Stem cell disclosure resisted

The stem cell research institute created by California voters in 2004 approved this month what its leaders call the strongest conflict of interest rules of any U.S. medical research organization. But some voices are calling for one further step: Make public the disclosure statements signed by grant application reviewers."We think we have a very strong system to stand behind and think it would not be strengthened by having public disclosure," said Zach Hall, president of the California Institute for Regenerative Medicine (CIRM), which provides state funding for the research. The rules "go beyond the rules of other state agencies in California and in fact they go beyond the national standards," he told The Scientist.The institute has $3 billion dollars provided by voter-approved bonds to dole out to academic and industry researchers within the state, although legal disputes have prevented CIRM from distributing the funds. Once the money becomes available, grant applications will be reviewed and ranked by experts from outside of California, who are therefore not eligible for CIRM grants.The new conflicts of interest regulations require grant reviewers to sign statements listing any financial, professional, or personal conflicts, including those of a spouse or anyone with a "common financial interest." The definition of financial conflicts includes receiving more than $5,000 in a year from an institution that is applying for a CIRM grant, or a California business that is eligible to apply.John Simpson, stem cell project director for the Foundation for Taxpayer & Consumer Rights based in Santa Monica, Ca., said CIRM's conflict of interest disclosure policy is a step in the right direction, but the review of those statements should not be done only behind closed doors."They are saying they have to disclose financial, personal, and professional conflicts. I think that those statements should be public. If you are going to be making recommendations for how to spend $3 billion of the taxpayers' money, that should be done in a completely transparent and public manner," Simpson told The Scientist.But Hall said that making personal financial information public might frighten away experts. "These are not public employees. They are consultants from outside of the state. They have nothing to gain, in the sense that they are not going to get any grant money," Hall said.One reviewer, Rainer Storb, from the Fred Hutchinson Cancer Research Center in Seattle, Washington, told The Scientist he isn't bothered by the idea of public disclosure of his financial statements. "The burden is that you have to fill out these forms all the time. That's a bit of a nuisance. But I'm perfectly fine with things being made public," Storb said.Other members of the Grants Review Working Group were either unavailable or said they didn't know enough about the debate to comment. Arlene Chiu, director of scientific activities at CIRM, said many reviewers she had spoken with oppose public disclosure.The Director of the Oregon Stem Cell Center, Markus Grompe, who said he was contacted about becoming a reviewer, said his financial ties are already public. "If they bar you from being involved with biotech to be a reviewer, then that will scare off a majority actually; but if it's just about disclosing it, we disclose all the time," Grompe said.Lisa A. Bero, from the Institute for Health Policy Studies at University of California San Francisco, who has studied conflict of interest issues in medical research, said people have difficulty judging their conflicts of interest. She said the specific CIRM disclosure rules improve upon policies that ask general questions about "relevant" financial ties, but public disclosure would still help detect cases where disclosure is less than complete.The CIRM conflicts of interest regulations are undergoing final state review. CIRM President Hall said he would support necessary changes, but suggested that people let the current policy, without public disclosure, have a chance to work. Andrew Holtz mail@the-scientist.comLinks within this article:California Institute for Regenerative Medicine http://www.cirm.ca.govG Slack, "California stem cell program is legal: Judge," The Scientist, April 24, 2006. http://www.the-scientist.com/news/display/23342/CIRM Conflicts of Interest Regulations http://www.cirm.ca.gov/meetings/pdf/2006/08/080206_item_16d.pdfFoundation for Taxpayer & Consumer Rights http://www.consumerwatchdog.org/healthcare/StemCell/Rainer F. Storb, MD http://myprofile.cos.com/STORBT Agres, "NIH defends consulting deals," The Scientist, January 23, 2004. http://www.the-scientist.com/article/display/21953/Markus Grompe, M.D. http://www.ohsu.edu/oscc/faculty.php#grompeLisa A. Bero, Ph.D., Professor, Institute for Health Policy Studies, University of California San Francisco http://www.ucsf.edu/clpharm/bero.htmN. Munro, "Academics' ties to business muddy disclosure statements," The Scientist, April 21, 2003. http://www.the-scientist.com/article/display/13728/

Stem cell disclosure resisted

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