Navigation path

Policy

Research Ethics

Policy

For all activities funded by the European Union, ethics is an integral part of research from beginning to end, and ethical compliance is seen as pivotal to achieve real research excellence. It is only by getting the ethics right that research excellence can be achieved. Ethical research conduct implies the application of fundamental ethical principles and legislation to scientific research in all possible domains of research – for example biomedical research, nature sciences, social sciences and humanities. Ethics is given the highest priority in EU funded research: all the activities carried out under Horizon 2020 must comply with ethical principles and relevant national, EU and international legislation, for example the Charter of Fundamental Rights of the European Union and the European Convention on Human Rights.

The most common ethical issues include the involvement of children, patients, vulnerable populations, the use of human embryonic stem cells, privacy and data protection issues and research on animals and non-human primates, misuse/malevolent use, impact on the environment, etc. It also includes the avoidance of any breach of research integrity, which means, in particular, avoiding fabrication, falsification, plagiarism or other research misconduct.

Ethics is dealt with extensively in the Horizon 2020 legislation (Horizon 2020 Rules for Participation: Ethics Reviews (Article 14), Horizon 2020 - Regulation of Establishment: Ethical principles (Article 19) and the Model Grant Agreement: Ethics (Article 34)

Special feature: Ethics Appraisal Procedure in Horizon 2020

There is a clear need to make a thorough ethical evaluation from the conceptual stage of the research proposal, not only to respect the legal framework but also to enhance the quality of the research. Ethical research conduct implies the application of fundamental ethical principles and legislation. The process to assess and address the ethical dimension is called the Ethics Appraisal Procedure. It concerns all activities funded in Horizon 2020 and includes the Ethics Review Procedure, which is conducted before the start of the project, as well as the Ethics Checks and Audits. When preparing a proposal, it is required to conduct an Ethics Self-assessment starting with the completion of an Ethics Issues Table.

Ethics Review Procedure

All proposals above threshold and considered for funding will undergo an Ethics Review carried out by independent ethics experts working in a panel. The Review starts with an Ethics Screening and if appropriate a further analysis called the Ethics Assessment is conducted. The Ethics Review can lead to ethics requirements that become contractual obligations.

The Ethics Review Procedure focusses on the compliance with ethical rules and standards, relevant European legislation, international conventions and declarations, national authorizations and ethics approvals, proportionality of the research methods and the applicants' awareness of the ethical aspects and social impact of the planned research.

STEP 1. Ethics Screening

The first phase of the Ethics Review Procedure, the Ethics Screening, is carried out during the scientific evaluation or soon after. When applicants didn’t signal ethical issues, the ethics experts first perform an Ethics Pre-Screening taking into account the Self-assessment. The objective of the pre-screening is to list the (potential) ethical issues but not to assess them.

When there is at least one confirmed ethical issues, the proposal is subject to a complete Ethics Screening. Whenever necessary, the experts will formulate requirements and notably identify all proposals that require (ethical) approval at the national level (e.g. with regards to data protection, the conduct of clinical trials and animal welfare). Because of the complexity or the nature of the ethical issues they at stake (e.g. severe intervention on humans) the ethics experts may also recommend an Ethics Assessment rather than formulating directly requirements. Proposals involving the use of Human Embryonic Stems Cells (hESCs) automatically proceed to the second step, the Ethics Assessment.

STEP 2. Ethics Assessment

For a limited number of proposals (e.g. severe intervention on humans, lack of appropriate ethics framework in the country where the research will be performed, etc.) the Ethics Screening can be followed by an Ethics Assessment prior to the signature of the grant agreement.

The Ethics Assessment is a more in-depth analysis of the ethical issues of the proposals, taking into account, when available the conclusions of the Ethics screening. As mentioned above, it is systematically performed on all proposals involving the use of Human Embryonic Stem Cells.

Ethics Checks and Audits

During the Ethics Screening or the Ethics Assessment, the experts identify the projects that need an Ethics Check, which are executed during the course of the research project. The procedure can also be initiated by the Commission services.

