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Ethics

Regulation of scientific procedures using animals in each participant country

MUGEN participants conform to all current legislation and regulations applicable in the EU and countries where research within MUGEN is carried out. Where required, participants seek the approval of relevant ethics committees prior to initiating RTD activities that might raise ethical issues. The Coordinator implements the JPA with full respect to the legal and ethical requirements and codes of practices valid in participant countries.

 

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Denmark

 
French flag

France

  • The Institut Pasteur follows the “ Loi Huriet n o 88 – 1138 / 20.12.1990” (decret d’application n o 90-872 / 27.09.1990) and “ Loi sur la Bioethique” of July 1994 on handling genetically modified organisms; animals should be handled in compliance with the rules of the French Ministry of Agriculture and Fisheries.
  • The Centre d’Immnunologie de Marseille-Luminy has been credited by national authorities with authorization No 02875 for experimenting on living animals, and with authorization No 1322 for handling genetically modified organisms.
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Germany

  • The “Tierschutzgesetz” which regulates keeping and handling of laboratory animals.
  • The “Gentechnikgesetz” which regulates keeping and handling of genetically modified organisms
  • License to keep animals (#931/1 dated 12/3/1987).
  • License to manipulate animals (#23.203 K13 19/95, dated 9/28/95).

 

  • The German Cancer Research Center will follow the German laws and regulations concerning work with animals and genetically modified organisms. All experiments with animals will have to be approved by the German Cancer Research Center and authorized by local Government authorities.
  • The German Arthritis Research Center will follow the German laws and regulations concerning work with animals and genetically modified organisms. All experiments with animals are or will have to be approved by the German Arthritis Research Center and authorized by local Government authorities.
  • All experiments involving human material are approved by an ethical commission from the local partner university hospitals or clinics. For all blood samples taken for scientific purposes from the local blood bank or the local institute for transfusion medicine from healthy blood donors also an informal consent is required.
  • All the tests established at Ingenium Pharmaceutical AG for the project are accepted and approved by the local ethical committees for human and animal studies (Regierung von Oberbayern).
  • License number: 211-2531-18/2000, July 27, 2003
  • The German Research Center for Biotechnolgy (GBF) will follow the German laws and regulations concerning work with animals and genetically modified organisms. All experiments with animals will have to be approved by the German Cancer Research Center and authorized by local Government authorities. We have a running animal experimental licence for infection experiments with the number 509.42502/07-06.02 which will cover three years of research.
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Greece

  • The Animals Act 160/3.05.1991 applicable in Greece, and revised according to the EEC Directive 86/609/EEC/24.11.1986.
  • The Revised Ministerial Decree 96287/1893/13-12-1995 regulating the release into the environment of genetically modified organisms, revised according to the EEC Directive 90/219/EEC/23.04.1990, as amended by EEC Directive 94/51/EEC/07.11.1994.
  • Authorization for animal experimentation by local authorities.
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Italy

  • All animal research including use of genetically modified mice will be done under the provision of the Italian law (Legislative Decree 116 of Jan. 1992. Authorization n. 169/94-A issued Dec.19, by Ministry of Health). Studies have been subject to approval by the Ministry of Health (May 28, 2001).
  • All experimental research activities involving animals performed at any time at the Laboratories established in Italy comply with all valid international and national rules and regulations protecting the welfare of animals used for research purposes.
  • All activities concerning the production and use of transgenic mice within the scopes of the proposed project will conform to the Italian Legislative Decree n. 116/1992, in application of the EU Directive 86/609/EC.
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The Netherlands

  • All experiments are carried out in agreement with institutional guidelines for animal care and treatment, as laid down and checked by the Animal Experimentation Committee of The Netherlands Cancer Institute.
  • Generation and maintenance of recombinant mice is in agreement with the rules laid down by the committee on genetic modification of the Ministry of Environmental Affairs. All recombinant mice at The Netherlands Cancer Institute are covered by a common licence from this Ministry.
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Sweden

  • Protection for animals in research is regulated by the Swedish National Board for Laboratory Animals (Centrala Försöksdjursnämnd ( www.cfn.se). On 27 May 1988, the Swedish Parliament adopted regulations on the use of animals for research purposes (prop. 1987/88:93, JoU 22, rskr 327). After a parliamentary decision, the animal protection law was adopted (1988:534), the animal protection ordinance (djurskyddsförordningen (1988:539) and ordinance for The Swedish National Board for Laboratory Animals (1988:541).
  • Genetically modified organisms: Regulations and recommendations are provided by the Arbetsmiljöverket (Swedish Work Environment Agency) recommendations (AFS 2000:5). A guide for risk assessment has been modified as to March 2000 considering the EU Directive 90/219 adopted on June 2000. It also takes into consideration the new requirements of the Genetically Modified Organisms (Contained Use) Regulations 2000 (which consider the amendments of the EU directive).
  • Arexis follows a strict policy for animal research, which fulfils the following criteria:
  • All animals must be treated with respect and the highest consideration should be given for their health and welfare consistent with meeting our scientific objectives.
  • All research involving animals shall be designed and undertaken so as to minimise and preferably avoid, pain, suffering and distress.
  • All studies should use the minimum numbers of the most appropriate species and strain of animal to achieve the scientific objectives.
  • All employees must be adequately trained and competent in the procedures they are to perform
  • All work involving animals will be undertaken strictly in accordance with:
  • The Animal Protection Act (SFS 1988:534)
  • The Statutory Order on Animal Protection (1988:539).
  • Authorization for animal experimentation by local authorities.
 

Switzerland

  • At the Institute of Experimental Immunology, all animal experiments are carried out according to rules given by Swiss federal and Cantonal laws and by the Swiss academy for medical research (SAMW).
  • In all cases, principles expressed in widely recognized international texts or codes of practices shall be respected (i.e. the Helsinki declaration, conventions of the Council of Europe on human rights and biomedicine, and the UNESCO Declaration on the human genome). Whenever possible, experimentation and testing on animals will be replaced by in vitro or other methods. No research modifying or seeking to modify, the genetic constitution of human beings by alteration of stem, cells or of any stage embryo development which may make these alteration hereditary, nor research seeking to replace a nucleus of a cell of an embryo with a nucleus of a cell of any person, embryo or subsequent development of an embryo, known as cloning, will be carried out in this proposal.
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UK

  • UK Institutions adhere strictly to Home Office requirements through veterinary supervision of animal house practice, monitored by Ethics Committees and appropriate government issued project licences and a personal license.
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USA

  • The Harvard Medical School and the Center for Blood Research animal care management programs are accredited by the American Association for the Accreditation of Laboratory Animal Care (AAALAC), and meet NIH standards as set forth in the Guide for the Care and Use of Laboratory Animals (DHHS Publication No. (NIH) 5-23, Revised 1995). The Institution also accepts as mandatory the PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions and NIH Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training. There is on file with the office for Protection from Research Risks an approved Assurance of Compliance. The CBR animal assurance number is A3251-01. Our animal experimentation protocol has been reviewed and approved by Harvard's ARCM Standing Committee on Animals and the Center for Blood Research IACUC.
  • Mice are maintained at the barrier facility of the Harvard School of Public Health. This new facility has SPF status and is regularly monitored for the presence of microbiological contaminants (sentinel testing system). Our mice are housed in individually ventilated cages (Thoren Caging Systems). Daily assessment is performed by animal technicians from the Animal Resources and Comparative Medicine (ARCM) unit, with back-up from and under supervision of qualified veterinarians (Dr. A. Lage, DVM, ARCM director).

 

 

 

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