University readies guidelines for embryonic stem cell work

Arthur Bienenstock

Ann Arvin

University researchers who work with human embryonic stem cells will have to contend with a new campus-wide policy designed to ensure that Stanford doesn't run afoul of federal law on use of these politically controversial cells.

The university is in the final throes of developing a policy requiring researchers to provide a detailed accounting of space, equipment and staff involved in any work they do with stem cell lines not approved by the federal government.

The Bush administration imposed restrictions on such research in August 2001, limiting use of any federal funds to the small number of human embryonic stem cell lines in existence at that time. However, California has taken a divergent path from the federal government, encouraging work with new cell lines under the $3 billion California Institute for Regenerative Medicine established by Proposition 71 last November. Stanford intends to seek grants to pursue this research with state support, noted Arthur Bienenstock, PhD, vice provost and dean of research and graduate policy.

"We must be careful to comply with federal law as we pursue these other cell lines," Bienenstock told the Senate of the Academic Council on Thursday. "We are actually in a situation where we have to watch our use of, say, our equipment. So we're having to take special measures to ensure compliance."

Ann Arvin, MD, associate dean of research, told the senate this field of study will be subject to "intense scrutiny." She said the university already has received an unannounced visit from an auditor with the U.S. Food and Drug Administration who asked to review stem cell protocols submitted to the university's Institutional Review Board, which oversees all human and animal research.

Arvin, a professor of pediatrics and of microbiology and immunology, acknowledged that the new university policy poses a special challenge in that researchers are accustomed to using the same facilities, equipment and personnel to work on multiple projects funded by multiple sources. Under the new guidelines, she explained, researchers will have to do a separate accounting for all work specifically related to unapproved embryonic stem cell lines, ensuring that no federal money is used directly or indirectly in the research. The policy does not apply to work with adult stem cells, she said.

Robert Simoni, PhD, professor of biological sciences, praised the new policy. "I think this is a terrific start, and I suspect it's going to evolve as the whole field of research begins to evolve," he said.

The guidelines allow scientists to use Stanford facilities to do human embryonic stem cell research, except at the federally-funded Veterans Administration facilities and the Stanford Linear Accelerator Center. Still, the university is proceeding with caution and is initially requiring that such research be done in laboratories separate from those used for federally-sponsored research, even though this isn't required under federal rules.

Scientists will also have to tag every piece of equipment in the lab used in embryonic stem cell research—from centrifuges and microscopes to computer equipment—to ensure there's no overlap with federally-funded materials.

Stanley Falkow, MD, professor of microbiology and immunology and of medicine, asked whether that meant he had to buy a special microscope just to peer at unapproved lines. Arvin responded that there wasn't a clear answer, noting the federal government hasn't offered specific guidelines for this and myriad other situations that could arise. Falkow then turned to Philip Pizzo, MD, dean of the School of Medicine, and quipped, "It's easier working on bacteria," Falkow's area of expertise. "Or viruses, or other cells," added Pizzo.

Falkow also asked whether the guidelines applied to collaborative work with other institutions, including those in other countries where the limitations don't apply, and Arvin assured him they did.

Harvey Cohen, MD, professor of pediatrics, also queried about off-campus research. The guidelines apply equally to both on- and off-campus work, responded Pizzo, who is a member of the Independent Citizens Oversight Committee, the governing board for the state institute.

Because of the new policy's complexity, the university plans to require that all faculty, staff, post-docs, students and visiting scholars involved in embryonic stem cell research undergo training in the guidelines.

The university will establish a Human Embryonic Stem Cell Research Panel to oversee all work with these specialized cells. The panel will report to Bienenstock. Details of the new policy are expected to be published within the next several months in the Faculty Research Handbook.