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5 - Regulation and Legislation: Overview and Background

Published online by Cambridge University Press:  19 October 2017

Helena Röcklinsberg
Affiliation:
Swedish University of Agricultural Sciences
Mickey Gjerris
Affiliation:
University of Copenhagen
I. Anna S. Olsson
Affiliation:
Instituto de Biologia Molecular E Celular, Porto
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Publisher: Cambridge University Press
Print publication year: 2017

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References

AAALAC (American Association for the Assessment and Accreditation of Laboratory of Animal Care). (2015). Rules of accreditation (Section 1. Definition. Laboratory Animals). www.aaalac.org/accreditation/rules.cfm (accessed 12 December 2016).Google Scholar
Abbott, A. (2010). Lab-animal battle reaches truce. Nature News, 464: 964.Google Scholar
Alexius Borgström, K. (2009). Djuren, läkarna och lagen: en rättslig studie om djurförsöksetik. Uppsala: Justus förlag.Google Scholar
Animal Procedures Committee (APC). (2003). Review of Cost-Benefit Assessment in the Use of Animals in Research. Report of the Cost-Benefit Working Group of the Animal Procedures Committee. Home Office, Communication Directorate, London.Google Scholar
Anonymous. (1997). Guidelines for the treatment of animals in behavioural research and teaching. Animal Behaviour, 53: 229234.Google Scholar
Anonymous. (2008). Proposed reform to animal testing rules draws fire. Nature, 456: 152.Google Scholar
The Basel Declaration. (2015). http://www.basel-declaration.org (accessed 12 December 2016).Google Scholar
Brody, B. A. (1998). The ethics of biomedical research: An international perspective. Oxford: Oxford University Press.Google Scholar
Canadian Council on Animal Care (CCAC). (1991). CCAC policy statement on: categories of invasiveness in animal experiments. http://www.ccac.ca/en_/standards/policies/policy-categories_of_invasiveness (accessed 12 December 2016).Google Scholar
Canadian Council on Animal Care (CCAC). (1997). CCAC Guide to Protocol Review. http://www.ccac.ca/Documents/Standards/Guidelines/Protocol_Review.pdf (accessed 12 December 2016).Google Scholar
Canadian Council on Animal Care (CCAC). (2006). Terms of Reference for Animal Care Committees. http://www.ccac.ca/Documents/Standards/Policies/Terms_of_reference_for_ACC.pdf (accessed 12 December 2016).Google Scholar
Canadian Council on Animal Care (CCAC). (2015). Working together to enhance animal ethics and care in science. Canadian Council on Animal Care Strategic Plan, 2015–2020. http://www.ccac.ca/Documents/About/CCAC_Strategic_Plan_2015-2020.pdf (accessed 12 December 2016).Google Scholar
CFR (Code of Federal Regulations). (1985). Animal Welfare Act (7 U.S.C. 2131) 9 CFR, 2.31 (a) (b). https://www.nal.usda.gov/awic/animal-welfare-act (accessed 9 April 2017).Google Scholar
Council of Europe. (1986). European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes. CETS No. 123. https://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/123Google Scholar
Dresser, R. (2001). When science offers salvation: Patient advocacy and research ethics. New York: Oxford University Press.Google Scholar
European Commission. (2014a). National Competent Authorities for the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes – A working document on the development of a common education and training framework to fulfil the requirements under the Directive. http://ec.europa.eu/environment/chemicals/lab_animals/pdf/Endorsed_E-T.pdf (accessed 12 December 2016).Google Scholar
European Commission. (2014b). National Competent Authorities for the Implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes – A working document on Animal Welfare Bodies and National Committees to fulfil the requirements under the Directive. http://ec.europa.eu/environment/chemicals/lab_animals/pdf/endorsed_awb-nc.pdf (accessed 12 December 2016).Google Scholar
European Commission. (2015). Animals used for scientific purposes. http://ec.europa.eu/environment/chemicals/lab_animals/home_en.htm (accessed 12 December 2016).Google Scholar
