Moving Human Embryonic Stem Cells from Legislature to Lab: Remaining Legal and Ethical Questions

May 2006 | Volume 3 | Issue 5 | e143 Research with human embryonic stem cells (hESCs) has been controversial, but in the seven years since their isolation by James Thomson [1], governments have largely answered, at least for now, the fi rst-level questions about this research. We now know in most jurisdictions whether derivation of hESC lines will not be permitted from any embryos or whether it will be permitted from all embryos, only from embryos created as part of in vitro fertilization clinical services (IVF), or only from embryos not created by somatic cell nuclear transfer (SCNT). We also have learned where the various kinds of cell lines, if derived elsewhere, may be used, and whether public funding for the derivation or use of some or all of the lines will be possible. A set of secondlevel questions, revolving around the donors of cells and embryos used in this research, is also rapidly being answered. I live in California, which has answered all the fi rst-level questions with an enthusiastic endorsement of research (Box 1) and which has begun to fl esh out the donor-related issues. And yet as my university gears up for hESC research, it fi nds that a host of other ethical and legal questions, which I will discuss in this Essay, still need to be answered. Those questions will not be answered in a vacuum—far from it. When California researchers and their institutions receive funds from the California Institute for Regenerative Medicine (CIRM), created by Proposition 71 [2], they will be bound both by some rules set in the proposition and by other rules that CIRM will impose as regulations. Research in California not funded by CIRM is governed by standards contained in two California statutes [3,4], and by regulations that will be adopted under those statutes. Federal laws and regulations will also apply. And although technically only recommendations, the report of the National Research Council and Institute of Medicine panel on hESC research (hereafter referred to as the National Academy of Science [NAS] report) [5] will be watched closely, especially if funding agencies and journals require adherence to them. But these extensive regulations and guidelines do not come close to answering all existing questions; rather, they raise some new ones, individually and through their interaction. The issues are discussed below in the context of California and, more broadly, the United States, but, wherever in the world this research is done (and regulated), most researchers across the globe will face most of these issues in some form (Figure 1). In many parts of the world, continuing opposition to this research means that it will be done under closer, more hostile, public scrutiny than researchers have ever experienced. It is important for hESC research and for the general standing of biomedical research with Moving Human Embryonic Stem Cells from Legislature to Lab: Remaining Legal and Ethical Questions