List of relevant ethical regulations

Relevant EU documents and guidelines are:

  • The Charter of Fundamental Rights of the EU.
  • Recommendations of the Ad Hoc group for the development of implementing guidelines for Directive 2001/20/EC Ethical considerations for clinical trials performed in children.  
  • Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. The most recent data protection and privacy ethical guidelines developed by the expert Working Party established by Article 29 of Directive 95/46/EC will be followed. This group is the independent EU Advisory Body on Data Protection and Privacy. Its tasks are laid down in Article 30 of Directive 95/46/EC and in Article 15 of Directive 2002/58/EC. 
  • Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation laid down by law, regulation or administrative action relating to proprietary medicinal products. 
  • Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions. 
  • Directive 2005/28/ECC of the European Parliament and of the Council of 8th April, laying down principles and detailed guidelines for good practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. 
  • Clinical trials Directive 2001/20/EEC of the European Parliament on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. 
  • European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment No.2) Regulations, 2006 (SI No 374 of 2006).

 

Countries participating in the study will take into account the opinions of the European Group of Advisers on the Ethical Implications of Biotechnology (1991 1997), and the opinions of the European Group on Ethics in Science and New technologies

 

The Consortium is also aware of international conventions and declarations including:

  • The Nuremberg Code (1947)
  • Helsinki Declaration in its latest version
  • Convention of the Council of Europe on Human Rights and Biomedicine signed in Oviedo on 4 April 1997
  • United Nations Convention on the Rights of the Child
  • Universal Declaration on the human genome and human rights adopted by UNESCO
  • Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the
  • World Health Organization (WHO): International Ethical Guidelines for Biomedical Research Involving Human Subjects (1993) In: Ethics and Research on Human Subjects: International Guidelines (Geneva: CIOMS, 1993), pp.1-45 (excerpts).