Analysing the Concept of Informed Consent in Healthcare

Analysing the Concept of Informed Consent in Healthcare Chapter 1-Introduction 1.1 In modern society, everyone has the basic right to consent to medical treatment. However, this is a recent development as consent was not always considered a critical issue in medical treatment. Hippocrates himself, advised doctors that they should conceal the effects of medical treatment from their patients, his reasoning being he believed that when patients were given relevant information they would take a turn for the worse. It was not standard practice for patients to question a doctors decision or authority. Recent changes have contributed to this change in attitude and as such altered the method of practice of a doctors obligation. The final years of the twentieth century as witnessed the most dramatic shift in the reputation of the medical profession within the United Kingdom, due to scandal after scandal plaguing doctors. Major news headlines left the doctor-patient relationship in a state of concern, for example, Doctors who steal organs face jail.This headline refers to the Bristol and Liverpool Hospital where it was discovered that they were retaining childrens organs, without consent or knowledge of the parents. It became apparent in the Bristol and Liverpool reports that organ retention, of both children and adults was widespread practice. Another significant humiliation for the medical profession was the case of Harold Shipman, a general practitioner who was convicted of murdering fifteen of his patients. Whether these circumstances are due to the actions of individualist or media influence makes little difference to the effect they had on societys viewpoint. There was need for change and this brought about the introduction of regulations and guidelines that protected both the patient and the doctor. 1.2 Informed consent was seen to break the doctor knows best concept and established a liberated choice for the patient. The locus classicus for informed consent is contained within the case Schloendroff v Society of New York Hospital, where it was held, â€Å"Every person being of adult years and sound mind has a right to determine what shall be done with his own body.† There are many examples within the UK system which confirms this principle of law, one being the case Re A (Minors) in which Robert Walker L.J stated, â€Å"Every human beings right to life carries with it, as an intrinsic part of it, rights of bodily integrity and autonomy The principle underpins the common law concerning consent to treatment within the UK. The consent that a patient has the right to choose is a fundamental part of receiving medical treatment. No considerations need to be examined whether the choice is rational or irrational, as the patient has an absolute right. 1.3 The Department of Health 1993 stated, â€Å"Consent is the voluntary and continuing permission of the patient to receive a particular treatment based on an adequate knowledge of the purpose, nature and likely risks of the treatment including the likelihood of its success and any alternatives to it.† Meaning any permission given under any unfair or undue pressure is not consent. Consent may be expressed or implied, however the validity of informed consent does not depend upon the form in which it is given 1.4 This dissertation will firstly consider the development of informed consent, as the English courts initially had reservations of its establishment and for this reason was gradually introduced in stages, until the case of Chester v Afshar which saw the full acceptance of the doctrine. It needs to be considered how the medical profession dealt with this change and in addition how patients themselves are exercising such powers. The effect in which the Human Acts 1998 has had on the courts decision making process will also be analysed to observe the relevance this may have had on informed consent. Another factor of informed consent includes giving sufficient information and the patients understanding of this. For informed consent to exist, the patient must have all the relevant information and capability to make an informed choice as to the treatment they decide to receive. This was made apparent in the case Reibiu v Hughes, where Laskin J stated, â€Å"the genuineness of consent to medical treatment depends on proper disclosure of the risks it entails† For informed consent to exist within the UK; provisions need to be made for those who are simply unable to give an informed choice. The capacity of a patient needs to be considered and if they lack this then a doctor must make a decision as to what is in the patients best interest. This can be seen to restrict informed consent as it goes against its true principle, however if a patient can not make an informed choice for themselves then it is only passable that someone has to act on their behalf. This dissertation will examine the procedure for this and how the law enables decisions to be made fairly and respectably. Chapter 2-The Development of Informed Consent 2.1 The area of law that needs to be established is the nature and scope of the duty to inform and the extent to which this has been incorporated into the English legal system. The existence of a duty to warn came about when the relationship between a doctor and