Tuesday, January 31, 2006

CIRM Readying Egg Donor Protections

The California stem cell agency said today it is moving ahead with rules to ensure that state-funded research does not use eggs from women who were paid to donate them. It also said it is intends to ensure that research institutions cover any medical care needed by donors as a result of complications in the egg donation process.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, said that the agency was making it clear there would be no loophole for eggs that may have been paid for and procured overseas, which he and the Center for Genetics and Society had raised concerns about.

“This loophole is just the latest example of why public oversight and control of Prop. 71 research is so important.  This case is a good example that when the public speaks out, policymakers can listen," Simpson said in a press release.

CIRM issued a press release summarizing Monday's decisions by the Standards Working Group. The statement did not detail the mechanism to be used to ensure that payments were not being made for eggs.

Here are the key paragraphs from the release on the standards group recommendations to the Oversight Committee.
Adopt "a broad definition of 'covered stem cell lines' to ensure that human stem cells derived from any source are subject to strict ethical standards. Guidelines for Human Embryonic Stem Cell Research, published by the National Academies, only covered embryonic stem cell lines."

Create "a single 'gold' standard intended to ensure that all cell lines used by CIRM-funded researchers are derived according to the highest ethical standards. This revised standard has the practical implication of guaranteeing that all cell lines used by CIRM-funded researchers are derived without payment to egg donors."

Require that "research institutions ensure that oocyte donors do not have to pay for any immediate and short-term complications for oocyte retrieval. The National Academies’ guidelines make no mention of this issue."

"Strengthen existing regulations to make clear that it is not acceptable to provide payments for eggs (beyond reimbursement for expenses) used in CIRM-funded research under any circumstances."

"Reaffirm that the Draft CIRM Regulations go above and beyond state regulations and federal guidelines for assuring that potential eggs donors are fully informed of their decision and the research. Institutional review committees are required to approve a process for determining whether prospective donors have understood the essential aspects of the research, including but not limited to how eggs will be used and the medical risks associated with participation."
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