because they fear the unrestricted future use of their genetic material.

Consent to donation of gametes for third party use must emanate from a free and informed choice. Several landmark court rulings, including Halushka v University of Saskatchewan, (6) Reibl v Hughes, (7) Hopp v Lepp, (8) and Weiss v Solomon, (9) have issued judgments affirming the autonomy and inviolability of patient and research subject and the correlated necessity for consent to be both informed and freely given. In Hopp, which considered these issues in the context of therapy, the Court emphasized the requirement of informed consent, stating:

 The underlying principle is the right of a patient to decide what, if anything, should be done with his body.... It follows, therefore, that a patient's consent, whether to surgery or to therapy, will give protection to his surgeon or physician only if the patient has been sufficiently informed to enable him to make a choice whether or not to submit to the surgery or therapy. The issue of informed consent is at bottom a question whether there is a duty of disclosure, a duty by the surgeon or physician to provide information and, if so, the extent or scope of the duty. (10) 

In defining the scope of necessary disclosure under informed consent, Chief Justice Laskin, writing for the Court in Hopp, stated, "I am far from persuaded that the surgeon should decide on his own not to warn of the probable risk of hearing or other impairment if the course of treatment contemplated is administered. A surgeon is better advised to give the warning, which may be coupled with a warning of the likely consequence if the treatment is rejected." (11) Both Hopp and Reibl made clear that doctors must disclose to their patients all "material risks" of treatment.

More on point, Halushka and the more recent Weiss case considered consent in the context of medical research. Halushka established that "in order for a consent to be effective it must be an informed consent, freely given, and it is the duty of a doctor to give a fair and reasonable explanation of the proposed treatment including the probable effect thereof and any special or unusual risks." (12) Halushka continued, noting, "the duty imposed upon those engaged in medical research ... to those who offer themselves as subjects for experimentation ... is at least as great as, if not greater than, the duty owed by the ordinary physician or surgeon to his patient." (13) Weiss strengthened this latter statement from Halushka, holding that the law imposes a more exacting standard for obtaining free and informed consent in the context of research than in the context of therapy. (14) The Weiss court also reaffirmed the duty of disclosure set forth in Hopp and Reibl--a duty to disclose all "material risks," including those that are transitory discomforts or rare but serious complications. (15) In arriving at its ruling, the court in Weiss relied not only on Halushka, but also on articles 19 and 20 of the Civil Code of Quebec, which state that competent individuals may donate tissues for purposes of research, but only with consent and only in circumstances in which the donation of tissue or participation in research will not impose more risks than potential benefits. (16) From these legal sources, it follows that the duty of disclosure and requirements of informed consent are demanding and rigorous, and that the duties and requirements that exist in the context of human subjects research are more onerous than those that apply in circumstances involving therapeutic interventions.

Emerging from this common and civil law background are several policy documents that advance specific requirements for consent. Most germanely, the AHR Act identifies "the principle of free and informed consent ... as a fundamental condition of the use of human reproductive technologies...." (17) The Tri-Council Policy Statement (TCPS) further clarifies free and informed consent, stating that it requires that the donor understand and accept the "nature and goals" (18) of the intervention to which she is consenting. Without an understanding of the nature and goals of the intervention(s) to which a donor is consenting, her consent cannot properly be said to be informed. (19) The nature and goals of assisted reproduction using donor gametes are very different...