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More Stem Cells Lines Approved, Process Proves Smart
The National Institutes of Health have added 27 more human embryonic stem cell lines to the 13 approved two weeks ago. These new lines come from Harvard University and have some interesting stipulations attached to them that illustrate the diligence and ethical seriousness that the NIH has brought to the approval process.
Harvard submitted 28 lines for review, but one was rejected, as it was derived with a consent form that came during a lapse of the university’s institutional review board. Researchers at the university had been using the lines for various projects without federal dollars, but the consent forms for the lines specifically state that the lines support diabetes research:
These cells will be used to study the embryonic development of endoderm with a focus on pancreatic formation. The long-term goal is to create human pancreatic islets that contain ß cells, the cells that produce insulin, for transplantation into diabetics.
The NIH prudently chose to abide by the consent forms, so researchers will only receive federal funds to work on the lines if they follow those rules. NIH Director Francis Collins made this decision after the Advisory Committee to the Director recommended the rules to him following its December 4th meeting. The Committee also requested that the NIH issue guidelines regarding the broader use of embryos derived for a specific purpose, but according to Jef Akst at The Scientist, “the NIH has not responded.”
The NIH did however update its FAQ page, explaining to researchers that the NIH stem cell guidelines require informed consent from embryo donors, which is different from the provisions in the “Common Rule” governing most federally funded biomedical research—the Common Rule does not require consent for de-identified human cells. The NIH has also decided to honor any restrictive language in the informed consent forms regarding the scope of the allowed research.
We should commend the NIH for dealing with these nuances and complexities in an ethically consistent manner that respects the wishes of the embryo donors. This process embodies a genuine understanding of how scientific necessity, administrative transparency, and ethical clarity can lead to sound policies.
Eighty-three more lines are pending review, and we look forward to seeing them receive the same level of serious ethical scrutiny.
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