Conflicts of Interest in Human Subject Research: The Insufficiency of U.S. and International Standards

Abstract

Researchers, as well as individuals and institutions that oversee their conduct, sometimes have conflicts of interest that weaken or render ineffective efforts to protect human research subjects. This article analyzes United States and international standards used to address conflicts of interest and reviews evidence regarding compliance. It explains what conflicts of interest are and the risks they pose for human research subjects. It explores responses to conflicts of interest by international organization, and national governments. It evaluates current ethics standard and legal rules to reduce the risk that conflicts of interest pose for research subject in the United States. The article concludes that current standards are insufficient and recommends that the federal government and international organizations adopt stronger legal standards that require resolving most significant conflicts of interest and specifying how to manage conflicts of interest not resolved.

Keywords: pharmaceutical, HTA, health technology assessment, cost control, price controls, budgets