BY KRISTA CONGER

Academic institutions throughout the United States should work together to develop clear, specific policies governing conflicts of interest for faculty members with ties to industry, says a bioethicist at Stanford University Medical Center.

Mildred Cho, PhD, a senior research scholar at Stanford's Center for Biomedical Ethics, discussed the value and effectiveness of conflict-of-interest disclosure rules in scientific studies of health and the environment during a symposium Sunday at the annual meeting of the American Association for the Advancement of Science.

Cho authored an article that examined faculty conflict-of-interest policies at 89 academic institutions throughout the United States. The article appeared in the Nov. 1, 2000, issue of the Journal of the American Medical Association.

She and her colleagues found that
although the different institutions vary greatly in the management of such conflicts, most policies lack specific instructions to guide faculty members facing conflict-of-interest questions. The researchers recommended that institutions work together to develop "widely agreed-on, clear, specific and credible policies on conflicts of interest."

"It's a fairly new phenomenon for faculty to have ties with industry, so institutions may feel more comfortable dealing with this issue on a case-by-case basis," Cho said, explaining the discrepancy. But this lack of specificity can be confusing to researchers and their industrial partners, and could be used as a bargaining chip among universities as they compete for corporate sponsorship or prospective faculty members, she noted.

In addition to influencing relationships between academic institutions, their staffs and their industrial partnerships, accurately assessing and managing conflicts of interest is particularly important in medical research involving human subjects, Cho said.

"The major concern is that people who participate in the studies are not put at more risk than is necessary," she said. "One way that can happen is if people who aren't actually eligible for a study are enrolled anyway -- maybe not purposefully, but perhaps due to an error in judgement -- or if adverse events are not noticed or reported."

Cho pointed to the 1999 death of Jesse Gelsinger during a gene therapy trial at the University of Pennsylvania as one reason researchers and the public are becoming more interested in clarifying how conflicts of interest might contribute to inappropriate scientific practices. The U.S. Food and Drug Administration has asserted that Gelsinger, who died just days after receiving the first dose of a genetically engineered virus meant to combat his hereditary liver disease, had been ineligible to participate in the trial. The FDA also contended the researchers failed to notify the agency of previous, serious adverse effects of the treatment in other volunteers.

"These are not hypothetical issues; they're very important," Cho said. She also pointed out that conflicts of interest can also influence perceptions about how science affects public policy.

"It's a question not just about research but also high-level panels that give information to the government," Cho said. When expert panels are convened to direct government policy, their recommendations may appear to be biased if the researchers have financial or organizational ties to industries that may benefit from a change in the rules. She said a recent report from the National Academies indicating that genetically engineered food is safe to eat has been controversial because many of its panel members had ties to biotechnology companies.