- Stem Cell Research:The California Experience
It has been nearly a year since the groundbreaking passage of Proposition 71, the law that created the California Institute for Regenerative Medicine (CIRM) and authorized bonds that would provide $3 billion in funding for stem cell research. As the first anniversary approaches, what is the state of human embryonic stem cell research?
At this point, CIRM has yet to produce any research, and in fact it has not even sold any bonds to fund the research. Opponents of Proposition 71, having failed at the ballot box, have taken to the courts. Arguments in state court claim that there is not sufficient state oversight. While the suits meander [End Page 26] through the legal system, the bonds cannot easily be sold because of the increased risk of investing in an endeavor that may never even get started. As a result, CIRM has had to scramble for funding to set up its administrative structure and the rules and processes that will govern the research once the lawsuits are dismissed. One of the suits (in federal court) asks for recognition of embryos outside the body as full citizens of the United States with all the rights that children have. If this were to succeed, it would make most IVF and other reproductive technologies illegal—indeed it would mean that the thousands of embryos lying frozen in facilities around the country would become the source of a huge set of state obligations (presumably to find wombs so that each "child" has an opportunity to develop).
Meanwhile, CIRM and California's research institutions have been trying to sort out the ethical, legal, and oversight issues they will need to address to conduct stem cell research. This, too, has proved to be a greater challenge than expected. The bioethics community has been so focused on the issue of the moral status of ex vivo embryos that the challenges of how to ethically conduct stem cell research have been largely neglected. The recent report issued by the National Academies of Science, Guidelines for Human Embryonic Stem Cell Research, goes a long way toward filling that void. But the report does not answer every question, and there is still debate over whether all of its recommendations are warranted.
Issues that have been largely sorted out include the importance of getting consent from both gamete donors, many key elements in that process, and the need for adequate oversight of clinical trials, including the creation of what the NAS report calls "Embryonic Stem Cell Research Oversight" committees, or other structures that will achieve the same level of oversight. In an essay in Stem Cells this year, Bernard Lo and colleagues made a persuasive case that, prior to clinical trials, gamete donors would likely have to undergo tests that could not be anticipated at the time of donation, so that they, and donors of excess embryos, will likely need to be periodically recontacted. Although the practice of paying oocyte donors remains contentious, both the NAS guidelines and Proposition 71 prohibit paying for either embryos or oocytes.
Transparency and Oversight
Controversy still simmers over three large questions: how much transparency and oversight is appropriate for state-funded research; what intellectual property and commercialization policies ought to be pursued; and what level of protection should be in place for women who wish to donate oocytes for research purposes.
CIRM got off to a rocky start when its first meeting agenda, which was very ambitious, failed to meet California's open meeting standards and had to be shortened. Since then, political battles have raged over the funding priorities being debated by CIRM's Scientific Working Group (which reviews proposed research projects), conflict of interest standards for the working groups and the Independent Citizens Oversight Committee (ICOC), and the role of the state legislature in overseeing the program.
The authors of Proposition 71 wrote it as an amendment to the state constitution and never envisioned that CIRM funds would be embroiled in the politics of the legislative process. But this has angered the state legislature. In an unusual setup, the CIRM funding is overseen by the ICOC, which is composed of people appointed by elected...