The objective of the procedure is to assist the beneficiaries to deal with the ethics issues raised by their research and if necessary to take preventive or/and corrective measures. The Ethics Check is conducted on the basis of the information provided by the concerned beneficiaries, who may be invited to a meeting in Brussels to discuss the issues at stake. On site visits can also be organised.

In case of substantial breach of ethical principles, research integrity or relevant legislation, the Commission can carry out an Ethics Audit following the provisions and procedures laid down in the grant agreement.

The Checks and Audits can result in an amendment of the grant agreement. In severe cases, it can lead, upon the decision of the Commission services to a reduction of the grant, its termination or any other appropriate measures, in accordance with the provisions of the grant agreement.

» Projects by calls

H2020

SWAFS 2014-2015:

GARRI.5.2014 - Ethics in Research: Promoting Integrity

GARRI.6.2014 - Reducing the risk of exporting non ethical practices to third countries

In the work programme 2014-2015 'Science with and for Society', one of the ethics topics, aims at promoting research integrity.

The research misconduct cases in the 1980s in the United States have led to the adoption of guidelines and codes of conduct, however, the cases are very complex and diverse. As there is no single approach to research misconduct, the pros and cons of different methods should be assessed, including the analysis of cases where suspicion was confirmed and lead to sanctions.

The second topic focusses on “ethics dumping”. Due to the progressive globalisation of research activities, the risk is higher that research with sensitive ethical issues is conducted by European organisations outside the EU in a way that would not be accepted in Europe from an ethical point of view. This exportation of these non-compliant research practices is called ethics dumping.

In order to mitigate and reduce the risk, European, national and international ethics bodies should collaborate actively and at multiple levels: within the EU, between the EU and other high-income countries, and between high-income and low-income countries, where the risks of dumping is higher. Good practices shall be identified with the aim of elaborating a code of conduct for all actors.

FP7

FP7-SCIENCE-IN-SOCIETY-2007-1

FP7-Adhoc-2007-13

FP7-SCIENCE-IN-SOCIETY-2008-1

FP7-SCIENCE-IN-SOCIETY-2009-1

FP7-SCIENCE-IN-SOCIETY-2010-1

FP7-SCIENCE-IN-SOCIETY-2011-1

FP7-SCIENCE-IN-SOCIETY-2012-1

FP7-SCIENCE-IN-SOCIETY-2013-1

» Ethics legislation, regulation and conventions

Research Ethics and the European Commission's Ethics Review

  • Article 6 of Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013)

    Opinion n°22 - 13/07/2007 - The ethics review of hESC FP7 research projects

Research involving animal experimentation

European Union documents

  • Directive 2010/63/EU - the new directive concerning the use of animals for scientific purposes can be consulted at this web address.
  • Protocol on Protection and welfare of animals (annexed by the Treaty of Amsterdam to the Treaty establishing the European Community Protocol to the Amsterdam Treaty)
  • Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
  • Regulation (EC) No. 338/97 on the protection of species of wild fauna and flora by regulating trade therein (the Basic Regulation)
  • Regulation (EC) No 865/2006 laying down detailed rules concerning the implementation of Council Regulation (EC) No 338/97 (the Implementing Regulation)
  • Regulation (EC) No 359/2009 of 30 April 2009 suspending the introduction into the Community of specimens of certain wild fauna and flora (OJ L 110, 1.5.2009, p. 3)
  • Directive 86/609/EEC on the protection of animals used fore experimental and other scientific purposes
  • Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products
  • Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products
  • Commission Recommendation No 2007/425/EC identifying a set of actions for the enforcement of Regulation (EC) No 338/97 on the protection of species of wild fauna and flora by regulating trade therein was adopted in June 2007 (Official Journal L 159 of 20 June 2007)
  • Commission Recommendation 2007/526/EC on revised guidelines for the accommodation and care of animals used for experimental and other scientific purposes
  • Commission Recommendation of 7 June 2006 Establishing guidelines on the use of claims referring to the absence of tests on animals pursuant to Council Directive 76/768/EEC
  • European Parliament Written Declaration on non-human primates in scientific experiments

Council of Europe documents

International Law documents

  • Convention on International Trade in Endangered Species of Wild Fauna and Flora -CITES (Washington, D.C., 3 March 1973 amended at Bonn, on 22 June 1979)

