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101225L - ETHICO LEGAL ISSUES IN CONSENT TO TREATMENT

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Lecture Presented at the Faculty of Medicine King Fahad Medical City on 25th December 2010 by Dr Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics Faculty of Medicine King Fahad Medical City omarkasule@yahoo.com, WEB: http://omarkasule.tripod.com



Abstract
This lecture explains the legal basis of consent ethics and explains specific guidelines for consent in various clinical situations using actual clinical scenarios.

1.0 RELATION BETWEEN LAW AND ETHICS
Islamic Law is comprehensive being a combination of moral and positive laws. It can easily resolve ethical problems that secularized law, lacking a moral religious component, cannot solve. Many contemporary ethical issues in medicine are moral in nature and require moral guidance that can be provided only from religion. The Law is the expression and practical manifestation of morality. It automatically bans all immoral actions as haram and automatically permits all what is moral or is not specifically defined as haram.

The approach to ethics is a mixture of the fixed absolute and the variable. The fixed and absolute sets parameters of what is moral. Within these parameters, consensus can be reached on specific moral issues. Ethical theories and principles are derived from the basic Law but the detailed applications require further ijtihad by physicians.

Islam has a parsimonious and rigorously defined ethical theory of Islam based on the 5 purposes of the Law, maqasid al shari’at. The five purposes are preservation of ddiin, life, progeny, intellect, and wealth. Any medical action must fulfill one of the above purposes if it is to be considered ethical. Legal axioms or principles, qawa’id al shari’at, guide reasoning about specific ethico-legal issues and are listed as intention, qasd; certainty, yaqiin; injury, dharar; hardship, mashaqqat; and custom or precedent, ‘urf or ‘aadat.

All the above-mentioned purposes and principles of the Law are applicable in various ways to the issue of patient consent to treatment. The most relevant is the principle of harm, qaidat al dharar, which is the basis of the patient's autonomy to make decisions regarding the choice of physicians and treatments. No medical procedures can be carried out without informed consent of the patient except in cases of legal incompetence. The justification for this is that the patient has the purest intentions in decisions in the best interests of his or her life. Others may have bias in their decision-making. If the patient cannot exercise his / her autonomy rights, the next of kin or proxies pre-selected by the patient can make the necessary decisions. These decision makers have an inherent interest in the best interests and welfare of the patient. The decisions cannot be left in the hands of the physician because in real life he or she may have interests and considerations, professional or otherwise.

2.0 CONSENT AND REFUSAL OF TREATMENT FOR COMPETENT ADULTS
The patient must be free and capable of giving informed consent. Informed consent requires disclosure by the physician, understanding by the patient, voluntariness of the decision, legal competence of the patient, explanation of all alternatives, recommendation of the physician on the best course of action, decision by the patient, and authorization by the patient to carry out the procedures. Consent is limited to what was explained to the patient except in an emergency.

Refusal to consent must be an informed refusal (patient understands what he is doing). Refusal to consent by a competent adult even if irrational is conclusive and treatment can only be given by permission of the court. Doubts about consent are resolved in favor of preserving life.

Spouses and family members do not have an automatic right to consent for a competent patient. A spouse cannot overrule the patient’s choice.

Physician assisted suicide, active euthanasia, and voluntary euthanasia are illegal even if the patient consented.

Consent can be by proxy in the form of the patient delegating decision making or by means of a living will. Advance directives, proxy informed consent by the family are made for the unconscious terminal patient on withholding or withdrawal of treatment.

The living will has the following advantages: (a) reassuring the patient that terminal care will be carried out as he or she desires (b) providing guidance and legal protection and thus relieving the physicians of the burden of decision making and legal liabilities (c) relieving the family of the mental stress involved in making decisions about terminal care. The disadvantage of a living will is that it may not anticipate all developments of the future thus limiting the options available to the physicians and the family.

The device of the power of attorney can be used instead of the living will or advance directive.

Decision by a proxy can work in two ways: (a) decide what the patient would have decided if able (b) decide in the best interests of the patient.

Informed consent is still required for physicians in special practices such as a ship’s doctor, prison doctor, and doctors in armed forces. Police surgeons may have to carry out examinations on suspects without informed consent.

