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Comparing emerging ethical issues and legal differences impacting on European clinical trials, including a training workshop for researchers in the New Member States.


The expansion of Europe is resulting in inconsistent European research ethics. Countries are unable to best transfer each others knowledge and coherent foresight is limited. The European Research Area (ERA) relies on this partnership and knowledge transfer , so it is imperative for Europe to coordinate its researchers to ensure ethical equality. Comparative research is currently limited due to variability in local, national and international custom and practice. This variability will be categorised into the following disciplines: law, culture, theology, economics, technology, clinical practice and ethics, which will be studied in the context of comparing emerging ethical issues and legal differences in clinical trials in Europe. A Scientific Committee will be formed to represent the disciplines as listed above. The Committee will set up an Advisory Group network of leading European researchers, to identify present state of the art research, emerging ethical issues and legal differences that could affect clinic al trials. The Committee will collate evidence via the networks and produce a working document to form the focus for a workshop. A training element will be introduced by inviting Central European researchers to the workshop, where the Scientific Committee will formulate the preliminary findings into final form. There will then be an open forum where questions will be taken. The project outcomes will be compiled in a brochure, similar to those developed by the European Commission for the ?National Regulation s on Ethics and Research? (Luxembourg: Office for Official Publications of the European Communities), and will include present European knowledge and foresight, which will aid design and conduct of future clinical trials. The project will provide assistan ce in the expressed aims of the European Developing countries Clinical Trials Programme (EDCTP) i.e. networking, coordination of researchers and capacity building in ethical and regulatory issues.

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