European Parliament Legislative Observatory. (2010). Protection of animals used for scientific purposes. http://www.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2008/0211(COD) (accessed 12 December 2016).Google Scholar
European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). (2015). https://eurl-ecvam.jrc.ec.europa.eu/ (accessed 12 December 2016).Google Scholar
Expert Working Group (EWG). (2013). Expert Working Group for Project Evaluation and Retrospective Assessment. National Competent Authorities for the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes. Working document on Project Evaluation and Retrospective Assessment. http://ec.europa.eu/environment/chemicals/lab_animals/pdf/Endorsed_E-T.pdf (accessed 12 December 2016).Google Scholar
Federation of Animal Science Societies (FASS). (2010). The guide for the care and use of agricultural animals in research and teaching. https://www.aaalac.org/about/Ag_Guide_3rd_ed.pdf https://www.aaalac.org/about/Ag_Guide_3rd_ed.pdf (accessed 9 April 2017).Google Scholar
Federation of European Laboratory Animal Science Associations (FELASA). (2007). Outline for the revision of Directive 86/609/EEC. http://www.felasa.eu/policy-documents/outline-for-the-revision-of-directive-86-609-eec (accessed 12 December 2016).Google Scholar
Fisher, M., Feuerstein, G., Howells, D. W., Hurn, P. D., Kent, T. A., Savitz, S. I., and Lo, E. H. (2009). Update of the stroke therapy academic industry roundtable preclinical recommendations. Stroke: A Journal of Cerebral Circulation, 40(6): 22442250.Google Scholar
Government of New Zealand. (1999). Animal Welfare Act http://www.legislation.govt.nz/act/public/1999/0142/latest/DLM49664.html (accessed 12 December 2016).Google Scholar
Government of Uruguay. (2009). Ley n°18.611. Utilización de Animales en Actividades de Experimentación, Docencia e Investigación Científica 2009. http://www.iibce.edu.uy/ETICA/ley-18611-oct-2-2009.pdf (accessed 12 December 2016).Google Scholar
Guidelines for the Use of Animals. (1997). Guidelines for the treatment of animals in behavioural research and teaching. Animal Behaviour, 53: 229234.Google Scholar
Guillén, J. (2014). Laboratory animals: Regulations and recommendations for global collaborative research. Cambridge: Academic Press.Google Scholar
Hagelin, J., Hau, J. & Carlsson, H. E. (2003). The refining influence of ethics committees on animal experimentation in Sweden. Laboratory Animals, 37: 1018.Google Scholar
Hamm, T. E., Dell, R. B. & van Sluyters, R. C. (1995). Laboratory animal care policies and regulations: United States. ILAR Journal, 37: 7578.Google Scholar
Hau, J., Carlsson, H. E. & Hagelin, J. (2001). Animal research: Ethics committees have influenced animal experiments in Sweden. BMJ, 322: 1604.Google Scholar
Home Office. (1986). Animals (Scientific Procedures) Act 1986 (Chapter 14). London: The Stationery Office.Google Scholar
Ideland, M. (2009). Different views on ethics: How animal ethics is situated in a committee culture. Journal of Medical Ethics, 35: 258261.Google Scholar
Japan Science Council. (2006). Guidelines for Proper Conduct of Animal Experiments. http://www.scj.go.jp/en/animal/Google Scholar
Jennings, M. & Silcock, S. (1995). Benefits, necessity and justification in animal research. Alternatives to Laboratory Animals, 23: 828836.Google Scholar
Katz, D. M., Berger-Sweeney, J. E., Eubanks, J. H., Justice, M. J., Neul, J. L., Pozzo-Miller, L., Blue, M. E.Zoghbi, H. Y. & Mamounas, L.A. (2012). Preclinical research in Rett syndrome: Setting the foundation for translational success. Disease Models & Mechanisms, 5: 733745.Google Scholar
Kilkenny, C., Browne, W. J., Cuthill, I. C., Emerson, M. & Altman, D. G. (2010). Improving bioscience research reporting: The ARRIVE guidelines for reporting animal research. PLoS Biology, 8: e1000412.Google Scholar
Laber, K. Newcomer, C. E. Decelle, T. Everitt, J. I. Guillén, J. & Brønstad, A. (2016). Recommendations for addressing harm-benefit analysis and implementation in ethical evaluation – Report from the AALAS-FELASA working group on harm-benefit analysis – part 2. Laboratory Animals, 50: 2142.Google Scholar
Linzay, A. (1995). Animal theology. Urbana: University of Illinois Press.Google Scholar
