Consent to Embryo Donation for Human Embryonic Stem Cell Research

Article excerpt

Introduction

Since the first report of the derivation of human embryonic stem cells (hESCs) in 1998, (1) ethical debate has raged around hESC research. The primary, if not exclusive, concern raised in relation to hESC research is the inescapable reality that this research results in the destruction of human embryos. Stem cell research is not the only type of research performed using human embryos, and it is not the only focus of those who object to the use of human embryos in research. (2) But because stem cell research holds enormous promise in terms of its potential clinical applications, and because it is often linked in the public consciousness with somatic-cell nuclear transfer (roughly synonymous in the lay understanding with "cloning"), it has become a flash-point at the intersection of science, medicine and ethics.

Human embryos are inevitably destroyed in hESC research. Those who oppose embryo research because they ascribe full moral status to the embryo therefore take the view that such research is ethically impermissible. Those who hold that human embryos do not share the same moral status as persons, but do have heightened moral status compared to other human tissues or biologic matter, are prepared to permit stem cell research, but insist that as few embryos as possible be destroyed in the process. (3) Many who hold this view also oppose the creation of human embryos solely for research purposes, meaning that such research is acceptable only insofar as it uses embryos that are supernumerary to the reproductive needs of those for whom they were created. (4)

But even among those who do not agree that embryos deserve special treatment, morally speaking, ethical unease has been expressed around the use of human embryos in stem cell research. Concerns around the commodification of gametes and embryos, and the related worry that women's reproductive capacity and reproductive material will be exploited have been articulated. (5) Questions have also been raised about who decides what research is worth pursuing and about the use of public funds to support research into what are likely to become very expensive therapies, possibly available only to the "privileged few." (6)

In spite of these concerns, many nations, including Canada, have decided to pursue a research agenda that includes hESC research. In light of the fact that such research is permissible, we must consider the process by which those who will donate embryos to the pursuit of hESC research will provide consent.

In this paper, I consider the unique ethical issues that arise in hESC research. I then discuss consent policy in relation to human subjects research generally, and look to existing Canadian policy regarding consent to hESC research (the Guidelines for Human Pluripotent Stem Cell Research (7) and the Assisted Human Reproduction Act), (8) with a view to critiquing consent policy. I also reflect on the subject of consent to the donation of fresh embryos to research, given the national attention this matter has received. Finally, I conclude by suggesting points for discussion at the workshop for which this background paper has been written.

1. Stem Cell Research and Human Subjects Research

Regulation of research involving human subjects is of relatively recent vintage, having originated as an outcome of the Nuremberg trials that followed the Second World War. (9) The aim of regulation of research using human subjects is to attempt to find the elusive balance between permitting the conduct of scientifically sound, potentially beneficial research and ensuring that human subjects are treated in an ethically appropriate manner during their participation in research. Two important mechanisms employed to safeguard the interests of research subjects are the requirement of consent to research and mandated research ethics board (REB) review. In this paper, the focus will be on the former.

Research using human tissue is considered "human subjects research. …