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Presented at a seminar on the implementation of Islamic values in medical faculty curricula held at the Faculty of Medicine and Health Sciences Syarif Hidayatullah Islamic University Jakarta 16-18 November 2007 by Professor Dr Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) WEB: http://omarkasule.tripod.com
ABSTRACT
Islam encourages research to prevent and cure disease and considers it part of ijtihad. Ethico-legal issues relating to research with no direct textual, nass, guidelines can be resolved by reference to the higher purposes of the Law, maqasid al shari’at, and the principles of the Law, qawa’id al fiqh. For research to be ethical it must be conformity with the 5 purposes of the law: preservation of diin, hifdh al ddiin; preservation of life, hifdh al nafs; preservation of progeny, hifdh al nasl; preservation of intellect, hifdh al ‘aql; and preservation of resources, hifdh al maal. Specific guidelines on research procedures can be derived from the 5 principles of the Law. The principle of intention, qa’idat al qasd, enjoins good and beneficial intentions of the research. The principle of certainty, qa’idat al yaqeen, enjoins research on empirical evidence and not mere whims. The principle of injury, qa’idat al dharar, enjoins that benefits of research should outweigh the risks. The principle of hardship, qa’idat al mashaqqat, enjoins research procedures under the doctrine of necessity, dharurat, that would otherwise be prohibited. The principle of custom, qa’idat al ‘aadat, enjoins following standard research procedures.
1.0 RESEARCH IN ISLAM
1.1 Search for knowledge
Islam puts emphasis on seeking knowledge.. Islam encourages using knowledge. There is no consideration for knowledge not accompanied by practical application. Tadabbur involves critical observation and consideration of information. Humans are encouraged to derive empirical knowledge from observation of the earth and their own bodies. The observation referred to is serious and deliberative, al nadhar bi al tadabbur. Tadabbir is required even with the holy text of the Qur’an. Thought can be based on empirical observation. The observation can be of the earth. It can also be by observation of the human body. Islam encourages active intellectual effort in looking for knowledge.
1.2 Scientific research as a form of ijtihad
The process of ijtihad is exertion of maximum intellectual effort to discover the truth or understand the relation between truths. Ijtihad is also used to discover and identify falsehoods. There are parallels between the tools of ijtihad used by classical Muslim scholars and the processes of reaching conclusions in modern scientific research. The process of inductive logic used in medical research is the same as qiyaas usuuli used by scholars of the methodology of the Law. The process of reaching a scientific consensus is similar to the process of scholarly consensus, ijmaa. The prophet taught that there is a cure for every disease. There is an injunction to search for cures by processes of medical research.
3.0 RESEARCH ON HUMANS
3.1 Purposes of The Law In Human Experimentation
The Islamic ethical theory on research is based on the 5 purposes of the Law, maqasid al shari’at, religion, life, progeny, the mind, and wealth. If any of the 5 necessitiesis at risk permission is given to undertake human experiments that would otherwise be legally prohibited. Therapeutic research fulfills the purpose of protecting health and life. Infertility research fulfils the purpose of protecting progeny. Psychiatric research fulfills the purpose of protecting the mind. The search for cheaper treatments fulfills the purpose of protecting wealth.
3.2 Principles Of The Law In Human Experimentation
The 5 principles of the Law guide research. Research is judged by its underlying and not expressed intentions. Research is prohibited if certainty exists about beneficial existing treatment. Research is allowed if benefit outweighs the risk or if public interest outweighs individual interest. If the risk is equal to the benefit, prevention of a harm has priority over pursuit of a benefit of equal worth. The Law chooses the lesser of the two evils, injury due to disease or risk of experimentation. The principle of custom is used to define standards of good clinical practice as what the majority of reasonable physicians consider as reasonable. Under the doctrine of istishaab, an existing treatment is continued until there is evidence to the contrary. Under the doctrine of istihsaan a physician can ignore results of a new experiment because of some inclination in his mind. Under the doctrine of istislaah preventing a harm has priority over obtaining a benefit.
3.3 Informed Consent
Informed consent by a legally competent research subject is mandatory. Informed consent does not legalize risky non-therapeutic research with no potential benefit. It is illegal to force participation of the weak (prisoners, children, the ignorant, mentally incapacitated, and the poor) in clinical trials even if they sign informed consent forms.
3.4 Outstanding Ethico-Legal Issues
Research on fetal human tissues may encourage abortion. Cadaver dissection and post mortem examination are permitted under the necessity, dharurat, of knowledge and research. Use of human bodies in auto crass experiments violates human dignity. Genetic experiments may cause diseases hitherto unknown. The Law allows research on ageing as long as the aim is not prolongation of life or preventing death because those aspects are under Allah’s control. Research on ageing should be directed at improving the quality of life for the elderly and not seeking immortality for them.
4.0 RESEARCH ON ANIMALS
4.1 Enjoining Kindness To Animals And Prohibition Of Cruelty
The prophet enjoined kindness to animals. Saving animals from danger is a noble act. There is reward for kindness to animals. Cruelty and physical abuse of animals are prohibited. There is severe punishment is reserved for cruel treatment if animals. Face branding, beating, cursing, sexual abuse, sexual abuse, and wanton killing of animals were forbidden by the Prophet.
4.2 Animal Research: Purpose And Relevance
The purpose of animal research is to spare humans from risk. Findings in animals are relevant to humans because of similarities in physiology and biochemistry. However findings in animals cannot be directly transferred to humans; research on humans is still necessary for a definitive conclusion. Animal research is exploratory and is not definitive.
4.3 The Law And Animal Experimentation
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, al dharurat tuqaddar bi qadiriha. 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 taskhiir 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. The purposes and principles of the Law can be used to analyze all legal aspects of animal experimentation.
4.4 Outstanding Ethico-Legal Issues
There are limits to taskhiir. Humans were not given a carte blanche to exploit animals in any way they liked. They have to conform to the Law and moral guidelines. If the results of animal experimentation will lead to protection of human life, then research is allowed to proceed because then it is a necessity. This is similar to killing animals for food, a necessity for human life. If research is for general scientific curiosity unrelated to any tangible human benefit, then it is beyond the authorization of taskhiir.
There are differences among animals. Animals considered dangerous and must be killed. Use of such animals for research should therefore raise fewer ethical objections than other animals. All types of animals used in research cannot be subjected to unnecessary pain and suffering. 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. Animals, like humans, have rights to enjoyment of life and good health. The researcher must therefore follow Islamic etiquette to minimize animal suffering.
The basmalah is said at the start of an animal experiment, similar to slaughter of animals for food, in recognition of the fact that the experiment is carried out with the permission of the creator under the requirements of taskhiir. 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.