Sunday, May 22, 2011

$700,000 IOM Study of California Stem Cell Agency to Begin July 1

The California stem cell agency has signed a nearly $700,000 contract with the prestigious Institute of Medicine to produce a wide-ranging report to determine whether the agency is operating at "peak performance" and whether improvements are needed.

The 17-month study will cost $699,247, under the terms of a contract signed on April 21. The project is scheduled to begin July 1 and conclude by Nov. 30, 2012. CIRM directors authorized the study last August.

The original proposed schedule would have had the study completed by September 2012. That date would have made it available that fall for use in a campaign for a possible $3 billion to $5 billion bond ballot measure for CIRM, which has been talked up by outgoing CIRM Chairman Robert Klein. Such bond measures are usually placed before voters during a major statewide election, such as for governor or president, in order to help win passage. A presidential election is set for November 2012.

Last August, Klein said the study would be key to winning voter approval of more bonds($3 billion were approved in 2004). However, the current timing would appear to make the full report unavailable for a November 2012 campaign. Nonetheless, selected portions of it could be leaked in advance to help win support.

Most of CIRM's directors agreed last August that a study by the well-regarded IOM would benefit CIRM and create more enthusiasm for stem cell research. The lone no vote came from Duane Roth, a San Diego businessman and co-vice chair of the board. He told directors,
"I would just caution that the outcome on something like this can cut both ways. And to go in just sort of blind trust that they're going reach the conclusion you want them to reach, I don't think is a foregone conclusion. So you at least ought to think about the downside of a rather critical (study)."
The IOM's study proposal said,
"The principal objective of this review is to ensure that all aspects of CIRM's operations are functioning at peak performance."
Under the terms of the contract, the IOM will select a 14-member committee to hold four meetings (only two that are partially public). The first meeting will be held behind closed doors although it deals with the very public issues of bias and conflict of interest. The second and third meetings are scheduled to have public workshops in California and will be the only ones held in the state.

Once it is written, the report will go through the National Research Council's peer review process. CIRM will see a prepublication copy of the report as much as three months ahead of publication.

Here are some of the questions that the IOM study proposes to address:
  • "Does CIRM have the portfolio of projects and grant opportunïties necessary to meet its scientific goals?"
  •  "Are the internal organizational and management systems (in particular the board and working group structures and operations, the peer review system, the conflict of interest guidelines, and the grants management system) effective in working toward the institute's scientific goals?...Do they achieve the level of transparency and the level of stakeholder and scientific community involvement needed to meet the institute's public responsibilities and scientific goals?"
  • "What are the advantages of CIRM's model for covering long-term costs of medical research? Could aspects of this funding model serve as a paradigm for other states or counties? "
 Although the study is being financed at taxpayer expense, the contract said the report will be the property of the the IOM – not CIRM. The contract also said "minutes and working papers from the committee meetings in closed (deliberative) sessions are considered proprietary by the consultant (the IOM) and will not be available for review by CIRM or provided to CIRM."

CIRM plans to pay for the study with funds that it has gathered over the last few years from private donors. Klein has argued that the money thus does not come from California taxpayers. However, as the California Stem Cell Report and others have pointed out, once the money is given to the state, it is all public money and belongs to taxpayers.

The IOM project comes as CIRM is scheduled to undergo its first-ever performance audit. The audit is required as the result of legislation last year supported by CIRM. The review is budgeted for $250,000 for the coming fiscal year although the total was originally estimated at about $400,000. Last fall, CIRM conducted an "external review" of its performance that consumed 2,000 hours or more of staff time.

The IOM study director is Cathy Liverman. The IOM contract and proposal can be read below.
IOM/CIRM Contract

IOM/CIRM Contract

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