California has become the first U.S. state to legislate a set of standards and safeguards for procuring women's eggs for cloning and stem cell research. The new law is a victory for women's health, for protection of research subjects, and for responsible science.
Approved by near-unanimous votes in both the state Senate and Assembly, the bill was signed into law by Governor Arnold Schwarzenegger on September 26. Though several other countries have similar laws about providing eggs for research, egg retrieval for stem cell and cloning research in the U.S. has until now been covered almost entirely by voluntary guidelines.
Supporters and opponents
The law on standards for egg retrieval was authored by Democratic state Senator Deborah Ortiz. A champion of women's health and an early advocate of stem cell research, Ortiz supported the 2004 California stem cell initiative but immediately after its passage began working to fix some of its serious flaws.
The Center for Genetics and Society worked closely with Senator Ortiz's office to craft the bill, as did the Pro-Choice Alliance for Responsible Research and Planned Parenthood Affiliates of California. It was also supported by the Women's Foundation of California.
The law addresses only eggs procured for research, and has no effect on women who provide eggs for fertility purposes. But it was opposed by the American Society for Reproductive Medicine (ASRM), the professional organization of the assisted reproduction industry. Fertility clinics in the U.S. are notoriously under-regulated, and according to the Los Angeles Times, ASRM wanted to "ensure that the restrictions pertained only to research labs, not fertility clinics."
What the law does
The new law defines women who provide eggs for research as "research subjects," triggering federal and state regulatory protections. It ensures that women be given medically accurate information about the risks of egg retrieval, mandates that any woman who experiences adverse reactions from the procedure and needs medical treatment will not have to pay for it herself, and sets rules for disclosure of conflicts of interest between the medical personnel who conduct the egg retrieval procedures and the researchers working on cloning techniques.
The aspect of the law that has drawn most attention is the limit it places on paying women for providing eggs for research. In order to head off the emergence of a market in eggs for research, the law limits payment to reimbursement for direct expenses. If payments were permitted, researchers would likely be offering thousands of dollars to recruit women to supply eggs, encouraging their acceptance of known short-term health risks, and long-term risks that are little understood.
A committee of the National Academies of Sciences that studied standards for stem cell research has also recommended reimbursing women who provide eggs only for the expenses they incur. Limiting payment means that women who provide eggs are in fact "donors." In a statement to Genetic Crossroads, Senator Ortiz emphasizes the altruism involved: "[I]n unselfishly providing this incredible gift, we must ensure [that women] are fully informed about any adverse risks to their own reproductive health."
The law applies to stem cell and cloning research conducted in California that is not funded by the California Institute for Regenerative Medicine (CIRM). Efforts by CGS, the Pro-Choice Alliance for Responsible Research, and others helped persuade CIRM to adopt similar regulations for the research it funds.
As a result, all cloning and stem cell research efforts in California that require women's eggs must follow more or less the same rules, regardless of whether or not the eggs were procured in the state. This is especially important because several biotechnology companies and research teams in California have already begun experimenting with cloning techniques.
Read a fact sheet on SB 1260
Read the full text [PDF] of the bill