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Study Reveals Reluctance to Financial Disclosures in Research Involving Humans

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Duke Health News 919-660-1306

DURHAM, N.C. -- Researchers and officials charged with the ethical oversight of clinical trials involving humans often are reluctant to disclose financial interests to potential participants in the trials, for a variety of reasons, a new study has found.

In the study, conducted by researchers from Duke University Medical Center, Johns Hopkins University and Wake Forest University, most respondents said disclosure of financial interests should occur because it enables informed decision making, promotes trust in researchers and research institutions, and reduces the risk of legal liability.

But at the same time, the study identified a belief among some researchers who lead clinical trials that if patients considering whether or not to enroll in a trial are told the exact dollar amounts, they may be likely to overestimate the value and influence of the money involved.

Furthermore, many of those interviewed said that there is a risk of potential research participants not having the appropriate background or education to fully understand a financial conflict of interest when discussed in the context of the informed consent process, when patients typically are given full information about the trial, including its possible benefits and drawbacks, and that this situation could lead to possible misunderstandings.

The team published its results in the Fall 2006 issue of the Journal of Law, Medicine and Ethics.

In the study, the team interviewed researchers who have conducted clinical trials, as well as the chairs of institutional review boards and conflict of interest committees, at 40 academic medical centers, independent hospitals and unaffiliated research entities in the United States. Institutional review boards are panels that evaluate and approve research involving humans, while conflict of interest committees review financial relationships between individual researchers and sponsors and take steps to manage those interests that may pose conflicts.

Financial interests can include such things as corporate support for the costs of the trial and its personnel, a researcher's consulting contract with a company that has a vested interest in a clinical trial, or an investigator's ownership of stock in the sponsoring company.

The survey was conducted as part of the ongoing Conflict of Interest Notification Study (COINS), a five-year, $3 million project funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. COINS is led by Kevin Weinfurt, Ph.D., deputy director of the Center for Clinical and Genetic Economics at the Duke Clinical Research Institute, and Jeremy Sugarman, M.D., the Harvey M. Meyerhoff Professor of Bioethics and Medicine at the Phoebe R. Berman Bioethics Institute at Johns Hopkins. Weinfurt and Sugarman, along with Mark Hall, J.D., in Wake Forest's School of Law, were the main investigators for the study.

"The ultimate goal of the project is to provide a framework for establishing sound policy and practices for disclosing conflict of interest in clinical research," Sugarman said. "We are hoping that the data we're collecting will benefit officials who are struggling with the best ways of minimizing potential risks to study subjects and advancing the cause of clinical science."

While earlier COINS analyses looked at official institutional policies involving conflicts of interest in research and how potential study participants view these conflicts, the current survey focused on the views of institutional officials of what and how such information should be disclosed to patients.

"Previous COINS studies found a variety of conflict of interest policies at medical institutions across the United States, but no real settled opinion on how to move forward," Weinfurt said. "The latest results indicate that officials disagree on how best to disclose this information."

Sugarman added, "There's widespread disagreement on how to do it. Should researchers name the source of their funds? Should the disclosure highlight potential consequences of the financial relationship? When and how should all of that be disclosed?"

For example, some respondents expressed concern that the sheer complexity required by full disclosure of financial arrangements and interests involved in many clinical trials could shift patients' attention away from the actual decision of whether or not to participate. Others argued that full disclosure, including revealing the dollar amount and source of funding, should take place in a straightforward, simple manner to minimize confusion among potential participants.

"It's hard for those overseeing clinical trials to figure out what potential participants should be told when they don't even have a good sense of what exactly informed decision making means," Weinfurt said.

"As a next step, there is a clear need to gather data on exactly how potential research participants would use different forms of disclosure in their decision making," Sugarman said. "That way, we might better respect the integrity of the research enterprise while better protecting the rights and interests of research participants."

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