Review of California's stem cell agency calls for changes in oversight and governance

An independent review of the California Institute for Regenerative Medicine (CIRM) released Thursday applauds the state stem cell agency for achievements so far, but recommends a series of changes to ensure independent oversight of projects.

The review, by the Institute of Medicine (IOM), was commissioned by CIRM. The state agency was created  by Proposition 71,  approved by California voters in 2004, which funded CIRM with $3 billion in taxpayer dollars. 

In its review, the 15-member IOM team evaluated the agency’s governance structure and its scientific and intellectual property policies. It was not asked to evaluate CIRM’s stem cell grants or its impacts on the field of regenerative medicine.

The IOM report opens with praise for the voter-approved initiative as a  “social innovation” that “in both scope and design broke new ground” and established California as a key international hub for regenerative medicine at a time when federally-sponsored research in the field was stymied by “near paralysis.”

The report goes on to praise the agency for “successfully and thoughtfully” providing more than $1.3 billion in taxpayer-funded awards to dozens of California institutions during its initial period of operations.

The report also suggests ten non-binding recommendations for change. Among them is that the agency take action to eliminate widely perceived conflicts of interest — “real or perceived” — on its governing board that the authors concluded “has led some observers, perhaps unfairly, to continue to question the integrity and independence of some of CIRM’s decisions.”

The recommendations also include a restructuring of the CIRM governing board to “… include representatives of the diverse constituencies with interests in stem cell research, but no institution or organization should be guaranteed a seat on the board,” as is now the case under the Prop. 71 legislation that governs the agency's operations.

That recommendation further states: “Consideration should be given to adding members from the business community. The terms of board members should be staggered to balance fresh perspectives with continuity.”

Another recommendation focuses on CIRM’s advisory team that is charged with evaluating funding applications. The report suggests CIRM exclude from the team members of the governing board and replace them with “disease advocates who are not board members.”

The report commends CIRM for achieving its initial scientific goals of  funding basic stem cell research and of developing laboratory facilities to create an infrastructure in California for that research:

“Collaborations with funding partners and stem cell researchers in the United States and around the world have attracted tens of millions of dollars in matching funds for CIRM projects, and resulted in new levels of cooperation and funding in the field."

But the review suggest the agency is in need of a scientific advisory board “comprising individuals with expertise in the scientific, clinical, ethical, industry, and regulatory aspects of stem cell biology and cell-based therapies….which is lacking in the current CIRM organizational structure.”

 The report says the members of that board should be charged with helping CIRM maintain an appropriate balance in its research portfolio; to engage industry partners in developing new therapies; and to decide which discoveries should progress toward the clinic.  The recommendation further suggests the board’s reports and the president’s response to them would then be discussed in public sessions.

Perhaps most critical of the recommendations are those to help the stem cell agency maintain “the momentum of its achievements” beyond the $3 billion initially authorized by Prop. 71, of which only  $856 million remains. 

To that end, the report recommends CIRM work with current and future partners in developing new funding sources, which the agency would then present to the public.

We deeply appreciate all the hard work of the IOM committee in compiling this thoughtful report,” said Jonathan Thomas, chairman of CIRM's Independent Citizens Oversight Committee, in a statement. “We take their observations on how we can improve our performance very seriously and will bring those to our governing board, the Independent Citizens Oversight Committee, for a much more detailed discussion on how best to proceed with consideration of these recommendations.”

 Update 2:58 p.m.   A prior version of this story stated that CIRM was created in 2004.  The agency was created in 2005 after California voters approved Proposition 71 in 2004.