Clinical trials in neonates: How to optimise informed consent and decision making? A European Delphi survey of parent representatives and clinicians

Abstract

ObjectivesParental consent for the participation of their neonate in neonatal research is influenced by the quality of the information delivered and the interaction between parents and investigators. Failure to provide important information may lead to difficulties in the decision making process of parents. This Delphi survey aims to establish a consensus between parent representatives of neonatal associations and healthcare professionals concerning the information deemed essential by both parties in order to improve the recruitment of neonates into clinical trials.MethodThis study was conducted in Europe among parent representatives and healthcare professionals. In this 3-phase study, 96 items were defined by the Scientific Committee (CS), composed of 11 clinicians (from 8 countries) and 1 parent representative of the European network of neonatal associations. Then the Committee of Experts (CE) composed of 16 clinicians were matched by country with 16 national parent representatives and evaluated these items in two rounds. The importance of each item was evaluated by each member of the CE on a scale between 1 and 9 based on their personal experience.ResultsFifty eight items reached the second and final level of consensus. In contrast to clinicians, parent representatives preferred to be informed about the study by the physician in charge of their child. They also favoured additional support during the informed consent process and stated that both parents need to agree and sign.ConclusionThe set of 58 items on which parents and clinicians reached consensus will be helpful to healthcare professionals seeking parental consent for the inclusion of a neonate in a clinical trial. Providing parents with information about the trial by the investigator in the presence of the patient’s neonatologist, developing closer contacts with parents and informing them of the available support by parents associations may be helpful for parents.

Trust and consent: a prospective study on parents’ perspective during a neonatal trial

“…Recent literature on parental perspectives expressed by parental associations in Europe supports the importance of trust in the consent process 24. Neyro et al showed that parents want to be informed by the investigator of the research in the presence of the neonatologist in charge of their child 24. In our study, 56% of parents preferred being informed by the physician in charge of their infant.…”

“…In our study, the oral information was the major element for understanding and making a decision, because written information was criticised as poorly understandable and rarely read in full. According to another study with parents,24 well-communicated verbal information is always necessary as a concordant complement of written information, which serves more as a reminder during the period preceding the decision for inclusion 24. A randomised controlled trial in which parents were assigned to receive one or two information leaflets with or without a standardised verbal explanation showed the importance of the verbal information.…”

“…Informed consent cannot be separated from the trust relationship. Recent literature on parental perspectives expressed by parental associations in Europe supports the importance of trust in the consent process 24. Neyro et al showed that parents want to be informed by the investigator of the research in the presence of the neonatologist in charge of their child 24.…”

Oral Sirolimus: An Option in the Management of Neonates with Life-Threatening Upper Airway Lymphatic Malformations

“…6 Although clinical trials remain the gold standard for drug evaluation, children, especially neonates, have become ''therapeutic orphans'' of prescribed off-label drugs. 7 For that, there are no randomized studies in neonates, and information must be collected from series of cases.…”

Barriers and Challenges in Performing Pharmacokinetic Studies to Inform Dosing in the Neonatal Population

“…There are some limits to parental consent, with parents not able to give consent for their children to participate in as wide a range of studies as an autonomous adult [12]. Parents themselves have also noted concerns about consent, including that both parents should provide consent [14]. Best practice regarding consent and recruitment involves a process of continuous consent in the days and weeks after birth, with repeated discussions with the family, including the opportunity to confirm or withdraw consent.…”