Ethics, ambiguity aversion, and the review of complex translational clinical trials

Bioethics. 2012 Jun;26(5):242-50. doi: 10.1111/j.1467-8519.2010.01856.x. Epub 2011 Jan 17.


Clinical trials of novel agents often present several layers of ethical challenge. Because time and resources for ethical and safety review are limited, how investigators, IRBs, and regulators allocate attention to a trial's various safety dimensions itself represents a critical ethical question. In what follows, I use the example of a Parkinson's disease gene transfer trial to show how risks involving unknown probabilities or outcomes (ambiguity), might sometimes draw attention away from risks that involve known probabilities or outcomes. This potentially undermines the goal of 'systematic and nonarbitrary analysis of risk' during ethical review. To counteract the possible effects of such attention biases, I propose that reviewers develop 'cognitive aids' like lists and, where appropriate, set aside time to discuss non-ambiguous risks. I also propose further research for addressing and understanding how attention allocation, emotion, and ambiguity influence ethical decision-making.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Attention
  • Bias
  • Clinical Trials, Phase I as Topic / ethics*
  • Ethical Review*
  • Gene Transfer Techniques / ethics
  • Genetic Therapy / ethics
  • Humans
  • Parkinson Disease / therapy
  • Risk Assessment / methods
  • Risk Management* / ethics
  • Risk Management* / methods
  • Translational Research, Biomedical / ethics*
  • Uncertainty