Federal regulations that give universities much of the responsibility for policing financial conflicts of interest involving biomedical researchers have “limitations,” the General Accounting Office said in a report last month.
Citing the report, the top Republican on the Senate subcommittee that oversees biomedical research called for hearings and, possibly, additional legislation to improve protections for volunteers participating in such studies.
The General Accounting Office report noted that federal rules now give universities wide discretion to police conflicts themselves. As a result, there is variation in how institutions resolve such situations, and college officials in some cases have been confused about the federal requirements, the report found. The GAO, which is the investigative arm of Congress, called on the government to clarify the rules.
Higher-education organizations have tried to provide their own guidance in the past few months. For example, the Association of American Medical Colleges suggested in December that universities bar medical researchers who have a “significant” financial interest in the outcome of an experiment from conducting or overseeing it -- unless “compelling circumstances” required the researchers to be involved. The guidelines were designed as “baseline standards” for the association’s 125 member medical schools.
The GAO report, which focused on five universities, found several problems with their monitoring practices. The universities had not systematically watched how investigators complied with conflict-of-interest policies, typically allowing scientists “to self-certify compliance,” the report said. In addition, the universities’ records about financial interests were not well organized, “making it a challenge to ensure that conflicts of interest were appropriately managed and not overlooked.”
The five universities are the University of California at Los Angeles, the University of North Carolina at Chapel Hill, the University of Washington at Seattle, Washington University in St. Louis, and Yale University. GAO officials said that they picked those five universities, which are among the top recipients of federal research funds from the National Institutes of Health, partly based on the number of discoveries they had patented. The officials also interviewed administrators at other institutions.
The report added that the five universities rarely penalized scientists who failed to comply with conflict-of-interest rules, and that they relied largely on the scientists to comply voluntarily “because they believed it was important to have faculty support and maintain collegiality with the investigators.”
Some financial conflicts are less complex than others and thus require less monitoring, said Paul G. Ramsey, dean of the School of Medicine at the University of Washington, and a member of the committee that produced the guidelines for the medical-colleges’ association. But he added: “It’s an area where I do believe better guidance from [the Department of Health and Human Services] and from AAMC will be helpful.”
The report did not specifically identify the practices of any of the five universities. None of the institutions had “egregious problems that were being covered up,” said Marcia Crosse, assistant director for public-health issues at the GAO and a principal author of the report.
“We weren’t there to say, ‘You handled this case wrong,’” she added. “We were trying to find out how they had set up systems to deal with these issues.”
The GAO produced the report at the request of Sen. Bill Frist, a Republican from Tennessee. Dr. Frist, who is a heart-transplant surgeon, began scrutinizing federal rules on biomedical research after the 1999 death of Jesse Gelsinger, a volunteer in a gene-therapy experiment at the University of Pennsylvania. James M. Wilson, the director of the institute that conducted that study, had a financial stake in a company that financed the institute’s work.
“The report clearly indicates that additional measures are needed,” Dr. Frist said in a statement.
Existing rules require scientists to disclose significant conflicts of interest to their universities, which then must devise ways to ensure that those conflicts are eliminated or do not harm the research. For example, a scientist who owns stock in a company supporting his or her research may have to sell the stock, or agree to have the research reviewed by other scientists at the institution.
The GAO’s report cited several limitations in the regulations. For example, the report noted that the NIH and the Food and Drug Administration have established different standards for what constitutes a significant conflict of interest.
Some officials at the five universities also reported being confused about the circumstances under which they were required to report conflicts to the NIH. The agency requires reporting on research that it finances whenever an institution receives a disclosure from a scientist with a significant conflict of interest. However, the policy requires universities only to tell the NIH whether the conflict was resolved; the university is not required to give the agency details about the nature of the financial relationships.
Moreover, universities are not required to consistently report to institutional review boards that they received a disclosure by a researcher, or how they resolved a specific conflict of interest.
The boards, known as IRB’s, are charged under federal regulations with judging the risk posed to volunteers participating in the studies, and board members may need to know about conflicts of interest, the report said. Yet the conflicts are typically handled by separate conflict-of-interest committees, or by university administrators.
The report added that the government should advise universities on how to resolve conflicts when the institution itself holds a financial interest in the outcome of research, an area not adequately covered by existing regulations.
The Department of Health and Human Services proposed language providing such guidance in January 2001, but the GAO report said the agency’s wording lacked “detailed advice.” In a formal response included in the GAO report, department officials said they would take up that issue in the final version of the guidance, which is expected this month.
http://chronicle.com Section: Government & Politics Page: A33
