US stem cell rules clarified

On the one-year anniversary of a ban on using federal dollars in work involving human embryonic stem cell lines, U.S. scientists are still tiptoeing around the issue of stem cell research, even as it appears they have won a key concession on university funding policy from the Bush Administration.Simple bookkeeping will keep academic researchers from running afoul of a ban on using federal dollars in work involving human embryonic stem cells lines created after August 9, 2001, according to a March 29, 2002 posting on the National Institutes of Health web site. The posting, a question-and-answer session, was first reported in April by Science.As attorneys had read last year's policy, should government money touch human embryonic stem cell research involving post-Aug. 9 lines, all of the federal funding to that institution could be endangered. In the absence of guidance — and, until the appointment of Elias Zerhouni in May, in the absence of a permanent NIH director — university research administrators either moved human embryonic stem cell research off campus or held back. "There was too much uncertainty for institutions or individuals to make major investments in a research field that was so very controversial," Tony Mazzaschi, associate vice president at the Association of American Medical Colleges, told The Scientist. "Some of the uncertainty was in the minds of legal counsel, but it was critically important to get clarity."At least one institution, the University of California, San Francisco, moved stem cell research off campus, in September 2001. On-campus work continued on "allowable" stem cell lines — those already in existence at the time the federal ban came down. Stem cell research groups began pushing behind the scenes to persuade the administration to interpret the no-commingling policy favorably, or at least in a way that would let them know what to do. In response, the March 29 NIH Web site posting referred researchers to an existing set of accounting principles meant to keep federal dollars from being used on privately sponsored research projects. Instead of separate labs, separate staffs, separate equipment, all academic researchers had to provide "a method of separating the costs of supporting your laboratory so that any of the facilities and administrative (F&A) costs allocable to your new stem cell line work are excluded from the federal share of the organized research cost base," the NIH guidance said. "A lot of universities have firewalls in place already with respect to technologies that are being commercialized," said Jennie Hunter-Cevera, president of the University of Maryland Biotechnology Institute. "As long as the accounting is clean and the work is done appropriately so that you don't commingle funds, there's no problem." "All this is saying is that you can treat stem cell research just like any other privately funded research, and that's all we wanted," said Mazzaschi, referring to the lead lobbying group in the pro-research camp, the Coalition for the Advancement of Medical Research. The Coalition, however, did not publicize the clarification. "We made a conscious decision not to seek press on it, fearing it would stir up the right-to-life community," Mazzaschi said. Still, the research is proving as technically difficult as it is politically sensitive. "The 64 cell lines that we thought were available have not proven to be so available and many of those lines are not robust," said Mark Pittenger, director of discovery research for Baltimore-based Osiris Therapeutics Inc., one of the private firms involved in the science.

US stem cell rules clarified

A year after Bush ruling, scientists quietly work around ban by keeping research dollars strictly separate

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