Stem Cell Research Data May Not Be Disclosed

PUBLIC INFORMATION — A subcommittee of the board of the California Institute for Regenerative Medicine (CIRM)—the state's stem cell research agency—
today unanimously approved a $300,000 economic impact study of the
agency's work by a firm that is expected to “execute a vibrant and
aggressive strategy” supporting CIRM, but in a manner not all that transparent, notes the California Stem Cell Report.

Still
up in the air is whether CIRM will allow other researchers and
interested parties access to the basic data that will be gathered for the study at taxpayer expense. Much of the information will come from recipients of CIRM grants.

In response to an email query, Don Gibbons, spokesman for CIRM, said the Governance Subcommittee approved the study to be conducted by LECG
of Emeryville, Ca. Gibbons did not respond directly to questions about
whether the data would be available to other, non-CIRM researchers, who
could make an independent assessment about the financial impact of
spending $3 billion for research.

Gibbons looked askance at an earlier item on the California Stem Cell Report that discussed the issue of public availability of the information.

He
said in an email that the article was “grabbing at straws.” The item
was based on a brief response from Gibbons to two questions from the California Stem Cell Report.
Gibbons said that he was “in a hurry” when he looked at our emailed
questions and misread them as a request for a copy of a contract. (Our
two sentence request can be found here.)

Gibbons added that at the Governance meeting, CIRM Chairman Robert Klein “pledged that the (economic analysis) model created will be made public,” a statement that raised another question from us.

We asked Gibbons,“To
double-check, your message….omits any reference to making the basic
data public. The 'model' is different than the data used in it.

“Will the basic data be available to the public and will it be available in a non-proprietary format? Thanks.“Gibbons' verbatim response:“The
bulk of their work will be on the model. The only case that will be
worked through with full data will be the test case on Polycythemia
Vera. There will be some data that will be protected by patient privacy
laws. We have not worked out where that line will be drawn.”

CIRM's
position falls far short of ensuring public and researcher access to
the basic data, which is being generated with taxpayer funds. Bringing
up patient privacy laws only confuses the issue. In virtually all major
studies of this sort, individual names and personal information are not
important to the analysis. The data are aggregated in an anonymous
fashion.

The important point is to build a database from the
very start that is publicly usable and that does not co-mingle
confidential and public information in such a way that harms its public
accessibility. If the two categories are interwoven inappropriately, it
could make the data nearly impossible to unwind.

To fail to
ensure public access to the basic information only damages CIRM's
credibility, especially when the agency goes to Sacramento seeking
additional funding. Klein has promised to adhere to the highest
standards of openness. It is time for him to fulfill that promise.

As for the independence of the winning firm, CIRM's request for bids specifically stated that a successful bidder must “execute a vibrant and aggressive strategy to support the goals and initiatives of CIRM.”