Finders' fees in clinical trials; Alzheimer patients as research subjects
Conflicts of interest in recruiting research participants; controversy over Alzheimer patients as research subjects
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In a survey of policies posted on 117 IRB Web sites, fewer than half of the IRBs provided information about potential conflicts from finder’s fees. IRBs may consider this information unnecessary because of federal and state antikickback statutes that prohibit payments to induce patient referrals or for other health care business, according to the author, Leslie E. Wolf, associate professor of law at Georgia State University College of Law. However, she writes, clinical investigators may not realize that these laws might also apply to clinical research.
“The focus on legal restrictions ignores the underlying ethical concern with recruitment payments that many commentators have identified,” Wolf writes, “that such payments could lead to participants being enrolled inappropriately in studies and, as a result, being exposed to unnecessary risk.”
Another article explores the debate about whether Alzheimer disease patients, as a vulnerable population, should be included in clinical trials. The article in argues in favor of greater inclusion, not only in studies on Alzheimer disease itself but also studies on comorbid conditions such as heart disease and arthritis.
Treatment of these other medical conditions can improve functioning in people with Alzheimer disease, while Alzheimer disease and its treatments may alter the safety and effectiveness of treatments for other conditions. Therefore, if Alzheimer patients are excluded from research trials because of their difficulty or inability to give informed consent, “they will be protected from the risks of research, but they will also be denied the potential benefits of research participation, both individually and as a group,” writes Anji Wall, an MD/PhD student at the Center for Health Care Ethics, Saint Lois University, Saint Louis, Mo.
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