Proposition 71 (The California Stem Cell Research and Cures Act) was adopted by the voters of California on November 2, 2004, to provide substantial state support for a comprehensive in-state stem cell research program. The California Institute for Regenerative Medicine (CIRM) was created in 2005 to carry out this program. The act established a distinctive model of both finance and governance for CIRM. The Institute itself was to be governed by an Independent Citizens Oversight Committee (ICOC) and was to be financed through the issuance of long-term general obligation bonds of the State of California. CIRM was charged by Proposition 71 with determining the most effective means of distributing $3 billion in state funds for stem cell research and research on regenerative medicine more broadly over at least 10 years. Its principal aims are to accelerate certain critical aspects of the science of regenerative medicine and its translation into treatments for a spectrum of currently intractable human diseases.
Research on stem cells is an important area of biomedical research because of the promise it holds for developing new and more effective treatments for a wide variety of diseases. However, the past 15 years has seen continuing uncertainty regarding the federal government’s willingness to fund research using human embryonic stem (hES) cells. Given that the federal government has traditionally been the largest source of funding for biomedical research outside of industry and the largest funder of basic research, some believed that the United States was forgoing an important opportunity to be a pioneer in developing the basic research necessary to produce critical new clinical applications. It was in this context that a broad group of California-based scientists, leaders in higher education in the state, disease advocates, and others mounted the Proposition 71 initiative. The aim of this initiative was to fill the gap created by fluctuating and uncertain federal policies, thereby helping both to develop new clinical modalities and to create a leadership position for California in this critical area of biomedicine. It is worth remembering that in 2004, there had been little demonstration of the potential for reprogramming somatic cells to bring them to a pluripotent state.
CHARGE TO THE COMMITTEE AND STUDY APPROACH
At the request of CIRM, the Institute of Medicine (IOM) convened the Committee on a Review of the California Institute for Regenerative Medicine in 2011 to critically review the Institute and produce a report including recommendations for how CIRM could improve its performance. The committee’s statement of task is presented in Box S-1.
The committee was not asked to assess the wisdom of the California voters in passing Proposition 71. However, many of the detailed provisions of Proposition 71 directly impact aspects of CIRM’s operations that the