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Thursday, 25 August 2016 00:00

Informed Consent

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Pierre Mallia MD MPhil PhD FRCGP
Director, Centre for Bioethics, Medical School

The use of the phrase ‘informed consent’ has become much of a cliché. People perhaps use it without appreciating the meaning. I was recently at a meeting in Brussels, and the document we were reviewing spoke about ‘withdrawing informed consent’. You do not, of course withdraw informed consent; you withdraw consent. Informed consent is a process. Conversely, at a meeting with the Data Protection commissioner, an insurance company, argued that they obtained ‘consent’ from a lady in order to look into her hospital file. She was subsequently refused settlement. Was the process of consent a truly informed process? Given the fact it was not explained to her that in the event that she suffered from a related condition she would not get the settlement, one cannot argue that a legal consent was obtained. I will refrain from commenting on how actually the hospital gave them the records of the patient when they simply said that they had asked the patient.

There are at least five stages to the informed consent process. Although it seems complicated, doctors will usually go through them in their minds and it will only take a few moments to consider the stages. Informed consent presumes however the autonomy of the person giving the consent.

Autonomy is derived from the Greek auto (self), and nomos (control). It therefore speaks of self control. Just as a country exercises control over its territory, a person exercises control over his body. Nowadays, taking decisions ‘for the good of the patient’ without actually allowing the patient to participate in the process is not respecting the autonomy of the individual. A person who acts autonomously, acts according to his or her own free will (voluntariness); thus understanding what he or she is doing; and acts without any controlling influences. There are many examples one could bring to illustrate these, but of course it is obvious from the start that many categories of people cannot act autonomously (children, elderly with dementia, people who may be under the influence of drugs, those suffering from illness, or even stress). It is the responsibility of the physician to empower the person to see that he/she makes an autonomous choice. One must ask, ‘Is this person making a voluntary choice. Is he or has he understood what we are explaining. And are there any controlling influences’. Controlling influences can even be pressure from relatives or friends or perhaps the fear of the physician (people may fear that if they do not do what the doctor is saying, they will not get full attention or the doctor may abandon their cause). But any GP will tell you how many people do not speak up for their rights in hospital because they feel that they are under the control of others and in a way at their mercy.

1. Information

Having said that, we turn briefly to the five conditions. Information. What amount of information do I actually tell or give the patient? When prescribing an antibiotic, do I really have to explain all that is on the package leaflet. It is quite acceptable today to follow two basic rules. The first is to tell what a reasonable person would want to know. This is basically a transposition of the Golden Rule: Do to others….. Therefore if I am going in for a thyroidectomy, I would want to know that there is a moderate risk of hoarseness as a complication. Someone going in for a prostatectomy has given his consent for that procedure and not for sterilization – which may be a complication. We cannot take for granted that because the gentleman is beyond his reproductive years, then he automatically does not need to function. I once saw a patient being told when waiting outside the operating room that it would be better to remove his testicle in order that his inguinal hernia repair has less chance of recurrence. That is definitely not the ideal circumstance to concede, no matter how much faith the patient has in the doctor.

The second rule is to follow a personalized standard. Some patients merely let the doctor do the decisions. In this case the doctor would be wise to still explain what he or she feels the patient should know. Conversely, some people, perhaps out of anxiety or perhaps because they find it difficult to decide, find that they need a lot of detail, which may even tax on the doctor’s patience. Time spent here may make the difference between a fully satisfied patient and one who is not.

2. Understanding

Obvious as it may seem, do we actually make sure the patient has understood. Are we explaining what we have to say in the right conditions. Do we give news or explain outcomes in the hospital corridors; do we give advice on treatment when we have just imparted bad news? Do we allow moments for people to digest what we have said? In a busy outpatient’s department this is not all that easy. Only prudent doctors would put all else aside and focus on the being in front of them. Thankfully most are (prudent). Sometimes the environment we work in does not help people understand. Interruptions (telephone calls, nurses coming in and out of the office, etc) distract doctors, let alone patients. Patients may not yet be ready to take the news and may need time. Understanding really is a process studied considerably in social sciences and perhaps from the ethical point of view all we can have to ask is ‘Have you actually ever read and made an effort to understand and implement, a chapter from a psychology book, on understanding?’. How often have you seen colleagues on committees who make you wonder what effort they put in to understand patients – they seem to understand only after they would have taken up half the discussion time talking themselves, only to finally say what you or someone else has been saying all along. If only they make the effort to be quiet – and when they do so, actually think about what the person is saying rather than what they are going to say themselves. Understanding…Hmmm!

