120519P - THE ISLAMIC PERSPECTIVE ON MEDICAL ETHICS AND RESEARCH

Abstract of paper to be presented at the 1st Universiti Sains Islam Malaysia International Conference on Medicine and Health held in Kuala Lumpur 19-20th May 2012 by Dr Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Department of Bioethics and Chairman Institutional Review Board King Fahad Medical City Riyadh, Saudi Arabia. EM: omarkasule@yahoo.com, WEB: http://omarkasule-tib.blogspot.com

1.0 OVERVIEW

·      Tauhid is the integrating paradigm that is the basis for everything

·      Governing doctrines: istikhlaf, taskhiir, isti'mar

·      Ethics relate to morality; Islamic medical ethics relate to Islam's moral system

·      Morality in Islam is defined by the Law in most cases

·      The scope of ethics in Islam is wider because Islam is a comprehensive system

·      The Theory of maqasid al shari'at provides an underlying basis for Islamic medical practice and research

·      We have the theoretical basis we need to develop the empirical experience guided by the qawa'id al shari'at

2.0 MORALITY: Divine source:

·      Morality and ethics in Islam are of divine origin.

·      Human consensus not deriving from divine legislation cannot be a source of binding ethical guidelines.

·      All what humans do it to apply the legal and moral teachings of Islam to practical situations.

3.0 LAW AND MORALITY:

·      In Islam the law is the expression and practical manifestation of morality.

·      In Islamic law Islamic law automatically bans all immoral actions as haram and automatically permits all what is moral or is not specifically defined as halal. European law does not have to permit all morally acceptable practices neither does it automatically ban all immoral activities.

4.0 LAW AND ETHICS:

·      Islamic Law is comprehensive

·      A combination of moral and positive laws.

·      Strictly speaking we should not talk about ethics when we use Islamic law because ethical issues are encompassed within the law.

5.0 ETHICS: STABILITY AND CHANGE:

·      The Islamic approach to ethics is a mixture of the fixed absolute and the variable.

·      There are fixed principles that set the parameters beyond which it is absolutely immoral to operate.

·       Within these parameters, consensus can be reached on specific moral issues.

6.0 GENERAL AND MEDICAL ETHICS:

·      Islam considers medical ethics the same as ethics in other areas of life. There is no special code for physicians.

·      What we call medical ethics is restating general ethical principles using medical terminology and with medical applications.

·      The medical ethical codes can be derived from the basic law but the detailed applications require further intellectual effort, ijtihad, by physicians.

7.0 RIGHTS AND OBLIGATIONS:

·      Discussion of ethics brings into focus conflicts between rights and obligations.

·      Rights may be positive or negative.

·      Rights are correlated to obligations.

·      Rights of one person may conflict with those of another one thus creating a moral dilemma.

·      A human is free to enjoy his or her rights to the maximum as long as that enjoyment causes no harm to some one else, la yajuuz li sahib haqq al yasta’amila haqqahu fima yadhurru ghayruhi.

8.0 EVOLUTION OF MEDICAL JURISPRUDENCE, tatawwur al fiqh al tibbi

·      First period (0 to circa 1370H): derivation directly from the Qur’an and sunnat.

·      The second period (1370-1420):  rulings on the many novel problems arising from drastic changes in medical technology were derived from secondary sources of the Law either transmitted (such as analogy, qiyaas, or scholarly consensus, ijma) or rational (such as istishaab, istihsaan, & istirsaal).

·      The modern period:

·      The failure of the tools of qiyaas to deal with many new problems led to the modern era (1420H onwards) characterized by use of the Theory of Purposes of the Law, maqasid al shari’at, to derive robust and consistent rulings. Ijtihad maqasidi is becoming popular and will be more popular in the foreseeable future.

9.0 THE THEORY OF MAQASID AL SHARI’AT

·      Not new but many people had not heard about it because its time had not yet come.

·      By the 5-6th centuries of hijra the basic work on the closed part of the Law derived directly from primary sources was complete.

·      Any further developments in the law required opening up new the flexible part of the law which necessitated discussion of the purposes of the law. It was at this time that pioneers of maqasid stated

10.0 PIONEERS OF MAQASID AL SHARI'AT

·      al Ghazali and his teacher Imaam al Haramain al Juwayni introduced the ideas that underlie the concept of maqasid al shari’at.

