Commission européenne

The European Commission is committed to ensuring that research funded under the 6th Framework Programme respects ethical principles. What legal requirements do researchers have to respect in European Commission funded research projects? The text of the 6th Framework Programmes makes reference to the following international texts: • The Charter of Fundamental Rights of the European Union • European Union directives • Convention of the Council of Europe on Human Rights and Biomedicine (1997) and the additional protocol on the Prohibition of Cloning Human Beings (1998) • UN Convention on the Rights of the Child (1989) • Universal Declaration on the human genome and human rights adopted by UNESCO (1997) • Helsinki Declaration These regulations and texts are all well known and can be consulted on the website http://europa.eu.int/comm/research/science- society/ethics/legislation_en.html . Apart from such European legislation and international texts, the Specific Programme for research, technological development and demonstration ‘Integrating and strengthening the European Research Area’ (2002-2006) requires also that “In compliance with the principle of subsidiarity and the diversity of approaches existing in Europe, participants in research projects must conform to current legislation, regulations and ethical rules in the countries where the research will be carried out. In any case, national provisions apply and no research forbidden in any given Member State will be supported by Community funding in that Member State.(1)” The specific regulation of ethical issues is a matter of subsidiarity. Rooted in the cultural background of the nation state, there are many ethical rules and guidelines in the national legal system that the scientists have to apply when conducting research in a country. The guide for proposers of the 6th Framework Programme requires applicants to identify whether workpackages contain one or more of the five following ethical issues, namely whether the research work involves • humans, • human tissue, • personal or private data, • genetic information, • or animal experimentation. Detailed information on how these issues are handled has to be given, including the explanation of the applicable national legal background. Such projects that contain ethical issues may be submitted to an ethical review if they have been shortlisted after the scientific evaluation. When co-operating in a European research consortium, it is important that researchers from partner countries have easy access to the national regulations on those five areas, where ethical issues may arise. It is an advantage if researchers not only understand the regulation of their own countries, but also those of potential partners and when they seek to collaborate. This document is part of a series that aims to make the regulatory situation in the accession and candidate countries more transparent and better accessible to scientists in Europe.

(1) See Annex 1 (COUNCIL DECISION of 30 September 2002 adopting a specific programme for research, technological development and demonstration: ‘Integrating and strengthening the European Research Area 2002-2006).