[Proposal for participation in intensive care and emergency medicine studies for patients unable to give informed consent (Cologne Model)].

IF 1.3 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL
M Kochanek, G Grass, B Böll, D A Eichenauer, A Shimabukuro-Vornhagen, M Hallek, T Zander, J Mertens, R Voltz
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引用次数: 0

Abstract

When conducting clinical trials in intensive care and emergency medicine, physicians, ethics committees, and legal experts have differing views regarding the inclusion of patients who are incapable of giving consent. These different views on the participation of patients who are not capable of giving consent also complicate how clinical trials are prepared and conducted. Based on the results of a literature search, a consensus model (Cologne Model) was developed by physicians performing clinical research, ethics committees, and lawyers in order to provide patients, those scientifically responsible for the study, ethics committees, and probate (guardianship) judges with a maximum of patient safety and legal certainty, while simultaneously enabling scientific research.

[为无法给予知情同意的患者参与重症监护和急诊医学研究的建议(科隆模式)]。
在进行重症监护和急诊医学的临床试验时,医生、伦理委员会和法律专家对将无法给予同意的患者包括在内有不同的看法。对于无法给予同意的患者的参与,这些不同的观点也使临床试验的准备和进行方式复杂化。基于文献检索的结果,进行临床研究的医生、伦理委员会和律师开发了一个共识模型(科隆模型),以便为患者、科学负责人、伦理委员会以及遗嘱认证(监护)法官提供最大限度的患者安全和法律确定性,同时使科学研究成为可能。
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来源期刊
CiteScore
2.60
自引率
9.10%
发文量
93
审稿时长
6-12 weeks
期刊介绍: Medizinische Klinik – Intensivmedizin und Notfallmedizin is an internationally respected interdisciplinary journal. It is intended for physicians, nurses, respiratory and physical therapists active in intensive care and accident/emergency units, but also for internists, anesthesiologists, surgeons, neurologists, and pediatricians with special interest in intensive care medicine. Comprehensive reviews describe the most recent advances in the field of internal medicine with special focus on intensive care problems. Freely submitted original articles present important studies in this discipline and promote scientific exchange, while articles in the category Photo essay feature interesting cases and aim at optimizing diagnostic and therapeutic strategies. In the rubric journal club well-respected experts comment on outstanding international publications. Review articles under the rubric "Continuing Medical Education" present verified results of scientific research and their integration into daily practice. The rubrics "Nursing practice" and "Physical therapy" round out the information.
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