What is the role of ethics committees after Regulation (EU) 536/2014?
EU Regulation 536/2014 stipulates that when assessing applications for authorisation to conduct clinical trials, Member States should formulate a ‘single decision’. This raises the problem of identifying: (1) the facility designated to express this ‘single decision’ and (2) the role of ethics commit...
Main Author: | |
---|---|
Format: | Electronic Article |
Language: | English |
Check availability: | HBZ Gateway |
Journals Online & Print: | |
Fernleihe: | Fernleihe für die Fachinformationsdienste |
Published: |
BMJ Publ.
2016
|
In: |
Journal of medical ethics
Year: 2016, Volume: 42, Issue: 3, Pages: 186-188 |
Standardized Subjects / Keyword chains: | B
Europäische Union, Verfasserschaft1, Verordnung über klinische Prüfungen mit Humanarzneimitteln
/ Ethics committee
|
Online Access: |
Volltext (JSTOR) Volltext (lizenzpflichtig) Volltext (lizenzpflichtig) |
MARC
LEADER | 00000caa a22000002 4500 | ||
---|---|---|---|
001 | 1816153184 | ||
003 | DE-627 | ||
005 | 20230509103751.0 | ||
007 | cr uuu---uuuuu | ||
008 | 220908s2016 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1136/medethics-2015-103028 |2 doi | |
035 | |a (DE-627)1816153184 | ||
035 | |a (DE-599)KXP1816153184 | ||
040 | |a DE-627 |b ger |c DE-627 |e rda | ||
041 | |a eng | ||
084 | |a 1 |2 ssgn | ||
100 | 1 | |a Petrini, Carlo |e VerfasserIn |4 aut | |
245 | 1 | 0 | |a What is the role of ethics committees after Regulation (EU) 536/2014? |
264 | 1 | |c 2016 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a Computermedien |b c |2 rdamedia | ||
338 | |a Online-Ressource |b cr |2 rdacarrier | ||
520 | |a EU Regulation 536/2014 stipulates that when assessing applications for authorisation to conduct clinical trials, Member States should formulate a ‘single decision’. This raises the problem of identifying: (1) the facility designated to express this ‘single decision’ and (2) the role of ethics committees in the decision-making process. The article addresses the consequences of the requirement that for each Member State the assessment of an application for approval to conduct a trial must take the form of a ‘single decision’ by the Member State concerned. Three possible approaches to the procedures for expressing that ‘single decision’ and to the role of ethics committees in the decision-making process are described, one of which is indicated as the preferred option. | ||
689 | 0 | 0 | |d u |0 (DE-588)1288742568 |0 (DE-627)1844842487 |0 (DE-576)194702391 |a Europäische Union |2 gnd |4 aut1 |w r |i Verfasserschaft1 |e Verfasserschaft1 |t Verordnung über klinische Prüfungen mit Humanarzneimitteln |
689 | 0 | 1 | |d s |0 (DE-588)4193366-7 |0 (DE-627)105227609 |0 (DE-576)210086920 |2 gnd |a Ethik-Kommission |
689 | 0 | |5 (DE-627) | |
773 | 0 | 8 | |i Enthalten in |t Journal of medical ethics |d London : BMJ Publ., 1975 |g 42(2016), 3, Seite 186-188 |h Online-Ressource |w (DE-627)323607802 |w (DE-600)2026397-1 |w (DE-576)260773972 |x 1473-4257 |7 nnns |
773 | 1 | 8 | |g volume:42 |g year:2016 |g number:3 |g pages:186-188 |
856 | |3 Volltext |u http://www.jstor.org/stable/44014337 |x JSTOR | ||
856 | 4 | 0 | |u https://doi.org/10.1136/medethics-2015-103028 |x Resolving-System |z lizenzpflichtig |3 Volltext |
856 | 4 | 0 | |u http://jme.bmj.com/content/42/3/186.abstract |x Verlag |z lizenzpflichtig |3 Volltext |
935 | |a mteo | ||
951 | |a AR | ||
ELC | |a 1 | ||
ITA | |a 1 |t 1 | ||
LOK | |0 000 xxxxxcx a22 zn 4500 | ||
LOK | |0 001 4185607121 | ||
LOK | |0 003 DE-627 | ||
LOK | |0 004 1816153184 | ||
LOK | |0 005 20220908053654 | ||
LOK | |0 008 220908||||||||||||||||ger||||||| | ||
LOK | |0 035 |a (DE-Tue135)IxTheo#2022-08-03#E57B1474A482C7DBC36D09A53ABEE3689E31E182 | ||
LOK | |0 040 |a DE-Tue135 |c DE-627 |d DE-Tue135 | ||
LOK | |0 092 |o n | ||
LOK | |0 852 |a DE-Tue135 | ||
LOK | |0 852 1 |9 00 | ||
LOK | |0 866 |x JSTOR#http://www.jstor.org/stable/44014337 | ||
LOK | |0 935 |a ixzs |a ixrk |a zota | ||
OAS | |a 1 |b inherited from superior work | ||
ORI | |a SA-MARC-ixtheoa001.raw | ||
STA | 0 | 0 | |a Ethics committee |
STB | 0 | 0 | |a Comité d'éthique |
STC | 0 | 0 | |a Comisión de ética |
STD | 0 | 0 | |a Comitato etico |
STF | 0 | 0 | |a 机构审查委员会 |
STG | 0 | 0 | |a Comissão de ética |
STH | 0 | 0 | |a Этическая комиссия |
STI | 0 | 0 | |a Επιτροπή δεοντολογίας |
SYG | 0 | 0 | |a Europäische Union,Verordnung (EU) Nr. 536/2014 des Europäischen Parlaments und des Rates vom 16. April 2014 über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG,Europäische Union,Verordnung (EU) Nr. 536/2014,Europäische Union,Clinical Trials Regulation,Europäische Union,CTR , Ethikkomitee,Ethikkommission,Ethik-Beirat |