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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) http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/human-genome-and-human-rights/ 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) http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/human-genetic-data/ Recognition of ‘special status’ for human genetic data
The Charter of Fundamental Rights of the EU (2000) http://www.europarl.europa.eu/charter/default_en.htm Protection of personal data
European Directive on processing and free movement of personal data (Directive 95/46/EC) http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31995L0046:en:HTML Protection for individuals about the processing and free movement of personal data
European Group on Ethics in Science and New Technologies https://ec.europa.eu/research/ege/index.cfm An advisory body to the European Commission on ethical aspects of science and new technologies
European Clinical Trials Directive 2001/20/EC http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf 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) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf Principles of good clinical practice in clinical trials research
The Good Clinical Practice Directive 2005/28/EC http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:091:0013:0019:en:PDF Supplementing the Clinical Trials Directive
European Clinical Trials Regulation 2014 http://ec.europa.eu/health/human-use/clinical-trials/regulation/index_en.htm Improving coordination of the application process for trials involving multiple countries, with creation of single EU entry point and trials databank