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.
Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information.
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Collaborators ALBINO-consortium: The ALBINO-consortium involved in this project consists of the coordinating investigators as well as the beneficiaries and national coordinators. Coordinating investigators are Axel R Franz (University Hospital Tuebingen, Germany) and Mario Rüdiger (University Hospital CG Carus, Dresden, Germany). The beneficiaries and national coordinators are Axel R Franz and Christian F Poets (Tuebingen, Germany), Mario Rüdiger (Dresden, Germany), Manon Benders and Frank van Bel (Utrecht, the Netherlands), Karel Allegaert and Gunnar Naulaers (Leuven, Belgium), Dirk Bassler (Zurich, Switzerland), Katrin Klebermass-Schrehof (Vienna, Austria), Maximo Vento (Valencia, Spain), Hercilia Guimaraes (Porto, Portugal), Tom Stiris (Oslo, Norway), Isabella Mauro (Udine, Italy), Marjo Metsäranta (Helsinki, Finland), Sampsa Vanhatalo (Helsinki, Finland), Jan Mazela (Poznan, Poland), Tuuli Metsvaht (Tartu, Estonia) and Roselinda van der Vlugt-Meijer (ACE Pharmaceuticals, Zeewolde, the Netherlands).
Contributors CAM conceptualised the study, designed the survey, recruited parents on the maternity ward in Tübingen and drafted the first version of the manuscript (including translation of the survey and the answers). CAM approved the final version of the manuscript and agreed to be accountable for all aspects of the work. CR contributed to the design of the survey, recruited parents on the maternity ward in Tübingen and coordinated the data collection in the obstetric practices and in Dresden. CR revised the manuscript, making important contributions, approved the final version of the manuscript and agreed to be accountable for all aspects of the work. MR coordinated data collection in Dresden. MR and CFP supervised the project as heads of the neonatal departments involved and critically reviewed the manuscript for important intellectual content and translations. Both authors revised the manuscript, making important contributions, approved the final version of the manuscript and agreed to be accountable for all aspects of the work. HS and MM assisted in the design of the survey from a perspective of healthcare research and critically reviewed the manuscript. Both authors made important contributions and approved the final version of the manuscript. AJ encouraged this study by critically commenting on ‘deferred consent’ for ALBINO as member of the ALBINO Ethics Advisory Board. AJ revised the manuscript critically for important intellectual content and with regard to the English language as a native speaker. AJ agreed to the final version of the article and agreed to be accountable for all aspects of the work. GM made important contributions as member of the ALBINO ethics advisory board. GM revised the manuscript critically for important intellectual content, agreed to the final version of the article and agreed to be accountable for all aspects of the work. H-JE made important contributions as member of the ALBINO ethics advisory board. H-JE revised the manuscript critically for important intellectual content, agreed to the final version of the article and agreed to be accountable for all aspects of the work. ARF conceptualised the study and designed the survey and was coordinator of the project. ARF was responsible for concept and design and supervised assessment of the data. ARF revised the manuscript, making important contributions, approved the final version of the manuscript and the translations and agreed to be accountable for all aspects of the work. ARF and CAM are guarantors.
Funding This study has been partially funded within the ALBINO project under the Horizon 2020 Framework Program of the European Union, call H2020-PHC-2015-two-stage, grant 667224.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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