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The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY [email protected]

The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY [email protected]

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Page 1: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

The ethical issues in experimental animal researches

Abdurrahman Aksoy, DVM, PhDDean of Veterinary Medicine FacultyOndokuz Mayıs University/[email protected]

Page 2: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Definitions: Laboratory animals or animals: Any

vertebrate animal (e.g., traditional laboratory animals, agricultural animals, wildlife, and aquatic species) produced for or used in research, testing, or teaching.

Animal use: The proper care, use, and humane treatment of laboratory animals produced for or used in research, testing, or teaching.

Page 3: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Animal experimenting

Where scientists experiment on animals such as:

Rats, Mice, guinea pigs Other animals get tested on as well, Dogs, cats, monkeys, gorillas, hamsters etc.

Page 4: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr
Page 5: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Should animals be used as research subjects?

Page 6: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Absolutely No Animal Research - Why?

1. Animals have rights!

2. Animals surely deserve to live their lives free from suffering and exploitation.

3. Animals are not ours to:· eat· wear · experiment on · use for entertainment · abuse People for the Ethical Treatment of Animals

http://www.peta.org/

Page 7: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Benefits as a Result of Animal Research

Since the early 1900’s life expectancies have increased from 47 to about 77.

Economic Impact – the medical industry alone recognized about a 57 trillion dollar savings in the 70’s and 80’s

Drug treatments, vaccines and surgical procedures have been developed to improve the quality of life for animals

Page 8: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Thousands of people saved from diseases such as: swine flu, malaria and also cancer treatment.

Powerful medical drugs and tratments are all tested on animals before given to humans

The experimenting don’t always work because of the living organisms can be unpredictible.

Benefits as a Result of Animal Research

Page 9: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Basel declaration defends animal research‘‘Without research using animals, it will not be possible to overcome the social and humanitarian challenges posed by these problems. Despite new and refined alternative methods, animal experiments will remain essential in the foreseeable future for biomedical research.’’

29 November 2010

Page 10: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

The Legal Obligations

Page 11: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Legislations

There are countries chiefly in South America, Africa and Asia where there is no national animal welfare legisltaion and no national control over animal experiments.

Tanzania is one of the few(Kenya, south-Africa, Uganda) African countries to have legislation.(Tanzanian’s Animal Welfare Act 2008)

Page 12: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr
Page 13: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr
Page 14: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

United States Of America Animal Welfare Act (AWA) 1966, amended in most recently in 2007 Regulates use of dogs, cats, hamsters, guinea pigs,

rabbits, farm animals, marine mammals, and non-human primates in research and teaching (rats, mice, and birds are currently not regulated, but probably will be in the near future).

The regulations cover the procurement, handling, treatment, and transportation of these animals.

Page 15: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

EU Legislation

Since 1986, the EU has had in place specific legislation covering the use of animals for scientific purposes. On 22 September 2010 the EU adopted Directive 2010/63/EU which updates and replaces Directive 86/609/EU. The aim of the new Directive is to strengthen legislation, and improve the welfare of those animals still needed to be used as well as to firmly anchor the principle of Three Rs. Directive 2010/63/EU took full effect on 1 January 2013.

Page 16: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Turkey Legislation

Turkey is recently took (15 March 2014) in effect new regulations for experimental animal use which update and replaces of regulations published in 2006.

Page 17: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

The Animal Ethics Committee (Central and Local’s) Reviews animal use proposals Conducts semi-annual inspections of

animal facilities Organise Investigates concerns about

animal care and use Can suspend research or teaching

activities when a major violation has occurred

Page 18: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Legislations and recent situation in Africa on Experimental Animal Studies

Page 19: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr
Page 20: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr
Page 21: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Use of animals for science

1.28 million animals used in experiments (excluding rats, mice, birds, reptiles, amphibians, and agricultural animals used in agricultural experiments), plus an estimated 100 million mice and rats (2012)

Page 22: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

EU Member States

The total number of animals used for experimental and other scientific purposes in 2011 was11,5 million.

Page 23: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Canada

3.38 million animals used in experiments (2012)

Page 24: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Australia

4.930.466 (2011)

Page 25: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

United Kingdom

3.7 million experiments on animals (2011)

Page 26: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Turkey

173.152 (2012) 167.634 (2013)

Page 27: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

The use of animals in basic biological research:

Behavioral studies Physiological studies Studies on development Genetic studies The development of research tools and

techniques, for example: antibody production, biopharmaceuticals and cloning.

