Professor Omar Hasan Kasule Sr. 20th June 2010.
Q1. List and describe the traditional criteria of death
A1. There are 3 traditional criteria of death: respiratory failure, cardiovascular failure, and Neurological failure / coma. Respiratory failure (failure to deliver oxygen to tissues) is followed by death of tissues due to oxygen deprivation. In cardio-vascular failure, tissues are not perfused sufficiently with blood that carries food and oxygen as well as takes away tissue metabolic waste. Cardiovascular failure has 2 components: cardiac failure and circulatory failure. Its common manifestation is hypotension. Coma results when blood circulation to the brain stops or is decreased, brain function is impaired and a common manifestation of this is persistent impairment of consciousness called coma.
Q2. Explain the limitations of traditional criteria of death
A2. In general death is defined as irreversible loss of the integrated functioning of the organism. Technological developments in intensive care units have blurred the demarcation between life and death that was taken for granted before. Many unconscious people with no cardiac or respiratory functions can be kept apparently alive on artificial life support. The increase in transplantation has given momentum to the need to develop new criteria for death. This is because organs have to be harvested quite early in the death process to prevent them from further degeneration. The dilemma of modern medical technology is that it can ‘take over’ the command and control functions of the brain by continuing bodily functions after death of the brain. This gives rise to many ethico-legal issues the central one being the contrast between ‘supporting life’ versus ‘a dead corpse with a beating heart’. It seems that the motivation to use brain death as criterion of death was motivated by the need to have a very early declaration of death so that organs can be harvested before they deteriorate further.
Q3. Define brain death
A3. Death occurs with irreversible loss of function of the whole brain. The brain is very sensitive to injury and it has no potential for recovery or replacement after severe injury. Irreversible death of the brain will in time result in the death of all other organs because the brain is the command, coordination, and communication center of the bodily functions. Death of the brain manifests as loss of consciousness and all intellectual functions (cognition, memory, thought, and sensory perception) as well as loss of vital physiological functions like breathing and blood circulation.
Q4. Describe the persistent vegetative state (PVS)
A4. PVS is a state of higher brain death with lack of intellectual, emotional, memory, and other functions associated with a functioning cerebral cortex. Patients in PVS have a flat EEG of the cerebrum. They are not aware of who they are and where they are. They carry out movements but these are purposeless and are not coordinated. They have no sensory or language functions. They retain automatic cranial and spinal reflex response on stimulation. They can also produce meaningless sounds. Because of intact brain stem and hypothalamic function, they retain autonomic functions of swallowing, coughing, gagging, sucking, and gastro-intestinal movements. They can swallow food and drink on their own or assisted by means of nasogastric tubes. Patients can survive in the vegetative state for up to 30 years.
Q5. Explain brain stem death as the legal definition of legal death
A5. The shari’at definition of death is guided by the fiqh concept of custom or precedent, ‘aadat. Thus the shariat definition can change from time to time and also from place to place depending on the level of technological development. Since the invention of life support technology, a consensus is developing to use whole brain death (in essence brain stem death) as a necessary and sufficient criterion of death. Brain stem death has the same effect as complete decapitation. Just as life support measures are useless for a decapitared person, they are useless for a person with brain stem death. There is no consensus that cerebral death (higher brain death) with a functioning brain stem is an acceptable definition of legal death. In the absence of time and financial pressures, the traditional cardio-respiratory criteria of death remain operational.
Q6. Explain the pros and cons of research on animals
A6. Animal research is undertaken for a variety of reasons. The most important is to spare humans from danger. Animal research plays another role in that it indicates the possible risk and side effects from the research as a prelude to human research. There are several problems with research on animals. Results from animal research are relevant to humans and if relevant to what extent. There is similarity of human and animal physiology. 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.
Q7. Explain criteria used in selecting an animal for research
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.
Q8. Explain the main principles of the Nurenberg and Helsinki
A8. Unethical experiments without informed consent were carried out in the 1940s, 1950s, and 1960s. The Nuremberg
Q9. Discuss informed consent in research on humans
A9. 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.
Q10. List the 5 most important ethical issues in clinical practice
A10. Issues of consent (informed consent, decisions for the incapacitous/incompetent, consent for children), Issues of confidentiality and disclosure m(disclosure of surgical risk, confidentiality, truth telling), Physician’s dilemmas (conscience, dual responsibilities), Start of life issues (abortion, maternal-fetal conflict), Reproduction: contraception, genetics, End of life issues (organ transplantation, euthanasia, life support).
