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100120L - ETHICS OF RESEARCH ON ANIMALS

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Background material by Professor Omar Hasan Kasule Sr. for Year 6 Semester 1 Medical Students at KFMC FOM Riyadh on 20th January 2010.



1.0 ENJOINING KINDNESS TO ANIMALS
The prophet on many occasions enjoined kindness to animals. Saving animals from danger is a noble act. Cruelty to animals is inflicting pain, suffering, or death. It may also take the form of neglect of the animal. Cruelty and physical abuse of animals are prohibited. Branding animals in the face is prohibited. Beating animals was also prohibited. Cursing animals is prohibited. Sexual abuse of animals is prohibited and is considered a great sin.

2.0 WELFARE OF THE ANIMALS
Animals, like humans, have rights to enjoyment of life and good health. The prophet emphasized good and kind treatment of animals. The researcher must therefore minimize animal suffering. The animals must be shown kindness and respect. They should not be subjected to the psychological pain of seeing other animals in pain or being sacrificed. Pain must be minimized both during the experiment and when the animal is being terminally sacrificed. This is based on the legal requirement of slaughtering animals using a sharp knife and as quickly as possible to prevent pain and suffering. The long-term effects of the experiment on the animal must be considered and efforts made to decrease suffering and pain. The nutritional and medical needs of the animal must be taken care of before, during, and after the research.
3.0 PURPOSE OF ANIMAL RESEARCH
Animal research is undertaken for a variety of reasons. The most important is to spare humans from danger. This is done by carrying out the research in animals to establish preliminary findings which if promising will be the motivation for carrying out definitive research in humans. In this way humans are spared the risk of research that may have no useful follow-up in the future. Animal research plays another role in that it indicates the possible risk and side effects from the research as a prelude to human research.

4.0 RELEVANCE OF ANIMAL RESEARCH
The first conceptual issue that has to be resolved with regard to animal experimentation is whether results from animal research are relevant to humans and if relevant to what extent. Relevance establishes benefit; benefit to human life establishes a situation of necessity, dharuurat that legalizes subjecting animals to experiments that could involve permanent impairment or even death. There are two main arguments for the relevance of animal experiments to humans: (a) similarity of human and animal physiology and (b) biochemical unity of all life. The counter arguments could also be equally strong. Although human and animal physiology and biochemistry share many commonalities, findings from animal research cannot be directly transferred to humans; research on humans is still necessary for a definitive conclusion. Thus animal research is exploratory and not definitive; this is not a strong enough reason to subject the animals to pain, suffering and even death when the research has no direct or indirect benefit for the animals.  The issue of relevance cannot be considered in generalities. Each case has to be considered on its merits. There are some physiological systems for which given animal species are good models for human. Relevance could also depend on the nature of the agent tested and the expected findings.

5.0 PURPOSES OF THE LAW AND ANIMAL EXPERIMENTATION
5.1 OVER-VIEW
The position of the Law is that animal experiments are allowed if a prima facie case can be established that the result of the research is a necessity, dharuurat. Dharuurat under the Law is what is necessary for human life. The regulations of necessity require that no more than the absolute minimum necessary should be done. Animal research has definite risks for the animals that are not balanced by any benefits: pain, suffering, permanent injury, inhumane treatment and operations, and being killed (sacrificed). Thus use of animals in justifiable on the basis of human benefit and not any benefits that accrue to the animals. The risks to humans from animal research are minimal in the short term; long-term effects are difficult to fathom.

5.2 PURPOSE OF PROTECTION OF LIFE
Animal experimentation is allowed on the basis of searching for modalities of health promotion, disease prevention, or disease treatment that will maintain the body in the best health status thus fulfilling the legal purpose of protecting human life. Any animal experimentation whose purpose is to make products for use in industry or some other purpose not directly related to human health would therefore be offensive especially if it causes pain and suffering to the animal.

5.3 PURPOSE OF PROTECTION OF PROGENY
Animal experimentation is allowed if it is searching for better ways of treating infertility or better ways of maintaining the viability of he fetus both in utero and after birth because this would be fulfillment of the purpose of protecting human progeny. Animal experiments that aim at protecting animal progeny would also be allowed because animals provide food for humans, a necessity for continued human existence. Research aimed at animal reproduction for other purposes like breeding horses for racing would not be allowed if it causes pain and suffering to the animals.

