Finder’s Fees, Bonus Payments Present Conflict Of Interest Problems In Clinical Research

Prof. Leslie Wolf

But Less Than Half Of U.S. Med Schools Have Written Policies Addressing The Problem

Although paying finder’s fees to researchers and clinicians to identify study participants could compromise the recruitment process and harm human lives, many medical schools fail to address this conflict of interest in their Institutional Review Board (IRB) policies.

            The result, the study’s author told Stem Cell Research News, is that at least some study participants may have been “inappropriately enrolled in research studies because of the financial incentives.”

            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.

            According to Prof. Wolf, the data were collected between September 2005 and March 2006.

            The study  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.

            Prof. Wolf did not know the extent of the problem of enrolling ineligible study participants. Apparently, no studies have been done: it would be difficult to gather relevant data, she said.

            “However, there have been anecdotal stories reported suggesting that some people have been inappropriately enrolled in research studies because of the financial incentives,” she said. “Not knowing the extent of the problem makes it difficult to know whether any clinical studies have been compromised by these particular conflicts of interests. Studies of other potential conflicts (e.g., industry sponsored research, industry gifts to prescribing physicians) suggest that they do affect decision-making, so we could expect a similar effect in this context. Even without the scientific data, the anecdotal stories can undermine the public’s trust in research.”

            Concerns about conflicts of interest are only continuing to grow as more stories appear in the news, Wolf said.

            For instance, Ellen Roche was 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.

            According to Prof. Wolf, Johns Hopkins later settled out of court with the family for an undisclosed amount of money.

            “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.”

            Considering the risks involved to both patients and research institutions, why do so few medical schools have an IRB in place that addresses finder’s fees and bonus payments to study participants.

            Prof. Wolf said she could only speculate as to the reasons.

            “In my paper, I suggested that one plausible explanation is that ‘IRBs may consider discussion about recruitment payments unnecessary because of federal and state antikickback statutes that prohibit payments to induce patient referrals or for other health care business,’” she told Stem Cell Research News. 

            “However, if true, this could be a risky assumption because investigators may not appreciate that the laws might apply in the research context. In addition, reliance on legal reasons ignores the fundamental ethical concern that recruitment payments could place research participants at risk of being enrolled inappropriately in studies and misses an opportunity to educate investigators about this concern.”

            Prof. Wolfe said she used a 2003 NIH list of 121medical schools receiving NIH funding.

            “One had four different IRBs (including one for the medical school), so that there were 124 eligible IRBs,” she said.

            She excluded seven schools that didn’t have policieon the Web, resulting in the sample of 117 IRB Web sites.

            “We did not determine what kinds of research each medical school conducted, although I would expect that most, if not all, conduct some clinical studies,” she said. “That they all had IRBs suggests at least some studies involving human subjects.

            Contact: Leslie Wolf, 404-413-9164, lwolf@gsu.edu