Regulating Controversy: Overseeing Human Embryonic Stem Cell Research

Abstract

Research with human embryonic stem cells (hESCs) holds great promise, but it is controversial. The fundamental controversy arises because hESCs are derived from human embryos, and the derivation results in the destruction of the embryo. Although strategies have been proposed and techniques have been developed to avoid this controversy, the science has not yet moved sufficiently to do so. Other ethical concerns also arise. Use of human gametes for stem cell derivation, whether from embryos created to specifically for research or from induced pluripotent stem cells, not only raises questions about voluntariness and safety of research participation, but also about the meaning and uniqueness of human life. Proposals to use animal eggs or to introduce hESCs into animal models pose deeper questions about what it means to be human. Recognizing that hESC research presents numerous and, at times, unique ethical questions, national and international guidelines have recommended that hESC research undergo review by an oversight committee established specifically to review stem cell research. Such review is typically in addition to oversight by human research oversight committees (commonly referred to as institutional review boards (IRBs) or research ethics committees (RECs)). In this presentation, I will draw on my experiences as an original member of the University of California San Francisco stem cell oversight committee to explore the rationale for establishing separate committees to oversee hESC research and the value that such committees add to the oversight process. I will discuss how the mission differs from other committees, such as the human research oversight committees, and how that mission influences decisions about how the committee should be constituted. I will also discuss how the oversight process potentially can hinder the progress of research and suggest strategies for overcoming those potential barriers.