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30/07/2010

Visits to this Site:   8355247

 

   
   
Legislative Links
   
Clinical Trials Directive 2001/20/EC

Maltese Clinical Trials Regulations 2004 (LN490 of 2004)

Maltese Medical Devices Regulations (LN 47 of 2003)
   
Aim
   
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.
   
Terms of Reference 
  1. 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).


  2. 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.


  3. To advise on any relevant issues referred to it by the Minister or Director General (Public Health Regulation).

* 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.

   
Appointed from 3rd April 2008 to 2nd April 2011 by the Director General, Public Health Regulation.
   
Chairman
Dr. P. Vassallo Agius
   
Treasurer
Dr. A. Caruana Galizia
   
Secretary
Dr. R. Pace Asciak
   
Members
Dr. Neville Calleja
Dr. Bridget Ellul
Mr. Ian C. Ellul
Professor Albert Fenech
Rev. Dr. Ray Zammit


   

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