Conflicts Of Interest In Recruiting Research Participants; Controversy Over Alzheimer Patients As Research Subjects

Main Category: Alzheimer's / Dementia
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry;  Seniors / Aging
Article Date: 12 Feb 2009 - 6:00 PST

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There is growing concern about conflicts of interest in clinical research, including research sponsors paying finders' fees to researchers and clinicians to recruit participants. Institutional review boards can help prevent such conflicts, which may compromise the integrity of the research and potentially harm research subjects. But an article in IRB: Ethics & Human Research reviews IRB policies and finds room for improvement.

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.

The Hastings Center is a nonpartisan bioethics research institution dedicated to bioethics and the public interest since 1969. The Center is a pioneer in collaborative interdisciplinary research and dialogue on the ethical and social impact of advances in health care and the life sciences. The Center draws on a worldwide network of experts to frame and examine issues that inform professional practice, public conversation, and social policy.

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