Diese Präsentation wurde erfolgreich gemeldet.
Wir verwenden Ihre LinkedIn Profilangaben und Informationen zu Ihren Aktivitäten, um Anzeigen zu personalisieren und Ihnen relevantere Inhalte anzuzeigen. Sie können Ihre Anzeigeneinstellungen jederzeit ändern.

Guidelines on animal research review

3.695 Aufrufe

Veröffentlicht am

Guidelines on animal research review

Veröffentlicht in: Bildung
  • Als Erste(r) kommentieren

Guidelines on animal research review

  1. 1. Webinar on Research Ethics in Preclinical studies 28-06-2020 (2.30 – 4.00 MYT)
  2. 2. Principles on use of animals in the experiments & Guidelines on the animal Ethics application 6/29/2020 2
  3. 3. Animal experimentation • Animal experiments are widely used to develop new medicines and to test the safety of other products. • Many of these experiments cause pain to the animals involved or reduce their quality of life in other ways. Reference: Animal experimentation. Available in http://www.bbc.co.uk/ethics/animals/using/experiments_1.shtml Last assessed on 27-06-2020. 6/29/2020 3
  4. 4. In 1997 Dr Jay Vacanti and his team grew an ear on the back of a mouse Reference: Animal experimentation. Available in http://www.bbc.co.uk/ethics/animals/using/experiments_1.shtml Last assessed on 27-06-2020. 6/29/2020 4
  5. 5. Principles on use of animals • International Guiding Principles for Biomedical Research Involving Animals were issued in 1985. • This guidelines is developed by the Council of International Organizations of Medical Sciences (CIOMS) and are endorsed by both the European Medical Research Council (EMRC) and the World Health Organization (WHO). Reference: The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. National Research Council (US) Institute for Laboratory Animal Research. Washington (DC): National Academies Press (US); 2004. 6/29/2020 5
  6. 6. Principles on use of animals • PRINCIPLES – I • Protection of the health and well-being both of man and of animals – Vivisection and Animal Testing Crime – The Cosmetic Pain – Health Charities Abuse – Descartes, Darwin, and Vivisection – Animal Rights – Silver Spring monkeys Reference: The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. National Research Council (US) Institute for Laboratory Animal Research. Washington (DC): National Academies Press (US); 2004. 6/29/2020 6
  7. 7. Principles on use of animals • PRINCIPLES – II • Methods such as mathematical models, computer simulation and in vitro biological systems should be used wherever appropriate. Reference: • The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. National Research Council (US) Institute for Laboratory Animal Research. Washington (DC): National Academies Press (US); 2004. • https://www.scientificamerican.com/article/should-computer-simulations-replace-animal-testing-for-heart-drugs/ • https://www.fda.gov/media/72383/download6/29/2020 7
  8. 8. Principles on use of animals • PRINCIPLES – III • Animal experiments should be undertaken only after due consideration of their relevance for human or animal health. Reference: The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. National Research Council (US) Institute for Laboratory Animal Research. Washington (DC): National Academies Press (US); 2004. 6/29/2020 8
  9. 9. Principles on use of animals • PRINCIPLES – IV • The animals selected for an experiment should be of an appropriate species and quality, and the minimum number required to obtain scientifically valid results. Reference: The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. National Research Council (US) Institute for Laboratory Animal Research. Washington (DC): National Academies Press (US); 2004. 6/29/2020 9
  10. 10. Principles on use of animals • PRINCIPLES – V • Investigators and other personnel should never fail to treat animals as sentient, and should regard their proper care and use and the avoidance or minimization of discomfort, distress, or pain as ethical imperatives. Reference: The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. National Research Council (US) Institute for Laboratory Animal Research. Washington (DC): National Academies Press (US); 2004. 6/29/2020 10
  11. 11. Principles on use of animals • PRINCIPLES – VI • Investigators should assume that procedures that would cause pain in human beings cause pain in other vertebrate species, although more needs to be known about the perception of pain in animals. Reference: The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. National Research Council (US) Institute for Laboratory Animal Research. Washington (DC): National Academies Press (US); 2004. 6/29/2020 11
