Monday, December 08, 2014

California Stem Cell Agency Overhauls Grant Review Conflict Rules; Secrecy Remains

The California stem cell agency this week is expected to begin sweeping out its current conflict-of-interest rules for multi-million dollar research applications and giving applicants wider range to disqualify some grant reviewers in advance.

Little about the operation of the rules, however, will be disclosed to the public or applicants, although the regulations are critical to the integrity of the $3 billion operation.

The new grant review procedures received a preliminary go-ahead Nov. 24 from the Governance Subcommittee of the governing board of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. The proposals will come before the full board this Thursday at a meeting in Berkeley.

James Harrison, the outside counsel to the CIRM board, described the changes concerning scientific grant reviewers as “substantial” in a memo to the board. One key provision would involve “a screening mechanism that would permit applicants to identify up to a total of three individuals (including labs and companies) whom the applicants believe could be biased (whether for personal, professional, competitive, or any other reasons).”

The exact mechanism was not otherwise described in Harrison’s memo. 

CIRM’s grant review process is currently shrouded in secrecy in keeping with tradition in the scientific research community and will remain that way under the new rules. Virtually all of the grant review is performed behind closed doors. Identities of specific reviewers on an application are withheld. Names of applicants are withheld. Financial and professional interests of the reviewers are withheld, revealed only to some CIRM staffers.

When an applicant files a complaint about a financial conflict of interest on the part of reviewers, all of the information is withheld.

That is the environment in which the agency’s scientific reviewers operate while they make the de facto decisions on virtually all of the $1.8 billion that has been handed out over the last 10 years. The governing board rarely overturns a positive decision by its reviewers, all of whom come from out of state.  

In response to a question today, Kevin McCormack, a spokesman for the agency, said that the secrecy would continue under the new rules. He said applicants could examine the list of more than 100 potential reviewers if they had concerns about conflicts. A much, much smaller number is actually involved in a specific application review. Those names are withheld. 

No restrictions exist, however, on applicants publicly disclosing their conflict-of-interest concerns either directly to the board or to any other private or public entity.

The proposed conflict changes would also disqualify reviewers from evaluating an application from a person who has “been on opposing sides of a formal legal dispute.”  A reviewer would be required “to recuse himself or herself if the member believes his or her objectivity could be compromised for any reason.”

Other changes would expand the scope of financial conflicts by including relationships with partnering organizations and subcontractors.

The Harrison memo said,
“The intent of this change is to capture other financial interests that could create a conflict of interest with respect to a particular application because they are significant participants in the proposed project or stand to benefit financially if the project is successful.”
The proposed rules originated more than a year ago as an outgrowth of a discussion at a stem cell agency board meeting involving earlier possible changes. The board was told that only two cases have surfaced involving violations by reviewers. No names were mentioned during the board meeting.

One case involved reviewer Lee Hood, a renown scientist from Washington state, in a conflict connected to another internationally known scientist, Stanford researcher Irv Weissman, in a $40 million round. The other involved John Sladek of the University of Colorado, who was head of the grant review group, in a $45 million round.  The violations were first disclosed publicly by the California Stem Cell Report. The agency did not post the violations on its Web site, reporting them only to the California legislative leadership as required by law.

At the October 2013 agency meeting of the agency governing board meeting, Jeff Sheehy, a board member and communications manager at UC San Francisco, asked if the Hood and Sladek violations would also be considered violations under the rules being proposed at that 2013 meeting.  Sheehy was told that they would not, according to the transcript of the meeting. Sheehy replied,
“Well then, I think it's not possible for me to even support the initiation of this process because in the last case(Hood-Weissman), at least what I've been told, the identification of the conflict, which was the reviewer and the grantee held property together, and the identification of that conflict was made by a fellow reviewer. So if we have a conflict that is deemed material by members of the scientific community, it's hard for me to understand why the net that we're casting should make the holes bigger in order to let the fish out.”
After some discussion of Sheehy’s remarks and other concerns voiced by board member Stephen Juelsgaard, former executive vice president of Genentech, the proposed changes were sent to the Governance Subcommittee for revision.  

Harrison’s memo for this week’s meeting did not specify whether the two past violations would now also be considered violations under the latest rules.

The new rules would apply initially to the agency’s new, $50 million fast-track clinical program and then be extended to all applications.  The action this week will impose the regulations on an interim basis while they work their way through the state’s official rule-making process during which the public may comment.

In addition to the Berkeley meeting location, interested parties can participate at a teleconference location in Sacramento and two in Los Angeles.  Specific addresses can be found on the agenda. Room numbers can be learned by emailing  Comments or suggestions can be sent to that email address as well.

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