Guidelines on animal research review

Webinar on Research Ethics in Preclinical studies
28-06-2020 (2.30 – 4.00 MYT)

Principles on use of animals in the
experiments & Guidelines on the animal
Ethics application
6/29/2020 2

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

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

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

• 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
6/29/2020 6

• 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

• PRINCIPLES – III
• Animal experiments should be
undertaken only after due
consideration of their
relevance for human or
animal health.
6/29/2020 8

• 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.
6/29/2020 9

• 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.
6/29/2020 10

• 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.
6/29/2020 11

• 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.
6/29/2020 12

• 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.
6/29/2020 13

• 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.
6/29/2020 14

• PRINCIPLES – X
• The best possible living conditions should be
maintained for animals kept for biomedical purposes.
6/29/2020 15

• 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.
6/29/2020 16

Investigator responsibilities
6/29/2020 17

• 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

• 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.
Baumans V. Use of animals in experimental research: an ethical dilemma?. Gene therapy. 2004 ;11(1):S64-6.
6/29/2020 19

• 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?
Baumans V. Use of animals in experimental research: an ethical dilemma?. Gene therapy. 2004 ;11(1):S64-6.6/29/2020 20

• Animal users need to be aware that animals
are living beings just as humans are living
beings
Ethical Principles and Guidelines for the Use of Animals. National Research Council of Thailand 1999.
6/29/2020 21

• Animal users must keep detailed data and
records of animal experiments
Distribution of vertebrate
animal species used for
research, testing and
education.
Ethical Principles and Guidelines for the Use of Animals. National Research Council of Thailand 1999.
6/29/2020 22

• 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

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

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

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

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.
2020
6/29/2020 28

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.
2020
6/29/2020 29

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.
20206/29/2020 30

Important points
• Disposal of euthanized laboratory animals
must be conducted in accord with all relevant
legislation.
2020
6/29/2020 31

Animal welfare initiatives in selected
countries in Asia
6/29/2020 32

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

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

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

Please fill the feedback form
https://forms.gle/s1Yi6XvHJzGuMjQp7
6/29/2020 37

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

• The Cosmetic 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

• Health Charities Abuse
Back
Bill Maher (American
comedian) has given the
Unv. of Wisconsin–Madison
(UW) a wake-up call-
literally.
6/29/2020 40

• Descartes, Darwin, and Vivisection
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

• Peter Singer and Animal Rights
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

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

Guidelines on animal research review

Recomendados

Recomendados

Mais conteúdo relacionado

Mais procurados

Mais procurados (20)

Semelhante a Guidelines on animal research review

Semelhante a Guidelines on animal research review (20)

Mais de Subramani Parasuraman

Mais de Subramani Parasuraman (20)

Último

Último (20)

Guidelines on animal research review