Home' Technology Review : September 2005 Contents 49
more or less, inside the rst. The tools used by a research group---
such as electron microscopes, DNA synthesizers, and centri-
fuges---can together cost up to a million dollars per scientist.
Laboratories typically reduce those costs by sharing equipment
among research teams. But as a practical matter, that won't work
for stem cell research, because most scienti c equipment at ma-
jor research institutions is at least partly funded by the federal
government. Inadvertently, Daley says, the president's decision
made embryonic-stem-cell research much more expensive.
But equipment and facilities weren't the only added
costs. To ensure that it was complying with federal
guidelines, Taylor says, "Children's gathered together
the senior management from each of the a ected
areas--- nance, intellectual property, sponsored re-
search, compliance, clinical research, research ethics,
and administration, together with legal and account-
ing sta ." The managers conducted Talmudic studies
of the 106 sections of the U.S. O ce of Management
and Budget's Circular A-21 that establish the "cost ac-
counting standards" for distinguishing unallowable
"facilities and administration costs," which for Chil-
dren's included the heating and janitorial expenses for the stem
cell rooms. In the process, Daley says, they ended up "creating an
entire parallel oversight system, which sounds easy but, if you've
ever tried it, is time consuming and expensive."
As an example, Daley cites the internal registration sheet,
common to almost all research facilities, which scientists period-
ically ll out "to let their institutions know who is doing what."
According to Daley, the lab administrators charged with design-
ing the relevant for m for the Children's stem cell program wanted
it to ask scientists to certify that their experiments "were being
reviewed by Finance to ensure they were privately funded, had
institutional review-board clearance, had clinical-studies appli-
cation, had obtained their lines through a proper materials trans-
fer agreement, and so on."
At the top of the for m, researchers are asked to describe the
purposes of their research. "We've had an enormous back-and-
forth about how much information to provide," Daley says. Sci-
entists want maximum exibility to take advantage of
serendipitous discoveries on the lab bench, whereas lawyers
want the thickest paper trail possible. With animal experiments,
Daley says, standards have been worked out. "Since nobody has
worked in embryonic stem cells, we've had to set that balance all
over again. That's okay, but now we have no guidance from the
federal government. Everybody's o on their own, wondering if
they are doing the right thing." Designing the registration sheet,
he says, consumed hundreds of hours of time.
Despite all the e ort invested in untangling the federal re-
strictions, Lensch says, some questions are still unanswered. "If
you have a stem cell line, it's alive," Lensch says. "If you break the
cells open and extract their RNA, that's not alive. But it's a deriv-
ative [of the live cell lines], so you still can't work with it. Now,
the data you generate from that RNA---can they be included in an
NIH-approved experiment?" If researchers experiment on non-
presidential embryonic stem cells "in a building oating in space
over international waters and publish the results, is it complicit
for a federally funded researcher to read it? Can an editor or pub-
lisher at a federally funded institution publish it? Believe me, we
have been wondering that." Nobody in the group, he says, "wants
to end up making license plates."
Even as regulations upped costs, they shrank the nancing
pool. Not only has the ban on federal funding closed the co ers of
NIH and NSF and created inhospitable conditions for industry,
but it has also scared o much private philanthropy. Among those
saying no to embryonic-stem-cell research are the American
Heart Association and the American Cancer Society.
With many funding sources
shut o , researchers must seek
support from wealthy individu-
als and smaller groups, such as
the Juvenile Diabetes Research
Foundation. In the future, re-
searchers in stem-cell-friendly
places like Califor nia, Massa-
chusetts, and Wisconsin may
be able to draw on special ear-
marked funds created by state
legislatures, though state fund-
ing is already raising a new set of legal and logistical questions.
Researchers can cobble together funding from these and other
sources, but many at Children's still bemoan the federal govern-
ment's lack of involvement. NIH usually awards long-ter m, rela-
tively open grants. Unsurprisingly, smaller out ts tend to be
more narrowly focused; they typically give short-term grants
with speci c benchmarks. But in brand-new elds like stem
cells, researchers are bound to need more latitude.
More important, Daley says, the federal government sets the
r ules in the research world. For decades, NIH and NSF have grad-
ually established a set of procedures that all institutions must fol-
low if they are to receive federal research funding. The rules range
from the need to obtain informed consent from research subjects
to requirements for transparency in record-keeping. When the
government suddenly absents itself, Daley says, nobody knows
whether the rules still apply and whether they will be enforced.
"If things get worse, the best scientists may simply drop out,"
Taylor says. "That would be a tragedy. Who will be left then---the
people who want to make headlines cloning babies?"
Made in Korea
"We'll get through this," Daley says. "But it's terribly frustrating
having to move at a crawl when the science is so exciting---and
when other nations are ying ahead." In May, Daley learned with
a pang that Korean scientists had discovered how to create
patient-speci c embryonic stem cells---exactly the kind of break-
through work that he and Lensch want to do in trying to under-
stand genetic blood diseases. "No disrespect to them," Lensch
says, "but I couldn't help thinking that we could have done that."
He sighs. "I really do think that we could've done that if we'd had
Charles C. Mann's just published book is 1491: New Revelations
of the Americas before Columbus. His website can be found at
Among those saying
no to embryonic-
are the American
and the American
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