printable versionSafeguards for egg donors needed for stem cell research
Committee overseeing Prop. 71 grants begins to consider ethical guidelines for the funding of stem cell work
BY MICHELLE L. BRANDT AND ROSANNE SPECTOR
Bioethicist R. Alta Charo spoke Tuesday at Fairchild Auditorium at a meeting of the committee charged with overseeing the state’s effort to distribute nearly $3 billion for stem cell research over the next 10 years.
Now that California voters have embraced stem cell research, the people who have been charged with overseeing the work are faced with an ethical challenge: what protections need to be offered to the people who provide the eggs, sperm and embryos for the research?
To help sort through the issues, the governing board of the state's new stem cell institute heard Tuesday from University of Wisconsin bioethicist R. Alta Charo, who offered an overview of existing regulations—and highlighted what needs to be developed.
It was the fourth meeting of the governing board, known officially as the Independent Citizens Oversight Committee or ICOC, which was established under Proposition 71 to oversee the new stem cell institute—the California Institute of Regenerative Medicine. As a result of the passage of the measure last November, the institute has been charged with doling out nearly $3 billion for stem cell research over the next 10 years; the ICOC is required to make sure that's done responsibly, and it aims to have its ethics rules in place in the coming months.
At Tuesday's meeting, which was held in Fairchild Auditorium at the medical school, the 29 members of the ICOC and roughly 70 members of the public heard about the ethical provisions already on the books—or in the works—as well as guidelines that Prop. 71 mandates them to develop.
Charo pointed out that there are numerous federal laws and regulations that govern this type of work. Furthermore, nations with longer histories of stem cell research, such as Australia, Israel, Singapore and the United Kingdom, have created guidelines that can serve as starting points. And in April, said Charo, the U.S. National Academy of Sciences is due to issue voluntary guidelines for human stem cell research.
"It's not as overwhelming as it seems," said Charo.
Ethical concerns have surrounded embryonic stem cell research from the get-go, and Charo and other experts agree that the protection of human subjects involved with stem cell research is a critical issue. Stem cells are derived from blastocysts—usually obtained from in-vitro fertilization clinics' leftover embryos—and Charo said state law requires the permission of both donors. Studies involving stem cell lines in which a donor could be identified are considered human subjects research and are also governed by federal regulations.
"This is a point of tremendous confusion at almost every place I've spoken," Charo said.
A second way to create stem cell lines—somatic cell nuclear transfer—raises other concerns. This technique, which researchers are likely to conduct once state grant money is awarded, involves inserting genetic material into an egg cell and then stimulating it to reproduce. Some see the donation of eggs specifically for stem cell research as an ethical hot spot. They are concerned that the lure of lucrative compensation for donors could cause some women to overlook the risks.
Though Prop. 71 includes a prohibition on compensation for eggs as well as embryos and somatic cells, it does allow reimbursement for expenses.
"If reimbursement is set high, would that serve as an inducement?" asked Marcy Darnovsky, MD, associate director of the Oakland-based Center for Genetics and Society. Her organization's concern is that research cloning would trigger an exploitive market in women's eggs.
Charo, who addressed other ethical issues that could arise as the state begins distributing research dollars, is well versed on stem cell ethics. She was a member of President Bill Clinton's National Bioethics Advisory Commission, where she participated in drafting several reports on stem cell research, and she served on the National Institutes of Health Human Embryo Research Panel in 1994. She now sits on the Wisconsin Stem Cell Research Program's advisory board.
Charo's presentation was just one item on an ambitious agenda for the ICOC's monthly meeting. The members also approved the appointment of Zach Hall, PhD, as interim president of the institute. Hall is senior associate dean for research at the University of Southern California and the former director of the NIH's National Institute of Neurological Disorders and Stroke; he will serve as interim president until the end of a national search for a permanent leader.
Click on photo(s) to enlarge.