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

被引：0

作者：

Kochanek, M. ^{[1
,2
]}

Grass, G. ^{[3
]}

Boell, B. ^{[1
,2
]}

Eichenauer, D. A. ^{[1
,2
]}

Shimabukuro-Vornhagen, A. ^{[1
,2
]}

Hallek, M. ^{[1
,2
]}

Zander, T. ^{[1
,2
]}

Mertens, J. ^{[4
]}

Voltz, R. ^{[3
]}

机构：

[1] Univ Cologne, Med Fak, Kerpener Str 62, D-50937 Cologne, Germany

[2] Univ Cologne, Univ Klin Koln, Med Klin Innere Med 1, Ctr Integrated Oncol Aachen Bonn Cologne Dusseldor, Kerpener Str 62, D-50937 Cologne, Germany

[3] Univ Cologne, Eth Kommiss, Med Fak, Cologne, Germany

[4] Amtsgericht Koln, Cologne, Germany

来源：

MEDIZINISCHE KLINIK-INTENSIVMEDIZIN UND NOTFALLMEDIZIN | 2024年 / 119卷 / 05期

关键词：

Clinical trials; Ethics committee; Spousal representation law; Guardianship; Informed consent; ABILITY; LEGAL;

D O I：

10.1007/s00063-023-01063-2

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：391 / 397

页数：7

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