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California’s Stem Cell Agency Seeks to Quell Criticism on Conflicts

CIRM moves to institute changes based on IOM recommendations.


The Burrill Report

“These proposals take a significant step towards dealing with financial conflicts of interest.”

The California Institute for Regenerative Medicine—California’s stem cell agency backed by a $3 billion ballot initiative—said its board has adopted a framework of proposals that could “dramatically change some aspects of its work.” The proposal is aimed at addressing criticism over potential conflicts of interest in the way the board decides how to allocate grants.

The proposals come in response to a series of recommendations from the Institute of Medicine. The IOM made those recommendations as part of a report requested by the agency, which was seeking an independent assessment of its programs, operations, strategies, and performance.

“Improvements to CIRM’s governance structure, scientific program, and policies are critical to better serving California taxpayers who elected to devote funding to promote stem cell research in the state,” the IOM report said. “The necessary changes outlined by the IOM committee, if enacted by the state and/or the institute, would help to instill confidence among the scientific community and California residents in the vital work that CIRM is accomplishing.”

The recommendations covered a range of issues from the structure of the agency’s board to the role of patient advocates on advisory committees. The Board voted unanimously with one abstention in favor of the proposed framework.

“One of the big issues raised by the IOM report was that our current governing structure created a perception of conflicts of interest in how we fund research,” says Jonathan Thomas, chairman of the board. “While no one has found any actual conflicts, these changes directly address the broad public perception. By having Board members who belong to institutions that can get CIRM money abstain from all votes on funding we take even the perception of conflict of interest out of the picture.”

Under the proposal, board members appointed from institutions eligible for funding from the agency would no longer vote on any grants before the board. While those members would participate in discussion on applications, they would not be involved in discussions about specific applications from their institutions. Patient advocates would continue to be members of the Grants Working Groups, but would not vote on individual applications.

In an effort to increase transparency, the board voted to have programmatic review, aimed at balancing the agency’s portfolio, take place at public board meetings where members have a chance to make changes to recommendations from the Grants Working Group.

Industry involvement would also increase under the plan for the Grants Working Group. Industry would also play a role on a newly constituted Scientific Advisory Board. The structure and membership has not yet been determined.

Under the proposal, the chair would be responsible for handling external affairs for the agency, such as raising additional funds, meeting with state legislators, and public outreach. The president would supervise scientific operations and internal operations.

Harold Shapiro, head of the IOM panel that produced the report, called the proposal a “thoughtful and significant response” to the recommendations made in December. “These proposals take a significant step towards dealing with financial conflicts of interest, enhancing the credibility and integrity of the scientific review process, increasing the role of industry representatives, further clarifying the roles of the president and board chair, and establish the Scientific Advisory Board as the IOM Committee recommended,” he says.

The proposal will be open for public input until CIRM’s March board meeting, when a final vote will be taken on the changed policies, regulations and by-laws implementing the plan.

January 25, 2013

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