Journal Archives

Spring 2006 

02-21-2019 10:28 AM

Introduction

Research involving human subjects should be a partnership between the subjects who volunteer for the research, the public who hope to benefit from future drugs, devices, and biological products, investigators who design and conduct research, sponsors (institutions and companies that design, conduct, and sponsor or fund research), and IRBs who review research. I argue that “compliance with the regulations” governing research with human subjects has taken a front seat to broader ethical considerations of such research. While regulations contain practical applications of the ethical principles respect for persons, beneficence, and justice from such documents as the Belmont Report and Declaration of Helsinki, regulations do not explicitly reference these principles or provide procedures for ensuring that those who design, conduct, or review research have properly considered such matters.

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