Oversight of stem cell research in Canada: protecting the rights, health, and safety of embryo donors.

AuthorCohen, Cynthia B.

Introduction

Stem cell research has come to the fore of scientific and public interest in the past decade, bearing the promise of providing treatments for many serious diseases and conditions. (1) Yet the pursuit of this research has raised significant issues of public policy and ethics in Canada and elsewhere. Recent policy discussion centers on developing ways of overseeing stem cell research that are consistent with the regulation of other forms of scientific research and yet take into account distinctive aspects of this research. (2) Ethical issues revolve around the derivation, study and research use of human pluripotent stem cells within the bounds of the ethical requirements of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). (3)

In 2002, the Canadian Institutes of Health Research (CIHR) developed guidelines to address the oversight and associated ethical issues raised by stem cell research, the Human Pluripotent Stem Cell Research Guidelines (the Guidelines). (4) It also established the Stem Cell Oversight Committee (SCOC) to ensure that all pluripotent stem cell research carried out at institutions receiving funding from the Tri-Council Agencies--and, on a voluntary basis, at other public or private granting agencies in Canada or within the private sector--is in accordance with the Guidelines. (5)

The SCOC consists of a chair and a minimum of 11 additional members chosen by the CIHR Governing Council on advice from the Nominating Committee. (6) It is structured to be:

a heterogeneous group of individuals with a range of backgrounds and disciplines relevant to the mandate of the Committee. Technical experts will provide the Committee access to the latest scientific and ethical information, and representatives from the general public will represent the views and values of Canadians potentially affected by the new technologies. (7) Members of the SCOC include professionals in stem cell biology and therapeutics; developmental biology or embryology; health care (in vitro fertilization [IVF] specialist); ethics; law; international stem cell research policy; and the social sciences. Persons from the voluntary health sector, IVF patients, and members of the general public who have a general interest in health research (8) and who are not advocates for any specific interest group are also included. (9) Members of the SCOC are not employees of CIHR and do not receive an honorarium or remuneration of any kind from CIHR.

The SCOC was mandated to provide periodic updating and proposals for revision of the Guidelines to the CIHR Governing Council and has done so twice, once in 2005 (10) and again in 2006. (11) Important questions have recently been raised by several commentators about modifications made in the Guidelines before and after their publication. Others have questioned certain requirements of the Guidelines that they believe are too restrictive. In this article, those who were members of the SCOC from 2003 to 2006 trace certain clarifications of the Guidelines made during that period and discuss the rationale for them in light of these concerns. They also address criticisms made of the substance of the Guidelines. The thrust of this article is to exhibit that the paramount consideration underlying the development of the Guidelines has been the need to protect the rights, health, and safety of those who donate embryos for human pluripotent stem cell research.

  1. Major Provisions of the CIHR Guidelines for the Oversight of Stem Cell Research

    The Guidelines permit research to study human embryonic stem cell lines derived from human embryos created but no longer required for reproductive purposes, as well as preexisting human embryonic stem cell lines. (12) They mandate that persons for whom the embryos were created, and third parties who have donated gametes for the development of embryos, must have given free and informed consent for the research use of such spare embryos. They also require that no commercial transactions be carried out in connection with the development and use of such embryos. (13)

    The Guidelines also cover research to derive and study pluripotent cell lines from human fetal tissue or amniotic fluid, the umbilical cord and placenta, and from somatic tissues. (14) Research involving the grafting of human pluripotent cells into non-human animals from birth to adulthood and into legally competent humans is also considered. (15) They preclude research involving somatic cell nuclear transfer into human oocytes, transfer of human pluripotent cells to a human embryo or human fetus, and the merging of human pluripotent cells with a non-human embryo or non-human fetus. (16) Finally, the Guidelines provide additional detailed conditions regarding consent, privacy and confidentiality. (17)

