Research studies in countries participating in NEMO are regulated by national and international legal and ethical rules. Concerning international statutes, the Nuremberg Code (1947), the Revised Declaration of Helsinki (1975), and the "Convention on Human Rights and Biomedicine" (Council of Europe, 1997), are the main international guidelines for medical research. National legal and ethical requirements will be fulfilled for each country participating in NEMO. The established framework will use the highest standards in Good Laboratory, Good Clinical and Good Manufacturing Practices and Ethics applied in European studies.
Relevant EU documents and guidelines of which the consortium is aware are listed:
· 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.
· 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.
· Countries participating in NEMO 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 (as from 1998).
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).
The NEMO clinical trial will involve term neonates. The study will be conducted in several European member states (Ireland, UK, France, Sweden, Finland, and the Netherlands). In addition to the European regulations listed under section 4.4.1, the study will abide by specific regulations in these countries. All participating centres will apply for ethical approval for this study to their institutional ethics committee. All participating centres will require parents or guardians to complete a written consent form. These forms will be translated into the local language.
NEMO will be managed and run according to the rules for Good Clinical Practice (GCP), described by the Committee for Proprietary Medical Products (CPMP) of the European Union and the International Committee on Harmonisation (ICH) in "Note for Guidance on Good Clinical Practice, document CPMP/ICH/135/95", January 17th 1997, updated July 2002. All work involving human information in electronic data bases or otherwise will adhere to the law as described in the European Directive 95/46 CE.