Proposal for participation in intensive care and emergency medicine studies for patients unable to give informed consent (Cologne Model)
© 2023. The Author(s)..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2023 |
|---|---|
| Enthalten in: |
Medizinische Klinik, Intensivmedizin und Notfallmedizin - (2023) vom: 29. Sept. |
| Sprache: |
Deutsch |
|---|
| Weiterer Titel: |
Vorschlag für ein Verfahren zur Teilnahme an intensiv- und notfallmedizinischen Studien bei nichteinwilligungsfähigen Patient*innen (Kölner Modell) |
|---|
| Beteiligte Personen: |
Kochanek, M [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Clinical trials |
|---|
| Anmerkungen: |
Date Revised 29.09.2023 published: Print-Electronic Citation Status Publisher |
|---|
| doi: |
10.1007/s00063-023-01063-2 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM362696411 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM362696411 | ||
| 003 | DE-627 | ||
| 005 | 20231226210950.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||ger c | ||
| 024 | 7 | |a 10.1007/s00063-023-01063-2 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1208.xml |
| 035 | |a (DE-627)NLM362696411 | ||
| 035 | |a (NLM)37773455 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a ger | ||
| 100 | 1 | |a Kochanek, M |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Proposal for participation in intensive care and emergency medicine studies for patients unable to give informed consent (Cologne Model) |
| 246 | 3 | 3 | |a Vorschlag für ein Verfahren zur Teilnahme an intensiv- und notfallmedizinischen Studien bei nichteinwilligungsfähigen Patient*innen (Kölner Modell) |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 29.09.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a 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 | ||
| 650 | 4 | |a English Abstract | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Clinical trials | |
| 650 | 4 | |a Ethics committee | |
| 650 | 4 | |a Guardianship | |
| 650 | 4 | |a Informed consent | |
| 650 | 4 | |a Spousal representation law | |
| 700 | 1 | |a Grass, G |e verfasserin |4 aut | |
| 700 | 1 | |a Böll, B |e verfasserin |4 aut | |
| 700 | 1 | |a Eichenauer, D A |e verfasserin |4 aut | |
| 700 | 1 | |a Shimabukuro-Vornhagen, A |e verfasserin |4 aut | |
| 700 | 1 | |a Hallek, M |e verfasserin |4 aut | |
| 700 | 1 | |a Zander, T |e verfasserin |4 aut | |
| 700 | 1 | |a Mertens, J |e verfasserin |4 aut | |
| 700 | 1 | |a Voltz, R |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Medizinische Klinik, Intensivmedizin und Notfallmedizin |d 2012 |g (2023) vom: 29. Sept. |w (DE-627)NLM216019842 |x 2193-6226 |7 nnns |
| 773 | 1 | 8 | |g year:2023 |g day:29 |g month:09 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s00063-023-01063-2 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |j 2023 |b 29 |c 09 | ||