Clinical trials in neonates: ethical issues

Semin Fetal Neonatal Med. 2007 Aug;12(4):318-23. doi: 10.1016/j.siny.2007.01.023. Epub 2007 Mar 9.


If neonates are to receive the best possible treatment, they must be involved in clinical trials. However, doing such trials raises complicated ethical issues. These issues are not unique to neonatology but some are more common or acute than in other areas of medicine. In practice, two particular issues -- equipoise and informed consent -- arise as many different types of problem. The question 'What is an ethical issue?' is important because issues that are not ethical are sometimes mistakenly thought to be so, and vice versa. When we can recognize what types of problem are ethical, we can also recognize the correct means to tackle them.

Publication types

  • Review

MeSH terms

  • Bioethical Issues*
  • Ethics, Clinical*
  • Human Experimentation / ethics*
  • Humans
  • Infant, Newborn
  • Informed Consent / ethics*
  • Randomized Controlled Trials as Topic / ethics*