Attitudes of patients and family members towards deferred and waived consent in ECPR research, an ancillary study of the INCEPTION trial
Publication date
2026-03
Authors
Eussen, Stijn E.D.M.
van de Koolwijk, Anina F.
Delnoij, Thijs S.R.
Suverein, Martje M.
Essers, Brigitte
Hermanides, Renicus C.
Otterspoor, Luuk
Elzo Kraemer, Carlos V.
van der Heijden, J. J.
Scholten, Erik
Editors
Advisors
Supervisors
Document Type
Article
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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.
Keywords
Ethics, Extracorporeal cardiopulmonary resuscitation, Informed consent, Out-of-hospital cardiac arrest, Emergency Medicine, Emergency, Cardiology and Cardiovascular Medicine
Citation
Eussen, S E D M, van de Koolwijk, A F, Delnoij, T S R, Suverein, M M, Essers, B, Hermanides, R C, Otterspoor, L, Elzo Kraemer, C V, van der Heijden, J J, Scholten, E, Uil, C D, Reis Mirada, D D, Akin, S, de Metz, J, van der Horst, I, Winkens, B, Maessen, J G, Lorusso, R, van de Poll, M C G, Suverein, M M, Delnoij, T S R, Lorusso, R, Brandon Bravo, G J, Otterspoor, L, Elzo Kraemer, C V, Vlaar, A P J, Scholten, E, Jansen, T, van den Bogaard, B, Kuijpers, M, Lam, K Y, Montero Cabezas, J M, Driessen, A H G, Rittersma, S Z H, Heijnen, B G, Dos Reis Miranda, D, Bleeker, G, de Metz, J, Hermanides, R S, Matta, J L, Eberl, S, Donker, D W, van Thiel, R J, Akin, S, van Meer, O, Henriques, J, Bokhoven, K C, Endeman, H, Bunge, J J H, Bol, M E, Winkens, B, Essers, B, Weerwind, P W & Maessen, J G 2026, 'Attitudes of patients and family members towards deferred and waived consent in ECPR research, an ancillary study of the INCEPTION trial', Resuscitation Plus, vol. 28, 101239. https://doi.org/10.1016/j.resplu.2026.101239