Parental perspectives about information and deferred versus two-stage consent in studies of neonatal asphyxia.

Autor:	Maiwald CA; Department of Neonatology, University Children's Hospital Tübingen, Tübingen, Baden-Württemberg, Germany Christian.Maiwald@med.uni-tuebingen.de.; Center for Pediatric Clinical Studies (CPCS), University Hospital Tübingen, Tübingen, Baden-Württemberg, Germany., Rovers C; Department of Neonatology, University Children's Hospital Tübingen, Tübingen, Baden-Württemberg, Germany., Janvier A; Department of Pediatrics, Bureau de l'Éthique Clinique, Université de Montréal, Montreal, Québec, Canada.; Division of Neonatology, Research Center, Clinical Ethics Unit, Palliative Care Unit, Unité de recherche en éthique clinique et partenariat famille, CHU Sainte-Justine, Montreal, Québec, Canada., Sturm H; Centre for Public Health and Health Services Research, Faculty of Medicine, University Hospital Tübingen, Tübingen, Baden-Württemberg, Germany., Michaelis M; Centre for Public Health and Health Services Research, Faculty of Medicine, University Hospital Tübingen, Tübingen, Baden-Württemberg, Germany.; Institute of Occupational and Social Medicine and Health Services Research, University Hospital Tübingen, Tübingen, Baden-Württemberg, Germany., Marckmann G; Institute of Ethics, History and Theory of Medicine, Ludwig Maximilians University (LMU) Munich, Munich, Bayern, Germany., Ehni HJ; Institute for Ethics and History of Medicine, Medical Faculty, University of Tübingen, Tübingen, Baden-Württemberg, Germany., Poets CF; Department of Neonatology, University Children's Hospital Tübingen, Tübingen, Baden-Württemberg, Germany., Rüdiger M; Clinic for Pediatrics, Department of Neonatology and Pediatric Intensive Care, Medical Faculty Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany., Franz AR; Department of Neonatology, University Children's Hospital Tübingen, Tübingen, Baden-Württemberg, Germany.; Center for Pediatric Clinical Studies (CPCS), University Hospital Tübingen, Tübingen, Baden-Württemberg, Germany.
Jazyk:	angličtina
Zdroj:	Archives of disease in childhood. Fetal and neonatal edition [Arch Dis Child Fetal Neonatal Ed] 2023 Dec 15; Vol. 109 (1), pp. 106-111. Date of Electronic Publication: 2023 Dec 15.
DOI:	10.1136/archdischild-2023-325900
Abstrakt:	Objective: The ALBINO Trial (NCT03162653) investigates effects of very early postnatal allopurinol on neurocognitive outcome following perinatal asphyxia where prenatal informed consent (IC) is impossible. Ethically and legally, waiver of consent and/or deferred consent (DC) is acceptable in such an emergency. Short oral/two-step consent (SOC, brief information and oral consent followed by IC) has recently been investigated. Methods: Mixed-methods analysis of parental opinions on DC versus SOC in the context of neonatal asphyxia in a survey at two German centres. Prospective parents (ProP), parents of healthy newborns (PNeo) and parents of asphyxiated infants (PAx) born between 2006 and 2016 were invited. Results: 108 of 422 parents participated (ProP:43; PNeo:35; PAx:30). Most parents trusted physicians, wanted preinterventional information and agreed that in emergencies interventions should begin immediately. Intergroup and intragroup variability existed for questions about DC and SOC. In the ALBINO Trial situation, 55% preferred SOC, and 26% reported DC without information might adversely affect their trust. Only 3% reported to potentially take legal action after DC. PAx were significantly more likely to support DC. PAx more frequently expressed positive emotions and appreciation for neonatal research. In open-ended questions, parents gave many constructive recommendations. Conclusion: In this survey, parents expressed diverse opinions on consent, but the majority preferred SOC over DC. Parents who had experienced emergency admission of their asphyxiated neonates were more trusting. Obtaining parental perspectives is essential when designing studies, while being cognisant that these groups of parents may not represent the opinion of all parents. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu