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Paper presented at the 12th Malaysian Medical Students Conference held at Kuantan on 19th June 2004 by Professor Dr Omar Hasan Kasule, Sr.
HISTORICAL BACKGROUND
Early humans experimented with several plants and by trial and error found some to be useful as medicines and others to be poisonous. These early experiments were not planned in a systematic way neither were they documented. Galen founded experimental medicine before 200 CE. Historical experiments were carried out by James Lind In 1747 on scurvy, Dr Edward Jenner in 1798 on small pox, and Goldberger in 1914 on pellagra. Community trials were carried out on vitamin C, the Salk and HBV vaccines, cardiac disease risk factors, and water fluoridation for dental caries. Clinical trials were on streptomycin in TB 1948, aspirin and vitamin C for cancer prevention, alpha-tocopherol and beta-carotene in lung cancer prevention in smokers.
Unethical experiments without informed consent were carried out in the 1940s, 1950s, and 1960s. The Nuremberg code of 1946 laid down rules on voluntary informed consent, unnecessary experiments, animal before human experimentation, physical and mental suffering, scientific qualification of researchers, freedom of subjects to withdraw, and stopping the investigation if patient are in danger. The Helsinki Declaration of 1964 incorporated the Nurenberg code. Its basic principles were: conformity generally accepted scientific principles, qualified researchers, risk benefit assessment, research subject welfare, and full disclosure before informed consent. The Nuremberg and Helsinki codes on experimentation did not stop all unethical research. They lack were neither laws enforceable by the state nor moral standards enforced by conscience. They are an unsuccessful attempt at bridging the secular divide between morality and public life.
Islam on the other hand looks at problems of human experimentation as purely legal issues. The Law provides adequate guidelines and safeguards. Islamic Law, unlike western law, incorporates morality in its fabric. There is therefore no need to have special ethical codes outside the Law.
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.
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.
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.
OUTSTANDING ETHICO-LEGAL ISSUES
Research on fetal human tissues may encourage abortion. Cadaver dissection and post mortem examination are permitted under necessity. 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.