Alternative consent methods used in the multinational, pragmatic, randomised clinical trial SafeBoosC-III

• DOI: 10.1186/s13063-024-08074-0
• Publication Date: 2024-04-04T14:02:13Z
• Authors: Maria Linander Ve...; Mathias Lühr Hansen; Gorm Greisen; ; Adelina Pellicer; Caitriona Ni Chat...; Chantal Lecart; Claudia Knoepfli; Cornelia Hagmann; Dario Gallo; Ebru Ergenekon; Eleftheria Hatzidaki; Eugene Dempsey; Evangelina Papathoma; Gabriel Dimitrou; Gerhard Pichler; Gitte Holst Hahn; Gunnar Naulaers; Hans Fuchs; Hilal Ozkan; Isabel de las Cuevas; Itziar Serrano-Vi...; Jan Sirc; Julie de Buyst; Kosmos Sarafidis; Luis Arrusa; Mariana Baserga; Martin Stocker; Merih Cetinkaya; Miguel Alsina; Monica Fumagalli; Olalla Otero Vacc...; Olivier Baud; Pamela Zafra-Rodr...; Pierre Maton; Quoqiang Cheng; Ruth del Rio Flor...; Ryszard Lauterbach; Salvador Piris-Bo...; Saudamini Nesargi; Siv Fredly; Sylwia Marciniak; Tomasz Szczapa; Xiaoyang Gao; Xin Xu
• Keywords: Parental consent; Declaration of Helsinki; Research Ethics

Abstract Background The process of obtaining prior informed consent for experimental treatment does not fit well into the clinical reality acute and intensive care. therapeutic window interventions is often short, which may reduce validity rate enrolled participants, to delay trial completion external results. Deferred ‘opt-out’ are alternative methods. SafeBoosC-III was a randomised investigating benefits harms cerebral oximetry monitoring in extremely preterm infants during first 3 days after birth, starting within 6 h birth. Prior, deferred opt-out were all allowed by protocol. This study aimed evaluate use different methods trial, Furthermore, we describe analyse concerns or complaints that arose months conduct. Methods All 70 principal investigators invited join this descriptive ancillary study. Each investigator received questionnaire on their centre including possibility any related used as raised parents staff. Results Data from 61 centres available. In 43 centres, only used: seven, consent. No method only, but five deferred, prior, (all possibilities) one both opt-out. Six applied local research ethics committee denied using it. One denied. There 23 registered execution trial. Conclusions Consent protocol multinational few opted it some boards did accept its use. It likely need promotion community unfold potential.