TY - JOUR
T1 - Attitudes of patients and family members towards deferred and waived consent in ECPR research, an ancillary study of the INCEPTION trial
AU - Eussen, Stijn E.D.M.
AU - van de Koolwijk, Anina F.
AU - Delnoij, Thijs S.R.
AU - Suverein, Martje M.
AU - Essers, Brigitte
AU - Hermanides, Renicus C.
AU - Otterspoor, Luuk
AU - Elzo Kraemer, Carlos V.
AU - van der Heijden, Joris J.
AU - Scholten, Erik
AU - Uil, Corstiaan den
AU - Reis Mirada, Dinis Dos
AU - Akin, Sakir
AU - de Metz, Jesse
AU - van der Horst, Iwan
AU - Winkens, Bjorn
AU - Maessen, Jos G.
AU - Lorusso, Roberto
AU - van de Poll, Marcel C.G.
AU - Suverein, Martje M.
AU - Delnoij, Thijs S.R.
AU - Lorusso, Roberto
AU - Brandon Bravo, George J.
AU - Otterspoor, Luuk
AU - Elzo Kraemer, Carlos V.
AU - Vlaar, Alexander P.J.
AU - Scholten, Erik
AU - Jansen, Tim
AU - van den Bogaard, Bas
AU - Kuijpers, Marijn
AU - Lam, Ka Yan
AU - Montero Cabezas, José M.
AU - Driessen, Antoine H.G.
AU - Rittersma, Saskia Z.H.
AU - Heijnen, Bram G.
AU - Dos Reis Miranda, Dinis
AU - Bleeker, Gabe
AU - de Metz, Jesse
AU - Hermanides, Renicus S.
AU - Matta, Jorge Lopez
AU - Eberl, Susanne
AU - Donker, Dirk W.
AU - van Thiel, Robert J.
AU - Akin, Sakir
AU - van Meer, Oene
AU - Henriques, José
AU - Bokhoven, Karen C.
AU - Endeman, Henrik
AU - Bunge, Jeroen J.H.
AU - Bol, Martine E.
AU - Winkens, Bjorn
AU - Essers, Brigitte
AU - Weerwind, Patrick W.
AU - Maessen, Jos G.
N1 - Publisher Copyright:
© 2026 The Author(s).
PY - 2026/3
Y1 - 2026/3
N2 - 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.
AB - 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.
KW - Ethics
KW - Extracorporeal cardiopulmonary resuscitation
KW - Informed consent
KW - Out-of-hospital cardiac arrest
UR - https://www.scopus.com/pages/publications/105029406347
U2 - 10.1016/j.resplu.2026.101239
DO - 10.1016/j.resplu.2026.101239
M3 - Article
AN - SCOPUS:105029406347
SN - 2666-5204
VL - 28
JO - Resuscitation Plus
JF - Resuscitation Plus
M1 - 101239
ER -