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Background reading material for Year 4 Semester 2 Medical Students at the Faculty of Medicine King Fahad Medical City Riyadh 09th May 2011 by Professor Omar Hasan Kasule Sr.
1.0CAPACITY (COMPETENCE) TO GIVE CONSENT
Informed consent is given only by a person who is capacitous (competent). The following are criteria (tests of capacity) are used to judge whether the patient is capacitous: (a) Understands what the procedure is. (b) Understands the reason for the procedure. (c) Understand the benefits and risks of the procedure. (d) Has the ability of judging and weighing the information before coming to a decision (e) Has sufficient memory to retain information given for a long enough period to enable effective decision making (f) Understands the consequences of refusing treatment
2.0 THE RIGHT OF AUTONOMY
The patient has the right of autonomy which is control of what is done to his/her body. Autonomy is a basic human right that cannot be violated except in exceptional circumstances explained below. No medical examination or medical procedures can be carried out without informed consent of the patient except in cases of legal incompetence. The patient has the purest intentions in decisions in the best interests of his or her life. Others may have bias their decision-making.
3.0 CONSENT FOR COMPETENT ADULTS
Consent can be explicit (oral, written, or non-verbal) or implied. For example a patient undressing for examination implies consent but often this is not enough we need to ask specifically for informed consent as explained below.
The patient must be free and capable of giving informed consent. Pressure on the patient by the family or the healthcare workers invalidates consent. Informed consent requires disclosure by the physician, understanding by the patient, voluntariness of the decision, legal competence of the patient (also called capacity), disclosure of all treatment alternatives and 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 should be properly documented.
The patient is free to make decisions regarding choice of physicians and choice of treatments. Consent is limited to what was explained to the patient except in an emergency. The scope of consent is limited to what the patient agreed to and the procedures cannot exceed that except in emergencies. Consent also has a time limitation. If a long time elapses between consent and the procedure it is better to obtain new consent.
The patient is free to withdraw consent at a later time and this decision must be respected. Refusal of treatment is a human right that must be respected. Refusal to consent must be an informed refusal (patient understands what he is doing). Refusal of treatment should be documented properly. Refusal to consent by a competent adult even if irrational is conclusive and treatment can only be given by permission of the court. A patient who refuses a treatment has no automatic right to demand an alternative and may be more expensive procedure.
Doubts about whether consent was or was not given consent are resolved in favor of preserving life.
In some legal systems spouses and family members do not have an automatic right to consent and a spouse cannot overrule the patient’s choice.
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.
Physician assisted suicide, active euthanasia, and voluntary euthanasia are illegal even if done with the consent of the patient.
4.0 CONSENT FOR INCOMPETENT ADULTS
Three tools are used for consent in cases of incompetent adults who are unconscious regarding starting, withholding, or withdrawal of treatment: a do not resuscitate order (DNR), advance directives and proxy informed consent by the family or any other person with the power of attorney. In some legal systems the family does not automatically have the right to decide unless authorized beforehand. In some cases courts may be asked to intervene and solve the controversy.
A do not resuscitate order (DNR) by a physician could create legal complications and must be used with care.
Consent can be by proxy in the form of the patient delegating decision making or by means of a living will. 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.
In general in cases of incompetence and in the absence of an alternative decision mechanism the physician in charge does what he thinks is in the best interests of the patient. This is particularly relevant in cases of emergencies.
5.0 CONSENT IN SPECIAL CASES
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. In this case treatment is compulsory.
Nutrition, hydration, and treatment can be withdrawn in a persistent vegetative state since the chance of recovery is low. There is no moral difference between withholding and withdrawing futile treatment.
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.
Suicidal patients tend to refuse treatment because they want to die.
6.0 CONSENT FOR CHILDREN
In general parents or persons with parental responsibilities make decisions for children. Competent children can consent to treatment but cannot refuse treatment. The consent of one parent is sufficient if the 2 disagree. Parental choice takes precedence over the child’s choice. 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.
DISUSSIONS
Define Informed Consent:
1. Describe the forms of consent (oral, written, or body language).
2. Distinguish between explicit/express consent (spoken or written) and implicit consent (taking off clothes for examination)
3. Describe the purposes of getting informed consent (autonomy rights & protect the physician).
The Principle Of Autonomy:
4. Appreciate that adults are presumed to be competent unless otherwise proved
5. Appreciate that irrational decisions by a competent person are binding.
6. Describe the scope of consent in terms of duration (if time relapses new consent should be sought) and the extent of the procedure (only what was consented to is done).
