Attitudes of patients and family members towards deferred and waived consent in ECPR research, an ancillary study of the INCEPTION trial
Year: 2026
Type: article
Abstract: Background: In emergency settings, obtaining timely informed consent is not always feasible, making deferred and waived consent a potential solution. Despite its frequent use in high-risk research, the experiences and opinions of patients and (bereaved) relatives have been scarcely investigated. This study examined their attitudes towards enrolment in the INCEPTION-trial (NCT03101787) on extracorporeal cardiopulmonary resuscitation (ECPR). Methods: Questionnaires were sent to survivors and (bereaved) relatives who had signed consent forms for follow-up research in the initial INCEPTION-trial. Additionally, relatives where consent was waived were contacted through their general practitioner with a request to participate. Responses included Likert-scale and free-text data, were analysed using descriptive statistics and non-parametric tests. Results: A total of 32 of 38 (overall response rate 84.2%) sent questionnaires were returned, from 9 survivors, 9 corresponding relatives of these survivors, 6 relatives of non-survivors who provided proxy consent and 8 relatives of non-survivors whose consent was waived. 81.3% of the respondents (strongly) supported alternative consent procedures. No statistically significant differences were found between survivors and non-survivors or ECPR versus conventional cardiopulmonary resuscitation (CCPR). The need for, and challenges of research in an emergency setting were acknowledged. Aftercare contact improved understanding of the trial and helped in bereavement processing. Conclusions: Overall, patients and (bereaved) relatives had a positive attitude towards waived and deferred consent procedures in high-risk, high-mortality research in the emergency setting. Information provision at a later stage, once the emotional burden has eased, is appreciated.
Source: Resuscitation Plus
Authors: Stijn E.D.M. Eussen, Anina F. van de Koolwijk, Thijs S.R. Delnoij, Martje M. Suverein, Brigitte A.B. Essers, Renicus C. Hermanides, Luuk C. Otterspoor, Carlos V. Elzo Kraemer, Alexander P.J. Vlaar, Joris J. van der Heijden, Erik Scholten, Corstiaan A. den Uil, Dinis Dos Reis Miranda, Sakir Akin, Jesse de Metz, Iwan van der Horst, Bjorn Winkens, Jos G. Maessen, Roberto Lorusso, Marcel C.G. van de Poll, Martje M. Suverein, Thijs S.R. Delnoij, Roberto Lorusso, George J. Brandon Bravo, Luuk Otterspoor, Carlos V. Elzo Kraemer, Alexander P.J. Vlaar, Joris J. van der Heijden, Erik Scholten, Corstiaan den Uil, Tim Jansen, Bas van den Bogaard, Marijn Kuijpers, Ka Yan Lam, José M. Montero Cabezas, Antoine H.G. Driessen, Saskia Z.H. Rittersma, Bram G. Heijnen, Dinis Dos Reis Miranda, Gabe Bleeker, Jesse de Metz, Renicus S. Hermanides, Jorge Lopez Matta, Susanne Eberl, Dirk W. Donker, Robert J. van Thiel, Sakir Akin, Oene van Meer, José Henriques, Karen C. Bokhoven, Henrik Endeman, Jeroen J.H. Bunge, Martine E. Bol, Bjorn Winkens, Brigitte Essers, Patrick W. Weerwind, Jos G. Maessen, Marcel C.G. van de Poll
Institutions: Maastricht University Medical Centre, Maastricht University, Isala, Catharina Ziekenhuis, Leiden University Medical Center, Amsterdam University Medical Centers, University of Amsterdam, Utrecht University, University Medical Center Utrecht, St. Antonius Ziekenhuis, Erasmus MC, Maasstad Ziekenhuis, Erasmus University Rotterdam, Haga Hospital, OLVG, Care and Public Health Research Institute
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,450
Funder: ZonMw
Award: G2272508248
OpenAlex ID: W7125184376