Thursday, August 30, 2012

Stem Cell Agency Moving to Curb Free-Wheeling Appeals by Researchers

The $3 billion California stem cell agency on Tuesday released details of proposed, major changes in how scientists are allowed to appeal decisions when their applications for millions of dollars are rejected by grant reviewers.

The agency posted on its web site a 4 ½ page plan to curb the free-wheeling pitches that reached a record level at last month's governing board meeting. Some of the changes would formalize ad hoc procedures that have emerged over the last several years. The plan would also make it clearer exactly what can and cannot be done or expected under the agency's appeal process, which is poorly understood by at least some researchers.

The agency's proposal, due to be acted on at the CIRM board meeting next Wednesday and Tuesday, is heavily nuanced, dealing with such matters as “supplemental information,” an “additional analysis option,” “criteria for material dispute of fact,” “criteria for material new information” – not to mention the old standby – “extraordinary petition.”

CIRM also reiterates in a footnote its distinction between an “appeal” and an “extraordinary petition.” However, it is a distinction without a difference except to those in thrall of bureaucratic jargon. Both are appeals. Their purpose is to provide a method for overturning reviewers' decision under certain conditions.

Details on CIRM's proposed changes came only four business days prior to next week's governing board meeting – a little late to generate thoughtful comment and constructive suggestions from those most likely to be affected by the changes – the 500 or so recipients of $1.6 billion in CIRM funding. Before final action on the changes, the board may well want to send out the proposal to all of its grant recipients and ask them for written comment that could then be considered at a public meeting of its Science Subcommittee.

The CIRM board has been bedeviled by the appeal process for more than four years, including the presentations at its public meetings by scientists. Ironically, the first such public appearance was made by Bert Lubin, who is now a member of the CIRM board  and CEO of Childrens Hospital in Oakland, Ca..

As the California Stem Cell Report wrote at the time, the pitch by Lubin, who was unsuccessful, disturbed some board members. Gerald Levey, then dean of the UCLA medical school and a member of the board, said,
"I don't think we can run a board this way. If we do, it would be chaos." 
Lubin was later quoted in the journal Nature as saying that his rejected application did not come from “the in crowd” of stem cell researchers or organization.
“So a project that was really going to go into patients was essentially triaged.”
A final note: CIRM's proposal for changes in the appeal process also uses language that obfuscates exactly what researchers can do under state law. The document says that scientists “may” make oral and written comments to the board, which is a state government entity. In fact, state law makes it clear that researchers as well as any member of the public have the “right” to comment. The board legally cannot prevent them from speaking or making comments. And the board, to its credit, has always allowed ample public comment even when it slows the board's work.  
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