Evaluation of the content and process of informed consent discussions for neonatal research

J Empir Res Hum Res Ethics. 2012 Jul;7(3):78-83. doi: 10.1525/jer.2012.7.3.78.

Abstract

Studies of informed consent for neonatal research suggest that there are gaps in parental understanding of key aspects of research. Few studies have examined parental understanding and investigator disclosure simultaneously. This pilot study evaluated the content and processes of 21 audio-recorded consent discussions with parents of eligible newborns, as well as parents' self-reported comprehension of research elements following these discussions. Gaps in both investigator disclosure and parental understanding were found. Nevertheless, parents reported comprehension of a greater number of research elements than were actually disclosed by investigators. Our preliminary results indicate the feasibility and potential utility of jointly examining parental understanding and investigator behavior to characterize consent for neonatal research. Directions for future research are suggested.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Comprehension*
  • Disclosure*
  • Ethics, Research*
  • Feasibility Studies
  • Female
  • Health Knowledge, Attitudes, Practice*
  • Humans
  • Infant, Newborn
  • Informed Consent*
  • Male
  • Parents*
  • Pilot Projects
  • Research Personnel
  • Self Report
  • Young Adult