Research Malpractice and the Issue of Incidental Findings

J Law Med Ethics. Summer 2008;36(2):356-60, 214. doi: 10.1111/j.1748-720X.2008.00280.x.

Abstract

Human subject research involving brain imaging is likely to reveal significant incidental findings of abnormal brain morphology. Because of this fact and because of the fiduciary relationship between researcher and subject, board-certified or board-eligible radiologists should review the scans to look for any abnormality, the scans should be conducted in accordance with standard medical practice for reviewing the clinical status of the whole brain, and the informed consent process should disclose the possibility that incidental findings may be revealed and what consequences will follow. In the event such findings are revealed, qualified physicians should explain to the subject the significance of the findings and the alternatives available.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Biomedical Research / economics
  • Biomedical Research / ethics*
  • Biomedical Research / legislation & jurisprudence
  • Brain / abnormalities
  • Brain Diseases / diagnosis
  • Child
  • Clinical Trials as Topic / economics
  • Clinical Trials as Topic / ethics*
  • Clinical Trials as Topic / legislation & jurisprudence
  • Diagnostic Errors / economics
  • Diagnostic Errors / legislation & jurisprudence
  • Ethics Committees, Research
  • Humans
  • Incidental Findings*
  • Magnetic Resonance Imaging / standards*
  • Malpractice / legislation & jurisprudence*
  • Research Subjects*