How is California regulating its $3 billion stem cell research initiative?

In November 2004, California voters approved $3 billion over 10 years for public funding of stem cell research through the CIRM. In their policy paper in PLoS Medicine, Geoffrey Lomax, Zach Hall, and Bernard Lo discuss how CIRM came to adopt its legally binding regulations for the stem cell research it funds.

In addition to the goal of “setting high ethical standards,” say the authors, there were five other crucial objectives that guided the regulations:

– Encourage research institutions and researchers to develop best practices for ethical conduct of human stem cell research
– Avoid unnecessary regulatory burdens
– Involve the public in developing regulations
– Be consistent with existing laws, regulations, and ethical guidelines
– Facilitate collaboration to accelerate scientific progress.
Dr Lomax and colleagues describe two innovative features of the regulations: the informed consent process and the protection of egg (oocyte) donors.

“Because human embryonic stem cell research is controversial,” they say, “prospective donors need complete information about possible research uses of embryos, gametes, and tissue that they might donate. If donors have stated restrictions on the future uses of donated materials, CIRM-funded researchers must respect these.”

And for oocyte donors, in addition to obtaining consent, researchers must ascertain that such donors fully comprehend eight essential features of the research. “In other research settings,” say Dr Lomax and colleagues, “research participants often fail to understand the information in detailed consent forms.” The CIRM regulations require that CIRM researchers evaluate whether women have fully understood the benefits and risks of oocyte donation.

The regulations, they say, were developed with extensive public input and are a “critical first step in increasing public trust and support for human stem cell research.”

Citation: Lomax GP, Hall ZW, Lo B (2007) Responsible oversight of human stem cell research: The California Institute for Regenerative Medicine’s medical and ethical standards. PLoS Med 4(5): e114.