A review of pressing ethical issues relevant to stem cell transnational research.

• Author: Ogbogu, Ubaka

Introduction

In recent months, a number of national and international events have led to renewed interest in the ethical issues relevant to stem cell research (SCR). Some of the notable events include: the Korean egg donation and fabricated stem cell experiments/publication scandal, (1) the controversy over the use for research of donated fresh embryos created for reproductive purposes by Canadian stem cell researcher, Andras Nagy, (2) a recently published study on gaps in informed consent procedures in Canadian in vitro fertilization (IVF) clinics, (3) and the current debate in the UK over altruistic egg donation for research purposes. (4) Most, if not all of these events, played out in the media and public eye, thereby generating more public debate and controversy in a field arguably considered the most socially controversial and divisive in biomedical research. More importantly, the relatively close proximity between these events has made it difficult for policymakers and researchers to keep pace with the issues. As Canadian researchers edge closer to the first stem cell clinical trials, (5) many would agree it is imperative to identify and examine the most salient and pressing ethical issues relevant to stem cell research.

This investigation is important for two reasons. First, identification and scholarly analysis of these issues will inform the direction of policy-making. Health Canada, the primary science policymaker and regulator, is currently reviewing regulations on a range of matters relating to controlled activities under the Assisted Human Reproduction Act (the Act). (6)

It seems axiomatic therefore that by focussing scholarly analysis on the most pressing and relevant ethical issues, ethics researchers are likely to play a significant role in the development of sustainable science policy.

Second, by focussing research on the most important issues, individuals that research ethical, legal and social issues in biomedical research (ELSI researchers) can provide ethical guidance to stem cell researchers. Such guidance is pivotal to the ethical conduct of translational research and maintenance of public trust in stem cell research.

In the following sections of this brief review piece, I identify and outline pressing ethical issues relevant to stem cell research as it moves towards clinical trials and applications. These issues are compiled from consultations with Canadian research ethics experts, stem cell researchers, ethics review board (REB) members, and policymakers, including those within Health Canada, the Department of Justice and the Stem Cell Oversight Committee. (7)

The methods of this study are as follows. Participants were sent email messages soliciting their ideas on what constitutes the most pressing research ethics issues relevant to stem cell translational research. Responses were collated and categorized under broad topic areas. The topics were then reviewed by a panel of experts through teleconference discussions.

Note that no attempt is made to analyze or examine these issues in any exhaustive detail as this is outside the possible scope of a single paper. However, in some cases, I have provided relevant background information garnered from the panel discussion.

1. Consent issues

   There was overwhelming consensus among our participants on the need to identify and address issues around informed consent principles and processes within the stem cell clinical research context. This agreement is reflective of the current interest of researchers and policymakers in existing consent processes for human subjects research in Canadian research institutions. Specifically, in September 2005, Health Canada released proposed regulations governing informed consent procedures under the Act for public comment. (8) The regulations will give effect to Section 8 of the Act, which prohibits the use of human reproductive material to create embryos, and the use of in vitro embryos for any purpose, without the donor's written consent. Matters addressed by the regulations include conditions for obtaining consent, validity of consent, and conditions for the withdrawal of consent. The regulations will take effect when they are published in the Canada Gazette, Part II, expected in Spring 2006. (9)

   Another issue of interest to our participants was a recent empirical study of consent processes in Canadian IVF clinics, which concluded that only one clinic had legally adequate consent procedures for the future donation of cryopreserved embryos for SCR. (10) However, the study did not clearly indicate whether the defaulting clinics were typically involved in providing cryopreserved embryos for SCR. It...