A European consistency for functioning of RECs? We just lost our chance
On 17 July 2012, the European Commission formally adopted a proposal for a new European Union (EU) Directive regarding clinical trials, which will repeal and replace the existing Directive 2001/20/EC. The main reasons for the revision were: (1) the decreasing number of clinical trials in the region...
| Auteur principal: | |
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| Type de support: | Électronique Article |
| Langue: | Anglais |
| Vérifier la disponibilité: | HBZ Gateway |
| Journals Online & Print: | En cours de chargement...
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| Interlibrary Loan: | Interlibrary Loan for the Fachinformationsdienste (Specialized Information Services in Germany) |
| Publié: |
2013
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| Dans: |
Journal of medical ethics
Année: 2013, Volume: 39, Numéro: 6, Pages: 408-409 |
| Accès en ligne: |
Volltext (JSTOR) Volltext (lizenzpflichtig) Volltext (lizenzpflichtig) |
| Résumé: | On 17 July 2012, the European Commission formally adopted a proposal for a new European Union (EU) Directive regarding clinical trials, which will repeal and replace the existing Directive 2001/20/EC. The main reasons for the revision were: (1) the decreasing number of clinical trials in the region and (2) harsh criticism of the present version of the Directive. The proposed regulation could simplify the rules for conducting clinical trials and also rebuild the entire system of clinical trial assessment. However, it seems that we probably have already lost our chance regarding the consistency and quality of functioning of research ethics committees in the EU. |
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| ISSN: | 1473-4257 |
| Contient: | Enthalten in: Journal of medical ethics
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| Persistent identifiers: | DOI: 10.1136/medethics-2012-101228 |