Sunday, October 11, 2009

CIRM Acts on Revised Research Standards This Week

The California stem cell agency Monday takes up changes in its research standards aimed at achieving consistency with national rules for human embryonic stem cell research.

The changes appear to be non-controversial although researchers and other interested parties would be well-advised to listen in on the audiocast proceedings of the 10 a.m. meeting of the Standards Working Group. Its discussions often shed light on questions that may pop up later when the standards are to be applied.

If you can't tune in, CIRM has posted the regulations along with additional details and the Powerpoint briefing slides to be used at the meeting. The documents are also necessary if one wants to follow the audiocast.

The rules being considered by CIRM apply only to research that is funded by the agency. Stem cell research in California that is not funded by CIRM is regulated by the state Department of Health.

From day one, CIRM has banned the use of stem cell lines if they are derived in a process that provides compensation – “valuable consideration” – for eggs or embryos. One of the proposed changes that caught our attention involves an exception to the ban on “valuable consideration” in the case of embryos created in reproductive IVF. The proposed rule states:
“For embryos originally created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose 'valuable consideration' does not include payments to original gamete donors in excess of 'permissible expenses.'”
Having watched laws and regulations formulated for several decades as a journalist, creation of exceptions piques my interest. In this case, I wondered whether money could be made by using the proposed exception. What happens if human eggs have real economic value at some point in the future in terms of research i.e. a high demand and a supply shortage? Is it possible that crafty entrepreneurs could use the cover of IVF to generate eggs to meet that demand?

CIRM firmly believes that will not happen under its proposed rules. Their intent is clear plus CIRM also reviews its grantees' research protocols and audits the institutions, the agency says.

We also asked Hank Greely, a Stanford law professor familiar with stem cell issues, about the matter. Greely, who is not involved with the CIRM regulations, offered this quick and informal response that basically supports the CIRM regulation.
“I think that's a defensible interpretation. She is being paid to 'donate' ('paid to donate' is odd wording, in itself) her eggs for reproductive purposes. She cannot be told, in advance, that not all of her eggs will be used to make embryos for reproductive purposes, because no one knows, in advance, how many eggs she will provide, how many embryos will thrive, and how many the recipient will need for reproductive purposes. She doesn't get any money because of the research use and she doesn't 'donate the eggs for research use' - the woman/couple who pay her for her eggs ultimately donate the embryos made from those eggs for research use. The egg donor gets the same amount of money whether the recipient ends up using all of the embryos created with the donated eggs for reproductive use or none. No more or less money changes hands depending on whether all the eggs are used for reproduction or some of the eggs are used for research.

“Assume I pay you $3 for a six pack of Coke Zero and I tell you I plan to drink as many as I need, which may or may not be all of them. I end up giving one of the cans to my wife. Have you received 'valuable consideration' for donating the can to my wife?”
For an earlier discussion of the regulations, you can see the transcript of the standards group meeting on Sept. 18.

Directions for hearing the audiocast can be found on the standards group agenda.

(Editor's note: An earlier version of this item incorrectly said that the proposed regulations will be considered by the CIRM board Friday. They will be heard by the board at its meeting in Los Angeles Oct. 27-28.) Sphere: Related Content

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