Background and Need for Legislation

Scientists are attempting a new type of stem cell research, called research cloning or somatic cell nuclear transfer (SCNT). SCNT requires fresh eggs from women. The egg extraction process involves short-term health risks and unknown long-term health consequences. Tens of thousands, if not millions, of eggs may be needed for researchers to attempt to achieve "patient-specific" stem cell lines to treat certain diseases.

The California Institute for Regenerative Medicine (CIRM), created by Proposition 71, has developed regulations for research done with public funds, but there is no such state regulation of privately-funded research.[1] SB 1260 would ensure that women in California who provide eggs for private research be accorded all established federal and state protections for human research subjects. It would also provide local Institutional Review Boards (IRBs) with responsible and ethical guidelines for ensuring that proposals in this novel area of research meet the highest standards for safeguarding women's health.

This bill would:

Require subjects be given a standardized medically accurate written summary of health and consumer issues associated with the egg extraction procedure.

Ensure that informed consent documents are in easily understood language and linguistically appropriate.

Require IRBs to ensure that research projects provide access to and coverage of medical treatment for any adverse consequence that may arise as a direct result of the egg extraction process.

Prohibit financial conflicts of interest; require disclosure of other relationships for physicians/researchers.

Prohibit payment for eggs for research.

Limit reimbursement to women who provide eggs to direct expenses.

Extend existing law that requires the Department of Health Services to review human embryonic stem cell research projects and require the Department to report biennially to the Legislature.

Why does SB 1260 prohibit compensation (payment) to women who provide eggs for research?

Prohibition on compensation is becoming a national and international trend. SB 1260's prohibition of compensation will be consistent with national [2] and state [3] guidelines and regulations that recommend against or prohibit payment.

Offering payment would likely induce economically vulnerable women to sell their eggs, asking them to undergo an invasive and risky procedure with no direct benefit to themselves and no current demonstrated benefit to science. Donating eggs is more like donating organs (which involves high risk) than sperm (which involves no risk). It is illegal for people to be compensated for their organs because it would create undue incentive to undergo high risk with no personal benefit. The potential for disproportionate recruitment of low-income women, women of color, and young college women for their eggs for research is high. SB 1260 does allow women to be reimbursed for expenses incurred during the process and requires medical coverage and care for any adverse reactions they experience. The intent of this bill is to promote women's health, safety, dignity, autonomy, and rights and prevent increased commercialization and commodification of their bodies and reproductive material.

SB 1260 is supported by:

• Center for Genetics and Society
• Pro-Choice Alliance for Responsible Research
• Planned Parenthood Affiliates of California
• Women's Foundation of California

Notes

1. SB 1260 will not affect research funded by the CIRM under Proposition 71, but will extend to all other research using human eggs in California.

2. Guidelines for Human Embryonic Stem Cell Research issued by the National Academies recommend against payment.

3. The CIRM prohibits payment for Prop. 71-funded research, and the state of MA prohibits payment.