______________________

3. Voluntariness

Are we making sure that people are making a voluntary choice? Are they being influences by relatives or perhaps the situation. We are all determined to a certain extent by the circumstances that we are in. If I have cancer I may make a so-called voluntary choice to have chemotherapy. But if I really had the choice, I would not have it. It is the nature of my circumstance that made me make that decision. Without entering the philosophical debate on determinism and free will, it is obvious however that a free choice is not a random one. It follows a process of thinking and understanding. Thinking can only be done if I am given the information to evaluate. I can exercise my right not to know, but then I am compromising the information I have with which to think about my condition and make a choice.

However there are clear circumstances which compromise a voluntary choice. Coercion,  the forcing of someone to make a choice, is the most obvious. People, especially the frail and/or dependent, patient; such as an elderly person, may be forced to take medication or to make a decision regarding an operation or entering a home, by their children. I patient of mine decided to enter a home, against her own will, because one of her sons categorically repeated that he will never visit her if she lived with her daughter. He was at loggerhead with his sister’s husband. A second way in which a voluntary choice is effected is manipulation. Do we try to make things look nicer than they actually are? Do we try to give a better picture or omit telling the patient some information which we are sure will make them change their minds. If we do we are paternalistic, period. This is not to say that we cannot exercise a therapeutic privilege, in extreme circumstances when we know that a particular piece of information is gong to be harmful to the patient. Neither has it to do with being optimistic. These are in themselves virtuous acts. But being unduly optimistic may actually harm a person by forcing him or her to make a choice that they otherwise would not have made. Perhaps the person would prefer staying at home the last few months of his life instead of doubling the life-span but spending it in and out of hospital and treatment rooms. Manipulation is therefore the thwarting of news in a way that people understand something differently or understand what we want them to understand. Our political news channels are a clear example. You say something in public and one station makes it sound one way and another station makes it sound the exact opposite. Il tono fa la musica.

4. Competence

This is by far the most important condition. Is the patient competent to make a choice. Obviously, as pointed out, children, demented people, psychotic patients, are all not competent to make a choice. But some older children can be considered competent to participate in their treatment. Certainly paediatricians are used not to give a particular medication because the child has expressed an aversion and moreover asked if he or she can do without it; or perhaps refuse altogether to take it.

Conversely a fever, or simply after just receiving bad news may render me incompetent for a while. Emergency situations are also a clear example of situations in which patients are not always competent. In this circumstance the physician must exercise the time-honoured virtue of prudence and act in order to save life. No one can have a case against someone who practiced the socially accepted ethos of her profession.

5. Consenting

Finally the actual act of giving consent (or refusing). Ideally this is done in writing but morally it is really not required. We witness countless patients signing consent forms which in a court of law will automatically be thrown out. A signature signifies nothing unless the above procedures have been followed and thought through. What is more important is actually making a note that one has been through the process; and, of course, patient satisfaction. The signing is a mere formality which is completely different from when we sign a business contract – although it should not be. Therefore if I sign a consent form without actually having understood, or without actually having been given the information, I may be competent to sign the document and but indeed would not have acted autonomously and therefore that contract does not hold. It is the doctor’s responsibility to see that the patient has understood and not merely that he ‘told’ the patient. Relying on other doctors (those junior to you, for example) may be risky, as at the end of the day it is the person performing the procedure who is responsible. Negligence can even be considered when there is an act of omission – such as not practicing informed consent.

Naturally being incompetent in one area of life need not render me incompetent in another. Therefore epilepsy, notwithstanding being a neurological condition, may render someone incompetent to drive a vehicle, but still able to participate in the treatment and therefore still competent. And regarding that fever…well, it is obvious we have to act on our good judgement. Whoever said our job was straight forward.

In the following article I will discuss Negligence and Malpractice and following that, we will attempt to debunk the myth of data protection, which everybody suddenly is speaking about – as if it never existed.

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