3.0 CONSENT AND REFUSAL OF TREATMENT FOR INCOMPETENT ADULTS and CHILDREN’
3.1 Consent for children
Competent children can consent to treatment but cannot refuse treatment. The consent of one parent is sufficient if the other one disagrees. Parental choice takes precedence over the child’s choice. The courts can overrule parents. Life-saving treatment of minors is given even if parents refuse. Parental choice is final in therapeutic or non-therapeutic research on children.

3.2 Mental patients
Mental patients cannot consent to treatment, research, or sterilization because of their intellectual incompetence. They are admitted, detained, and treated voluntarily or involuntarily for their own benefit, in emergencies, for purposes of assessment, if they are a danger to themselves, or on a court order. Suicidal patients tend to refuse treatment because they want to die.

3.3 The unconscious
For patients in coma, proxy consent by family members can be resorted to. If no family members are available, the physician does what he as a professional thinks is in the best interest of the patient.

There are many disputes about withdrawing nutrition, hydration, and treatment in a persistent vegetative state since the chance of recovery is low. There is no moral difference between withholding and withdrawing futile treatment.

3.4 Obstetrics
Labor and delivery are emergencies that require immediate decisions but the woman may not be competent and proxies are used. Forced medical intervention and cesarean section may be ordered in the fetal interest. Birth plans can be treated as an advance directive.

4.0 DISUSSION SCENARIOS ON CONSENT TO TREATMENT
4.1 A bed-ridden patient with limited movements and sensation communicated by sign language and limited speech. She could recognize letters and could write sentences by nodding when the right letter was touched. She indicated that she did not want physiotherapy, wanted to divorce her spouse, and wanted to give the family home to the kind doctor taking care of her. She wanted to disinherit her sons for not sitting around her bed and caring for her daily. She wanted to return to her home and leave the nursing home.

4.2 A patient with a benign prostatic enlargement and mild urinary retention asked the urologist for prostatectomy. The urologist refused after examination revealed no complications and a normal PSA level. Because there was only one urologist in the government hospital, the patient sued the hospital in the High Court to force them to carry out the operation. Due to delays in scheduling a hearing the patient went overseas and had the operation done. Histological examination showed low grade prostate carcinoma confined within the prostatic capsule.

4.3 A patient was brought to the emergency room by the police after attempting to kill himself by hanging. He was unconscious when first brought in and had a signed suicide note in his shirt pocket saying that he wanted to die. The doctors ignored the note and started resuscitation measures. The patient became conscious after 30 minutes and protested at the medical treatment arguing that he wanted to die. The doctor was thinking of stopping resuscitation measures when the patient’s father and wife arrived and instructed the doctor to continue resuscitation.

5.0 DISCUSSION SCENARIOS ON REFUSAL OF TREATMENT
5.1 A 40-year old theater nurse refused to accept the diagnosis of breast cancer and refused surgery. The tumor grew larger, broke through the skin and became foul smelling because of bacterial infection. The hospital director put her on unpaid leave.

5.2 A 40-year old policeman refused surgery to drain a pyomyositis abscess. He still refused surgery after the abscess burst spontaneously. The surgeons sedated him and carried out the surgery without his consent.

5.3 A 30-year old soldier with a history of schizophrenia refused a chest X-ray for a severe cough lasting 2 months. His commanding officer authorized using force to take the X-ray and to treat him accordingly. The army doctors were not sure what to do but being army officers they obeyed orders of the commanding officer.

5.4 A 42-year old actress pregnant for the first time refused an elective caesarean section. She continued to refuse the procedure when labor became obstructed and signs of fetal distress appeared. The obstetrician went ahead to operate on the basis of consent by the husband. The baby was delivered alive and well.

5.5 A 14-year old patient refused admission because he hated the physicians on the pediatric ward.  The father agreed with the patient but the mother disagreed. Both parents agreed with the patient’s refusal of any blood transfusion which the doctors considered necessary since the hemoglobin level had fallen to a dangerous level.

5.6 A 60-year old retired nurse refused HRT after a diagnosis of osteoporosis was made. She argued that HRT was anticipating and contradicting Allah’s pre-determination, takdir.