Department of Paediatric Pharmacology and Pharmacogenetics, Assistance Publique des Hôpitaux de Paris, Robert Debré Hospital, Paris, France.
Doctoral School MTCI - Paris Descartes University, Paris, France.
PLoS One. 2018 Jun 13;13(6):e0198097. doi: 10.1371/journal.pone.0198097. eCollection 2018.
Parental 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.
This 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.
Fifty 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.
The 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.
新生儿父母对新生儿参与新生儿研究的同意受到所提供信息的质量以及父母与研究人员之间互动的影响。未能提供重要信息可能导致父母决策过程出现困难。这项德尔菲调查旨在确定新生儿协会的父母代表和医疗保健专业人员之间的共识，即双方认为对于提高临床试验中新生儿的入组至关重要的信息。
本研究在欧洲的父母代表和医疗保健专业人员中进行。在这项 3 期研究中，科学委员会（CS）确定了 96 项内容，由 11 名临床医生（来自 8 个国家）和 1 名新生儿协会欧洲网络的家长代表组成。然后，由 16 名临床医生组成的专家委员会（CE）按国家与 16 名国家家长代表相匹配，并在两轮中评估这些项目。CE 的每位成员根据个人经验，在 1 到 9 的范围内对每项内容的重要性进行评估。
有 58 项内容达到了第二轮和最终的共识水平。与临床医生相比，家长代表更希望由负责他们孩子的医生告知他们有关研究的情况。他们还希望在知情同意过程中获得额外的支持，并表示需要父母双方同意并签字。
父母和临床医生达成共识的 58 项内容将有助于医疗保健专业人员在临床试验中寻求父母对新生儿入组的同意。由研究者在新生儿科医生在场的情况下向父母提供有关试验的信息，与父母建立更密切的联系，并告知他们父母协会提供的支持，这可能对父母有所帮助。
