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Stanford Report, December 10, 2003

Bench-side consult program delivers ethics guidance

By SHAWNE NEEPER

Legal and biomedical ethics experts at the Stanford Center for Biomedical Ethics are helping researchers address lab dilemmas in real time through a program called bench-side consultation.

The program is a testing ground for integrating ethics into cutting-edge biomedical research as it unfolds, addressing topics from stem cells to genetic manipulation of disease microbes.

The bench-side program was rolled out this fall by biomedical ethics center co-director, David Magnus, PhD, and associate director, Mildred Cho, PhD, to identify ethical or social impacts of biomedical lab research and suggest actions to minimize risks and maximize benefits to society.

Center members seek solutions acceptable to a range of stakeholders in science, policymaking and the public. They go on to contribute to state, national and international committees working on biomedical policy.

"Bioethics helps the media and public to understand issues coming up, and helps scientists think about what the issues are," said Magnus, associate professor (teaching) of pediatrics and of medicine.

The new program’s roots go back to work Magnus and Cho did together before they joined Stanford, Magnus said. A researcher contacted them at the University of Pennsylvania with concerns about the implications of creating a synthetic virus.

"We were able to lay out a lot of the issues in advance," Magnus said. The project prompted media discussion. "So when the technology happened, it wasn’t in a vacuum," he said. "This was very much in contrast to what happened with Dolly, where it came out of left field. People were playing catch-up." In 1996, Dolly was the first mammal to be cloned from an adult cell.

"We came to realize that this represented a model for how to do bioethics that really was the wave of the future," Magnus said. Once at Stanford, Magnus and Cho "put two and two together" to make a formal program.

Stanford stem cell expert Irving Weissman, MD, came to the bioethics center for help with what became the bench-side program’s first test case. Weissman, the Karel and Avice Beekhuis Professor of Cancer Biology and professor of pathology, developmental biology and, by courtesy, of biological sciences, was seeking animal models to study human brain diseases, such as Alzheimer’s and Parkinson’s, that do not normally occur in animals. To do that, he considered combining human and mouse stem cells to create a mouse with human brain cells.

"But he recognized that the idea of having a mouse with human neurons is at the least unsettling and may have ethical implications," said Hank Greely, the C. Wendell and Edith M. Carlsmith Professor in Law and chair of the center’s steering committee. "So he came to us to ask for a review."

Greely and Cho researched the case and advised Weissman, "we think you can go forward, but only under certain conditions," Greely said. They suggested that Weissman change the order of his experiments, conducting the least controversial work first and re-evaluating future plans as results became available.

Stanford bioethics work also helps to guide policy outside the university. Greely recently participated on a California advisory committee created to review a 1997 ban on human reproductive cloning.

Based on the committee’s January 2002 report, California enacted new legislation banning reproductive cloning indefinitely and allowing, but regulating, non-reproductive cloning.

"The recommendations were, by and large, enacted into law," Greely said. He is now working with a new committee reviewing stem cell research.

Bioethics creates bridges between science, policy and public discussion. It promotes a common understanding of terms like "clone," "embryo" and "stem cell" to help disparate groups discuss the implications of bench science and agree on policy and research conduct.

The Center for Biomedical Ethics provides education and consultation and performs research on ethical problems in our health-care system. Community clinicians and researchers can request a panel to explore issues in depth or call the center with shorter-term problems, such as responding to grant agency concerns.

"We have helped the researchers with response letters and helped to adapt consent forms to address issues," Magnus said.

Magnus is also co-chair of the ethics committee for the Stanford Health Center where he runs a bedside consultation program after which the bench-side program is modeled. "We’re trying to give researchers the same kind of consultation service that we’ve been giving on the clinical side for a long time," he said.



Center for Biomedical Ethics