Page 28: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr
Page 29: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

The Three Rs (3Rs) Described by W.M.S. Russell and R.L. Burch in 1959.The 3Rs are;

Replacement : Which refers to the preferred use of non-animal methods over animal methods whenever it is possible to achieve the same scientific aims.

Reduction: which refers to methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals.

Refinement: which refers to methods that alleviate or minimize potential pain, suffering or distress, and enhance animal welfare for the animals used.

Page 30: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

When drafting an animal experiment protocol* The objective and necessity of the animal experiment

* Whether or not the animal experiment is unnecessary repetition

* Whether an in vitro experiment could be conducted or the animal could be replaced by a phylogenetically lower species (use of alternative methods)

* Whether a change could be made to a less invasive animal experimentation method.

* The species of laboratory animals used and the genetic and microbiologic quality

Page 31: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

* The number of laboratory animals used

* Educational and training experience of the researcher(s) and animal technicians.

* Reasons why special cages and rearing environment are required

* The anticipated disorders, symptoms and severity of pain resulting from experimental procedures

* Measures to alleviate pain when it is anticipated that the laboratory animal will suffer severe pain

* Whether major surgical procedures should be repeated

* Terminal treatment of laboratory animals (method of euthanasia, etc.)

* Issues concerning the occupational health and safety of the researcher(s) and animal technicians.

Page 32: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Three Steps of Experimental Animal Study

Before• Question/

problem• Hypothesis• Alternative• Animal

species• Route of

administration• Drug• Dose• Model

Experiment• Animal

welfare• Observation/

record• Endpoint

After

Euthanasia

Analysis

Results

Conclusion

Page 33: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Alternatives

Many alternatives to the use of animals have been developed, particularly in toxicity testing and teaching. Studies of systems in cell culture provide many opportunities of substitution for animal experiments.

The failure to use alternatives is too often caused by inertia, lack of funding, and reluctance to deviate from established methods. The use of alternatives must be rewarded and encouraged to ensure that the transition to alternatives is not impeded.

Page 34: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Toxicological Replacement methods The European Centre for the Validation of Alternative

Methods (ECVAM) http://ecvam.jrc.it/

index.htmandECVAMScienceInformationService http://ecvam-sis.jrc.it/ Interagency Coordinating Committee on the Validation of Animal Models (ICCVAM)

http://iccvam.niehs.nih.gov/Interagency Coordinating Committee on the Validation of Animal Models (ICCVAM)

http://ntp.server.niehs.nih.gov/htdocs/ICCVAM/ICCVAM.html

Page 35: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Toxicity Replacement Testing

National Library of Medicine (NLM) (USA)- ALTBIB and TOXNET http://toxnet.nlm.nih.gov/altbib.html and http://toxnet.nlm.nih.gov/ INVITTOX :This is a direct and concise site listing numerous in

vitro protocols for toxicity testing. http://embryo.ib.amwaw.edu.pl/invittox/list.html ECOTOX: The ECOTOX (ECOTOXicology) database provides

single chemical toxicity information for aquatic and terrestrial life. MECI/ MEMO

http://www.cctoxconsulting.a.se/ INVITRODERM: Database of some 200 references to in vitro

alternatives to the use of animals in skin irritation testing. www.invitroderm.com/

Page 36: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Animal’s welfare breeding (including the use of wild-caught

animals); transportation; housing; husbandry and care; handling; restraint; identification;

Page 37: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

An appropriate Endpoint

In experiments involving animals,

any actual or potential pain, distress, or discomfort should be minimized or alleviated by choosing the earliest endpoint that is compatible with the scientific objectives of the research.

Page 38: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Happy scientist!!!

Page 39: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

What do the regulations ensure?

That animals are used in research only when it’s absolutely necessary.

That when animals are used in research they are humanely treated.

Page 40: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

The Controversy Continues – Ethical responsibilities when using animals

People also have an ethical responsibility to respect and treat animals humanely

They also have an ethical responsibility to avoid or minimize the pain and distress animals endure

The Regulations and Policies help to ensure animals are treated humanely.

Page 41: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Guidelines and Regulations used to ensure animals are humanely treated

1. Guide for Care and Use of Laboratory Animals

2. The Guide for Care and Use of Agriculture Animals in Agricultural Research and Teaching

3. Report of the AVMA Panel on Euthanasia

4. Guidelines for the Use of Fish in Research

5. USDA Animal Care and Use Policies

6. Animal Welfare Act Regulations

7. Public Health Services Policy

8. ….

Page 42: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr
Page 43: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr
Page 44: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr
Page 45: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr
Page 46: The ethical issues in experimental animal researches Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY aaksoy@omu.edu.tr

Questions?