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Incomplete Consent in the NIH Stem Cell Registry

By February 8, 2013

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Following president Obama's 2009 Executive Order allowing federal funding of research using human embryonic stem cells (hESCs), the NIH issued guidelines defining the ethical standards for research involving these cells. For example, the guidelines specify that embryos created by in vitro fertilization for reproduction, but no longer needed, may be used for research provided the parental donors give informed consent.

However, embryos can also be created directly for research purposes outside of fertility clinics using sperm and eggs donated from various sources. It turns out the NIH guidelines do not specifically require individuals who provided just sperm and eggs for research purposes to give their explicit consent that their donated can be used for embryonic stem cell research.

This omission was noted soon after the guidelines were released. It can create a problem with other groups, such as the National Academy of Sciences and some international agencies, who do require individuals providing researchers with their sperm and eggs to give specific consent that they may be used to make embryonic stem cells. It is not enough that these donors just give consent to use their donations for general research.

Concerned about this gap in consent, bioethicists at Rockefeller University and the Hasting Center investigated the sources of the 198 human embryonic stem cell lines currently on the NIH registry approved for use in NIH-funded research. The investigators were able to confirm appropriate consent had been given by all parties for 137 of the cell lines on the list. For 19 stem cell lines, however, they could not track down the pertinent consent information, and for 30 stem cell lines, the labs providing the embryos did not have specific consent from the egg and sperm donors.

In a ScienceInsider article, Amy Wilkerson, one of the investigators that looked into this issue, points out that the purpose was not to get the NIH to change the stem cell line list or its guidelines. It was just important for other university ethics committees reviewing embryonic research to be aware of the information so they could make decisions about research proposals they reviewed.

For more information, you can read the letter about the analysis published in the journal Cell Stem Cell.

Comments

February 14, 2013 at 4:29 am
(1) Walter Reale says:

Wow, what a quirky scenario we’ve created. Eh…

Think something similar was happening in China with Rongxiang Xu and his company MEBO International. Although, their legislation is probably a little bit behind (but their technology isn’t).

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