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Conduct of emergency research in patients unable to give consent—Experiences and perceptions of patients, their consent providing next of kin, and treating physicians following a prehospital resuscitation trial
Abstract
Objective According to a directive of the European Parliament, informed consent is required to conduct a clinical trial also in emergencies when the patient is unable to provide consent. In these cases surrogate consent can be obtained from the patient's next of kin. There are no reports describing how patients and their next of kin perceive this policy. The perceptions of patients and their spouses involved in an emergency trial conducted under surrogate consent were surveyed. Methods A survey was sent to survivors of prehospital cardiac arrest, to consent providers regardless of patient outcome, and to physicians who had recruited the patients. Results 11 (92%) patients, 17 (68%) consent providers, and all physicians returned the survey. All held a positive attitude towards emergency research and were willing to participate without own consent in a trial approved by an institutional review board (IRB). Opinions among responding groups were similar albeit a significant difference regarding the perceived capability of the consent provider to decide upon patient's enrolment. Spouses felt able to provide consent, but physicians were sceptical of this. Patients and their spouses would have appreciated additional information regarding the index trial after the acute phase. Conclusions Emergency research was perceived positively by cardiac arrest victims and their spouses previously involved in a resuscitation trial. Possible own participation in an emergency trial without persona…
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“Another ethically acceptable and legally supported consent model comprises exception to informed consent (EIC) with prior community consultation (and a possibility of prospective opt out for community members). 328 335”
From European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions (2021) · cites this paper as [335]
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Cited by
European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions
Mentzelopoulos, S. D., Couper, K., Voorde, P. V. D., Druwé, P., Blom, M., Perkins, G. D., Lulic, I., Djakow, J., Raffay, V., Lilja, G., et al. (2021) · Resuscitation · doi:10.1016/j.resuscitation.2021.02.017 · Cited by 246
Evolution of European Union legislation on emergency research
Mentzelopoulos, S. D., Mantzanas, M., van Belle, G., & Nichol, G. (2015) · Resuscitation · doi:10.1016/j.resuscitation.2015.03.006 · Cited by 32
Metadata
- Authors
- Kämäräinen, A., Silfvast, T., Saarinen, S., Virta, J., & Virkkunen, I.
- Affiliations
- Helsinki University Hospital (FI)
- Tampere University Hospital (FI)
- Corresponding author
- Kämäräinen, Antti
- Venue
- Resuscitation
- Publisher
- Elsevier BV
- Published
- 2012-01
- Volume
- 83
- Issue
- 1
- Pages
- 81-85
- ISSN
- 0300-9572 (ISSN-L)
- OpenAlex
- W2050635631
- Cited by
- 29
- References
- 0
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 1 · 2022: 2 · 2021: 3 · 2020: 6 · 2017: 1 · 2016: 2 · 2015: 4 · 2014: 1 · 2013: 2
- FWCI
- 1.57
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- Locations
- Resuscitation (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative Care and End-of-Life Issues
- Keywords
- emergency research, surrogate consent, informed consent, prehospital cardiac arrest, next of kin, patient perspectives, physician attitudes, research ethics committees, research ethics
- MeSH terms
- Adult, Aged, Aged, 80 and over, Attitude of Health Personnel, Emergency Medical Services, Female, Follow-Up Studies, Humans, Informed Consent, Male, Middle Aged, Physicians, Resuscitation, Time Factors, Randomized Controlled Trials as Topic, Out-of-Hospital Cardiac Arrest
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