Attorney, philosopher and UC Davis bioethics professor Ben Rich says stem cell research must be viewed through a wide lens that captures science, emotion and the question of human dignity.
"Ethicists range across the spectrum of opinion, from those who claim for stem cells the full moral status of a live human being, to those who believe in some measure of respect, but nothing rising to the level of a right to life," Rich explains.
The considerate opinions of Rich, UC Davis Associate Vice Chancellor for Research Lynne Chronister, and UC Davis law school professor Lisa Ikemoto help guide the study of stem cells at UC Davis. They know that researchers must navigate a complex and evolving landscape of activism, litigation, law – and hope.
Mazes and firewalls
In addition to following the same ethical and legal standards as other researchers, stem cell investigators face several unique challenges, Ikemoto says. "Cast within the stark terms of the abortion debate," stem cell research is highly politicized, and subject to media hype that has greatly inflated the possibility of creating therapies in the near future, she explains.
Ikemoto advises researchers to enter the court of public opinion with cognizance and care. "It is especially important to counter exaggerations and oversimplifications," she says.
Federal funding dilemmas
A firewall that must be kept impenetrable separates approved and unapproved human embryonic stem cell lines, Lynne Chronister says. "Researchers must be careful not to commingle federal and nonfederal funds. Supplies purchased with federal funds or graduate students paid with federal funds may not be involved with research on unapproved cell lines."
California's Proposition 71 further defines the ethical fabric. Under that law, "each institution conducting stem cell research must establish a stem cell research oversight committee," notes the medical school's bioethicist Rich.
UC Davis established its stem cell research oversight committee earlier this year. The committee's activities will be coordinated by the university's Institutional Review Board Administration. As required by proposed California Institute of Regenerative Medicine (CIRM) regulations, the committee will provide oversight on all issues related to derivation and use of human embryonic stem cells lines; review and approve the scientific merit of research protocols; review compliance of all stem cell research; and facilitate education of investigators involved in the research.
Funding from the CIRM generates added supervision of stem cell researchers. The state's Independent Citizens' Oversight Committee is charged with formulating regulations that govern stem cell research conduct funded by Prop. 71, Rich says.
Chronister says that UC Davis deals "proactively" with this complicated regulatory maze through an internal Stem Cell Advisory Committee and a formal written policy on stem cell research.
To advise and consent
With laws, regulations and federal firewalls, the public debate over stem cell research may seem loud and aggressive.
But discussion has been limited on an important ethical front: "the extent of the risk posed to egg donors and the extent to which a fully informed consent is possible," explains Rich.
"In some cases, women who donate eggs may not be considered human research subjects," Ikemoto adds. "The most widely used methods of obtaining human eggs create health risks. The challenge for research institutions is to develop the best standards and practices in a near vacuum of models to follow."
Harvesting eggs left over from in vitro fertilization – a commonplace practice designed to help families conceive – poses additional ethical dilemmas.
Frozen in liquid nitrogen, "sometimes the remaining embryos will be thawed and discarded" at the family's request, says new UC Davis stem cell research program director Jan Nolta. "Rather, we hope that these otherwise discarded embryos can be used, with full consent when approvals and policies are in place, to generate new stem cell lines using modern technology."
Some people find this practice "understandably objectionable, for both religious and personal reasons," Nolta adds. "But the benefits for the health and medical treatment of children and adults are immeasurable."
Culture of collaboration
Balance between promising benefits and problematic ethics will be critical to resolving what UC Davis' Institute for Pediatric Regenerative Medicine molecular pathologist Paul Knoepfler calls the "overregulation of science."
"A key hurdle will be to develop the appropriate level of regulation of human stem cell work that allows research to proceed unfettered, but also avoids ethical minefields that lay ahead," Knoepfler explains.
Teaching researchers how to navigate those minefields, Ben Rich says he is "developing a training curriculum that will include ethical and legal considerations" as part of the $2.6 million CIRM stem cell biology training program now at UC Davis.
Ultimately, the ability of UC Davis researchers to resolve moral and ethical conundrums that can hamper stem cell research rests on what Lynne Chronister calls a strong culture of collaboration. "We are known nationally and internationally for our ability to address research issues and solve problems that will benefit society. We do this because our researchers know how to work together."