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ETHICS
Undue Influence? Equity Interests In Biomedical ResearchIn 1980, the U.S. Congress passed legislation designed to stimulate the commercialization of faculty inventions by permitting academic institutions and scientists to benefit financially if their federally sponsored research led to commercial products. At the same time, the growth rate of biomedical research began outpacing federal funding, compelling universities and hospitals to begin developing partnerships with industry. These changes heightened concern about potential conflicts of interest that had potential to harm educational, research, and clinical missions. HMS's Policy on Conflict of Interest and Commitment, last revised substantially in 1990, seeks to ensure the continued confidence of the public in the integrity of scientific research. Ten years later, faculty members are reviewing these guidelines to ensure they uphold the HMS mission and reflect contemporary science. At a Division of Medical Ethics forum on equity interests in biomedical research held on Jan. 12, panelists from Harvard and MIT agreed on the need for researchers to disclose potential conflicts of interests but disagreed on how extensive rules and regulations should be. Dennis Thompson, associate provost and director of the Center for Ethics and the Professions at Harvard, opened the forum by defining conflict of interest as "a set of circumstances or conditions in which professional judgment of primary interest, such as the good of the patient or the quality of the research, tends to be unduly influenced by a secondary interest, such as financial gain." If rules are too strict, important research may not get done, Thompson said. On the other hand, strict rules protect research integrity. Eugene Braunwald, the Hersey distinguished professor of theory and practice of physic and chair of the Committee to Review HMS Policy on Conflict of Interest and Commitment, reminded the audience there are no simple answers to the complex questions of what precisely constitutes a conflict of interest. He believes conflict-of-interest rules should be different in clinical vs. non-clinical research because the stakes are higher in terms of public perception, and the need to guard against causing harm to patients is absolute. When it comes to equity, many issues are germane, including company size and when vis-à-vis the research the investigator acquired the equity. "It's difficult with one study to influence the stock of a multibillion dollar company," said Braunwald. Further defining the issue, David Blumenthal, HMS professor of medicine and health care policy, noted that university–industry relationships involve clear risks, including secrecy and withholding data as well as shifting research away from fundamental to applied science. John Parrish, the Edward Wiggleworth professor of dermatology, argued that conflict-of-interest problems should be solved by disclosure, including disclosure to one's patients, and surveillance more than rules and regulations. MIT director of technology transfer Lita Nelson, while acknowledging that clinical research is not an issue for her institution, described MIT's conflict avoidance rule, which prohibits faculty members who hold equity in a company from doing research for that company in their lab. "It hurts us sometimes," she said. The complexity of developing and revising conflict-of-interest guidelines was summed up by Allan Brandt, the Amalie Moses Kass professor of the history of medicine and director of the HMS Division of Medical Ethics, who said, "How we deal with conflicts of interest requires a sophisticated understanding of a wide range of economic forces, social issues, and ethical sensibilities about the nature of scientific research in an academic setting." —Peta Gillyatt |
