Big Bucks Giveaways and CIRM Integrity

Handing out hundreds of millions of dollars behind closed doors naturally leads to concerns about fairness and conflicts of interest.

Especially when it becomes personal, such as when a scientist's career and the economic well-being of his family, his business or his employer may be at stake.

It is even more complicated when those who make the de facto decisions (the scientific reviewers) are competitors in the field, albeit from a different state, and when their economic and professional interests are cloaked by secrecy.

Then couple all that to a public agency with $3 billion to hand out for research in a controversial area of science. The agency itself has its own important needs and responsibilities. Above all, it must maintain public trust and its own integrity. It must have candor from its reviewers and protect them from unwarranted attacks and retribution from disgruntled applicants. It must somehow provide the reviewers with the incentive to come to the Golden State and work hard to hand out tons of cash that they will not have a chance to compete for. Beyond that, the agency must maintain the confidence of applicants and potential applicants. They must feel that they are being treated fairly regardless of the final outcome on their bids for the golden ring.

No small challenge. But one that faces the California Institute of Regenerative Medicine.

CIRM's 29 directors will wrestle with the task once again on Thursday in San Diego. They constitute the body that has the legal authority to make the grants. However, scientific reviewers, during closed door sessions, have already scored each grant and made their decisions on funding, which are presented to CIRM directors. The CIRM board almost never overturns a positive or negative decision by reviewers.

But state law permits any person to appear before directors and make a pitch, including rejected grant applicants. When that first occurred last January, it made some directors more than uneasy. It happened again in June. In an effort to bring order to the process, CIRM staff has come up with a plan to deal with requests for reconsideration of negative application reviews.

The proposed "policy regarding extraordinary petitions" for "special consideration" calls for them to be submitted to CIRM at least five days before the directors meeting at which the application will be considered for funding. The policy declares that the petitions should only be submitted under "extraordinary circumstances" and be limited to no more than three pages. They will be posted on the CIRM website. Material may be cut from the public versions to "protect personal, proprietary or confidential" information.

The staff will evaluate the petitions and be prepared to make a recommendation to the board of directors. However, the evaluations will only be presented if requested by a director.

The policy is slightly modified from the plan offered at last month's directors meeting. CIRM President Alan Trounson then described the proposal as a method for handling "extraordinary requests for reconsideration," declaring,

"What we don't want to do is have a raft of complaints that might topple continuously into the press, which would be very damaging, I think, for the reviewers."

CIRM's outside counsel, James Harrison of Remcho, Johansen & Purcell, of San Leandro, Ca., said,

"We have tried to develop a policy that strikes a balance between the right of applicants to communicate with the board and the necessity for thorough, fair, and thoughtful consideration of applications."

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., had his own perspective:

"It is a way to bring order to the chaos of people who decide to, in fact, lobby the board, which ...people are entitled to do."

CIRM Director Sherry Lansing, a former Hollywood studio executive, told Simpson his was an "incredibly clear" summary.

This week's proposed policy has its flaws. It does not make clear what "extraordinary circumstances" justify an appeal, a word that CIRM does not want to use to describe the petitions. Applicants certainly will ask for a definition of "extraordinary circumstances" from CIRM before filing a petition. The proposed policy also appears to allow considerable fiddling with the public version of the petition, permitting material to be censored on the basis of overly broad, undefined terms such as "personal" and "confidential." The proposed policy additionally does not specify that the petitions must be posted publicly before the CIRM directors meeting.

Both CIRM management and board members have acknowledged the review process is not perfect. The proposed policy is a good first step in beginning improvements that will both help CIRM with its mission and protect the organization's integrity as well.