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

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