·      Other pioneers of the theory of maqasid al shari’at were Imaam an Haramain al Juwayni and his student Abu Hamid al Ghazzali (d. 505 H),

·      Sheikh al Islam Ahmad Ibn Taymiyyah (d. 728H) and his student Ibn al Qayyim al Jawziyyat (d. 751H).

·      The field of the purposes of the law witnessed little development until revived by the Abdalusian Maliki scholar Imaam Abu Ishaq al Shatibi in the 8th century AH who elaborated Ghazzali's theory.

11.0 HOW TO SOLVE AN ETHICO-LEGAL PROBLEM I: stages of rational systematic problem solving

·      The problem: analysis of the environment, recognition of the problem, identification of the problem, determination of the ownership of the problem, definition of the problem, classification of the problem, prioritizing the problem

·      Information: collection of information and making assumptions and forecasts

·      Authority: Apply laws, fatawa, and principles

·      Solution alternatives

·      Solution: selection of the best alternative, analysis of the impact of the chosen alternative, implementation, control of the implementation, evaluation of the results.

12.0 HOW TO SOLVE AN ETHICO-LEGAL PROBLEM II: authoritative sources

·      At the International Levels: The Fiqh Academy of the Organization of the Islamic Conference

·      At the National level: National Fatwa Council, laws and regulations

·      At the local level: Hospital ethics committee, local scholar, regulations

13.0 HOW TO SOLVE AN ETHICO-LEGAL PROBLEM III: solutions from classical sources

·      Qur’an provides general foundations and principles. May be qatui or dhanni. It is the primary source of law.

·      The sunnat comes second to the Qur'an as a primary source of law. The daliil of the sunnat may be definitive, qatai, or probable, dhanni. The sunnat is interpreted in the light of general principles of the Qur'an, the social situation in the prophetic era, and the Arabic language.

·      Ijma and Qiyaas are secondary sources of law. Ijma is agreement of all mujtahids existing at one time on a particular legal ruling based on nass. It can be ijma sariih or ijma sukuuti. Qiyas is use of a ruling of one matter for another matter when the two share the same illat.

·      Other secondary sources: (a) Custom or precedent, ‘aadat or 'urf, is a source of law if it does not contradict nass, there is ijma on it, and is in the public interest, and closes the door to evil. (b) Istishaab is continuation of an existing ruling until there is evidence to the contrary. (c) Istihsaan is preference for one qiyaas by a mujtahid. (d)  Istislaah is assuring a benefit or preventing a harm used in mu’amalat but not ‘ibadat.(e) Sadd al dhari'at is prohibition of an act that is otherwise mubaah because it has a high probability of leading to haram.

14.0 SOLUTIONS USING MAQASID AL SHARI'AT 1: Protection of ddiin

·      Protection of ddiin is essentially involves ibadat in the wide sense that every human endeavor is a form of ibadat.

·      Thus medical treatment makes a direct contribution to ibadat by protecting and promoting good health so that the worshipper will have the energy to undertake all the responsibilities of ibadat.

·      The principal forms of physical ibadat are the 4 pillars of Islam: prayer, salat; fasting, siyaam; pilgrimage, and hajj.

·      A sick or a weak body can perform none of them properly. Balanced mental health is necessary for understanding aqidat and avoiding false ideas that violate aqidat.

·      Thus medical treatment of mental disorders thus contributes to ibadat.

15.0 SOLUTIONS USING MAQASID AL SHARI'AT 2: Protection of life, hifdh al nafs

·      The primary purpose of medicine is to fulfill the second purpose of the shari’at, the preservation of life, hifdh al nafs.

·      Medicine cannot prevent or postpone death since such matters are in the hands of Allah alone. It however tries to maintain as high a quality of life until the appointed time of death arrives.

·      Medicine contributes to the preservation and continuation of life by making sure that the physiological functions are well maintained.

·      Medical knowledge is used in the prevention of disease that impairs human health.

·      Disease treatment and rehabilitation lead to better quality health.

