Five Bush Administration-Approved Stem Cell Lines Used Insufficient Consent Forms, Bioethicist Reports

Main Category: Stem Cell Research
Article Date: 06 Aug 2008 - 12:00 PDT

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Informed consent forms for nearly one-fourth of the human embryonic stem cell lines approved for federal funding by President Bush in 2001 could present serious ethical problems, according to a report published in the journal Hastings Center Report, the Milwaukee Journal Sentinel reports (Dolgin, Milwaukee Journal Sentinel, 8/3). Federal funding for embryonic stem cell research is allowed only for research using embryonic stem cell lines created on or before Aug. 9, 2001, under a policy announced by Bush on that date. Bush twice has vetoed bills that would have allowed federal funding for research using stem cells derived from human embryos originally created for fertility treatments and willingly donated by patients (Daily Women's Health Policy Report, 5/8).

University of Wisconsin-Madison bioethicist Robert Streiffer reviewed the informed consent forms of the 21 lines approved by Bush and concluded that five of them had ethical limitations. He reported that for three of the lines, derived by the company BresaGen, the informed consent forms given to the patients were not for research but for patients to begin fertility treatment and did not sufficiently state that the embryos could be used for research purposes. The company WiCell -- which distributes 15 of the Bush-approved lines under an NIH contract -- began taking requests for the three BresaGen lines in January. The company said it has distributed those lines twice out of 700 total stem cell line requests, Janet Kelly, WiCell's communications director, said.

For two other lines, created by the firm Cellartis, women who donated embryos for a specific research experiment were told that embryos would be destroyed after the experiment, according to Streiffer. "It's not that they are unacceptable consent forms, they're just acceptable for only certain kinds of research," Streiffer said, adding, "Without looking at the original consent forms, I don't think you can say you can use them for any type of research."

Streiffer said, "It doesn't make sense to fund or not fund research just because of when a stem cell line was derived," adding, "It's preferable to use cell lines that have even better consent than ones used on the (Bush-approved) registry." Jonathan Moreno, a medical ethicist at the University of Pennsylvania, said the study "points to the fact that" Bush's policy is "not tenable anymore."

UW-Madison last year created a Stem Cell Research Oversight Committee that will consider the ethical appropriateness of all current and future stem cell projects on the campus. Committee Chair Richard Moss said the group has not reviewed Streiffer's findings but noted, "An important step for us is to take into account these findings." Other large research universities, including Johns Hopkins University, have acknowledged the report and are evaluating their use of the five stem cell lines, according to the Center for American Progress (Milwaukee Journal Sentinel, 8/3).

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