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Limits to research risks
  1. F G Miller1,
  2. S Joffe2
  1. 1
    Department of Bioethics, National Institutes of Health, USA
  2. 2
    Department of Pediatric Oncology, Dana-Farber Cancer Institute, Department of Medicine, Children’s Hospital, Boston, Massachusetts, USA
  1. Dr F G Miller, Ph.D., Department of Bioethics, Clinical Center, National Institutes of Health, Building 10, Room 1C118, Bethesda, Maryland 208921-156, USA; fmiller{at}


Risk–benefit assessment is a routine requirement for research ethics committees that review and oversee biomedical research with human subjects. Nevertheless, it remains unclear how to weigh and balance risks to research participants against the social benefits that flow from generating biomedical knowledge. In this article, we address the question of whether there are any reasonable criteria for defining the limit of permissible risks to individuals who provide informed consent for research participation. We argue against any a priori limit to permissible research risks. However, attention to the uncertainty of potential social benefit that can be derived from any particular study warrants caution in exposing prospective research participants to a substantial likelihood of serious harm.

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  • Competing interests: None declared.

  • Provenance and Peer review: Not commissioned; externally peer reviewed.

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