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In Luxemburg the CNER works according to the rules established by the International Conference on Harmonisation (ICH), the Grand Ducal Regulation of 30th May 2005 and the Law on hospital establishments of 28th August 1998, whilst observing the Declaration of Helsinki. The CNER was established on the 17th July 2000 by ministerial decree.

The CNER, as a national body, gives a single opinion for the country of Luxembourg.

The CNER functions according to the following international and national regulatory frameworks:

 
1. GENERAL LEGAL FRAMEWORK:

A) 4th APRIL 1997 "OVIEDO" CONVENTION FOR THE PROTECTION OF HUMAN RIGHTS AND DIGNITY OF THE HUMAN BEIN WITH REGARD TO THE APPLICATION OF BIOLOGY AND MEDICINE: CONVENTION ON HUMAN RIGHTS AND BIOMEDICINE

See in particular the additional protocol concerning biomedical research

B) THE WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI (JUNE 1964, AS AMENDED BY THE 64TH WMA GENERAL ASSEMBLY OF OCTOBER 2013)
See in particular the following articles:
Article 20: Participation by competent individuals as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no competent individual may be enrolled in a research study unless he or she freely agrees.
Article 21: Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information and to minimize the impact of the study on their physical, mental and social integrity.
Article 22: (…) The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.. (…)
Article 27: (…) Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.
Article 30: At the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care or benefits.

C) CLINICAL TRIALS DIRECTIVE (Directive 2001/20/EC of the 4th April 2011)
In Luxemburg, this Directive is transposed into national law through the Grand Ducal Regulation of 30th May 2005 on clinical trials of drugs for human use.

D) CLINICAL TRIALS REGULATION (EU) No 536/2014

The Clinical Trials Regulation is set to replace the Clinical Trials Directive once it comes into application (currently estimated to occur in 2019)

E) COUNCIL OF EUROPE
The National Research Ethics Committee is organized and works according to the rules established by the ICH on good clinical practice and follows the provisions of Directive 2001/20/EC of 4th April 2001 of the European Parliament and Council.

F) GOOD CLINICAL PRACTICE DIRECTIVE (Directive 2005/28/EC of the 8th April 2005)
This Directive lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.

G) GENERAL DATA PROTECTION REGULATION (EU) 2016/679

2. LUXEMBURGISH REGULATORY FRAMEWORK

A) 8th MARCH 2018 LAW ON HOSPITALS
See in particular the following article:
Article 27: No trial, study or clinical experimentation can be practiced on human beings for the development of biological or medical knowledge without the Health Minister's authorization, after requesting the opinions of the Health Directorate (Direction de la Santé) and National Research Ethics Committee (Comité National d'Ethique de Recherche).

B) 13th March 2013 MEDICAL DEONTOLOGY CODE
See in particular the following chapter:
CHAPTER V:  Human experimentation (articles 69, 70, 71, 72)
Article 72:  The protocol of any hospital and extra-hospital trial must be duly authorized. The experimentation can only start after delivery of a positive opinion by the research ethics committee and after explicit or implicit approval of the Minister, in accordance with the applicable laws and regulations in this section.

C) REGLEMENT GRAND-DUCAL DU 30 MAI 2005 RELATIF A L'APPLICATION DE BONNES PRATIQUES CLINIQUES DANS LA CONDUITE D'ESSAIS CLINIQUES DE MEDICAMENTS A USAGE HUMAIN

D) 1st AUGUST 2018 ACT ON THE ORGANISATION OF THE NATIONAL DATA PROTECTION COMMISSION AND THE GENERAL DATA PROTECTION FRAMEWORK
See Articles 63 to 65 in particular

  
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