ABSTRACT
Background: In emergency settings, obtaining immediate informed consent is not always feasible, necessitating deferred and waived consent. 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, analysed using descriptive statistics and non-parametric tests. Results: A total of 32 of 38 sent questionnaires were returned (from 9 survivors, 9 corresponding relatives, 6 proxies and 8 relatives whose consent was waived (overall response rate 84.2%). 81.3% of the respondents (strongly) supported alternative consent procedures. No statistically significant differences were found between survivors and non-survivors. The need for, and challenges of research in an emergency setting were acknowledged. Aftercare contact improved understanding of the trial and helped processing difficulties. 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. The guidelines for alternative consent procedures of the Helsinki principles and the Dutch Central Committee on Research Involving Human Subjects (CCMO) appear to be an acceptable framework for research in these circumstances. Information provision at a later stage, once the emotional burden has eased, is appreciated.
Eussen, Stijn EDM and van de Koolwijk, Anina F and Delnoij, Thijs and Suverein, Martje M and Essers, Brigitte AB and Hermanides, Renicus S and Otterspoor, Luuk C and Elzo Kraemer, Carlos V and Vlaar, Alexander PJ and Van der Heijden, Joris J and Scholten, Erik and den Uil, Corstiaan A and Reis Miranda, Dinis and Akin, Sakir and De Metz, Jesse and van der Horst, Iwan CC and Winkens, B and Maessen, Jos G and Lorusso, Roberto and van de Poll, Marcel CG, Attitudes of patients and family members towards deferred and waived consent in ECPR research, a post-hoc analysis of the INCEPTION trial. Posted on SSRN 25 October 2025.
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