  12. 12. Principles on use of animals • PRINCIPLES – VII • Procedures with animals that may cause more than momentary or minimal pain or distress should be performed with appropriate sedation, analgesia, or anesthesia in accordance with accepted veterinary practice. • Surgical or other painful procedures should not be performed on unanesthetized animals. Reference: The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. National Research Council (US) Institute for Laboratory Animal Research. Washington (DC): National Academies Press (US); 2004. 6/29/2020 12
  13. 13. Principles on use of animals • PRINCIPLES – VIII • Where waivers are required in relation to the provisions of PRINCIPLES – VII, such waivers should not be made solely for the purposes of teaching or demonstration. Reference: The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. National Research Council (US) Institute for Laboratory Animal Research. Washington (DC): National Academies Press (US); 2004. 6/29/2020 13
  14. 14. Principles on use of animals • PRINCIPLES – XI • At the end of, or, when appropriate, during an experiment, animals that would otherwise suffer severe that cannot be relieved should be painlessly killed. Reference: The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. National Research Council (US) Institute for Laboratory Animal Research. Washington (DC): National Academies Press (US); 2004. 6/29/2020 14
  15. 15. Principles on use of animals • PRINCIPLES – X • The best possible living conditions should be maintained for animals kept for biomedical purposes. Reference: The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. National Research Council (US) Institute for Laboratory Animal Research. Washington (DC): National Academies Press (US); 2004. 6/29/2020 15
  16. 16. Principles on use of animals • PRINCIPLES – XI • It is the responsibility of the director of an institute or department using animals to ensure that investigators and personnel have appropriate qualifications or experience for conducting procedures on animals. Reference: The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. National Research Council (US) Institute for Laboratory Animal Research. Washington (DC): National Academies Press (US); 2004. 6/29/2020 16
  17. 17. Investigator responsibilities 6/29/2020 17
  18. 18. Investigator responsibilities • Animal users are to be aware of the value of life of animals Development of animal use in the 20th century. Reference: Ethical Principles and Guidelines for the Use of Animals. National Research Council of Thailand 1999. Baumans V. Use of animals in experimental research: an ethical dilemma?. Gene therapy. 2004 ;11(1):S64-6. 6/29/2020 18
  19. 19. Investigator responsibilities • Animal users are to be aware of the accuracy of the research outcome using the minimal number of animals Distribution of the purposes for animal use. Reference: Ethical Principles and Guidelines for the Use of Animals. National Research Council of Thailand 1999. Baumans V. Use of animals in experimental research: an ethical dilemma?. Gene therapy. 2004 ;11(1):S64-6. 6/29/2020 19
  20. 20. Investigator responsibilities • The Use of wild animals must not violate laws or policies for wildlife conservation • The frog has been used regularly as an experimental animal for more than a century. • Selection of an experimental animal depends on three factors, viz. sensitivity, reproducibility and availability. • The frog is certainly one of the most suitable animals for training students in biology, physiology, pharmacology and toxicology. • The large scale capture of frogs from agricultural fields and supply to laboratories has led to an ecological imbalance. • Industrial pollution, pesticides in agriculture, deforestation, global warming and infection are the major causes for decline in the number of amphibians. Why ban the use of frog in laboratory? Reference: Ethical Principles and Guidelines for the Use of Animals. National Research Council of Thailand 1999. Baumans V. Use of animals in experimental research: an ethical dilemma?. Gene therapy. 2004 ;11(1):S64-6.6/29/2020 20
  21. 21. Investigator responsibilities • Animal users need to be aware that animals are living beings just as humans are living beings Reference: Ethical Principles and Guidelines for the Use of Animals. National Research Council of Thailand 1999. Ethical Principles and Guidelines for the Use of Animals. National Research Council of Thailand 1999. 6/29/2020 21
