In the EU context, the probably most important international references are the Data Protection Directive (95/46/EC), the Oviedo Convention , more in particular its Additional Protocol concerning biomedical research and Rec(2006)4 on research on biological material of human origin.
The COPHES and DEMOCOPHES activities took place in a pan European level and complied with national regulations and protocols. The aim was to protect study participants adequately throughout the whole of Europe while safeguarding possibilities for environmental health related studies to progress and obtain optimal and harmonised results.
Within and across European countries difficulties, ambiguities and even inconsistencies exist in the way ethical and juridical challenges are framed and dealt with. Of particular relevance for COPHES was the question of whether the diverse implementations of EU regulations and international guidelines into domestic law and practices would hinder a comparable and harmonized approach. Reports of the experiences in the 17 DEMOCOPHES countries were analysed to prepare recommendations for further studies.