Ludolph, A. C., Bendotti, C., Blaugrund, E., Chio, A., Greensmith, L., Loeffler, J. P., Mead, R.Vieira, F. & von Horsten, S. (2010). Guidelines for preclinical animal research in ALS/MND: A consensus meeting. Amyotrophic Lateral Sclerosis, 11: 3845.Google Scholar
Mendelsohn, E. (1987). The political anatomy of controversy in the sciences. In Engelhart, T. J. & Caplan, A. (eds.), Scientific controversies: Case studies in the resolution and closure of disputes in science and technology. Cambridge: Cambridge University Press, pp. 93–124.Google Scholar
Messerli – Research Institute. (2012). University of Veterinary Medicine Vienna. Developing a methodology to evaluate animal experiments. http://www.vetmeduni.ac.at/en/messerli/science/ethik/projects/methodology-for-the-evaluation-of-animal-experiments/ (accessed 30 November 2014).Google Scholar
Ministry of Agriculture Food and Rural Affairs (South Korea). (1991) Animal Protecting Act. (revised 2008).Google Scholar
Ministry of Environment and Forest I. (1960). The Prevention of Cruelty to Animals Act. No. 59 of 1960. http://www.awbi.org/awbi-pdf/Act%20&%20Rules%20-%20English.pdfGoogle Scholar
Ministry of Environment and Forest I. (1998a). S.O.732 (E), [26/8/1998] – The Experiments on Animals (Controls and Supervision) (Amendment) Rules. http://envfor.nic.in/legis/awbi/awbi04.html (accessed 12 December 2016).Google Scholar
Ministry of Environment and Forest I. (1998b). S.O.1074, [15/12/1998] – The Breeding of and Experiments on Animals (Control and Supervision) Rules. http://envfor.nic.in/legis/awbi/awbi10.html (accessed 12 December 2016).Google Scholar
Ministry of Environment and Forest I (2001) S.O.134 (E), [15/2/2001] – The Breeding of and Experiments on animals (Control and Supervision) Amendment Rules. http://envfor.nic.in/legis/awbi/awbi11.html (accessed 12 December 2016).Google Scholar
Ministry of Science and Technology (MOST), China. (2006). Guidelines of humane treatment of laboratory animals. http://www.most.gov.cn/fggw/zfwj/zfwj2006/200609/t20060930_54389.htmGoogle Scholar
Monamy, V. (2009). Animal experimentation: A guide to the issues. Cambridge: Cambridge University Press.Google Scholar
National Health and Medical Research Council (NHMRC). (2013). Australian Code of Practice for the Care and Use of Animals for Scientific Purposes, 8th ed. http://www.nhmrc.gov.au/guidelines/publications/ea28 (accessed 12 December 2016).Google Scholar
National Research Council (NRC). (2011). Guide for the Care and Use of Laboratory Animals: 8th edition. https://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-use-of-laboratory-animals.pdf (accessed 12 December 2016).Google Scholar
National Science Board (NSB). (2014). Reducing investigators’ administrative workload for federally funded research. https://www.nsf.gov/pubs/2014/nsb1418/nsb1418.pdfGoogle Scholar
Office of Laboratory Animal Welfare (OLAW). (2002). Public health service policy on humane care and use of laboratory animals. Bethesda, MD: NIH Publication.Google Scholar
Olsson, I. A. S., Hansen, A. K. & Sandøe, P. (2008). Animal welfare and the refinement of neuroscience research methods – a case study of Huntington’s disease models. Laboratory Animals, 42: 277283.Google Scholar
Olsson, I. A. S., Silva, S. P., Townend, D. & Sandøe, P. (2016) Protecting animals and enabling research in the European Union: An overview of development and implementation of Directive 2010/63/EU. ILAR Journal. 57: 347–357.Google Scholar
Ormandy, E. H. (2012). The use of animals in research: Trends and public attitudes. Doctor of Philosophy Thesis, Faculty of Graduate Studies, Animal Science, University of British Columbia, Vancouver, BC. http://lfs-awp.sites.olt.ubc.ca/files/2012/11/ubc_2012_fall_ormandy_elisabeth.pdf (accessed April 9, 2017).Google Scholar
Ormandy, E. H., Dale, J. & Griffin, G. (2013). Use of genetically-engineered animals in science: Perspectives of Canadian animal care committee members. Alternatives to Laboratory Animals, 41: 18.Google Scholar
Persson, S. (2009). Etisk prövning: nästan alla djurförsök godkänns. Göteborg: TGM. http://www.djurensratt.se/sites/default/files/etiskprovning_0.pdf (accessed 12 December 2016).Google Scholar
Phillips, B. & Jennings, M. (2008). Home Office licence abstracts – an assessment. Atla-Alternatives to Laboratory Animals, 36: 465471.Google Scholar
