Besides challenging traditional methods of funding, Klein says, CIRM can also streamline work for scientists by reducing legal and administrative burdens and accelerating the grant review process. He might negotiate a statewide master license on intellectual property, for instance, so that biological material could move between institutions. He would like to approve grants on a three-month timeline instead of the nine months required by the NIH. "I believe we have a mandate from the public to improve the current model," Klein declares. Besides paying for work unlikely to win federal money, CIRM could be more adventuresome than the NIH, Hall adds. As a model, Hall points to the sequencing race in which the private firm Celera challenged the NIH's Human Genome Project.
Scientists outside California hope CIRM will succeed, but they are not as certain that improvements are needed and fear that the "can-do" attitude of entrepreneurialism may not work well for research. Applying a lot of money to a biological problem does not ensure results, cautions Stuart H. Orkin of Children's Hospital Boston. Orkin, who will chair CIRM's grants working group, also notes that federal standards for quality, peer review, conflict of interest, and ethics have been honed over many years at the NIH. Like others, he worries that a patchwork of guidelines is developing as more states pursue this work. New Jersey has dedicated $11.5 million for its own stem cell institute, with another $380 million in the works. Nine other states are considering their own funding efforts or regulatory schemes. And private donations have enabled several institutions to set up research centers independently.
The proliferation may relieve pressure on the Bush administration to loosen its stance on stem cells. But the separate rules for private, state and federal funding confuse both scientists and the public, says Gordon M. Keller, director of the stem cell institute at the Mount Sinai School of Medicine. Whereas many states are happy to finance embryonic stem cells, six states have banned cloning research. "How can it be moral to do research with one [type of funds] but not the other?" he asks.
CIRM's scientific and medical accountability board did adopt proposed national oversight and ethical guidelines laid out by the National Academy of Sciences, but the rules still must go through a 270-day public review. While California stem cell biologists impatiently await standards for consent, oocyte tracking and other processes, some scientists working elsewhere in the nation would like to see a more cautious, deliberate approach. Keller worries about the public's moral qualms as well as what he sees as unrealistically high expectations from stem cell enthusiasts for therapies, new jobs and health care savings.
Others think that the public, particularly patient advocates, may have too much power at CIRM. They make up at least one quarter of the grants review board and a third of the oversight committee. Mildred K. Cho, associate director of the Stanford Center for Biomedical Ethics, wonders about the long-term effect on the culture of science when research is funded by popular vote. She points to the patient-driven factions arising around autism research, in which parent groups attack study results they don't like and raise money to test their own treatment theories. "The public drives not just what disease areas get attention but what the research strategies are," she warns.
Klein believes he has an institute that will be able to lead the way responsibly. "There's a tremendous amount of experience and knowledge on our board," he says. Klein clearly feels all eyes are on him as the institute navigates the scientific, financial, political and ethical shoals of embryonic stem cell research. If California can achieve a major breakthrough, he predicts, "the nation will change forever in this area of science."
This article was originally published with the title A Proposition for Stem Cells.