Ethical legislation and conventions

Brussels, Oct 2003

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The Commission aims to promote responsible research in Europe and to keep the rapidly advancing progress in science in harmony with the ethical values of all Europeans.

The purpose of this web page is to guide researchers towards the most important reference texts in the area of ethics in research.

It offers an access to the most important pieces of European legislation and international conventions, as well as international declarations and codes of conduct relevant to research activities. It also gives access to a series of opinions of the European Group on Ethics that are relevant to research activities.

By clicking on the links below you can get access to key documents in the area of ethics in research:

Charter of Fundamental Rights of the European Union
Directives of the European Union
Ethical rules of the Sixth Framework Programme
Conventions and Protocols of the Council of Europe
Universal declarations of Unesco
World Medical Association - Declaration of Helsinki
European Group on Ethics in science and new technologies
Opinions of the European Group on Ethics relevant to research activities
Resolution of the European Parliament on Human Cloning
European Science Foundation: policy briefings
The Nuremberg Code
European Commission Staff Working Paper - Report on human embryonic stem cell research
EU strategy on sustainable development
Ethical considerations in HIV preventive vaccine research
Some examples of codes of conduct

1. Charter of Fundamental Rights of the European Union

Charter of the Fundamental Rights of the European Union - signed in Nice, 7 December 2000 (2000/C 364/01)

2. Directives of the European Union

Directive 95/46 on the protection of personal data

Directive 2001/20/EC of 4 April 2001 on good clinical practice

Directive 2001/20/EC

Detailed Guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion

Detailed Guidance for the request for authorisation of a clinical trial to the competent authorities

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use

COMMISSION 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

COMMISSION REGULATION (EC) No 1084/2003 of 3 June 2003 concerning 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

COMMISSION REGULATION (EC) No 1085/2003 of 3 June 2003 concerning 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

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions

Directive 86/609/EEC of 24 Nov. 1986 on the protection of animals used fore experimental and other scientific purposes

Directive 86/609/EEC

Protocol on Protection and welfare of animals (Protocol to the Amsterdam Treaty)

Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms.

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC .

3. Ethical rules of the Sixth Framework Programme

An ethical review will be implemented systematically by the Commission for proposals dealing with ethically sensitive issues, in particular proposals involving the use of human embryos and human embryonic stem cells

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) ( 2002/834/EC )

Article 3 of FP6 "All the research activities carried out under the Framework Programme 2002-2006 must be carried out in compliance with fundamental ethical principles"

Annex 1, page 8:

"An ethical review will be implemented systematically by the Commission for proposals dealing with ethically sensitive issues, in particular proposals involving the use of human embryos and human embryonic stem cells.

Any research project involving the use of human embryos and human embryonic stem cells, following the ethical review mentioned above, will be submitted to a Regulatory Committee.

In specific cases, an ethical review may take place during the implementation of a project.

Extracts of the information package - Work programme Annex B of the Work programme for Priority 1 " Life sciences

4. Conventions of the Council of Europe

Convention on human convention on human rights and biomedicine of the Council of Europe

Convention

Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings

Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin

5. Universal declaration of Unesco

Universal Declaration on the Human Genome and Human Rights, 11 November 1997

Cartagena Protocol on Biosafety

Convention on Biological Diversity - 5 June 1992

6. World Medical Association - Declaration of Helsinki

Helsinki Declaration 2000

7. European Group on Ethics in science and new technologies

About the European Group on Ethics in science and new technologies (EGE)

8. Opinions of the European Group on Ethics relevant to research activities

N° 7 - Ethical aspects of genetic modifications of animals

N°11 - Ethical aspects of human tissue banking ( P 71)

N°12 - Ethical aspects of research involving the use of human embryo in the context of the 5th FWP (P 81 )

N°15 - Ethical aspects of human stem cell research and use (P 121)

N°16 - Ethical aspects of patenting inventions involving human stem cells

N° 17 - Ethical aspects of clinical research in developing countries

9. Resolution of the European Parliament on Human Cloning

European Parliament resolution on human cloning - 7 September 2000

10. European Science Foundation: Policy Briefings

Human stem cell research: Scientific uncertainties and ethical dilemmas

Controlled clinical trials

Genetically modified plants

Are we daring enough? Conservatism in the science system

Good Scientific Practice in Research and Scholarship

Use of Animals in Research

11. The Nuremberg Code

The Nuremberg Code [from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946-April 1949. Washington, D.C.: U.S. G.P.O, 1949-1953.]

12. Biological diversity

European Commission Staff Working Paper - Report on human embryonic stem cell research

13. EU strategy on sustainable development

EU strategy on sustainable development

14. Ethical considerations in HIV preventive vaccine research

UNAIDS (Joint United Nations Programme on HIV/AIDS): guidance document on "Ethical considerations in HIV preventive vaccine research" (June 2001) in English, Spanish, Russian, and French at the following address: http:///www.unaids.org/publications/docum ents/vaccines/index.html

New ethical guidelines on HIV Vaccine research pave the way for large-scale international trials of HIV vaccines - 24/02/2003

15. Some examples of codes of conduct

Ethical guidelines for the use of human embryonic or fetal tissue for experimental and clinical neurotransplantation and research - NECTAR

Code of conduct for the access to and sustainable use of microbial resources within the framework of the convention on biological diversity - Mosaicc

DG Research
http:///europa.eu.int/comm/dgs/research/i ndex_en.html
Item source: http:///europa.eu.int/comm/research/scien ce-society/ethics/legislation_en.html#04