Contextualizing clinical research: the epistemological role of clinical equipoise

Theor Med Bioeth. 2009;30(4):269-88. doi: 10.1007/s11017-009-9104-6. Epub 2009 Apr 30.

Abstract

Since its introduction in 1987, Benjamin Freedman's principle of clinical equipoise has enjoyed widespread uptake in bioethics discourse. Recent years, however, have witnessed a growing consensus that the principle is fundamentally flawed. One of the most vocal critics has undoubtedly been Franklin Miller. In a 2008 paper, Steven Joffe and Miller build on this critical work, offering a new conception of clinical research ethics based on science, taking what they call a "scientific orientation" toward the ethics of clinical research. Though there is much to recommend Joffe and Miller's scientifically oriented conception of clinical research ethics, I believe that both the critical and constructive projects suffer from the same basic mistake: inattention to context. The internal norms of science cannot be fully specified, let alone satisfied, independently of contextual (external) factors that only come into view when we are attentive to the particular context of that form of inquiry.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biomedical Research / ethics
  • Conflict of Interest*
  • Ethics, Medical
  • Ethics, Research*
  • Evidence-Based Medicine / ethics*
  • Global Health
  • Humans
  • Informed Consent / ethics
  • Knowledge
  • Moral Obligations*
  • Physician-Patient Relations / ethics
  • Randomized Controlled Trials as Topic / ethics*
  • Researcher-Subject Relations / ethics*
  • Social Values