California Institute for Regenerative Medicine
The California Institute for Regenerative Medicine (CIRM) was created in 2004 after 59% of California voters approved California Proposition 71, which allocated $3 billion to fund stem cell research in California.
CIRM was established via California Proposition 71 (2004) however its implementation was delayed when opponents filed two lawsuits that challenged the proposition's constitutionality. Opponents argued that the initiative created a taxpayer-funded entity not under state control, that the ICOC had a conflict of interest with representatives being eligible for grant money, and that the initiative violated the single-subject requirement of initiatives by funding areas beyond stem cell research. In May 2007, the Supreme Court of California declined to review the two lower court decisions, thereby upholding Proposition 71 as constitutional and permitting CIRM to fund stem cell research in California.
CIRM eventually got underway and began awarding grants. Specific examples of CIRM funding have included:
- In 2009, CIRM awarded $67 million in early translational grants that was allocated to 13 nonprofit organizations and two for-profit organizations, BioTime and Novocell.
- In 2013, Cellular Dynamics of Madison, Wisconsin was awarded $16 million from CIRM to create three iPSC lines using tissue samples from both healthy and diseased individuals  CIRM also awarded the Coriell Institute for Medical Research $10 million to establish and manage a biobank in California for the iPSC lines created by Cellular Dynamics.
The $3 billion initially provided to CIRM through Proposition 71 was budged to last until 2017. In February 2014, Robert Klein, a leader in the initial campaign for Proposition 71 and former CIRM Board Chair, presented a proposal at the UC San Diego Moores Cancer Center to extend CIRM funding. Another option discussed at that time, was for CIRM to become a private, non-profit organization that would rely solely on outside funding.
In 2008 the Little Hoover Commission evaluated CIRM at the request of California Senators Sheila Kuehl and George Runner. The Commission commented specifically on the structure of the CIRM governance board and the need for greater transparency and accountability. The Commission provided suggestions on how to improve the structure and enhance the functioning of the CIRM board some of which included: decreasing the size of the ICOC from 29 to 15 members with four having no affiliations with CIRM-funded organizations; allow board members to serve a maximum of four years; and eliminating the overlapping responsibilities of the agency chair and the board president. In addition, the Commission recommended that CIRM also allow outside experts to evaluate grant proposals.
In December 2012, the Institute of Medicine (IOM) released a report, “The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures”, that evaluated CIRM programs and operations since its start in 2004. The IOM committee made recommendations similar to those made in the Little Hoover Commission. In general, the IOM recommended that the ICOC separate their responsibilities as executor and overseer and noted potential conflicts of interest among the CIRM board members. Several active CIRM board members also represented organizations that currently received or benefited from CIRM grants. The IOM committee also recommended that CIRM organize a single Scientific Advisory Board with experts in stem cell biology and cell-based therapies.
In 2014 the integrity of CIRM's grant review process was challenged, after CIRM awarded a Stanford-led consortium $40 million stem cell genomics award, making it the largest CIRM research grant. In February 2013, CIRM reviewers evaluated applications for genomics awards but, for the first time, declined to send any grant proposals to the board for a final decision. Comments were sent back to the researchers and re-submissions were accepted in Fall 2013. During the Fall 2013 review, CIRM reviewers sent all four genomic award proposals to the CIRM board, recommending that all four projects receive funding despite the projects exceeding the budget of $40 million. The CIRM President, Alan Trounson became involved in the selection process and the final decision was to fund the Stanford project only, totaling $40 million. The CIRM grant review and scoring process and the role of President Trounson have been questioned, especially by those that did not receive funding like Jeanne Loring from the stem cell program at Scripps Research Institute.
- Varney, Sarah. "Court Challenge Stalls Calif. Stem Cell Funding". NPR. Retrieved 24 March 2014.
- Adelson, Joel; Joanna Weinberg (2010). "The California Stem Cell Initiative: Persuasion, Politics, and Public Science". American Journal of Public Health. 100 (3): 446–451. doi:10.2105/ajph.2009.168120. PMC 2820047. PMID 20075315.
- California Family Bioethics v. California Institute for Regenerative Medicine, 55 Cal Rptr 3d 272 (Cal App 1 Dist 2007).
- "CIRM Doles Out $67M in Early Translational Grants". Genetic Engineering News. 20 April 2009. Retrieved 24 March 2014.
- George, John (21 March 2013). "Research institute gets millions for stem cell work". Philadelphia Business Journal. Retrieved 24 March 2014.
- Fikes, Bradley (20 February 2014). "$5B initiative proposed for stem cell research". The San Diego Union-Tribune. Retrieved 8 April 2014.
- "The Case for CIRM 2.0: Continuing California's Stem Cell Leadership". Knoepfler Lab Stem Cell Blog. 31 October 2013. Retrieved 8 April 2014.
- Little Hoover Commission (25 June 2009). "Stem Cell Research: Strengthening Governance to Further the Voters' Mandate" (PDF). Retrieved 1 April 2014.
- Institute of Medicine (2013). "The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures". Retrieved 24 March 2014.
- Jenson, David. "California's $40 Million Stem Cell Genomics Award: irregularities, Complaints and Integrity". Retrieved 8 April 2014.
- Jensen, David (10 February 2014). "Amid Allegations of Unfairness, California's Stem Cell Agency Begins Examinations of $40 million Genomics Award Round". Retrieved 8 April 2014.