Review Calls for External Scientific Oversight for CA Stem Cell Research

In a new report, the National Academies' Institute of Medicine (IOM) praises the remarkable research output of California's Institute for Regenerative Medicine (CIRM) during its first seven years, but recommends several changes in oversight that could improve the quality and defensibility of its work. IOM suggests that external scientific reviews and independent oversight of the institute's management could help ameliorate concerns about conflicts of interest and increase transparency.

Launched in 2004 by ballot initiative, CIRM is tasked with distributing $3 billion in state funds for stem cell research and regenerative medicine over at least ten years. The state raised the funds through the issuance of general obligation bonds, which has helped to ensure that the state's stem cell research community has a reliable source of funding for its work. This is particularly important in the field of regenerative medicine, due to continuing uncertainty about the federal government's willingness to fund research using human embryonic stem cells.

CIRM grants are intended to accelerate regenerative medicine research and help translate that research into treatments for a range of diseases that currently are intractable. By providing a dependable source of funding, California has capitalized on its existing competitive advantage in biomedical research and has been able to attract researchers and biomedical firms from across the country engaged in cutting-edge treatments. The grants themselves have contributed 40 patent applications and three license agreements since the institute's founding, as well as helped grant recipients attract over $1 billion in funding. CIRM's expenditures currently are helping to support approximately 3,400 jobs in California, according to the IOM report.

Despite the remarkable level of support stem cell research has received from California voters, the field remains subject to political debate and attracts an inordinate amount of public scrutiny. The institute, therefore, has a larger-than-usual incentive to ensure that its management is transparent and that its decisions are subject to review by independent bodies. There is an even greater need for transparency now that the institute is approaching the end of its ten year commitment and has invested the majority of its state-provided funds. If CIRM pursues partnerships with the private sector to ensure continuing funding for its operations, a lack of independent review could contribute to actual and perceived conflicts of interest.

IOM's recommendations include the developments and publication of a sustainability strategy that could help sustain the institute following the dispersal of state funds. This strategy should make clear any industry inputs and how private involvement would affect existing intellectual property agreements. CIRM should also separate its operations from institutional oversight. Currently, CIRM's governing board, the Independent Citizens' Oversight Committee (ICOC), oversees strategic planning, financial performance and legal compliance, but also is charged with significant operational responsibilities. The report calls for all operations duties to be delegated to the CIRM president, while the ICOC focuses on strategic oversight.

IOC also suggests that the ICOC board itself be restructured. Many of the board's 29 members represent institutions that have benefitted from CIRM activities, making the institute susceptible to claims of conflicting interests. IOC also calls for a review of the institutes conflict of interest definitions and policies.

Finally, the IOC recommends establishing a scientific advisory board to provide expert advice on its strategic priorities. Such a board could help ensure a balanced portfolio of grants, and ensure that CIRM is tackling research challenges that currently hamper progress towards treatments for many diseases. CIRM's current plans to create multiple advisory boards could impair its ability to make these decisions.

Read the report...