16.0 SOLUTIONS USING MAQASID AL SHARI'AT 3:Protection of progeny, hifdh al nasl

·      Medicine contributes to the fulfillment of this function by making sure that children are cared for well so that they grow into healthy adults who can bear children.

·      Treatment of infertility ensures successful child bearing.

·      The care for the pregnant woman, perinatal medicine, and pediatric medicine all ensure that children are born and grow healthy.

·      Intra-partum care, infant and child care ensure survival of healthy children.

17.0 SOLUTIONS USING MAQASID AL SHARI'AT 4: protection of the mind, hifdh al ‘aql

·      Medical treatment plays a very important role in protection of the mind.

·      Treatment of physical illnesses removes stress that affects the mental state.

·      Treatment of neuroses and psychoses restores intellectual and emotional functions.

·      Medical treatment of alcohol and drug abuse prevents deterioration of the intellect.

  

18.0 SOLUTIONS USING MAQASID AL SHARI'AT 5: Protection of wealth, hifdh al mal

The wealth of any community depends on the productive activities of its healthy citizens. Medicine contributes to wealth generation by prevention of disease, promotion of health, and treatment of any diseases and their sequelae. Communities with general poor health are less productive than a healthy vibrant community. The principles of protection of life and protection of wealth may conflict in cases of terminal illness. Care for the terminally ill consumes a lot of resources that could have been used to treat other persons with treatable conditions. The question may be posed whether the effort to protect life is worth the cost. The issue of opportunity cost and equitable resource distribution also arises.

19.0 MAQASID IN RESEARCH ETHICS 1: NECESSITIES, NEEDS, and REFINEMENTS: dharuraat; haajiyaat, & tahsiinaat

·      Normal human life cannot exist and continue without dharuuraat.

·      Haajiyat are for the proper functioning of life beyond the requirements of basic survival.

·      Tahsinaat aim at achieving a higher level of human dignity.

·      Human experimentation in order to fulfill dharurat has priority over that research that aims at fulfilling hajiyat.

·      The Law will allow taking a higher risk for dharurat than for hajiyat.

·      Experimentation for refinements may not be considered at all if there is any risk.

·      The 5 dharurat recognized by the law are preservation of religion, life, progeny, the mind, and wealth. An example of a dharurat is a life-saving drug like insulin for the insulin-dependent diabetic.

·      An example of a haajat is a drug to treat mild anxiety.

·      An example of a tahsin is a cosmetic cream or female circumcision, al khafdh.

20.0 MAQASID IN RESEARCH ETHICS 1: Purpose of protection of religion, hifdh al din

·      Experiments on humans become unethical when the scientists involved are not guided by morality.

·      Thus violation of the purpose of protecting religion brings cruelty and injustice in its wake.

·      The great Islamic principle of jarh & ta'adiil / ilm al rijaal does not exist in modern science

21.0 MAQASID IN RESEARCH ETHICS 2: The purpose of protection of life, hifdh al nafs

·      Experiments on humans for the purpose of finding new cures for disease fulfill the purpose of protecting health and life.

·      Phase 1 and phase 2 clinical trials may have no direct benefit to the patient but they provide basic scientific information. Phase 3 trials have potential benefit for the patient. Phase 4 trials have a general societal benefit.

·      The state has a responsibility for the life and health of its citizens. It therefore must promulgate and enforce laws on the conduct of human experiments in order to prevent abuses.

·      The risks involved in experimentation may appear to contradict the purpose of preserving life. Injury or harm in an experiment is only a potential but not a certainty. Any human experiment will be deemed illegal if there is a 100% certainty of a hazard.

22.0 MAQASID IN RESEARCH ETHICS 3: The purpose of protection of progeny, hifdh al nasl

·      Research on methods of curing infertility fulfils the purpose of protecting progeny.

·      The whole of medicine especially pediatrics and obstetrics also fulfils this purpose.

·      Good health of potential parents ensures that they will be healthy enough to bear the next generation.

·      Good prenatal and obstetric care ensures delivery of a healthy baby who therefore has more chances of growing into a healthy adult.

23.0 MAQASID IN RESEARCH ETHICS 4: The purpose of protection of the mind, hifdh al ‘aql

·      Research on cure of mental conditions fulfills the purpose of protecting the mind.

