The Potential Benefits of Research May Justify Certain Research Risks

Pediatrics. 2019 Mar;143(3):e20181703. doi: 10.1542/peds.2018-1703. Epub 2019 Feb 20.

Abstract

US regulations allow institutional review boards to approve pediatric clinical trials only when the risks are minimal or (in some cases) a minor increase over minimal, or when the risks are justified by a potential for direct benefit to the participants. But how should an institutional review board determine if the risks of pediatric clinical trials are justified by a potential for participant benefit? In this Ethics Rounds article, we consider which potential benefits can justify which research risks with a focus on randomized clinical trials.

MeSH terms

  • Administration, Intravenous
  • Biliary Atresia / diagnosis
  • Biliary Atresia / drug therapy
  • Biomedical Research / methods*
  • Biomedical Research / standards*
  • Child
  • Ethics Committees, Research / standards*
  • Glucocorticoids / administration & dosage
  • Humans
  • Methylprednisolone / administration & dosage
  • Prospective Studies
  • Randomized Controlled Trials as Topic / methods*
  • Randomized Controlled Trials as Topic / standards*
  • Risk Assessment

Substances

  • Glucocorticoids
  • Methylprednisolone