Appeals at the California Stem Cell Agency: Worthwhile or Worthless?

Jon Shestack, a patient advocate member of the governing board of the California stem cell agency, weighed in today on the virtues of the grant application appeal process at the $3 billion research enterprise.

His remarks came in a “comment” filed on the Duchenne item that appeared yesterday on this site. (His full comment can be found at the end of that item.)

Shestack said that the handling of the $6 million CIRM grant involving Duchenne research is “a casebook study on why the special(extraordinary) petition is worthwhile. There was indeed new and relevant information that only became available after grant review. Scientific staff and leadership flagged it.”

The utility of the petitions is one of the reasons that we ran the story about Duchenne and the team at UCLA. The extraordinary petition process is currently under fire by both the Institute of Medicine and the stem cell agency itself, which has appointed a task force to come up with changes. But, while the petition process is certainly less than perfect, so is the peer review/grant review process.

The Duchenne application is not the only “case study.” An application by Karen Aboody of the City of Hope is often cited as another case. There are undoubtedly others.

The petition process was adopted several years ago by the board as a tool to manage willy-nilly appearances of scientists before the CIRM governing board whose applications were rejected by reviewers. Now the Institute of Medicine has recommended the petitions be abandoned, saying they undermine the integrity of grant review process. The IOM cited a major controversy in Texas involving its cancer research agency as an example of how grant reviews or the lack of them can go bad – not to mention conflict of interest problems there. CIRM has already started to look for better solutions regarding appeals. Many of its directors are troubled by emotional presentations from patients in connection with petitions and the lack of adequate information to make informed decisions on the spot about the contested matters.

Whether appeals can be put in a tidy, scientific box is debatable. Researchers have the right, under state law, to address the board on any issue whatsoever. And at least some of them will continue to do so -- regardless of any appeals changes --  when millions of dollars and their careers are at stake.

Opinions and decisions of CIRM reviewers are not holy writ. They can and do make mistakes, as we all do. In making changes in the appeals process, the goal of the agency should be to devise a public and transparent process rather than enshroud it in more secrecy. CIRM also should find a way to do a much better job of communicating to applicants the availability of appeals and precisely how to appeal when it becomes necessary.   

Six Scientists Appeal Rejection of Grants; Read Their Letters to CIRM

Six researchers this week are publicly appealing negative decisions on their requests for millions of dollars from the $3 billion California stem cell agency.

The “extraordinary petitions,” which are available online, were filed in connection with a $30 million round of stem cell immunology grants that the CIRM board is scheduled to vote on at a meeting in San Diego beginning next Tuesday.

The petitions generally focus on reviewer comments concerning the science of the proposals. Some discuss value judgments made by reviewers. Some cite what the applicant considers are errors. One researcher notes that she is a Latina leader in bringing minorities into science(one of CIRM's aims is to increase diversity in the field). Another said that “certain key points of our proposal that may not have been fully appreciated by the review panel, perhaps due to lack of clarity on our part.” Another took issue with a reviewer's comment that the principal investigator did not have a “sufficiently strong CV.” Another pointed out that the application received a score of 67, which is two points below the cutoff line. CIRM board members have noted in the past that such minor numerical differences are virtually meaningless.

Here are the names of the scientists filing the petitions: Genhong Cheng of UCLA, Elaine Reed also of UCLA, Jeanne Loring of Scripps, Olivia Martinez of Stanford,  and Defu Zeng  of the City of Hope and Chih-Pin Liu, also of the City of Hope. The CIRM board includes members from all those institutions. However, they are not allowed to take part in deliberations or vote on applications of their institutions.

Click on names of the researchers to read their letters. Summaries of reviewer comments on all 44 applications can be found via this item.

Reviewers made positive decisions on 15 proposals. The board, however, can do anything it wants with the applications, although it rarely acts favorably on petitions. A number of board members are uncomfortable with the process, which is slated for a major public review in August.

Some of the scientists filing petitions are also likely to appear before the CIRM board meeting next week to make an additional pitch for their applications.

Interested persons can hear a discussion of the grants and the petitions during the meeting via an Internet audiocast. Directions for listening to the audiocast can be found on the board agenda.

Here is a link to additional reading on the appeal process at CIRM, including agency documents.

(Editor's note: An earlier version of this item incorrectly said that 44 applications were received and 16 approved.)