·      Research on other somatic diseases fulfils the same purpose because any disease will through pain, suffering, and loss of function lead to mental symptoms of depression and anxiety.

·      Research on drugs and nutrients that alter the mind is justified in order to protect humans from such deleterious effects.

24.0 MAQASID IN RESEARCH ETHICS 4: The purpose of protection of wealth, hifdh al mal

·      In general good health ensures a healthy workforce that works to generate wealth for the community.

·      Human experimentation may lead to safer, more effective, and cheaper methods of treating disease which saves wealth.

25.0 QAWA'ID IN RESEARCH 1: The principle of intention, qaidat al maqsad

·      The basic principle is that each action is judged by the intention behind it, al umuur bi maqasidiha. A research protocol is judged by the underlying objectives of the researcher as manifest in actual implementation and not the stated objectives that may be deceptive.

·      Means are judged with the same criteria as the intentions, al wasail laha hukm al maqasid. If the intention, qasd, is wrong the means, wasiilah, is wrong and vice versa. Under this principle a research protocol with beneficial scientific results will be rejected if the methods used are unethical.

26.0 QAWA'ID IN RESEARCH 2: The principle of certainty, qaidat al yaqeen

·      Human experimentation is carried out because of uncertainty about what is the best treatment. If there is certainty that the current treatment is the best that there can be, an unlikely practical situation, then there is no legal justification for further research. Further research cannot commence on the basis of some doubt about an existing treatment method.

·      According to the principle that certainty cannot be removed by doubt, al yaqeen la yazuulu bi al shakk, there must be some empirical evidence of low efficacy in the current treatment or probable efficacy in the new treatment before an experiment is authorized.

·      The above principles can protect against proliferation of human experiments that are unnecessary and are harmful but yet leave room for those that have a good prospect of reaching a better treatment modality.

27.0 QAWA'ID IN RESEARCH 2: The principle of injury, qaidat al dharar

·      Human experimentation has associated potential hazards and risks. These risks have to be balanced against the injury by disease and the potential benefit from the new treatment. The basic principle is that injury, if it occurs, should be relieved, al dharar yuzaal. Thus a clinical trial in search of an effective cure for a disease is an attempt to remove an injury.

·      Preventive clinical trials are justified under the principle that an injury should be prevented as much as is possible, al dharar yudfau bi qadr al imkaan.

·      The new treatment being sought should not be as harmful as the disease condition according to the principle that an injury is not relieved inflicting or causing an injury of the same degree, al dharar la yuzaal bi mithlihi.

28.0 QAWA'ID IN RESEARCH 2: The principle of injury, qaidat al dharar (Continued)

·      Decisions to proceed with human experimentation involve a careful balancing of benefits and risks. The easiest situation is when the potential benefit far outweighs the potential risk, in which case the research proceeds in pursuit of the benefit. If the risk is equal to the benefit, we use the principle that prevention of a harm has priority over pursuit of a benefit of equal worth, dariu an mafasid awla min jalbi al masaalih.

·      If the risk is more than the benefit for the individual research subject, but there is a larger societal benefit, we may proceed with the research under the principle that public interest has priority over individual interest, al maslahat al aamat muqaddamat ala al maslahat al khaassat.

·      The individual may have to sustain a harm in order to protect public interest, yatahammalu al dharar al khaas li dafiu al dharar al aam.

·      In some situations benefits may not figure in the equation; the consideration being the injury of the disease against the potential risk of the experiment. The principle of the law used is to choose the lesser of the two evils, ikhtiyaar ahwan al sharrain.

29.0 QAWA'ID IN RESEARCH 3:Principle of hardship, qaidat al mashaqqat

·      Hardship mitigates easing of the sharia rules and obligations, al mashaqqa tajlibu al tayseer and necessity legalizes the prohibited, al dharuraat tubiihu al mahdhuuraat. If any of the 5 necessities, al dharuraat al khamsat, is at risk permission is given to undertake experiments that would otherwise be legally prohibited.

·      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, al dharuraat tuqaddar bi qadriha.

·      Necessity however does not permanently abrogate the patient’s right, al idhtiraar la yubtilu haqq al ghair.

