A framework for risk-benefit evaluations in biomedical research

Kennedy Inst Ethics J. 2011 Jun;21(2):141-79. doi: 10.1353/ken.2011.0007.


Essentially all guidelines and regulations require that biomedical research studies have an acceptable risk-benefit profile. However, these documents offer little concrete guidance for implementing this requirement and determining when it is satisfied. As a result, those charged with risk-benefit evaluations currently assess the risk-benefit profile of biomedical research studies in unsystematic ways, raising concern that some research participants are not being protected from excessive risks and that some valuable studies involving acceptable risk are being rejected. The present paper aims to address this situation by delineating the first comprehensive framework, which is based on existing guidelines and regulations as well as the relevant literature, for risk-benefit evaluations in biomedical research.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biomedical Research* / ethics
  • Biomedical Research* / organization & administration
  • Biomedical Research* / standards
  • Clinical Trials as Topic / ethics*
  • Clinical Trials as Topic / standards
  • Ethics, Research
  • Humans
  • Informed Consent / ethics
  • Informed Consent / standards
  • Research / organization & administration
  • Research / standards
  • Risk Assessment* / methods
  • Risk Assessment* / standards
  • Risk Assessment* / trends
  • Social Values