7. Appreciate that consent does not force a physician to carry out a procedure he things is inappropriate eg amputation of a healthy limb, sex change operation.
8. Describe the autonomous right of a patient to be treated by a physician of his choice.
9. Describe ethico-legal issues that arise if the physician and the patient are of opposite genders.
10. Describe compulsion for purposes of public health (quarantine, isolation, mass immunization, mass treatment during an epidemic).
The Process Of Informed Consent:
11. Understand consent as a process and not a one-off event.
12. Describe the conditions for validity of consent (understand nature and purpose of the intervention, sufficient information, believe info and be able to weigh it in balance to reach a decision, voluntary and free from pressure, be aware that can refuse).
13. Describe who should seek informed consent.
14. List and describe the type of information to be provided to the patient (diagnosis, prognosis, proposed treatment and alternatives with explanation of benefits, risks, and costs of each procedure, name of doctor who will carry out the procedure, reminding the patient that he has the right to refuse or change his mind
15. Describe situations in which it would be appropriate to withhold some information from the patient.
16. Describe what is done if the patient refuses to receive information.
17. Describe procedures for which consent must be obtained in writing (complex risky procedures, research).
18. Describe special features of consent in the following situations: surrogate motherhood (must understand the consequences), organ donation (understand risks and benefits for both donor and recipient).
Capacity To Consent:
19. Distinguish between global and specific competence (patient may be competent to make some decisions and not others).
20. Describe the tests for capacity / competence (understand the intervention and its purpose; understand the benefits, risks, and alternatives; understand the consequences of not receiving the treatment; be able to retain the information long enough to make a decision; be able to weigh the information).
21. Describe methods of enhancing capacity (non threatening venue, treatment of stressful symptoms, talk with patients when side effects of medication are minimal, break down the decision into several steps).
The Process Of Informed Refusal:
22. Explain the concept of informed refusal and its documentation.
23. Explain what is done if a patient rejects a cheap intervention in favor of a more expensive one.
24. Describe ethico-legal issues in informed refusal of admission and treatment
Consent By Children:
1. Describe how children can be involved in decision making.
2. Describe the growth of child competence by age.
3. Describe limitations to consent or refusal by children (they can accept treatment but cannot refuse treatment considered necessary by the professionals).
Parental Consent For Children:
4. Describe parental responsibility for decisions on the child (parents can consent for their children, the consent must be in the best interests of the patient, courts of law can intervene if the professionals think that parents are not acting in the best interests of the child, parents cannot override decision of a competent child),
5. Describe the course of action if parents disagree (for a life threatening situation the consent of one parent is enough if the other refuses, for irreversible procedures a court is consulted).
Interventions In Children Without Consent:
6. Describe how the consideration of best interests differs between children and adults (adults know their best interest whereas children do not).
7. Discuss the ethical guidelines for an intervention in a child to save an adult’s life or to prevent psychological harm.
8. Describe interventions that are carried out against the wishes of the child (treatment of drug addiction, depression, anorexia nervosa, life-threatening disease).
Treatment Of Adults Without Consent
1. Describe the basis for a physician treating an incompetent patient without consent (best interests /benefit of the patient, necessity).
2. Describe situations in which physicians can treat patients without consent (emergencies, compulsory treatment of mental patients).
3. Describe legal guidelines of consent for preventive procedures (screening, immunization).
4. Describe 2 considerations in detaining or restraining patient movements (freedom to move, protection of the patient and others from harm).
5. Describe the main provisions of the mental health act regarding treatment of mental patients and describe the committal procedure.
Processes Of Consent For Incompetent Adults:
6. Describe the involvement / role of the family in the consent process for the incompetent
7. Describe 2 ways in which a proxy decision maker can reach a decision (preferences of the patient, best interests of the patient).
8. Explain how an advance statement is a form of prospective autonomy. Describe advantages of advance statements
9. Describe disadvantages of advance statements
10. Describe the format of an advance statement.
11. List conditions in which a physician must seek a second opinion or court review if the patient in incapacitous (detention and restraint, sterilization or impairing fertility, pregnancy termination, withdrawing or withholding artificial nutrition and hydration, organ donation).