·      The law asserts vicarious liability. It is illegal to get out of a difficulty by delegating to someone else to undertake a harmful act, ma haruma fi’iluhu, haruma talabuhu. Thus legal action will be brought against all officials in the chain of command for negligence in experiments in their institution even if they did not personally take part.

30.0 QAWA'ID IN RESEARCH 4:The principle of  custom  or precedent, qaidat al urf

·      The principle of custom is used to define standards of good clinical practice. The basic principle is that custom or precedent has legal effect, al aadat muhakkamat.

·      What is considered customary is what is uniform, widespread, and predominant, innama tutabaru al aaadat idha atradat aw ghalabat, or is predominant, widespread, and not what is rare, al ibrat li al ghaalib al shaiu la al naadir.

·      Thus the standard of clinical care or experimental procedure is what the majority of reasonable physicians consider as reasonable care and which constitutes a professional standard.

·      An innovative therapy is departure from the standard care. It is however allowed under the law but the physicians will be held liable for any injuries to the patient. This liability also arises even if standard care were used.

·      The Law recognizes that what is customary changes with time, la yunkiru taghayyur al ahkaam bi taghayyuri al azmaan wa al ahwaal wa al aadaat wa a’raaf.

31.0 QAWA'ID IN RESEARCH 5: The doctrine of istishaab:

·      This is continuation of an existing ruling either affirming, ithbaat, or denying, dafau.

·      Matters are left as they are until there is evidence to the contrary.

·      Recourse is made to istishaab if there is no evidence, daliil.

·      This doctrine has the same impact as the principle of yaqeen discussed above.

32.0 QAWA'ID IN RESEARCH 6:The doctrine of istihsaan:

·      The doctrine operates in a clinical situation in which a physician obtains experimental evidence about the efficacy of a new treatment but continues to use the old treatment because of some inclination in his mind.

·      This problem does not arise if Bayesian inference is used. The experimenter will have to state a probability of prior belief in the efficacy of the new treatment. The results of the experiment are then used to generate a posterior probability from the prior probability. The posterior probability may reinforce or decrease the original assumption.

·      In this way prior clinical experience or judgment is combined with new experimental evidence to reach a practical conclusion.

33.0 QAWA'ID IN RESEARCH 6a: The doctrine of benefit, istislaah:

·      Istislah is obtaining a benefit, jalb manufa'at, and preventing a harm, dafiu mafsadat.

·      Consideration of maslahat arises when we have to compare an existing to a new innovative treatment. The potential benefit from the new treatment must be more than the standard treatment for the experiment to be allowed to proceed.

·      Consideration of maslahat also distinguishes a patient as a subject from a healthy volunteer; the former may get some personal benefit from the experiment since experimentation is combined with care whereas the latter has no benefits at all but may be exposed to hazards.

·      Therapeutic research has immediate benefits whereas the benefits of non-therapeutic research are remote. In non-therapeutic research, the subjects are volunteers who may be healthy with or patients.

34.0 QAWA'ID IN RESEARCH 6b: The doctrine of benefit, istislaah:

·      In a randomized trial, subjects who receive a placebo have no benefit and no hazard but of they are patients they are missing the potential benefits of either the traditional or the innovative treatment.

·      Research ethics: unethical research violates the purpose of hifdh al ddiin. Research to discover new or better therapies fulfills the purpose of preserving life. Research to treat infertility or improve obstetric and pediatric outcomes fulfills the purpose of protecting progeny. Research to alleviate psychiatric disease fulfills the purpose of protecting the mind. Research on cheaper therapies fulfills the purpose of preserving resources. The principle of intention that requires that the declared research objectives correspond to the underlying intentions and that no immoral means are used for a good objective. According to the principle of yaqiin new research must be started only if there is empirical evidence of need. The principle of dharar requires that the benefits of research to the individual and the community far outweigh its potential harm. The principle of hardship would allow risky experiments for the purpose of saving further lives. The principle of 'aadat requires that generally accepted procedures of research be followed. The doctrine of continuity, istishaab, ensures stability and order by requiring that existing therapies until there is evidence to the contrary. The doctrine of personal preference, istihsaan, allows personal preference of one’s evidence over another one. Under the doctrine of public interest, istislaah, research subjects on placebo treatment or those in non-therapeutic research undertake risk in the public interest.