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Table 1 European regulations, position statements and advisory bodies affecting clinical research

From: Methodological challenges in European ethics approvals for a genetic epidemiology study in critically ill patients: the GenOSept experience

Document Source Impact
Helsinki Declaration and the Universal Declaration on the human genome and human rights adopted by UNESCO (1997) Need for legal representative or deferred consent, in the event of incapacity;
Genetic counselling;
Research should ‘contribute to the health benefit of other persons in the same age category or with the same genetic condition...
International Declaration on Human Genetic Data (2003) Recognition of ‘special status’ for human genetic data
The Charter of Fundamental Rights of the EU (2000) Protection of personal data
European Directive on processing and free movement of personal data (Directive 95/46/EC) Protection for individuals about the processing and free movement of personal data
European Group on Ethics in Science and New Technologies An advisory body to the European Commission on ethical aspects of science and new technologies
European Clinical Trials Directive 2001/20/EC Requirement for prior informed consent from legal representative made emergency research impossible;
Semantic confusion of ‘therapeutic’ and ‘non-therapeutic’ research
The International Conference on Harmonisation Guidance on Good Clinical Practice (Topic E6) (CPMP/ICH/135/95) Principles of good clinical practice in clinical trials research
The Good Clinical Practice Directive 2005/28/EC Supplementing the Clinical Trials Directive
European Clinical Trials Regulation 2014 Improving coordination of the application process for trials involving multiple countries, with creation of single EU entry point and trials databank