Two Dogmas of Research Ethics and the Integrative Approach to Human-Subjects Research

Abstract

This article argues that lingering uncertainty about the normative foundations of research ethics is perpetuated by two unfounded dogmas of research ethics. The first dogma is that clinical research, as a social activity, is an inherently utilitarian endeavor. The second dogma is that an acceptable framework for research ethics must impose constraints on this endeavor whose moral force is grounded in role-related obligations of either physicians or researchers. This article argues that these dogmas are common to traditional articulations of the equipoise requirement and to recently articulated alternatives, such as the non-exploitation approach. Moreover, important shortcomings of these approaches can be traced to their acceptance of these dogmas. After highlighting these shortcomings, this article illustrates the benefits of rejecting these dogmas by sketching the broad outlines of an alternative called the “integrative approach” to clinical research.

Keywords:

• common good
• common rule
• equipoise
• non-exploitation
• reasonable risk
• therapeutic obligation

ACKNOWLEDGMENT

My work on this article was supported by a New Directions Fellowship from the Andrew W. Mellon Foundation.