The Limits of Disclosure as a Response to Financial Conflicts of Interest in Clinical Research

Abstract

While allowing that transparency should be one of the tools employed to manage clinical researchers' conflicts of interest, this paper disagrees with the numerous recommendations that such information become part of the informed consent process. Empirical research in several areas suggests that the provision of this information to prospective trial participants will too often cause information overload; further, few research participants understand the relevance of the information to them once provided. Because many clinical trial participants do not have viable alternatives to trial participation, the information is not facilitating exit from participation. In short, we conclude that embedding this complicated information will ultimately do more harm than good for most recipients.