Q11. List and describe 2 of the 6 ethical theories according to Beauchamp and Childress (1994) A11. (a) According to the utilitarian consequence-based theory, an act is judged as good or bad according to the balance of its good and bad consequences. Utilitarianism means attaining the greatest positive with the least negative. This theory has a problem in that it can permit acts that are clearly immoral on the basis of utility. (b) The obligation-based theory is based on Kantian philosophy. Immanuel Kant (1724-1804) argued that morality was based on pure reasoning. He rejected tradition, intuition, conscience, or emotions as sources of moral judgment. A morally valid reason justifies action. Acts are based on moral obligations. The problem with the Kantian theory is that it has no solution for conflicting obligations because it considers moral rules as absolute. (c) The rights-based theory is based on respect for human rights of property, life, liberty, and expression. The individual is considered to have a private area in which he is master of his own destiny. Rights may be absolute or relative. A positive right is one that has to be provided to the individual. A negative right is one that assures prevention of or protection from harm. There is a complex inter-relation between rights and obligations. Individual rights may conflict with communal rights. The problem of the rights-based theory is that emphasis on individual rights creates an adversarial atmosphere. (d) According to the community-based theory, ethical judgments are controlled by community values that include considerations of the common good, social goals, and tradition. This theory repudiates the rights-based theory that is based on individualism. The problem with this theory is that it is difficult to reach a consensus on what constitutes a community value in today’s complex and diverse society. (e) The relation-based theory gives emphasis to family relations and the special physician-patient relation. For example a moral judgment may be based on the consideration that nothing should be done to disrupt the normal functioning of the family unit. The problem of this theory is that it is difficult to deal with and analyze emotional and psychological factors that are involved in relationships. (f) The case-based theory is practical decision-making on each case as it arises. It does have fixed philosophical prior assumptions.
Q12. List and describe the 5 ethical principles according to Beauchamp and Childress (1994)
A12 The Principle of Autonomy is the power of the patient to decide on medical procedures. (b) The Principle of Non-malefacence is avoiding causation of harm. (c) The Principle of Beneficence is the providing benefits and balancing them against risks and costs. (d) The principle of justice is distribution of benefits, costs, and risks fairly. Application of the above principles requires ethical rules.
Q13. Explain the maqasid al shari"at as the theory of Islamic medical ethics
A13. The Islamic theory of ethics is based on the 5 general purposes, maqasid al shari'at[i]. They are protection, preservation, and promotion of religion, life & health, the progeny, the intellect, and resources. With clear and robust purposes and operating under various sources of the Law, Muslims can analyze and resolve all ethical issues from within the Law and do not therefore need another discipline outside the Law. For any medical issue to be considered ethical, it must fulfill or not violate one or more of the 5 purposes that constitute the Islamic Theory of Ethics. All ethical violations can be related to violation of one or more of the 5 purposes.
Q14. Explain 2 of the 5 principles of shari'at as sources of ethical principles
A14. In practice the theory of purposes of the Law is supplemented by ethical principles based on the 5 major fiqh principles[ii]. These principles are axioms that make rational decisions on contentious ethico-legal issues systematic and robust. It must be emphasized that they are not themselves a source of law but they make the understanding of the law easier. (a) The principle of intention, qa’idat al qasd: requires pure and sincere intentions in all medical decisions and procedures. The intentions should be fully in the patient's interests; any other considerations can be considered unprofessional. Real intentions are internal and only the practitioner knows what is in his or her heart. This implies that a professional must consult his inner conscience. It is possible to do wrong things by the book and nothing but conscience can prevent such transgression. (b) The principle of certainty, qa’idat al yaqeen, requires that medical decisions are evidence-based. Subjective feelings are not acceptable. The issue that arises is the definition of the degree of certainty. It is impossible to reach absolute certainty and if that were the standard, few medical interventions would be carried out. Interventions can be undertaken if the evidence is preponderant. In emergencies interventions can be undertaken on imperfect evidence but in all circumstances we must attempt to reach as high a degree of certainty as is possible. (c) The principle of injury, qa’idat al dharar, requires careful balancing of the benefits of an intervention against its side effects. If the benefits clearly exceed the side effects then the intervention is undertaken. If the side effects clearly exceed the benefits in worth, a more conservative approach is advised. If the benefits and the side effects are equal in worth, it is best not to undertake the intervention unless there are specific extenuating circumstances. If confronted with two choices, both being risky, it is advised to undertake the one with the lesser risk. This reflects the general conservative trend of Islamic law. (d) The principle of hardship, qaidat al mashaqqat, allows medical procedures and therapies that are normally prohibited, haram, if there is a necessity, dharurat, of saving life. This is a great enabling principle that makes the practice of medicine in difficult circumstances. It is based on the premise that protection of life is supreme and supersedes many provisions of the Law. (e) The principle of custom or precedent, qaidat al urf, is the basis for treating generally acceptable protocols and procedures as legally binding on every practitioner. A physician should practice according to what is considered customary. This principle protects patients from adventurous treatments.
