5 Stem-Cell Lines' Consent Forms Questioned
4 August 2008, 03:00 CDT
By Elie Dolgin, Milwaukee Journal Sentinel
Aug. 4--Nearly one-quarter of the human stem cell lines approved for
federal funding by the Bush administration may have serious ethical
problems, according to a report by University of Wisconsin-Madison
bioethicist Robert Streiffer.
Streiffer reviewed the informed consent forms of the 21 embryonic
stem cell lines eligible for taxpayer dollars and concluded that five
of the lines were marred by major ethical concerns.
"There was a range of acceptability,
forms) were well done, but others did not provide enough information
and detail to count as informed consent."
On Aug. 9, 2001, President Bush, citing moral concerns over stem cell
research, announced that federal funding would be restricted to only
those colonies, or "lines," of embryonic stem cells derived before
that date. The consent forms were completed by the donors between
1997 and 2001.
For three of the Bush-approved lines derived by Athens, Ga.-based
BresaGen, the informed consent forms were not for research but for
patients to begin fertility treatment, with only a vague mention that
some embryos might be used for research.
For two other cell lines, created by Swedish biotechnology company
Cellartis, women donated embryos for a specific research experiment,
but the consent forms stated that the cells would subsequently be
destroyed.
"It's not that they are unacceptable consent forms; they're just
acceptable for only certain kinds of research," said Streiffer, who
published his findings in the journal Hastings Center
Report. "Without looking at the original consent forms, I don't think
you can say you can use them for any type of research."
All 21 cell lines are routinely used by researchers around the
country without additional stipulations or limitations relating to
the original informed consent given by the donors.
Last year, UW-Madison created a Stem Cell Research Oversight
Committee that will soon consider the ethical appropriateness of all
current and future stem cell research projects on the campus.
"All human stem cell research will need to be reviewed and approved
by the committee, and that will include how cells were obtained and
if the consent was adequate," said Norman Fost, a committee member
and UW-Madison pediatrics professor.
The committee has not discussed Streiffer's specific findings,
though, said committee chair and UW-Madison physiology professor
Richard Moss.
"An important step for us is to take into account these findings,"
Moss said, "but we haven't done that as a group, and we haven't
reached a decision on these cell lines."
Other large research institutions, however, including Stanford
University in Palo Alto, Calif., and Johns Hopkins University in
Baltimore, have responded directly to Streiffer's study and are
assessing the appropriateness of these particular cell lines, the
Center for American Progress, a left-leaning think tank in
Washington, D.C., reported last month.
UW-Madison does not maintain a record of what cell lines are used by
its researchers, and until the committee is active, they will not
know if any of the five cell lines are currently used, both Fost and
Moss said.
Stephen Duncan, director of the program in regenerative medicine at
the Medical College of Wisconsin in Wauwatosa, said no one in his
program uses any of the five lines in question.
Madison-based WiCell, an affiliate of the Wisconsin Alumni Research
Foundation, maintains and distributes 15 of the Bush-approved cell
lines -- including the three BresaGen lines called into question --
through its National Stem Cell Bank.
WiCell has been distributing the three BresaGen lines only since
January, however. And since then, they have been dispatched only
twice among over 700 total cell line requests, said Janet Kelly,
WiCell's communications director.
WiCell is under contract from the National Institutes of Health to
host the cells and will continue to distribute all the available cell
lines unless told otherwise by the NIH, Kelly noted.
A statement released by the NIH said that it "required the deriver or
provider of each candidate cell line to provide written assurance
that all the criteria set forth by the President had been fulfilled,
including the specified components of the informed consent process."
Since 2001, scientists have developed hundreds of new embryonic stem
cells lines using ethically and scientifically improved methods, but
none of these lines has been eligible for federal funds.
Based on his findings, Streiffer argues that cell lines should be
judged on how, rather than when, they were obtained.
"It doesn't make sense to fund or not fund research just because of
when a stem cell line was derived," he said. "It's preferable to use
cell lines that have even better consent than ones used on the (Bush-
approved) registry."
The study "points to the fact that this policy is not tenable
anymore," said Jonathan Moreno, a medical ethicist at the University
of Pennsylvania and a senior fellow with the Center for American
Progress.
-----
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Source: The Milwaukee Journal Sentinel
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The CNS Healing Group
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