Abstract

In an effort to improve parents’ understanding of key information during the informed consent process for neonatal research, we developed an enhanced consent process to measure parents’ understanding and recall of key information for a phase II clinical trial in the neonatal setting. We divided parents into standard and enhanced consent groups, with the enhanced consent group receiving a nine-point true or false questionnaire immediately after signing the consent form. We provided parents who responded incorrectly to the questions with additional counseling and literature on the clinical trial. When the patient was discharged, we then asked parents twenty questions to determine what they recalled about the trial. Eighty-six parents completed this second questionnaire at time of discharge. We saw no difference between groups in their memory of the study’s purpose, its benefits, or its specific risks. However, the enhanced consent group was more likely to feel that their questions were answered more completely, to remember that there were risks associated with the study, and to know that they could withdraw their child from the study. While our study did not demonstrate any improvement in understanding during the informed consent process, the parents who received the enhanced consent process were more likely to remember important aspects of it