Guidance documents

  • Guide for the Care and Use of Laboratory Animals (1996) Institute of Laboratory Animal Research, Commission on Life Sciences, National Research Council
  • IUCN Guidelines for the prevention of biodiversity loss caused by alien invasive species (51st Meeting of Council, February 2000)
  • Report from the Commission to the Council and the European Parliament - Report on the Development, Validation and Legal Acceptance of Alternative Methods to Animal Tests in the Field of Cosmetics (2007) - Cosmetics Technical report drafted by ECVAM in 2006/2007 in support of the preparation of the above report
  • Principles and Practice in Ethical Review of Animal Experiments across Europe, FELASA Working Group on Ethical Evaluation of Animal Experiments, 2005
  • The ethics of research involving animals. (2005) Nuffield Council on Bioethics: London
  • International Guiding Principles for Biomedical Research involving animals (1985) issued by the Council for International Organizations of Medical Sciences (CIOMS)

Research involving dual use or misuse

Research involving genetic modification

  • Regulation (EC) No 1829/2003 on genetically modified food and feed
  • Regulation (EC) No 1830/2003 on traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC
  • Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms
  • Regulation (EC) No 641/2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed
  • Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
  • Directive 98/81/EC amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms
  • Directive 90/219/EEC on the contained use of genetically modified micro-organisms
  • Commission Recommendation No 2003/556/EC on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming
  • UN Cartagena Protocol on Biosafety to the Convention on Biological Diversity

Research involving data processing

European Union documents

  • More information concerning the EC proposal for the reform of the data protection framework
  • Regulation (EC) 45/2001 of the European Parliament and of the Council of 18. December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data
  • 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.
  • Directive 97/66/EC of the European Parliament and of the Council of 15 December 1997 concerning the processing of personal data and the protection of privacy in the telecommunications sector
  • Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)
  • Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector;
  • Directive 2006/24/EC of the European Parliament and of the Council of 15 March 2006 on the retention of data generated or processed in connection with the provision of publicly available electronic communications services or of public communications networks and amending Directive 2002/58/EC
  • Commission Decision 2000/520 of 26 July 2000 pursuant to Directive 95/46/EC of the European Parliament and of the Council on the adequacy of the protection provided by the safe harbour privacy principles and related frequently asked questions issued by the US Department of Commerce Official Journal L 215 , 25/08/2000

Council of Europe documents

Guidance Documents

  • UNESCO International Declaration on Human Genetic Data 2003
  • UNESCO Universal Declaration on the Human Genome and Human Rights 1997
  • Working Party on the Protection of Individuals with regard to the Processing of Personal data (Article 29 Working Group) - Working Document on the processing of personal data relating to health in electronic health records (EHR), 15 February 2007, WP 131
  • Article 29 Working Group - Opinion 6/2000 on the Human Genome and Privacy, July 2000
  • Article 29 Working Group - Working document on biometrics, March 2004
  • Article 29 Working Group - Recommendation 1/99 on Invisible and Automatic Processing of Personal Data on the Internet Performed by Software and Hardware, February 1999
  • Article 29 Working Group - Working Document: Processing of Personal Data on the Internet, February 1999
  • Article 29 Working Group - Opinion 1/2002 on the CEN/ISSS Report on Privacy Standardisation in Europe, May 2002
  • Article 29 Working Group - Working Document on Trusted Computing Platforms and in particular on the work done by the Trusted Computing Group (TCG group), January 2004
  • Article 29 Working Group - Opinion 5/2005 on the use of location data with a view to providing value-added services, November 2005
  • Article 29 Working Group - Working document on data protection issues related to RFID technology, January 2005
  • Working Document on Online Availability of Electronic Health Records by the International Working Group on Data Protection in Telecommunications