  22. 22. Investigator responsibilities • Animal users must keep detailed data and records of animal experiments Distribution of vertebrate animal species used for research, testing and education. Reference: Ethical Principles and Guidelines for the Use of Animals. National Research Council of Thailand 1999. Ethical Principles and Guidelines for the Use of Animals. National Research Council of Thailand 1999. 6/29/2020 22
  23. 23. Investigator responsibilities • Three Rs: The principles of the 3Rs (Replacement, Reduction and Refinement) were developed over 50 years ago providing a framework for performing more humane animal research. Reference: https://www.nc3rs.org.uk/the-3rs [Last assessed on 28-06-2020] 6/29/2020 23
  24. 24. Reference: https://www.hsi.org/news-media/legal-reform-needed-to-tackle-koreas-animal-testing/. Last assessed on 28-06-2020 6/29/2020 24
  25. 25. Guidelines 6/29/2020 25
  26. 26. Animal Ethics Timeline Reference: https://www.niehs.nih.gov/research/resources/bioethics/timeline/index.cfm . Last assessed on 28-06- 2020 1620 The Novum Organon, - argues that scientific research should benefit humanity. 1752 Peer review - Philosophical Transactions of the Royal Society of London. 1963 Guide for the Humane Care and Use of Laboratory Animals Published by U.S. Public Health Service publishes 1966 The U.S. Congress adopts the Animal Welfare Act. which protect animals used in research, excluding rodents and birds. 1975 Peter Singer publishes Animal Liberation 1975 Recombinant DNA experiments - Research institutions form Institutional Biosafety Committees (IBCs) 1989 NIH requires that all graduate students on training grants receive education in responsible conduct of research 1989 Short book on research ethics - NAS publishes 2010 Guidelines for Ethical Conduct in the Care and Use of Nonhuman Animals in Research 6/29/2020 26
  27. 27. American Psychological Association Committee on Animal Research and Ethics (CARE) • In 2010, American Psychological Association (APA) published “Guidelines for Ethical Conduct in the Care and Use of Nonhuman Animals in Research”. • The acquisition, care, housing, use, and disposition of nonhuman animals in research must be in compliance with applicable federal, state, and local, laws and regulations, institutional policies. Reference: https://www.apa.org/science/leadership/care/care-animal-guidelines.pdf. Last assessed on 28-06- 2020 6/29/2020 27
  28. 28. American Psychological Association Committee on Animal Research and Ethics (CARE) Important points • Research should be undertaken with a clear scientific purpose. • The scientific purpose of the research should be of sufficient potential significance to justify the use of nonhuman animals. • Research on nonhuman animals may not be conducted until the protocol has been reviewed by an appropriate animal care committee. • The facilities housing laboratory animals should meet current regulations and guidelines. Reference: https://www.apa.org/science/leadership/care/care-animal-guidelines.pdf. Last assessed on 28-06- 2020 6/29/2020 28
  29. 29. American Psychological Association Committee on Animal Research and Ethics (CARE) Important points • All procedures carried out on nonhuman animals are to be reviewed by an institutional animal ethics committee (IAEC) to ensure that the procedures are appropriate and humane. • Whenever possible behavioral procedures should be used that minimize discomfort to the nonhuman animal. • Procedures in which the research animal is anesthetized and insensitive to pain throughout the procedure, and is euthanized before regaining consciousness are generally acceptable. Reference: https://www.apa.org/science/leadership/care/care-animal-guidelines.pdf. Last assessed on 28-06- 2020 6/29/2020 29
  30. 30. American Psychological Association Committee on Animal Research and Ethics (CARE) Important points • All surgical procedures and anesthetization should be conducted under the direct supervision of a person who is trained and competent in the use of the procedures. • Postoperative monitoring and care, which may include the use of analgesics and antibiotics, should be provided. • To minimize the number of nonhuman animals used, multiple research uses of individual animals should be considered. Reference: https://www.apa.org/science/leadership/care/care-animal-guidelines.pdf. Last assessed on 28-06- 20206/29/2020 30
  31. 31. American Psychological Association Committee on Animal Research and Ethics (CARE) Important points • Disposal of euthanized laboratory animals must be conducted in accord with all relevant legislation. Reference: https://www.apa.org/science/leadership/care/care-animal-guidelines.pdf. Last assessed on 28-06- 2020 6/29/2020 31