5.4 PURPOSE OF PROTECTION OF THE MIND
Pharmacological research on animals for cures of mental illnesses is allowed because it contributes to the protection of the human mind. Also allowed are experiments that investigate effects of psychoactive substances on the nervous system. It is however prohibited to conduct animal experiments on effects of alcohol and drugs with view to guiding or encouraging people to take what can be established experimentally as safe levels. The position of the Law is that whatever affects the mind in large concentrations is prohibited even in minute doses.

5.5 PURPOSE OF PROTECTION OF WEALTH
Animal experimentation will be allowed if the purpose is to look for treatment modalities that are cheaper than available and equally effective cures. This will result in net saving of community or family resources; this is a purpose of the Law.

6.0 PRINCIPLES OF THE LAW AND ANIMAL EXPERIMENTATION
6.1 THE PRINCIPLE OF INTENTION
The basic principle is that each action is judged by the intention behind it. Those undertaking animal experimentation have a moral responsibility to ensure that their work is done for a purpose valid under the Law. Intentions are what matter and not literal interpretations of research objectives. It is possible to state good and acceptable objectives in a research protocol when the underlying intentions are different. Means are judged with the same criteria as the intentions. If the intention is wrong the means is wrong. Thus un-ethical animal research cannot be justified on the basis of some benefits at the end.

6.2 THE PRINCIPLE OF CERTAINTY
Doubts about the need for animal experimentation may arise. Animal experimentation is allowed on the basis that there is a need or necessity, dharuurat. It is often difficult in practice to establish necessity with certainty. Experimentation on a new treatment can be allowed only if there is evidence and not mere doubt about the effectiveness of the old treatment. In cases of doubt about usefulness of the research to human health, it is better to desist from any further animal experimentation and continue with the old treatment according to the principle that existing assertions should continue in force until there is compelling evidence to change them

6.3 THE PRINCIPLE OF INJURY
The basic principle is that injury, if it occurs, should be relieved. Animal experimentation to solve health problems is considered an effort to remove injury. Prevention of harm has priority over pursuit of benefit of equal worth. If the benefit from animal experimentation has far more importance and worth than the harm, then the pursuit of the benefit has priority. In this case we are talking about benefit and harm to human health and are not comparing human benefit to the harm caused to the animal because of the experimentation. If a definite human benefit can be proved, then harm to the animal is justifiable.

6.4 PRINCIPLE OF HARDSHIP
Hardship mitigates easing of the rules and obligations. Pain and suffering can be inflicted on the animal if there is a necessity that relates to human life and one of the 5 purposes of the Law. Necessity legalizes the prohibited. If any of the 5 necessities is at risk permission is given to commit an otherwise legally prohibited action. Committing the otherwise prohibited action should not extend beyond the limits needed to preserve the purpose of the Law that is the basis for the legalization. According to this principle the experimenter must take measures to minimize pain, suffering, and disability in the experimental animal. Necessity however does not permanently abrogate the experimental animal’s rights; it only legalizes temporary violation of rights. The temporary legalization of the prohibited action ends with the end of the necessity that justified it in the first place. The animal should be restored to its normal situation as soon as the experiment is concluded. As soon as alternative means of getting the research results are available, it becomes illegal to violate the right of the animal to enjoyment of a full and healthy life. Experimenters must guard against the slippery slope argument. Wanton and unnecessary violation of animal rights may be conducive to similar violation of human rights. Thus unnecessary and cruel animal experimentation may be prohibited or severely restricted under the principle of closing the door to potential evil.
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6.5 THE PRINCIPLE OF CUSTOM or PRECEDENT
The basic principle is that custom or precedent is a legal ruling or precedent. What is considered customary is what is uniform, widespread, and predominant. No animal experimentation should go beyond the limits of what is normally recognized as appropriate by consensus of leading researchers in the field.

7.0 DIFFERENCES AMONG ANIMALS
We have seen above that some animals are considered dangerous and must be killed. Use of such animals for research should therefore raise fewer ethical objections than other animals. Animals whose flesh is edible are preferably used in research. Use of animals that are haram like the pig should be avoided as much as possible and should be considered only in cases of dharurat. Small animals are preferably used instead of large animals. Wild animals are preferred to domestic animals. Attempts should be made to use tissues and cells instead of whole animals.