Phillips, W. D., Christadoss, P., Losen, M., Punga, A. R., Shigemoto, K., Verschuuren, J. & Vincent, A. (2015). Guidelines for pre-clinical animal and cellular models of MuSK-myasthenia gravis. Experimental Neurology, 270: 2940.Google Scholar
Plous, S. & Herzog, H. (2001). Reliability of protocol reviews for animal research. Science, 293: 608609.Google Scholar
Preece, R. (2002). Awe for the tiger, love for the lamb: A chronicle of sensibility to animals. Vancouver: UBC Press.Google Scholar
Presidência da República CC. (2008). Presidência da República CC, Subchefia para Assuntos Jurídicos, Brazil. Lei n° 11.794 de 8 de Outubro, 2008 (‘Arouca Law’). http://www.planalto.gov.br/ccivil_03/_ato2007-2010/2008/lei/l11794.htm (accessed 12 December 2016).Google Scholar
Ringblom, J., Törnqvist, E., Hansson, S. O., Rudén, C. & Öberg, M. (2017). Assigning ethical weights to clinical signs observed during toxicity testing. ALTEX, 34: 148156.Google Scholar
Röcklinsberg, H. (2015). Lay persons involvement and public interest. Ethical assessment in animal ethics committees in Sweden. The Swedish Transition Process of the EU Directive 2010/ 63/ EU with regard to Harm- Benefit Analysis in Animal Ethics Committees. ALTEX Proceedings, 4(1): 4548.Google Scholar
Ruhdel, I., Maisack, C. & Wagner, K. (2014). German animal welfare act in breach with Directive 2010/63/EU. ALTEX, 31: 219222. doi: http://dx.doi.org/10.14573/altex.1404011Google Scholar
Russell, W. & Burch, R. (1959). The principles of humane experimental technique. London: Methuen & Co. Ltd.Google Scholar
Schiermeier, Q. (2008). German authority halts primate work. Nature, 455: 1159.Google Scholar
Schuppli, C. A. (2011). Decisions about the use of animals in research: Ethical reflection by Animal ethics committee members. Anthrozoös, 24: 409425.Google Scholar
Schuppli, C. A. & Fraser, D. (2005). The interpretation and application of the three Rs by animal ethics committee members. Alternatives to Laboratory Animals, 33: 114.Google Scholar
Schuppli, C. A. & Fraser, G. (2007). Factors influencing the effectiveness of research ethics committees. Journal of Medical Ethics, 33: 294301.Google Scholar
Schuppli, C. A., Fraser, D. & McDonald, M. (2004). Expanding the three Rs to meet new challenges in humane animal experimentation. Alternatives to Laboratory Animals, 32: 525532.Google Scholar
Secretaría de Agricultura. (2001). Secretaría de Agricultura G, Desarrollo Rural, Pesca y Alimentación, Mexico. NOM-062-ZOO-1999. Especificaciones Técnicas para la Producción, Cuidado y Uso de Animales de Laboratorio. Diario Oficial de la Federación 22 de agosto de 2001. http://www.fmvz.unam.mx/fmvz/principal/archivos/062ZOO.PDF (accessed 12 December 2016).Google Scholar
Smith, J., van den Broek, F., Martorell, J. C., Hackbarth, H., Ruksenas, O. & Zeller, W. (2007). Principles and practice in ethical review of animal experiments across Europe: Summary of the report of a FELASA working group on ethical evaluation of animal experiments. Laboratory Animals, 41: 143160.Google Scholar
Vasbinder, M. A., Hawk, C. T. & Bennett, B. T. (2014). Regulations, policies, and guidelines impacting laboratory animal welfare. In Bayne, K. & Turner, P. V. (eds.), Laboratory animal welfare (pp. 1728). Waltham, MA: Elsevier Inc.Google Scholar
Vieira de Castro, A. C. & Olsson, I. A. (2015). Does the goal justify the methods? Harm and benefit in neuroscience research using animals. Current Topics in Behavioral Neurosciences, 19: 4778.Google Scholar
Walters, K. S. & Portmess, L. (1999). Ethical vegetarianism: From Pythagoras to Peter Singer. Albany: SUNY Press.Google Scholar
Webster, J. D., Dennis, M. M., Dervisis, N., Heller, J., Bacon, N. J., Bergman, P. J., Bienzle, D.Yager, J. & Kiupel, M. (2011). Recommended guidelines for the conduct and evaluation of prognostic studies in veterinary oncology. Veterinary Pathology, 48: 718.Google Scholar
Workman, P., Aboagye, E. O., Balkwill, F., Balmain, A., Bruder, G., Chaplin, D. J., Double, J. A.Wedge, S. R. & Eccles, S. A. (2010). Guidelines for the welfare and use of animals in cancer research. British Journal of Cancer, 102: 15551577.Google Scholar

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