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Recommendations in relation to the EU Clinical Trials Directive and Medical Research Involving Incapacitated Adults
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Such data may have to be linked for the detection of associations between potential predictor variables and patient outcomes.
“Such data may have to be linked for the detection of associations between potential predictor variables and patient outcomes. 363”
From European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions (2021) · cites this paper as [363]
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Research works printed but not linked: 17
- Lemaire F, Bion J, Blanco J, Damas P, Druml C, Falke K, Kesecioglu J, Larsson A, Mancebo J, Matamis D, Pesenti A, Pimentel J, Ranieri M (2005) The European Union Directive on Clinical Research: present status of implementation in EU member states' legislation with regard to the incompetent patient. Intensive Care Medicine 31: 476–479 · DOI
- Silverman H, Druml C, Lemaire F, Nelson R (2004) The European Union Directive and the protection of incapacitated subjects in research: an ethical analysis. Intensive Care Medicine 30: 1723–1729 · DOI
- Weijer C, Miller P (2004) When are research risks reasonable in relation to anticipated benefits? Nature Medicine 10: 570–573 · DOI
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- Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T (2005) Recombinant activated factor VII intracerebral hemorrhage trial investigators. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med 352: 777–785 · DOI
- Wainwright P, Saunders J (2004) What are the local issues? The problem of the local review of research. J Med Ethics 30: 313–317 · DOI
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- Tu JV, Willison DJ, Silver FL, Fang J, Richards JA, Laupacis A, Kapral MK (2004) Impracticability of informed consent in the registry of the Canadian stroke network. N Engl J Med 350: 1414–1421 · DOI
- Menon DK, Liddell K (2004) Legislation and research in intensive care and emergency medicine. J Int Care Soc 5(3): 98–99 · DOI
- Wright DW, Lancaster RT, Lowery DW (2001) Necessary time to achieve next of kin proxy consent for acutely injured altered status patients. Academic Emergency Medicine 8: 419–420 · DOI
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- Wright DW, Lancaster RT, Ratcliff JJ, Lowery DW, Wald MM (2004) Proxy identification: a time-dependent analysis. Academic Emergency Medicine 11: 204–207 · DOI
- De Maio VJ, Stiell IG, Wells GA, Spaite DW (2003) Optimal defibrillation response intervals for maximum out-of-hospital cardiac arrest survival rates. Ann Emergency Medicine 42: 242–250 · DOI
- Kompanje EJO, Maas AIR (2004) Treat first, ask later? Emergency research in acute neurology and neurotraumatology in the European Union. Intensive Care Medicine 30: 168–169 · DOI
- Kompanje EJO, Maas AIR, Hilhorst MT, Slieker FJA, Teasdale GM (2005) Ethical considerations on consent procedures for emergency research in severe and moderate traumatic brain injury. Acta Neurochirurgica (Wien) 147: 633–640 · DOI
Cited by
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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
Metadata
- Authors
- Liddell, K., Kompanje, E. J. O., Lemaire, F., Vrhovac, B., Menon, D. K., Bion, J., Chamberlain, D., Wiedermann, C. J., & Druml, C.
- Affiliations
- University of Cambridge (GB)
- Erasmus MC (NL)
- University of Birmingham (GB)
- Cardiff University (GB)
- Innsbruck Medical University (AT)
- Medical University of Vienna (AT)
- Corresponding author
- Liddell, Kathleen
- ORCID
- Venue
- Wiener klinische Wochenschrift
- Published
- 2006-04
- Volume
- 118
- Issue
- 5-6
- Pages
- 183-191
- ISSN
- 0043-5325 (ISSN-L)
- 1613-7671
- OpenAlex
- W2024428800
- Cited by
- 20
- References
- 0
- Citations by year
- 2025: 1 · 2022: 1 · 2021: 2 · 2020: 1 · 2019: 1 · 2015: 4 · 2014: 3 · 2013: 1
- FWCI
- 1.67
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Wiener klinische Wochenschrift (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Keywords
- trial, incapacitated adults, informed consent, research ethics, risk-benefit assessment, clinical equipoise, component analysis, intellectual disability, critical care research, emergency medicine research, research regulation, ethics committees, minimal risk
- MeSH terms
- Austria, Clinical Trials as Topic, Persons with Disabilities, Disabled Persons, Informed Consent, Practice Patterns, Physicians', Practice Guidelines as Topic, Biomedical Research
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