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| Legislative Links |
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Clinical Trials Directive 2001/20/EC
Maltese Clinical Trials Regulations 2004 (LN490 of 2004)
Maltese Medical Devices Regulations (LN 47 of 2003)
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| Aim |
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| The function of the Health Ethics Committee shall be to give an opinion before a clinical trial commences on any issue requested. In preparing its opinion the Ethics Committee shall consider the various factors outlined in Regulation 7 of the Clinical Trials Regulations 2004 and including devices and interventions.
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- The principal function of the Health Ethics Committee shall be to give an opinion on clinical trials on medicinal products and medical devices, in terms of the Maltese Clinical Trials Regulations (LN490 of 2004).
- To evaluate proposals for research being conducted in the health sector, including ethical and data protection aspects.
The Health Ethics Committee is to carry out this responsibility in close collaboration with the Research Ethics Committee within the Faculty of Medicine and Surgery in the University of Malta and in line with the provisions of the Data Protection Act.
- To advise on any relevant issues referred to it by the Minister or Director General (Public Health Regulation).
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* The Health Ethics Committee is to carry out this responsibility in close collaboration with and in full recognition of the Research Ethics Committee in the Faculty of Medicine and Surgery in the University of Malta. |
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Chairman
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| Dr. P. Vassallo Agius |
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Treasurer
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| Dr. A. Caruana Galizia |
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| Secretary |
Dr. R. Pace Asciak
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Members
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Dr. Neville Calleja
Dr. Bridget Ellul
Mr. Ian C. Ellul
Professor Albert Fenech
Rev. Dr. Ray Zammit
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PUBLICATIONS |
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