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Research involving Medical Intervention

European Union documents

  • Regulation (EC) No 1085/2003 on the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93
  • Regulation (EC) No 1084/2003 on the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State
  • Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
  • Directive 93/42/EEC of 14 June 1993 concerning medical devices
  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices;
  • Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/ EEC as regards medical devices incorporating stable derivates of human blood or human plasma
  • Directive 2001/20/EC of the European Parliament and of the Council 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 (Clinical Trials Directive)
  • Directive 2001/83/EC on the Community code relating to medicinal products for human use (the Community Code for medicinal products)
  • Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components
  • Commission Decision 2002/364/EC7 on common technical specifications for in-vitro diagnostic medical devices;
  • Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
  • Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
  • Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products" (Good Clinical Practice Directive)
  • Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells
  • Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
  • Communication on application of the Charter of Fundamental Rights of the European Union (2001)
  • Communication from the Commission on the legal nature of the Charter of fundamental rights of the European Union (2000)
  • Commission communication on the Charter of fundamental rights of the European Union (2000)
  • Charter of Fundamental Rights (2000)

Council of Europe documents

International Law documents

Guidance documents

  • The Nuremberg Code, Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law 10, Volume 2, Nuremberg, October 1946 - April 1949 Washington DC, US Government Printing Office, 1949; pp. 181-182
  • World Medical Association, Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
  • World Health Organization, Operational Guidelines for Ethics Committees That Review Biomedical Research (Geneva, 2000)
  • World Medical Association, Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects. Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964. Amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975; the 35th World Medical Assembly, Venice, Italy, October 1983; the 41st World Medical Assembly, Hong Kong, September 1989; and the 48th General Assembly, Somerset West, Republic of South Africa, October 1996
  • World Medical Association, Declaration of Lisbon on the Rights of the Patient. Adopted by the 34th World Medical Assembly, Lisbon, Portugal, September/October 1981 and amended by the 47th General Assembly, Bali, Indonesia, September 1995
  • WHO Operational guidelines for ethics committees that review biomedical research (2000) TDR/PRD/ETHICS/2000.1
  • WHO Scientific and Ethical Review Group Guidelines for the establishment of scientific and ethical review bodies
  • WHO Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products. Annex 3 of The Use of Essential Drugs. Sixth Report of the WHO Expert Committee. Geneva: World Health Organization, 1995: 97-137
  • UNAIDS guidance document on 'Ethical considerations in HIV preventive vaccine research'
  • UNAIDS/WHO, Guidance Document on Ethical considerations in biomedical HIV prevention trials
  • Department of Health, Education, and Welfare, Office of the Secretary, Protection of Human Subjects. Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979)
  • International Ethical Guidelines for Biomedical Research Involving Human Subjects issued by the Council for International Organizations of Medical Sciences (CIOMS)
  • International Guidelines for Ethical Review of Epidemiological Studies issued by the Council for International Organizations of Medical Sciences (CIOMS)
  • The Declaration of Inuyama-Human Genome Mapping, Genetic Screening and Gene Therapy issued by the Council for International Organizations of Medical Sciences (CIOMS)
  • International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences, adopted in 1982 and amended in 1993 and 2002
  • 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 (Geneva 2002)
  • International Ethical Guidelines for Biomedical Research Involving Human Subjects. Council for International Organizations of Medical Sciences (CIOMS) ISBN 92 9036 075 5
  • 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. Geneva 1993.
  • Council for International Organizations of Medical Sciences (CIOMS). International Guidelines for Ethical Review of Epidemiological Studies. Geneva 1991
  • Ethical guidelines for the use of human embryonic or foetal tissue for experimental and clinical neurotransplantation and research, Network for European CNS Transplantation and Restoration (NECTAR), 1994
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human Use -ICH Harmonised Tripartite Guideline - Guideline for Good Clinical Practice E6(R1)
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline - Choice of Control Group and Related Issues in Clinical Trials E10
  • European Group on Ethics in Science and New Technologies (EGE) - Opinion n°20 - 16/03/2005 - Ethical aspects of ICT Implants in the Human Body
  • EGE Opinion n°19 - 16/03/2004 - Ethical aspects of umbilical cord blood banking
  • EGE Opinion n°18 - 28/07/2003 - Ethical aspects of genetic testing in the workplace
  • EGE Opinion n°17 - 04/02/2003 - Ethical aspects of clinical research in developing countries
  • EGE Opinion n° 15 - 14/11/2000 - Ethical aspects of human stem cell research and use
  • EGE Opinion n° 11 - 21/07/1998 - Ethical aspects of human tissue banking
  • EGE Opinion n° 4 - 13/12/1994 - The ethical implications of gene therapy
  • Committee for Medicinal Products for Human Use (CHMP-EMEA) Guideline on clinical trials in small populations, CHMP/EWP/83561/2005
  • European Commission - DG ENTERPISE - Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use (revision 2) as required by Article 18 of Directive 2001/20/EC, 2006
  • European Commission - DG ENTERPISE - Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (EudraVigilance - Clinical Trial Module) (revision 1) as required by Article 11, Article 17 and Article 18 of Directive 2001/20/EC, 2004
  • European Commission - DG ENTERPISE - Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use (revision 1) as required by Article 8 of Directive 2001/20/EC, 2006
  • European Commission - DG ENTERPISE - Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial (revision 2), as required by Article 9 (8) of Directive 2001/20/EC, 2005
  • European Commission - DG ENTERPISE - Detailed guidance on the European clinical trials database (EUDRACT Database) as required by Article 11 and Article 17 of Directive 2001/20/EC, CT 5.1 Amendment describing the development of EudraCT Lot 1 for 1 May 2004 and CT 5.2 EudraCT core dataset, 2003
  • EuroSOCAP-Project: European Guidance for Healthcare Professional on Confidentiality and Privacy in Healthcare (2006)
  • UK Medical Research Council (MRC), Personal Information in Medical Research.
  • MRC (2001) Human Tissue and biological Samples for Use in Research: operational and ethical guidelines.
  • MRC (2004) Stem Cell Codes of Practice.
  • NESH (2001) Guidelines for the inclusion of women in medical research: gender as a variable in all medical research. National Committee for Research Ethics in the Social Sciences and the Humanities, Norway.
  • Nuffield Council on Bioethics (2002) The ethics of research related healthcare in developing countries. A Nuffield Council Publication

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