The study's recommendations provide a framework for establishing sound policy and practices for how best to disclose financial conflicts of interests to potential participants in clinical research, said Jeremy Sugarman, M.D., senior author of a paper published in the August 27th issue of The New England Journal of Medicine and the deputy director for medicine at the Berman Institute of Bioethics at Johns Hopkins.
The paper drew on five years of research from the Conflict of Interest Notification Study, (COINS), a $3 million project led by Sugarman and funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Overall, COINS gathered information from thousands of patients as well as many clinical trial investigators, and those charged with the ethical oversight of research.
Clinical investigators have long been urged to disclose their financial interests to potential participants in a study through the informed consent process. But in their NEJM paper, the authors questioned what goal this disclosure is hoping to achieve.
Examples of financial interests include corporate funding for the expense of enrolling a patient in a trial or a researcher having a consulting contract or stock ownership with corporate sponsors with a stake in a trial.
"Our study reveals that disclosure to participants by itself is not the remedy that many seek," Sugarman said. "But disclosure may have positive effects on people's satisfaction with and trust in the research process."
The authors recommend that research participants not be the sole decision-makers about the potential risks arising from investigators' financial relationships. They agreed that disclosure during the consent process should be brief and simple, and that trial coordinators should have the information they need to address questions about financial relationships.
Kevin Weinfurt, Ph.D., the lead author of the paper said "multiple studies show that most research participants want to know about investigators' financial relationships, but that this information often doesn't change their minds about enrolling."
The authors said participants likely won't fully understand the nature of investigators' financial interests, but that disclosure encourages transparency, often satisfies participants' perceived right to know, and could foster more trust.
If stock ownership is at play, other management techniques in addition to disclosure should be used. Simply disclosing this information is insufficient the authors said, because research participants are sometimes troubled by investigators' and institutions' equity interests in clinical research.
The authors also agreed that those overseeing conflicts of interest should be explicit about their goals and design plans for managing financial interests that include disclosure requirements toward meeting those goals. The recommendations were offered to investigators, institutional review boards, conflict-of-interest committees and policy makers.
The study was supported by grant from the National Heart, Lung, and Blood Institute.
Other authors are Kevin P. Weinfurt, Ph.D., Joëlle Y. Friedman, M.P.A., and Kevin A. Schulman, M.D., of Duke University and Mark A. Hall, J.D., and Nancy M. P. King, J.D., of Wake Forest University.
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