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) | 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) | 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 | 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 |