Monday, December 08, 2008

Once rejected $1.7 million grant is resurrected

In "a highly unusual" situation, directors of the California stem cell agency this week are likely to approve a $1.7 million grant application that was pulled off a previous round after scientific reviewers turned it down.

In June, CIRM President Alan Trounson removed the application from the list of those being considered for new cell line grants. During a brief exchange at the June meeting of CIRM directors, Chairman Robert Klein said that "there was a problem with it, that it technically has to be re-reviewed." Trounson said he directed that the application be reexamined after he discussed it with the chairman of the review group, Stuart Orkin of the Dana Farber Institute.

There was no further comment in June by CIRM directors on the proposal, numbered 642-1 and labeled "derivation of new ICM-stage hESCs."

In the initial consideration of the application, reviewers raised several scientific questions and concerns about the proposal, according to the summary posted on the CIRM web site. No scientific score for the application was disclosed by CIRM, which considers scores for rejected proposals not suitable for public release.

One member of the Grants Working Group, Chad Cowan of Harvard, was barred from participating in review or discussion of the applicant because of a conflict of interest. CIRM did not specify the nature of the conflict.

The latest summary of the review of the application says that its "technologies and methodologies are not novel and not particularly innovative." But the review also said other aspects of the proposal are "laudable" and that it has "significant potential."

The application was given a scientific score of 80 out of a possible 100. No reviewers were excluded from participation in the most recent review of the application. Cowan is currently listed as an alternate member of the Grants Working Group. It is not known whether he participated in the latest review of 642-1.

The identity of the applicant and his affiliated institution is being withheld by CIRM. The agency makes a practice of withholding the names of successful applicants until the full board acts, although exceptions to the policy have come up. Names of rejected applicants are never released.

Last July, we asked Don Gibbons, CIRM's chief communications officer , for more information on the re-review, which may be the first such public case.

Our questions included:
"Is the grant being re-examined in connection with provisions in the grant administration policy that state that appeal grounds are 'strictly limited to circumstances in which a demonstrable financial or scientific conflict of interest' played a role?

"If not, what sort of additional information justified redoing the review?

"Did the information come to CIRM first? Who generally provided the information: the applicant or ??? Was it forwarded with or without a recommendation to the chairman of the Grants Working Group? What action did he take?"
Gibbons replied at the time that it was the "president's decision." Gibbons said,
"This grant was a highly unusual circumstance; something that has not happened before and something we don’t expect to happen much, if ever, in the future. We are not treating it as an appeal through the GAP. New information came to us, and the president, in consultation with the chair of the working group, decided that it merited sending the grant back to the working group for further review."
Following approval of the grant Tuesday or Wednesday, CIRM is expected to release the name of the researcher and the institution.

(Correction: An earlier version of this item identified the chairman of the Working Group as Dana Orkin. His correct first name is Stuart.)

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