    In the course of the provision of IVF, more embryos frequently result from each cycle of ovarian stimulation than can safely be transferred to a woman's uterus for implantation. (18) Couples and individuals with spare embryos remaining after the completion of IVF treatment may choose to freeze them, donate them for research, donate them to others for their reproductive purposes, or discard them. (19) Some elect to donate such embryos for various forms of research, including stem cell research. (20) A basic principle underlying the Guidelines is that donors of spare embryos for stem cell research must give "[f]ree and informed consent, provided voluntarily and with full disclosure of all information relevant to the consent." (21) This means that those considering embryo donation should decide whether to proceed with it taking account of full information provided to them about the relevant medical, social, and psychological risks and benefits that such donation entails. Moreover, they should do so freely, without coercion or exploitation. Accordingly, the SCOC has reinforced strict and detailed requirements for the provision of voluntary and informed consent for the donation of embryos for stem cell research in Canada in the course of its clarifications of the Guidelines.

  2. Adequacy of the Informed Consent Provisions of the Guidelines

    Two sets of updates to the Guidelines regarding the conditions for providing and obtaining informed consent are of concern to Francoise Baylis (who was a member of the CIHR ad hoc Working Group on Stem Cell Research (ad hoc Working Group), an advisory body that recommended the initial 2002 Guidelines (22) and Caroline McInnes. (23) One set of updates was introduced between the acceptance of the final report of the ad hoc Working Group by the CIHR Governing Council on 16 January 2002 (24) and the issuance of the Guidelines by the Governing Council at the beginning of March 2002. (25) The other set was recommended by the SCOC and approved by the CIHR Governing Council in 2005 (26) and 2006. (27) These changes raise questions for Baylis and McInnes about the adequacy of the protection offered to women who donate embryos for stem cell research by the Guidelines. They believe that, in effect, these changes remove certain essential elements of informed consent.

    1. Putatively Missing Elements of Informed Consent

      The report of the ad hoc Working Group included a series of articles that were intended to "help clarify how the ethical principles and articles of the TCPS apply to the derivation and use of human embryonic stem cell lines and other human cells or cell lines of a pluripotent nature." (28) Baylis and McInnes note that the ad hoc Working Group detailed under article 5.4 of its report nine elements of information to be disclosed to prospective participants as part of the consent procedure for embryo donation. (29) Of these nine, four could be found in the 2002 Guidelines; five did not explicitly appear in them.

      The four elements of information carried forward from the report of the ad hoc Working Group to the 2002 Guidelines are as follows:

      1. An explanation that the research participants will not benefit directly financially from any future commercialization of cell lines ...;

      2. An explanation that the cell line(s) will be anonymized, except if the research involves autologous donation ...;

      3. An explanation that the research could result in the production of a cell line that could be maintained for many years and used for different research purposes;

      4. An assurance that prospective research participants are free not to participate and have the right to withdraw at any time before an anonymized cell line is created. (30)

        The five informed consent provisions of the report of the ad hoc Working Group that do not specifically appear in the 2002 Guidelines are as follows:

      5. A description of the purpose of the research;

      6. A description of the research procedures;

      7. A description of reasonably foreseeable harms and benefits that may arise from research participation;

      8. An explanation that consent to, or refusal of, research participation will not affect access to treatment;

      9. An explanation of the potential uses of the stem cells including any commercial uses, and the presence of any apparent or actual or potential conflict of interest on the part of researchers, their institutions or sponsors. (31)

        Although the version of the four requirements carried forward to the 2002 Guidelines differs somewhat in wording from the report of the ad hoc Working Group, (32) Baylis and McInnes appear to accept that it is substantially the same. However, the absence of the remaining five requirements of the ad hoc Working Group report from the 2002 Guidelines, and their replacement with the general instruction to provide the "usual information" to potential embryo donors, (33) is of considerable concern to them. They observe:

        As the 2002, 2005 and 2006 Guidelines are to be read in conjunction with the TCPS, which outlines information that researchers must disclose to prospective research participants, the TCPS is at least one potential source of the "usual...

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