J Med Ethics doi:10.1136/medethics-2012-100832
  • Research ethics

Phase 1 oncology trials and informed consent

  1. Steven Joffe2
  1. 1Department of Bioethics, National Institutes of Health, Bethesda, Maryland, USA
  2. 2Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
  1. Correspondence to Dr Franklin G Miller, Warren G. Magnuson Clinical Center, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD 208921156, USA; fmiller{at}
  • Received 1 June 2012
  • Revised 2 October 2012
  • Accepted 24 October 2012
  • Published Online First 17 November 2012


Ethical concerns have been raised about the quality of informed consent by participants in phase 1 oncology trials. Interview surveys indicate that substantial proportions of trial participants do not understand the purpose of these trials—evaluating toxicity and dosing for subsequent efficacy studies—and overestimate the prospect of therapeutic benefit that they offer. In this article we argue that although these data suggest the desirability of enhancing the process of information disclosure and assessment of comprehension of the implications of study participation, they do not necessarily invalidate consent by phase 1 trial participants.