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LEGISLATION AND ETHICAL POSTULATES


• Directive 2001/20/EC
of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. OJ L 121, 1.5.2001.
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• Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. OJ L 91, 9.4.2005.
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• Delaited guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use.
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• Royal Decree 1090/2015, of 4 December, regulating clinical trials with medicinal products, Ethics Committees for Investigation with medicinal products and the Spanish Clinical Studies Registry. BOE-A-2015-14082.
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• Circular 07/2004. Clinical investigations with medical devices. General Department for Pharmacy and Health Products.  Ministry of Health, Consumer Affairs and Social Welfare.
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• Royal Decree 577/2013, of 26 July, regulating pharmacovigilance of medicines for human use.
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• Royal Decree 1716/2011
, dated November 18, establishing the basic requirements of authorisation and functioning of biobanks for biomedical research and the management of human biological samples, and regulating the functioning and organization of the National Registry of Biobanks for biomedical research.
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• Organic Law 3/2018
, of 5 December, Protection of Personal Data and Guarantee of Digital Rights.
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• Royal Legislative Decree 1/2015
, of 24 July, which enacted the consolidated text of the Law on guarantees and rational use of medicinal products and medical devices.
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• Law 14/2007
, of 3 July, on Biomedical Research. BOE-A-2007-12945.
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• Order SCO/256/2007
, of 5 February, establishing principles and detailed guidelines for good clinical practice and the requirements governing the authorisation of the manufacture or importation of investigational medicinal products for human use. BOE-A-2007-2960.
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• Directive 1/2003
. Requirements to carry out post-authorisation studies with medicinal products in health centres that belong to the public health system of Catalonia.
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Decree 406/2006
, of 24 October, regulating the requirements and accreditation procedures for Research Ethics Committees.
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Directive 1/2017.Accreditation procedure for research ethics committees as ethics committees for research with medicinal products. General Department for Professional Planning and Health Regulation. Department of Health of Catalonia.
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• Spanish Royal Decree 957/2020, of 3 november, regulating observational studies with medicinal products for human use.

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Guideline for Good Clinical Practice.
International Conference on Harmonisation of Technical Requerements for Registration of Pharmaceuticals for Human Use, 1996.
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Nuremberg Code
. 1946.
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The World Medical Association (WMA) Declaration of Helsinki
-Ethical principles for medical research involving human subjects. 64th WMA General Assembly, Fortaleza, Brazil, October 2013.
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Belmont Report. Ethical principles and guidelines for the protection of human subjects of research. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (USA).
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Regulation (EU) 2016/679, of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).



 
 
Research Ethics Committee
Germans Trias i Pujol U. Hospital

 Ctra. Canyet s/n 08916 Badalona
 General Building, 1st Floor
Emergency Unit, 1st Floor
TECHNICAL SECRETARY
Àngels Fortes Villegas
Tel: +34 93 497 89 56
ceic.germanstrias@gencat.cat
ADMINISTRATION
Miriam Planell / Laura Lorca
Tel: + 34 93 497 89 74
 
 
 
 
HUGTiP REC- Hospital Universitari Germans Trias i Pujol