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California’s stem cell agency has embarked on what is likely to be an exhaustive review of genetic alteration of human embryos with likely recommendations for changes in the $3 billion research effort.

The 11-year-old agency plans to examine a host of issues ranging from inadvertent, inheritable changes in the human race to informed consent on the part of patients. The move emerged from a day-long review of the far-reaching subject at a meeting Thursday of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known.

Responding to a request from the California Stem Cell Report, Kevin McCormack, senior director for communications for CIRM, laid out the scope of the agency’s future steps and gave his impressions of the session, which suffered from audio quality issues in its audiocast. (See here and here.) McCormack said the issues were “too many and too complex” to produce recommendations immediately.

“In the end, it was decided that the most productive use of the day was not to limit the discussion at the workshop but to get those present to highlight the issues and questions that were most important,” McCormack said, “and leave it to the (research standard group) to then work through those and develop a series of recommendations that would eventually be presented to the (agency’s governing) board.”

Matters to be addressed include the following, McCormack said:

–Possible changes in language used in getting informed consent from donors in light of the ability of Crispr to make relatively easy changes in human changes. Crispr is a new technique that has brought the whole question to international attention.

–Use of Crispr on previously donated materials/samples where general consent was given without knowing that these technologies could be available.

–Genetic modification of mitochrondial DNA as well as genetic DNA.

–The possibility that somatic cell gene editing may lead to inadvertent germ line editing.

–Engaging patient advocates and other community groups such as the social justice and equity movements for their views. McCormack said, “After all, we are a taxpayer-created and funded organization so we clearly have some responsibility to the wider California community and not just to researchers and patients.”

–Financing the use of Crispr and other technologies that can modify the human embryo provided those embryos are not going to be implanted in a human uterus.

Click here to see the full text of McCormack’s summary, which is included in the original posting of this story on the California Stem Cell Report. The summary may be turned into an item for the agency’s own stem cell blog, The Stem Cellar.