Conflicts of interest in clinical research

Leslie Wolf, an associate professor of law at Georgia State University, studied the IRB policies posted on the Web sites of 117 medical schools that received National Institutes of Health funding. Among the study's findings, Wolf revealed that less than half of the IRB policies discuss finder's fees or bonus payments as conflicts of interest, where research sponsors pay members of the research team or clinicians to identify potential participants or for meeting predetermined enrollment targets.

"Since IRBs must review research protocols, and also are in a position to educate investigators about these issues, I thought their policies were an important place to look," Wolf said. "I thought they would have tried to address it more frequently than they did. That's a gap in IRB guidance."

Finder's fees raise concern because researchers and their colleagues may be tempted to enroll individuals in studies for which they are ineligible, Wolf said.

Wolf is also concerned that only 26 of the IRBs in the study mentioned potential conflicts when physicians recruit their own patients and that only four percent ask doctors to tell their patients that they are not obligated to participate.

"It was talked about much less frequently than either the employer/employee or the teacher/student role conflict. It's been in the literature and patients may be particularly vulnerable," Wolf said.

Concerns about conflicts of interest are only continuing to grow as more stories appear in the news, Wolf said. For instance, Ellen Roche, a healthy 24-year-old who died from lung failure in 2002, while in a study sponsored by her employer, the Johns Hopkins Asthma and Allergy Center. Roche became ill after she inhaled an experimental compound as part of a study to understand the cause of asthma.

An external committee that reviewed the circumstances of the death expressed concerns that there were "subtle coercive pressures" on employees to enroll in the Center's studies. Employees who participated in the study not only received compensation for participation, but were given time off from the workday to undergo study procedures.

"There have been situations that people have talked about in the media that undermine our confidence in research and could prevent important research from going forward," Wolf said. "We need to have a trustworthy research enterprise so that we can get good research that hopefully improves the lives of the rest of us."

Source: Georgia State University (news : web)