1. The ethical issues in experimental animal researches
Abdurrahman Aksoy, DVM, PhD Dean of Veterinary Medicine Faculty Ondokuz Mayıs University/TURKEY

2. 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.

3. 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.

5. Should animals be used as research subjects?

6. Absolutely No Animal Research - Why?
Animals have rights!
Animals surely deserve to live their lives free from suffering and exploitation.
Animals are not ours to:
eat
wear
experiment on
use for entertainment
abuse
People for the Ethical Treatment of Animals

7. 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

8. Benefits as a Result of Animal Research
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.

9. 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

10. The Legal Obligations

11. 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)

14. 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.
Institutions must be registered with the USDA if they use animals for teaching or research. Includes animal care program oversight, animal care and use committee membership, authority, functioning and responsibilities, attending vet’s authority and responsibilities, feeding, caging, housing, sanitation, transportation of animals.

15. 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.

16. 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.

17. 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
It is an obligatory issue to be approved from local animals ethics comittebefore to conduct and experimental animal research

18. Legislations and recent situation in Africa on Experimental Animal Studies

21. 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)
rationale and purpose of the proposed use of animals
a clear and concise sequential description of the procedures involv- ing the use of animals that is easily understood by all members of
the committee
availability or appropriateness of the use of less invasive proce-
dures, other species, isolated organ preparation, cell or tissue cul-
ture, or computer simulation (see Appendix A, Alternatives)
justification of the species and number of animals proposed; when- ever possible, the number of animals and experimental group sizes should be statistically justified (e.g., provision of a power analysis;
see Appendix A, Experimental Design and Statistics)
Copyright © National Academy of Sciences. All rights reserved.
Guide for the Care and Use of Laboratory Animals: Eighth Edition
26 GUIdE FOR ThE CARE ANd USE OF LAbORATORy ANIMALS
unnecessary duplication of experiments
nonstandard housing and husbandry requirements
impact of the proposed procedures on the animals’ well-being
appropriate sedation, analgesia, and anesthesia (indices of pain or
invasiveness might aid in the preparation and review of protocols;
see Appendix A, Anesthesia, Pain, and Surgery)
conduct of surgical procedures, including multiple operative
procedures
postprocedural care and observation (e.g., inclusion of post-treat-
ment or postsurgical animal assessment forms)
description and rationale for anticipated or selected endpoints
criteria and process for timely intervention, removal of animals
from a study, or euthanasia if painful or stressful outcomes are
anticipated
method of euthanasia or disposition of animals, including planning
for care of long-lived species after study completion
adequacy of training and experience of personnel in the procedures
used, and roles and responsibilities of the personnel involved
use of hazardous materials and provision of a safe working
environment.

22. EU Member States
The total number of animals used for experimental and other scientific purposes in 2011 was11,5 million.
This is a reduction of over half a million animals used in the EU from the number reported in 2008.

23. Canada
3.38 million animals used in experiments (2012)

24. Australia
(2011)

25. United Kingdom
3.7 million experiments on animals (2011)

26. Turkey
(2012)
(2013)

27. 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.

29. 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.

30. 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

31. The number of laboratory animals used
* 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.

32. 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

33. 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.

34. Toxicological Replacement methods
The European Centre for the Validation of Alternative Methods (ECVAM)
Interagency Coordinating Committee on the Validation of Animal Models (ICCVAM)
Coordinating Committee on the Validation of Animal Models (ICCVAM)
A number of organisations around the world are working towards the development and validation of replacement methods. Many of them have informative web sites:

35. Toxicity Replacement Testing
National Library of Medicine (NLM) (USA)- ALTBIB and TOXNET
and
INVITTOX :This is a direct and concise site listing numerous in vitro protocols for toxicity testing.
ECOTOX: The ECOTOX (ECOTOXicology) database provides single chemical toxicity information for aquatic and terrestrial life.
MECI/ MEMO
INVITRODERM: Database of some 200 references to in vitro alternatives to the use of animals in skin irritation testing.
NLM publishes a regular annotated bibliography on alternatives to animal testing that incorporates access to nine different toxicology-related databases. The ECOTOX (ECOTOXicology) database provides single chemical toxicity information for aquatic and terrestrial life. ECOTOX is a useful tool for examining impacts of chemicals on the environment. Peer-reviewed literature is the primary source of information encoded in the database. Pertinent information on the species, chemical, test methods, and results presented by the author(s) are abstracted and entered into the database. Another source of test results is independently compiled data files provided by various United States and International government agencies. Prior to using ECOTOX, you should visit the "About ECOTOX/Help" section of this Web Site. In addition, it is recommended that you consult the original scientific
These databases arose out of the MEIC study (Multicentre Evaluation of In Vitro Cytotoxicity) in which the same 50 chemicals were tested by a large number of laboratories worldwide in their own in vitro systems. The MEIC database contains this in vitro data together with information on the methodology of the assays used to generate the data. Both the MEIC data base and the associated MEMO database contain published and unpublished human toxicity data for the same substances, obtained from a large variety of sources.

36. Animal’s welfare breeding (including the use of wild-caught animals);
transportation;
housing;
husbandry and care;
handling;
restraint;
identification;
Animals may experience adverse physiological and psychological states that can result from a range of factors. We now give systematic consideration to a number of areas that influence an animal’s welfare independent of, or in addition to, specific experimental procedures. These include:

37. 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.

38. Happy scientist!!!

39. 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.

40. 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.

41. Guidelines and Regulations used to ensure animals are humanely treated
Guide for Care and Use of Laboratory Animals
The Guide for Care and Use of Agriculture Animals in Agricultural Research and Teaching
Report of the AVMA Panel on Euthanasia
Guidelines for the Use of Fish in Research
USDA Animal Care and Use Policies
Animal Welfare Act Regulations
Public Health Services Policy ….

46. Questions?