Researchers and officials charged with the ethical oversight of research are often reluctant to fully disclose financial interests to potential clinical research participants, according to the latest Conflict-of-Interest Notification Study (COINS), just published in the Fall 2006 issue of the Journal of Law, Medicine and Ethics. Instead, those interviewed suggest a better approach for such disclosures would be to offer potential research participants a range of dollars or even use adjectives such as a "substantial investment" to describe the extent of a researcher's financial interest.
The study, a survey of attitudes, beliefs and practices among members of institutional review boards, conflict-of-interest committees and researchers, reveals a key reason for the reluctance among researchers to share the full dollar amount: the belief that because potential research subjects may lack the sophistication to put conflicts of interest in context, they may overestimate the influence of money on the researcher's behavior and possibly refuse to participate.
"The findings raise important questions about the informed consent process," said principal investigator Jeremy Sugarman, M.D., the Harvey M. Meyerhoff Professor of Bioethics and Medicine at The Berman Bioethics Institute at Johns Hopkins University. "Some researchers appear to believe that because disclosing any dollar amount could influence a person's decision of whether or not to participate in a clinical trial, the dollar amount shouldn't be revealed at all. Instead, the person should only be told that a financial interest exists, but 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?"
The ongoing Conflict of Interest Notification Study (COINS) was initiated to establish a framework for developing po
Contact: Ed Bodensiek
Johns Hopkins University