Ethics in neonatal pain research.

A literature review of 98 articles concerning clinical pain research in newborn infants was conducted to evaluate how researchers report the ethical issues related to their studies and how journals guide this reporting. The articles were published in 49 different scientific journals. The ethical issues most often mentioned were parental informed consent (94%) and ethical review approval (87%). In 75% of the studies the infants suffered pain during the research when placebo, no treatment or otherwise inadequate pain management was applied. Discussion about benefits versus harm to research participants was lacking. A quarter of the journals did not have any ethical guidelines for submitted manuscripts. We conclude that ethical considerations did not play a significant role in the articles studied. Missing and superficial guidelines enable authors to offer studies with fragile research ethics.