Spare embryos and stem cell research: consent issues.

AuthorRegnier, Marie-Helene

Introduction

Embryonic stem cells are touted as a source of promising treatment for debilitating diseases such as Parkinsons, Alzheimers, diabetes, cardiovascular disease, and many others. (1) In order to exploit the therapeutic potential of stem cells, extensive research is required on the risks and benefits of their use. (2) Respect for ethical boundaries should be included in this risk-benefit evaluation.

Different sources of stem cells have different therapeutic potential. The four sources of stem cells are: embryonic stem cells (hESC), adult stem cells (ASC), stem cells of aborted foetuses, and finally, umbilical cord stem cells. hESC are either totipotent or pluripotent. Totipotent cells are found when the embryo is composed of eight cells or less. Each totipotent cell is capable of developing into a complete organism. (3) Pluripotent cells can differentiate into many cellular types but they cannot create an entire organism (i.e. an embryo), hESC that come from the blastocyst, an embryonic structure found six days post-fertilization, are pluripotent. (4) Spare embryos at the blastocyst stage can provide pluripotent hESC.

For their part, ASC are multipotent, that is, they can differentiate into certain specialized cellular types. (5) but most often are committed to a single function. (6) Their principal function is to replace differentiated cells in a particular tissue when it is damaged or old. (7)

Cells from aborted foetuses are multipotent. These cells can come, for example, from neural foetal tissue and be derived into neural stem ceils. Cells from the umbilical cord also form part of this multipotent cell type category. Haematopoietic stem cells can be extracted from the umbilical cord and represent an interesting alternative to bone marrow graft. (8)

The therapeutic potential of each of these stem cell types remains to be established. Each seems full of promise but only research will tell. The most controversial is that which requires the creation of embryos for the research. Indeed, current restrictions on the deliberate creation of embryos for research (9) have led researchers to go to another existing source of embryos: surplus embryos left over from in vitro fertilization (IVF). Access depends on the donation by the couple of embryos for research purposes. It is spare embryos of pluripotent potential that are the subject of this paper.

To date, donor consent to research on surplus embryos has been general in nature. Since March 4, 2002, however, the Human Pluripotent Stem Cell Research: Guidelines for CIHR-Eunded Research (hereinafter referred to as the "CIHR Guidelines") require a specific consent for stem cell research. The major reasons provided are as follows: immortalized cell lines will be created that will continue to divide indefinitely and could be used in different research projects for many years; these cell lines could have an important commercial value (10) (without profiting the embryo donors themselves) and such research necessarily requires the destruction of embryos.

In Canada, in the absence of the adoption of An Act Respecting Assisted Human Reproductive Technologies and Related Research (Bill C-13), (11) it is the CIHR Guidelines that govern the ethical review of stem cell research protocols. Since 1998, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Human, (hereinafter referred to as "the Tri-Council Policy Statement") governs the process of ethical review of research. Obviously, the general common law and civil law principles and procedures governing consent also apply.

We will begin our study of the issue of consent to stem cell research with a brief analysis of Bill C-13, followed by the Tri-Council, Policy Statement and the CIHR Guidelines. We will then examine the conformity of the consent forms used in eight Canadian fertility centres prior to 2003 against these norms. Finally, we will argue that stem cell research on spare embryos is not really that unique. Research on tissues generally, as well as genetic research, raises many of the same issues. The requirement of re-consent in stem cell research may, however, set a precedent for doing likewise in other research. In conclusion, we will propose core elements for stem cell research on spare embryos that could be included in future consent forms and any accompanying explanatory materials.

1. Bill C-13: An Act Respecting Assisted Human Reproductive Technologies and Related Research

Since the creation of the Royal Commission on New Reproductive Technologies in 1989, Canada has been attempting to define the proper legislative and regulatory controls for the governance of assisted human reproduction. In November 1993, the Royal Commission produced its report entitled Proceed with Care, recommending immediate regulation to protect the interests of all Canadians. (12) In 1995, the federal Minister of Health announced an interim voluntary moratorium on several activities of concern, such as human cloning and payment of surrogate mothers. Bill C-47, the proposed Human Reproductive and Genetic Technologies Act that was introduced in Parliament in 1996, would have prohibited specified activities, but it would not have set out a clear mechanism for regulating other activities that could be carried out under prescribed conditions. This legislation later died on the Order Paper with the call of the 1997 federal election. (13) On May 3, 2001, the federal Minister of Health invited the House of Commons Standing Committee on Health to conduct a full review of the Government of Canada's Proposals for Legislation Governing Assisted Human Reproduction. In December 2001, the Health Committee tabled its report and, among its multiple recommendations, requested that legislation be introduced on a priority basis.

Bill C-13, the proposed Assisted Human Reproduction Act (short title), incorporates many but not all of the Committee's recommendations. One significant change recommended by the Committee and reflected in the proposed Act is the establishment of a regulatory body to license, monitor, and enforce the Act. The Act would also prohibit a range of activities deemed by many Canadians to run contrary to human dignity and societal values, while permitting certain other controlled activities to be carried out, subject to governmental regulation and oversight. (14)

Some requirements of Bill C-13 (15) will not only affect the consent process for stem cell research but also for research on embryos in general. The first requirement is not novel. Donors must provide written consent for the use of their in vitro embryos;(16) the same applies for gamete donors regarding the use of their gametes (17). The biggest impact of C-13 on consent to stem cell (18) research is in the creation of a personal health information registry:

17. The Agency shall maintain a personal health information registry containing health reporting information about donors of human reproductive material and in vitro embryos, persons who undergo assisted reproduction and persons conceived by those procedures.

According to the Bill, donors must consent to the disclosure of information controlled by the Agency:

18(2). Notwithstanding section 8 of the Privacy Act but subject to subsections (3) to (8), health reporting information under the control of the Agency relating to a donor of human reproductive material or an in vitro embryo, a person who has undergone an assisted reproduction procedure or a person who was conceived by means of such a procedure is confidential and shall be disclosed only with the written consent of the donor or that person, as the case may be.

There are some situations, however, where the Agency will disclose health reporting information without consent: (19) to comply with a subpoena; an order made by a court, body or person with jurisdiction to compel the production of information; and to the extent required by provisions of any federal or provincial law respecting health and safety. Furthermore, the Agency may disclose health reporting information for the purpose of the enforcement of the Act, to the extent required for the administration of a health care insurance plan and for the purposes of disciplinary proceedings. (20) The identity of a donor or sufficient elements that would permit identification of a donor may not be disclosed by the Agency for research purposes:

18(8). The Agency may disclose health reporting information to an individual or organization for scientific research or statistical purposes, other than the identity--or information that can reasonably be expected to be used in the identification of any person. (21)

In short, Bill C-13 affects the disclosure in the consent process of the limits and safeguards of confidentiality for both the donor of gametes and for the patients who undergo fertility treatment. Future...

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