Neonatal Research and the Validity of Informed Consent Obtained in the Perinatal Period

Abstract

BACKGROUND:Consent for participation in clinical research is considered valid if it is informed, understood, and voluntary. In the case of minors, parents give permission for their child to participate in research studies after being presented with all information needed to make an informed decision. Although informed consent is a vital component of clinical research, there is little information evaluating its validity in neonatal intensive-care populations. The objective of this project was to determine the validity of informed consent obtained from parents of infants enrolled in the multicenter randomized research study, neurologic outcomes and preemptive analgesia in the neonate (NEOPAIN). DESIGN/METHODS:Parents of infants who survived to discharge and had signed consent for their newborn to participate in the NEOPAIN study at the University of Kentucky were asked 20 open-ended questions to determine their level of understanding about the NEOPAIN study. The NEOPAIN consent form, which had been approved by the University of Kentucky Medical Institutional Review Board (IRB), was used to formulate these questions. Questions addressed the timing of consent, parental understanding of the purpose, benefits, and risks of the study, the voluntary nature of the project, and their willingness to enroll in future studies if the opportunity presented. Answers were scored on a Likert scale, with 1 for no understanding and 5 for complete understanding. RESULTS:Five of 64 parents (7.8%) had no recollection of the NEOPAIN study or of signing consent. Of those who remembered the study, only 67.8% understood the purpose of the study, with a higher proportion of the mothers than fathers knowing the purpose of the study (73.3% vs 57.1%), (p ¼ 0.029). Of those who understood the purpose of the study 95% were able to verbalize the benefits, but only 5% understood any potential risks. No parents reported feeling pressured or coerced to sign consent for the project and all parents reported they would enroll their child in additional studies if asked.

Processes in recruitment to randomised controlled trials of medicines for children (RECRUIT): a qualitative study

“…While safety, benefits and practicalities have previously been identified as important in families' decision-making 14,49,50,57,59,71 this study adds two important dimensions. First, the factors identified in this study were voiced by the parents themselves, whereas much of the previous literature has asked parents to rate the importance of factors that researchers have predetermined.…”

Parents report positive experiences about enrolling babies in a cord‐related clinical trial before birth

“…Valid informed consent is central to the conduct of RCTs and parents must give permission for their baby to participate in neonatal research (2). For this consent to be valid, parents must be deemed to be mentally competent, to have received appropriate information and to have given consent voluntarily (3).…”

Honesty, Trust, and Respect During Consent Discussions in Neonatal Clinical Trials

“…3 However, neonatal research need not be viewed through such a negative lens. Parents who have participated in clinical trials may view their research involvement very differently, as an exciting opportunity rather than a burden.…”