  32. 32. Animal welfare initiatives in selected countries in Asia 6/29/2020 32
  33. 33. Animal welfare initiatives in selected countries in Asia • Malaysia: – Malaysia has taken firm steps to improve animal welfare under the Animals Act 1953. – The National Animal Welfare Strategic Plan (NAWSP) was launched during the 3d World Organisation for Animal Health (OIE) Global Conference on Animal Welfare in 2012. – The Malaysian Animal Welfare Act 2015 – Malaysian Code of Practice for the care and use of animals for scientific Purposes (Proposed Laboratory Animal Science Association of Malaysia) Reference: http://www.fondation-droit-animal.org/proceedings-aw/animal-welfare-in-asia/. Last assessed on 28- 06-2020 6/29/2020 33
  34. 34. Animal welfare initiatives in selected countries in Asia • India: – Regulatory aspect of animal welfare in India is under the purview of the Ministry of Environment & Forests which implements the Prevention of Cruelty to Animals Act, 1960 (59 of 1960). – The Animal Welfare Board of India (AWBI) and Committee for the Purpose of Supervision and Control of Experiments on Animals (CPCSEA) were set to facilitate the implementation of the Act. – CPCSEA guidelines (latest ed.: 2018) Reference: http://www.fondation-droit-animal.org/proceedings-aw/animal-welfare-in-asia/. Last assessed on 28- 06-2020 6/29/2020 34
  35. 35. Animal welfare initiatives in selected countries in Asia Reference: • http://www.fondation-droit-animal.org/proceedings-aw/animal-welfare-in-asia/. Last assessed on 28-06-2020 • Retnam et al. ILAR J. 2016;57(3):312-23. China • Animal Husbandry Law of People Republic of China (2006) • China introduced the Farm Animal Welfare Requirements for pigs (CAS 235-2014) South Korea • Animal Welfare Act is in place to regulate animal welfare while the Korean Animal Welfare Advisory Committee functions Philippines • Animal Welfare Act, 1998 Singapore • National Advisory Committee for Laboratory Animal Research (NACLAR) produced a draft of national guidelines in August 2003 Thailand • National Research Council of Thailand (NRCT) • Ethical Principles and Guidelines for the Use of Animals for Scientific Purposes 1999 Indonesia • Animal welfare legislation 1967 6/29/2020 35
  36. 36. 6/29/2020 36
  37. 37. Please fill the feedback form https://forms.gle/s1Yi6XvHJzGuMjQp7 6/29/2020 37
  38. 38. Animal ethics, Animal rights, Anti-vivisection • Vivisection and Animal Testing Crime https://www.citizenthought.net/Animal_Ethics_Animal_Rights.html#Pain Victims of laboratory crime "One animal dies in a laboratory in the USA every second, in Japan every two seconds, and in the UK every twelve seconds." Back 6/29/2020 38
  39. 39. Animal ethics, Animal rights, Anti-vivisection • The Cosmetic Pain https://www.citizenthought.net/Animal_Ethics_Animal_Rights.html#Pain Cosmetic victims in the stocks. Copyright Brian Gunn /IAAPEA Back Stop testing cosmetics on live animals. There are alternatives To minimize the use of animals in research and implement alternatives, in 2012 and 2016 US Environmental Protection Agency published a guideline for waving acute dermal toxicity tests 6/29/2020 39
  40. 40. Animal ethics, Animal rights, Anti-vivisection • Health Charities Abuse https://www.citizenthought.net/Animal_Ethics_Animal_Rights.html#Pain Back Bill Maher (American comedian) has given the Unv. of Wisconsin–Madison (UW) a wake-up call- literally. 6/29/2020 40
  41. 41. Animal ethics, Animal rights, Anti-vivisection • Descartes, Darwin, and Vivisection https://www.citizenthought.net/Animal_Ethics_Animal_Rights.html#Pain No escape from Darwin's Hell Back Descartes (1596-1650) ingloriously associated with vivisection and the abuse of animals. Darwin (1809- 1882) credited animals with feeling. 6/29/2020 41
  42. 42. Animal ethics, Animal rights, Anti-vivisection • Peter Singer and Animal Rights https://www.citizenthought.net/Animal_Ethics_Animal_Rights.html#Pain Peter Albert David Singer In 1975, The Australian philosopher Peter Singer contributed an influential counter-thesis to the laboratory abuse of animals. Back 6/29/2020 42
  43. 43. Animal ethics, Animal rights, Anti-vivisection Silver Spring monkeys The Silver Spring monkeys were 17 wild-born macaque monkeys from the Philippines who were kept in the Institute for Behavioral Research in Silver Spring, Maryland. • 1981: People for the Ethical Treatment of Animals (PETA) • 1985: Amendment in 1985 to the Animal Welfare Act https://en.wikipedia.org/wiki/Silver_Spring_monkeys Back 6/29/2020 43

×