Ethics

The COPHES activities are situated on a pan European scale and will comply with national guidelines and protocols. At the same time, they aim at adequately and equally protecting study participants 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 or even inconsistencies exist in the way ethical and juridical challenges are framed and being dealt with. Of particular relevance for COPHES is that the diverse implementations of EU regulations or of international guidelines into domestic law may hinder transnational studies or bring about inequalities in the level of protection.

Within an EU context, the probably most important international references currently in this respect are the Data Protection Directive (95/46/EC) ¹the Oviedo Convention ², more in particular its Additional Protocol concerning biomedical research and Rec(2006)4 ³ on research on biological material of human origin.

With respect to ethics and data protection in human biomarker studies an increasing demand exists for translation of results into (policy) preventive actions and policy making whenever relevant, and for adapted commu:nication strategies at all stages of a study, not only at the individual level. Indeed, monitoring for involuntary environmental exposure should consider the need for service - e.g. exposure mitigation- in circumstances where high exposures are detected. Researchers within COPHES will actively support the translation of research results into preventive actions and policy and will focus on tailored communication tools and strategies. Participatory processes will be developed to facilitate the inclusion of arguments from the societal perspective, increase trust and mutual understanding between all parties involved, and add to the legitimacy of the final outcome.