Hundreds of researchers will be directly affected by whatever decisions the governing board might make. The agency still has roughly $2 billion to hand out.
Indirectly affected are patient advocates and others who may think that research that could help them -- and others like them -- is receiving short shrift.
CIRM's directors have been bedeviled for more than 2 ½ years by appeals from researchers whose applications have been rejected by grant reviewers. It wasn't an issue up to that point because most rejected researchers did not avail themselves of the opportunity to make a personal pitch to the board – an action that they are entitled to under state law. Either scientists weren't aware they could speak to the board directly, as any member of the public can, or they weren't brazen enough to do so.
The directors' new Science Subcommittee has taken up the extraordinary petition process in two meetings this year. But nothing has been heard at those meetings from researchers. One likely reason is the agency's failure to make public in a timely fashion a draft of what they are considering. In July, a proposal for “re-scoring” rejected applications, under certain circumstances, was not made available to the public until one business day before the subcommittee meeting.
Jeff Sheehy, a communications manager at UC San Francisco, is chairman of the Science Subcommittee. A patient advocate member of the CIRM board and a member of the grants review committee, he is one of those who describe the petition process as broken. None of the 29 CIRM directors has expressed satisfaction with how petitions are handled.
At the July Science Subcommittee meeting, Sheehy noted that “a lot of applicants” see no disadvantage to filing a petition and consume an “an enormous amount” of CIRM staff time. According to the transcript, he said the petitions have degenerated into “gamesmanship.” Sheehy said, however, the ability of any person to appear before the CIRM governing board is a “positive feature of the California public policy process.”
CIRM director Joan Samuelson, also a patient advocate member of the board, said,
“I don't see it as a broken system exactly. There are concerns about it. But maybe it's like democracy. We're not nuts about it, but it's the best we've got.”CIRM divides its grant appeal process in two ways. One is formally called an appeal. It is handled behind closed doors, but probably shouldn't be, and involves conflicts of interests. The staff makes decisions on those issues, although they could be raised publicly by a researcher if he or she chose to do so. Over the past few years, more scientists came before directors seeking reconsideration on other grounds. As a result, the board created something called an extraordinary petition, which is just another way of appealing a negative decision by reviewers.
This spring, nine researchers filed petitions, nearly one-third of rejected applications that were rejected. Four petitions were successful. The process, however, tested the patience of the board.
Some scientists have appeared before the board backed by a small cadre of patient advocates for diseases and persons suffering from serious afflictions, which has raised concerns about the role of emotions in making funding decisions. The presentations are powerful. It would take a cold, cold individual not to be swayed.
In July, CIRM Director Philip Pizzo, dean of the Stanford School of Medicine, brought up what he described as the “emotional overtone” of the presentations. He said that board members understandably respond “when someone speaks with deep concern and passion, particularly about a member of their own family.”
Sheehy responded,
"To be perfectly honest, Dr. Pizzo, that was one of the driving forces for this policy because a lot of times I find myself compelled by emotion, and I've lost the science.”Sheehy said the re-scoring plan could evaluate a petition in “an atmosphere where there is no emotion.”
CIRM Director Oswald Steward, director of the Reeve-Irvine Research Center at UC Irvine, said he did not think that a new policy was needed on re-scoring. He said that directors already have the power to send back a grant for re-evaluation, although that has never happened as far as we know. It would seem to require nothing more than a vote of the board. However, no procedures are in place for staff to deal with such an action.
Steward also discussed how petitions can lead to favoritism. In the normal CIRM grant approval process, the names of applicants are not disclosed when their applications come before the board. However, in some cases it is not too difficult to determine their identities. But under the petition process, the researchers are required to publicly identify themselves, even if they do not appear before the board. The board also does not have copies of the actual applications, only a summary of reviewer comments.
Steward said,
“This is a more fundamental thing, and I've been thinking about this in terms of this whole issue of extraordinary petitions. The thing that we most often run into is an investigator who, first of all, identifies themselves, which is really...one of the fundamental problems with this process, because if this is somebody we all know, we say, 'Oh, well, this person deserves some really extra attention.' And if it's not somebody we know, then maybe we pay less attention to it. It really is a fundamental...unleveling of the playing field.An odd bit of CIRM management muddle also surfaced during the July session. CIRM President Alan Trounson said he was not aware of the staff proposal for re-scoring grants and expressed reservations. Trounson's comments triggered some irritation on the part of Sheehy, who said he had been working for some time with CIRM staff on the matter.
“The problem that we most often run into is that whoever says...the reviewer missed this, or there's a mistake or whatever, and we have in front of us the letter from the investigator, but we're still unable to look at the grant itself or the comments of the review panel. So my specific proposal that now I'm going to make for all of the extraordinary petitions is that if an investigator wants to make an extraordinary petition, they should volunteer themselves to provide the (directors) with a copy of the original proposal and a copy of the review. In other words, let's get all the issues out on the table for our consideration.”
No decisions were made last month on changes in the petition process. Another Science Subcommittee hearing is likely in the next couple of months.
California stem cell scientists do have something significant at stake in all this. Even if they cannot appear directly before the subcommittee, it is in their best interests to weigh in with constructive suggestions. They can be sent Gil Sambrano, the staff member who deals with grant reviews. His email address is gsambrano@cirm.ca.gov.
