Sunday, July 18, 2010

Sticky, Troubling Appeals by Rejected Researchers Targeted by Stem Cell Agency

A key step in the process for awarding billions of dollars in research grants is “broken,” according to many directors of the California stem cell agency, and major changes are looming that will affect hundreds of scientists.

Just what those changes are likely to be is unclear. The stem cell agency has not made available to the public any drafts of likely proposals or other related material for a meeting on the matter that begins in only one business day. The only information on the agenda for the directors' Science Subcommittee says: “consideration of changes to extraordinary petition and grant administration appeals processes.”

(Editor's note: Hours after this item was posted, CIRM added material to its agenda that outlined the proposed changes. You can find more on the plan here.)

Nonetheless, specific proposals are virtually certain to come out of the session. Those would then go to the full board meeting on Aug. 18 for ratification and perhaps modification.

Many CIRM directors have long been uncomfortable dealing with public appeals by applicants rejected by the agency's grant review group. On the first such occasion in January 2008, Gerald Levey, a CIRM director and then dean of the UCLA Medical School, said, "I don't think we can run a board this way. If we do, it would be chaos."

Eight months later, directors approved the use of “extraordinary petitions” by applicants. However, that has not eased the situation. Last month directors were hit with a record nine petitions and overturned negative decisions by reviewers on four grants, also a record.

The Science Subcommittee first dealt with the appeals process on May 25. According to the transcript, the panel's chairman, Jeff Sheehy, a patient advocate and communications manager at UC San Francisco, said during the brief discussion,
“This is a broken process. I think almost everybody on the board would agree that it is.”
Duane Roth, co-vice chairman of the CIRM board and a San Diego businessman, said,
"This is one that I think really needs to be rethought completely because what we have right now doesn't seem to be working. Even the extraordinary petitions, I think with the exception potentially of one which we responded to, we agreed with the reviewers. And then in the board meetings turned around and disagreed with our own disagreement. And I think we just don't want to do that.

"Second, I think we're inviting very bad precedent behavior by opening ourselves up to the kinds of things that we went through at the last meeting. We just invite people to continue to do that. I'd like to see us find a solution for grievances on the reviews that everybody can get behind and endorse and embrace."
Among the suggestions in May was one from Sheehy to create a “re-review” option. Facing an appeal, directors could send an application back to the review group for re-evaluation in the light of comments from an applicant. CIRM directors almost certainly already have that authority although it has never been used or formally articulated. Prop. 71 makes the CIRM board the final arbiter on applications. Directors can do anything they want with an application. In practice, however, the grant review group makes the de facto decisions with the board intervening in only a tiny percentage of cases.

Sheehy, who is also a member of the grants review group, additionally said he would like the bifurcated appeal process consolidated. Currently, an “appeal” can only be made on the grounds of a conflict of interest. However, those reviews are done behind closed doors and applicants do not know the identity of reviewers charged with close evaluation of their proposals. Conflict appeals are handled privately by CIRM staff and do not normally come before the full board. Extraordinary petitions are technically not appeals, according to CIRM, but in reality serve that purpose.

Complicating the whole matter is the fact that any scientist or member of the public can speak directly to the board at its meetings on any matter, including rejection of applications. They can also write or email the directors. That is a matter of law and cannot be changed by CIRM rules.

At the May subcommittee meeting, CIRM President Alan Trounson discussed the public appearances of researchers. He said,
"It makes it very difficult on the spot to try and provide the board with the kind of information that they need."
Trounson also said the schedule for petitions is tight and comes only days before a board meeting, making it difficult for CIRM staff to evaluate the issues that are raised. However, some petitions are being presented to the board even though they have not met the deadline for submission.

Art Torres, co-vice chairman of the board and a former state lawmaker, suggested that applicants sign a document stating that they have read the rules for filing petitions. CIRM Chairman Robert Klein concurred with that suggestion.

Whatever comes out of Tuesday's meeting, it is a dismal commentary on CIRM that it cannot or will not provide timely information to the public and its stakeholders about how it plans to handle this portion of $3 billion in taxpayers' business.

Here is a link to a reading list, prepared by the California Stem Cell Report, of articles and CIRM documents on appeals and extraordinary petitions.

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