Q15. The term 'patient autonomy' means
A. each patient has individual characteristics?
B. a patient’s own choice of treatments and possible outcomes must be respected?
C. patients must be regarded as valuable human beings?
D. the patient must automatically follow the best advice given to him?
Q16. Running your own clinic/ dispensary, you are asked for a certain treatment by a fifteen year old boy. However you aware that his parents violently disagree with the treatment, which however in your opinion will increase the boy’s ability to benefit from his schooling. Reasoning with the parents has had no effect. Do you
A. contact several colleagues in the same specialty and ask them what they would do?
B. seek legal advice?
C. merely proceed with the treatment?
D. ask the boy to go elsewhere?
Q17. Explain the ethico-legal position about in vivo insemination, al talqiih al istinaa’e al daakhilii
A17. Artificial intra-uterine insemination with husband’s sperm, talqiih sina’i dhaati is permitted by the Law provided safeguards are taken to ensure that spermatozoa do not get mixed up in the laboratory or the clinic. The Law prohibits artificial in vivo insemination of a wife with donated sperm from a strange man or in vivo insemination of a strange woman with the husband’s sperm because that would violate the principle of preserving lineage, hifdh al nasab.
Q18. Explain the ethico-legal position about in vitro fertilization, al talqiih al istinaa’e al khaariji:
A18. The Law permits in vitro fertilization (IVF) if the sperm and ovum are from legally wedded husband and wife and the zygote is implanted in the same wife. All other forms of IVF involving ovum or sperm donation are prohibited because they violate the principle of hifdh al nasab.
Q19. List 5 ethico-legal issues that arise in assisted reproduction
A19. Several ethical issues arise in assisted reproduction: disclosure of infertility before marriage, artificial insemination after death of the husband, legality of masturbation for obtaining sperms, paternity and maternity of children born of illegal procedures, disposal and use of unused fertilized ova, sex selection and selective fetal reduction, embryo splitting, developing embryos for purposes other than their use in assisted reproduction, using embryos to produce a clone, using fetal gametes for fertilization, trans-species fertilization (mixing human and animal gametes), mixing of gametes or embryos of different parentage to confuse biological parentage, implanting the embryo in a non-human species uterus, replacing the nucleus of the embryo, embryo flushing, commercial trading in sperms, gametes, or embryos, and use of gametes from cadavers. All these can be resolved by using the relevant Purpose of the Law and consideration of the specific circumstances of each case.
Q20. Discuss ethico-legal issues involved in sex selection, al tahakkum fi al jins
A21. Sex preference is natural. Gender selection is by Allah and no human efforts will contradict Allah’s will. Human efforts can only succeed if Allah wills so. Efforts to get an offspring of a particular gender are in general permissible because the dua that prophets made are considered part of the effort. Discussion centers on the methods used because some are permitted while others are prohibited. Natural methods (selecting days of copulation before and after ovulation & changing upper vaginal chemistry artificially) are not effective. Rulings are still being discussed on methods such as separation of male and female sperms by centrifuging followed by in vivo insemination and gender pre-selection and implanting only zygotes of desired gender in in vitro fertilization. Some jurists consider sex selection permissible for the couple but are prohibited when they are part of community or national policy. There are long-term consequences that must be considered. Severe gender imbalance will threaten marriage and lead to family breakdown. Eventually the purpose of the law to preserve progeny, hifdh al nasl, cannot be fulfilled.
Q20. Discuss ethico-legal issues involved in genetic testing and genetic counseling
Q20. Genetic testing is used for disease diagnosis, pre natal diagnosis, genetic screening, criminal investigations, and settling paternity issues. Genetic counseling is carried out before and after genetic testing. The objective of counseling before testing is to provide information about genetic disorders and the risks of disease to individuals and families so that they may make informed decisions. Pre marital counseling is recommended for close relatives. Genetic testing can be carried only if there is informed consent of competent adults. Genetic data is confidential and cannot be disclosed except following guidelines.
