Valuing risk: the ethical review of clinical trial safety

Kennedy Inst Ethics J. 2004 Dec;14(4):369-93. doi: 10.1353/ken.2004.0041.


Despite its mandate on minimizing harms in clinical trials, the Common Rule provides little guidance as to how IRBs should evaluate risk. The Common Rule and derivative commentaries tend to conceptualize risk review as an expert-based endeavor aimed at an objective and universal evaluation of possible harm; they also have tended to locate risk in the research activity itself rather than in the context of research. These views of risk conflict with scholarship showing that risk evaluations are socially determined even among experts, that the context of harms can influence how persons evaluate risks, and that forums that approach risk assessment as a technical endeavor bracket from discussion the numerous values that ground risk judgments. Possible reforms are proposed for clinical trial risk review that would render it more inclusive of the different types of risk encountered and more attuned to the priorities of trial subjects.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Academic Medical Centers
  • Advisory Committees
  • Biomedical Research / economics
  • Biomedical Research / trends
  • Clinical Trials as Topic / legislation & jurisprudence*
  • Committee Membership
  • Community Participation
  • Developing Countries
  • Ethical Review / legislation & jurisprudence
  • Ethical Review / standards*
  • Ethics Committees, Research / legislation & jurisprudence*
  • Ethics Committees, Research / organization & administration*
  • Federal Government
  • Government Regulation
  • Human Experimentation / legislation & jurisprudence*
  • Humans
  • Industry
  • Research Subjects
  • Risk Assessment / ethics*
  • Risk Assessment / legislation & jurisprudence
  • Risk Assessment / methods*
  • United States