• IRB: ETHICS & HUMAN RESEARCH

Informed Consent for Research: A Cross-Sectional Survey on the Views of Parents of Sick Newborns

Preterm infants in the neonatal intensive care unit are a vulnerable population whose parents are frequently approached to have their infants involved in research. However, few studies have addressed the parents’ experience with the consent process. To assess the informational needs of parents, we conducted a cross-sectional survey of their views using an interview containing open-ended questions and a forced ranking of the Common Rule’s elements of consent. Twenty parents of 16 neonates responded. Most parents surveyed (85%) responded that the risks to their child and study procedures were their biggest concerns, and parents ranked these elements most highly. Seven parents (35%) expressed interest in the altruistic intent associated with research. Of note, 80% of parents remarked that the verbal explanation was the most important aspect of the informed consent process. By understanding the perspective of parents, we may be able to better tailor the informed consent process to their concerns in an effort to improve comprehension.

Nunes AT, Trahms C, and D’Angio CT. Informed consent for research: A cross-sectional survey on the views of parents of sick newborns. IRB: Ethics & Human Research 2015;37(6)9-14.