Walking the Talk of Trust in Human Subjects Research: The Challenge of Regulating Financial Conflicts of Interest

Abstract:     
There has been a call for more stringent regulation of financial conflicts of interest in human subjects research following the deaths of several individuals who volunteered to participate in human subjects research, which deaths were linked to the financial conflicts of interest of participating researchers and research institutions. Each proposal argues that regulation is necessary to restore trust in medical research. This Article examines whether proposed strategies for regulating financial conflicts of interest are likely to achieve the goal of a trustworthy human research enterprise. It does not question whether enhancing trustworthiness is an appropriate goal; rather, it assumes that such a goal is worth pursuing. Instead, it argues that adopting trustworthiness as a regulatory goal has significant implications for the style of regulation that the law must employ. The Article then questions whether regulatory strategies proposed to date are consistent with a trust-promoting style and, thus, whether those strategies are likely to result in a more trustworthy human research enterprise.

Number of Pages in PDF File: 75

Keywords: Human Research, Pharmaceuticals, Conflict of Interest, Trust

Accepted Paper Series