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Stem cell research has oversight, just not federal oversight

Kristofer Eisenla, spokesperson for Representative Diana DeGette, called to say that when I was talking with him about DeGette’s position that his meaning was not that there was absolutely no oversight over research, but rather that there was no federal oversight of cell-based research. DeGette is drafting legislation that would provide federal oversight and eliminate the federal ban on funding for research on certain embryonic stem cell lines. Eisenla says he’s hoping legislation will be written before the August recess.

Here’s the news story from Nature Reports Stem Cells

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I would like to address a remark you recently attributed, in Nature Reports Stem Cells, to a spokesperson for U.S. Congresswoman Diana DeGette, stating that “private and state development [of stem cell research] is being done without ethical oversight." From what I understand, this citation does not correctly reflect either the position of Congresswoman DeGette or that of her spokesperson.

The California Institute for Regenerative Medicine’s mission is to ensure stem cell research is conducted under the highest scientific, medical and ethical standards. To support this mission the Institute has embraced the highest ethical guidelines and regulations, even surpassing the recommended standards of the National Academies (including the National Academy of Sciences and the Institute of Medicine).

With regard to ethical oversight, CIRM initially adopted the National Academies’ Guidelines for Human Stem Cell Research on an interim basis. An expert working group comprised of nationally-recognized ethicists, scientists and patient advocates then recommended legally-binding regulations that adopted the principles described in the National Academies’ Guidelines and exceeded them. The result of this process was the development of strict requirements to advance ethical oversight. These innovative requirements include, for example:

o A ban on human reproductive cloning;
o Free medical treatment to research donors for medical complications resulting from donation of oocytes for research;
o Evaluation of the informed consent process to ascertain that research donors comprehend the essential features of research;
o A requirement that infertility treatment not be compromised by stem cell research.

Collectively these requirements are a comprehensive and legally-binding set of rules to govern stem cell research in California. Subsequently, aspects of our regulations have been adopted in whole and part by other states and endorsed by National Academies. If you would like additional information about CIRM’s effort to advance research under the highest scientific, medical and ethical standards, please feel free to contact me. A more detailed summary of our Medical and Ethical Standards regulations may be found at the following link:

http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0040114


Robert Klein
Chairman, Governing Board
California Institute for Regenerative Medicine

In my opinion, as I have demonstrated elsewhere, e.g., in Nature blog (below), Washington Post website, a.s.o. (Ask Google.com for it) the main point to take into consideration in utilizing stemm cells is not ethical in origine, but scientific one! Since all scientists, who are researching on staminal cells of whatever origine, do not know at all biophysical-semeiotic constitutions, the danger is great that they use stemm cells involved by oncological terrain,or oncological predisposition, diabetic constitution, and so on, so that other disorders occur in treated patients, as a large literature refers to already. For further information See Nature blog http://blogs.nature.com/news/thegreatbeyond/2007/09/californias_new_stem_cell_supr.html

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