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

Research involving Children

Research involving the patenting of research findings

  • Directive EC 98/44 on the legal protection of biotechnological inventions
  • Convention on the grant of European patents (European Patent Convention) of 5 October 1973 (text as amended by the act revising Article 63 EPC of 17 December 1991 and by decisions of the Administrative Council of the European Patent Organisation of 21 December 1978, 13 December 1994, 20 October 1995, 5 December 1996, 10 December 1998 and 27 October 2005 and comprising the provisionally applicable provisions of the act revising the EPC of 29 November 2000)
  • Recommendation of the Parliamentary Assembly of the Council of Europe 1425 (1999) on biotechnology and intellectual property
  • Recommendation 1240 (1994) on the protection and patentability of material of human origin
  • European Parliament resolution on human cloning
  • EGE Opinion n°16 - 07/05/2002 - Ethical aspects of patenting inventions involving human stem cells
  • EGE Opinion n° 9 - 28/05/1997 - Ethical aspects of cloning techniques
  • EGE Opinion n° 8 - 25/09/1996 - Ethical aspects of patenting inventions involving elements of human origin

Research involving Environmental and Development considerations

  • Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market
  • UN Convention on Biological Diversity (1992)
  • International Treaty on Plant Genetic Resources for Food and Agriculture -International Seed Treaty- which was adopted by the FAO Conference on 3 November 2001
  • 27/06/1989. Convention (No. 169) concerning Indigenous and Tribal Peoples in Independent Countries. Adopted on 27 June 1989 by the General Conference of the International Labour. Organisation at its seventy-sixth session.
  • WTO Agreement on the Application of Sanitary and Phytosanitary Measures - also known as the SPS Agreement -Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)
  • UN Declaration on the Rights of Indigenous Peoples (2007)
  • UNESCO Universal Declaration on Cultural Diversity of 2 November 2001
  • Code of conduct for the access to and sustainable use of microbial resources within the framework of the convention on biological diversity
  • Recommendation 1468 (2000) of the Parliamentary Assembly of the Council of Europe on biotechnologies
  • Recommendation 934 (1982) on genetic engineering
  • EGE Opinion No 1 of 12 March 1993 on the ethical implications of the use of performance-enhancers in agriculture and fisheries,
  • EGE Opinion No 5 of 5 May 1995 on ethical aspects of the labeling of the food derived from modern biotechnology
  • Opinion n°25 - 17/11/2009 - Ethics of synthetic biology
  • Opinion n°24 - 17/12/2008 - Ethics of modern developments in agricultural technologies
  • Opinion n°23 - 16/01/2008 - Ethical aspects of animal cloning for food supply
  • Opinion n° 7 - 21/05/1996 - Ethical aspects of genetic modification of animals

The safety of researchers

  • Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation
  • Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work
  • Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work
  • Directive 2006/25/EC on the minimum health and safety requirements regarding the exposure of the workers to risks arising from physical agents (artificial optical radiation, 19th individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)
  • Directive 2004/40/EC of 29 April 2004 on the minimum health and safety requirements regarding the exposure of the workers to risks arising from electromagnetic fields and waves (18th individual directive within the meaning of Art. 16(1) of directive 89/391/EEC).
  • Directive 2003/10/EC of 6 February 2003 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (noise) (Seventeenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
  • Directive 2002/44/EC of the of 25 June 2002 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (vibration) (sixteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
  • Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation
  • Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations
  • Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC
  • Directive 2003/122/Euratom of 22 December 2003 on the control of high-activity sealed radioactive sources and orphan sources
  • Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors
  • Directive 2006/25/EC on the minimum health and safety requirements regarding the exposure of the workers to risks arising from physical agents (artificial optical radiation, 19th individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)
  • Directive 2004/40/EC of 29 April 2004 on the minimum health and safety requirements regarding the exposure of the workers to risks arising from electromagnetic fields and waves (18th individual directive within the meaning of Art. 16(1) of directive 89/391/EEC)
  • Directive 2003/10/EC of 6 February 2003 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (noise) (Seventeenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
  • Directive 2002/44/EC of 25 June 2002 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (vibration) (sixteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
  • Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation
  • Commission Recommendation on a code of conduct for responsible nanosciences and nanotechnologies research
  • Council of Europe Recommendation (84) 16 of the Committee of Ministers to member states concerning notification of work involving recombinant deoxyribonucleic acid (DNA)

Research ethics and Social Sciences