Most IRB rules don't ban finder's fees for clinical trials
■ Institutional review boards also are silent on conflicts that doctors may face when recruiting their patients as research subjects.
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The American Medical Association, the American College of Physicians and others have declared unethical the practice of paying doctors "finder's fees" for recruiting patients as clinical research subjects. But only half of institutional review boards address in writing the conflict of interest these kinds of payment incentives pose, according to a survey of IRB policies at 117 medical schools that received National Institutes of Health research funding.
About a quarter of the IRB policies prohibit investigators from offering finder's fees to doctors or other health professionals, said the study in the January-February IRB: Ethics & Human Research, a journal published by the Garrison, N.Y.-based Hastings Center. Payments can range from $2,000 to $10,000 per patient enrolled in a clinical trial, according to published reports.
Another potential conflict, say the AMA and others, is when doctors recruit their own patients as research subjects. Yet less than a quarter of IRB policies address this "role conflict," and only 4% ask doctors to tell their patients that they are not in any way obligated to participate in research trials.
Leslie E. Wolf, lead author of the study, said it is important for IRBs to address these conflicts in their policies and not just handle them on a case-by-case basis.
"If there is a written policy, it suggests there may be more consistency within an institution," said Wolf, associate law professor at the Georgia State University College of Law. "If it's written down and you're coming to the IRB for the first time and asking questions about what's appropriate, they can say, 'Oh, wait, we have a policy that answers this question.' "
IRBs appear to be falling short in addressing these conflicts, experts said.
"On the institutional level, it should be that finder's fees are targeted as creating a clear potential conflict of interest," said Trudo Lemmens, associate professor of law and medicine at the University of Toronto and co-editor of the 2006 book Law and Ethics in Biomedical Research: Regulation, Conflict of Interest, and Liability.
Funding by drug companies
The survey of IRB policies does not shed light on what is going on outside the academic context, where most clinical research takes place and is directly funded by pharmaceutical companies.
Experts said there is an ethical consensus that paying doctors or other health professionals a certain amount for each subject they recruit is problematic because it can encourage the enrollment of inappropriate patients and lead patients to feel pressure to participate. But, they said, reimbursing doctors for the extra time and work involved in recruiting patients and monitoring their involvement in a clinical trial is a murkier area.
AMA policy, adopted in 2000, states that "any financial compensation received from trial sponsors must be commensurate with the efforts of the physician performing the research. Financial compensation should be at fair market value and the rate of compensation per patient should not vary according to the volume of subjects enrolled by the physician."
Distinguishing between fair compensation and an unethical financial conflict is not easy for IRBs or other oversight bodies, Lemmens said.
"Research ethics boards have to do a better job of analyzing budgets and making sure that the rewards being paid are not hidden finder's fees," he said. "Reasonable reimbursement for extra time spent on filling out forms can be appropriate, but it does not necessarily mean that there is no conflict."
Kevin P. Weinfurt, PhD, associate professor of psychiatry and behavioral sciences at Duke University School of Medicine in North Carolina, has studied how patients think about research conflicts. He said great care should be taken to protect patients.
"Whatever decision's made about appropriate compensation really has to take into account the fact that we have people who are suffering and are very trusting of anyone associated with the medical establishment," Weinfurt said. "They are a vulnerable population."