Regulating Conflicts of Interest in Research: The Paper Tiger Needs Real Teeth

Abstract:     
This article describes the current state of the regulation of financial conflicts of interest in research in the United States. It notes the implications of the changing academic and private research environment and reviews recent empirical research on (1) the perceived implications of such conflicts on clinician and researcher behavior, and (2) the effect of disclosure of such conflicts to potential research participants. The article also details a number of widely publicized research “scandals” involving conflicts of interest and the effects these may have on both public support for research as well as on the quality of care that ultimately is delivered.

The article then discusses current U.S. federal regulations and initiatives by institutions and professional organizations to further guide researchers and describes how conflicts of interest are typically managed by institutions. It also presents a taxonomy of researcher reactions to efforts by institutional conflict of interest committees to regulate these conflicts. It notes critiques by the Office of the Inspector General of the U.S. Department of Health and Human Services (OIG) of the government's role in the current interplay between government agencies, research sponsors, and institutions in regulating conflicts. Concluding that current efforts to regulate conflicts are inadequate, the article sets forth a proposal for reform of the way conflicts of interest are managed at both the federal and institutional levels.

Number of Pages in PDF File: 43

Keywords: conflicts of interest, regulation of research, research ethics

Accepted Paper Series