OUR MISSION
The function of the Health Ethics Committee is to review and provide its advice on the ethical consideration of any research proposals or requests for data referred to it for its evaluation. This includes clinical trials and medical devices including in vitro diagnostic medical devices. In preparing its opinion, the Ethics Committee shall consider the various factors outlined in Article 7 of the Clinical Trial Regulations (S.L.458.43), the Data Protection Act (CAP. 586) and any other applicable local and EU legislation.
Terms of Reference
The Health Ethics Committee shall:
• Advise entities within the Ministry for Health on Data Protection issues arising from the secondary processing of health data or any research proposed.
• Advise on and exclude ethical concerns in proposals on health research and clinical trials/studies including proposals referred for ethical evaluation by the Malta Medicines Authority.
• Liaise with the Data Protection Commissioner on data protection issues.
• Assess adherence to the provisions of the Mental Health Act (CAP. 525) where applicable, as delegated by the Commissioner for Mental Health.
• Advise on any other ethical issues referred to it by the Ministry.