1. [Proposal for participation in intensive care and emergency medicine studies for patients unable to give informed consent (Cologne Model)].
- Author
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Kochanek M, Grass G, Böll B, Eichenauer DA, Shimabukuro-Vornhagen A, Hallek M, Zander T, Mertens J, and Voltz R
- Subjects
- Humans, Germany, Mental Competency legislation & jurisprudence, Emergency Medicine legislation & jurisprudence, Emergency Medicine ethics, Clinical Trials as Topic ethics, Clinical Trials as Topic legislation & jurisprudence, Interdisciplinary Communication, Intersectoral Collaboration, Patient Safety legislation & jurisprudence, Legal Guardians legislation & jurisprudence, Informed Consent legislation & jurisprudence, Informed Consent ethics, Critical Care ethics, Critical Care legislation & jurisprudence
- 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., (© 2023. The Author(s).)
- Published
- 2024
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