The California Institute for Regenerative Medicine Science, Governance, and the Pursuit of Cures (2013) / Chapter Skim
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1 Introduction and Context
1 Introduction and Context
Pages 17-28
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, charged by Proposition 71 with determining the most effective means of distributing $3 billion in state funds for stem cell research over at least 10 years, was created and began its operations. CIRM's principal aims were to accelerate certain critical aspects of the science of regenerative medicine, emphasizing pluripotent stem cell and progenitor cell research and other vital medical technologies, and its translation into the treatment of a spectrum of currently intractable human diseases.
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4 The Little Hoover Commission is an independent state oversight agency whose mission is to investigate state government operations with the aim of promoting efficiency, economy, and improved service. The Commission selects its own agenda in deciding which government operations it wishes to study.
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STATEMENT OF TASK AND STUDY APPROACH In 2010, as CIRM approached the midpoint of its 10-year state funding horizon, it asked the IOM to provide an independent assessment of the process through which it was established and of its programmatic and scientific scope, organizational and management systems, funding model, and intellectual property policies. The IOM Committee on a Review of the California Institute for Regenerative Medicine, comprising experts in developmental biology, stem cell research, research administration, bioethics, economics, business administration, finance, program evaluation, intellectual property, consumer perspectives, and policy, was assembled in 2011 to critically review the Institute and produce a report containing recommendations for ways in which it could improve its performance.
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How does this model compare to the model governing federally supported research? The principal objective of this review was to ensure that all aspects of CIRM's operations are functioning at peak performance.
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CHARACTER AND POTENTIAL OF STEM CELL RESEARCH Research on stem cells remains an important area of biomedical research because of its anticipated potential to yield new and more effective treatments for a wide variety of diseases. Stem cells have the critical characteristic that they can self-renew and also differentiate into a variety of specialized cell types (The National Academies, 2009; NIH, 2010)
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The ability of these different types of stem cells to self-renew and differentiate into more mature cell types is the foundation of the regenerative medicine field, providing hope for repairing or supplementing a patient's damaged tissue (Robinton and Daley, 2012)
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Bush, and Obama all found it necessary to clarify their differing views on these matters by issuing a series of policy guidelines governing the provision of federal funds for research that involves creating and/or using hES cells.9 It is also important to recall that the controversy over federal funding of research using human embryos or aborted fetuses predates these more recent developments in stem cell research. Embryo research was, for example, the focus of considerable controversy in the mid-1990s, which led to the DickeyWicker Amendment of 1995 forbidding the expenditure of federal funds for research that created or harmed human embryos.
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Executive Order 13505 -- Removing Barriers to Responsible Scientific Research Involving Human Stem Cells -- states that the Secretary of Health and Human Services, through the director of NIH, "may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law."15 Recognizing the controversial ethical issues involved, the new guidelines, issued in July 2009, contain provisions designed to ensure informed consent from donors, address potential conflicts of interest, and limit federal funding to research on hES cell lines derived from embryos originally created for reproductive purposes.
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Since the early years of this century, when the campaign for CIRM was energetically under way, a great deal of progress has been made in stem cell research. In particular, the increased ability to reprogram adult cells has made the field of regenerative medicine somewhat less dependent on hES cells, a development that is fully reflected both in CIRM's programs and the field of regenerative medicine worldwide.
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CIRM's intellectual property policies -- What are the strengths and 5 weaknesses of CIRM's policy for sharing revenue generated by intellectual property? How does this model compare to the model governing federally supported research?
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2011. Induced pluripotent stem cells -- opportunities for disease modeling and drug discovery.
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2002. Stem cells and the future of regenerative medicine.
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