the patient, which was based solely on trust, began to erode. There was a need for scrutiny and examination within the medical profession and this was achieved through the development of the law. The scope of the doctors duty of care is determined by a reference to the Bolam case. Mr Bolam agreed to electroconvulsive therapy to help improve his depression. He suffered fractures in the course of the treatment. The risk was known to his doctor, but he had not informed Mr Bolam of such. Mr Bolam alleged that the failure to warn him of the risk was negligent. The judge found that the amount of information harmonized with accepted medical practice and dismissed his claim. The judge, McNair J, directed the jury to the principle that, â€Å"A doctor is not guilty of negligence if he has acted in accordance with the practice accepted as proper by a responsible body of medical men skilled in that particular art† Therefore, the defendant doctor had conformed with a practice which was approved by a responsible body of medical opinion. This test was known as the Bolam test and it determines whether the doctor fell below â€Å"the standard of the ordinary skilled man exercising and professing to have that special skill† 2.2 Where there is a difference of judgment between two differing medical opinions, the defendant will be given the benefit of the doubt. As a result a doctor would not be found negligent if the court is satisfied that there is a responsible body of medical opinion that considers the doctor had acted appropriately. This responsible body need not be the majority of the profession. It appears that the courts allowed the medical profession to set their own standard. A doctor simply needed to provide an expert testimony and the courts assumed that it must be responsible. In exceptional cases, the courts perceived some established practice to be substandard, however it appears that only one reported case has materialized where such a judgement has occurred. The case, Hucks v Cole, where a woman contracted puerperal fever due to her doctor failing to treat her with penicillin for her septic toe and finger. Although a number of distinguished doctors gave evidence that they would not have administrated penicillin, the Court of Appeal found the defendant to have been negligent. The Judge, Sachs LJ, commented that the courts have to be in a position to verify that the medical opinion stood up to logical analysis and that they are not merely tailored to fit the requirements of the respective parties cases. This judgement was one of rarity, as Judges would not ordinarily cross examine a doctors opinion on a logical basis. 2.3 Often cases were even more favourable to the doctor, as is witnessed in the case Hatcher v Black. In this case Lord Denning stated, â€Å"As a matter of law it might be justifiable for a doctor to tell a lie, when he only does that which many a wise and good doctor would do.† It can be concluded from this that it is entirely for the individual doctor to determine what to inform his patient, even if the doctor went so far as to opt for what his lordship termed a therapeutic lie. Professor Michael Jones expressed the state of play as a football score, â€Å"In six medical negligence claims before the House of Lords between 1980-1999 the score stood at Plaintiffs 0, Defendants 6†. 2.4 The Bolam test which was adopted by English law focused on accepted practice and responsible profession opinion. The story was very different in America, as the American Courts rejected the professional medical standard and instead emphasised the patients right to know what the risks are inherent in the treatment. In Canterbury v. Spence a US Court stated that the prudent patient should prevail and its the doctors duty to disclose to their patient any material risk in a proposed line of treatment. The prudent patient principle emphasises what the doctor needs to inform the patient, according to what the average reasonable patient would want to know about potential risks and treatment options. This is made evident when the Judge commented, â€Å"A risk is material when a reasonable person†¦.is likely to attach significance to the risk† Contrary to the English Courts, the USA placed more importance on the patients rights and exigencies than those of the doctors. However, soon after the Bolam decision the English law was making changes towards incorporating this American style of law, to incorporating the doctrine of informed consent. 2.5 The question that needs to be examined is to what extent the Bolam test does or should apply to the duty to inform. Sidaway v Board of Governors of the Bethlem Royal Hospital was the subsequent, leading case to appear before the House of Lords that approached such a matter. While the majority of Lordships legitimatised the traditional test expressed in the case of Mr Bolam, the individual judgements were small steps towards informed consent. Four out of the five Law Lords rejected the transatlantic test that a duty to inform a patient should be based on the reasonable or prudent patient and Lord Scarman alone favoured this manner of law. 2.6 Lord Scarman made it apparent that he considered the patient to have the right to choose what happens to his body, which signified the patient needs to know the risks so can exercise an informed choice. He went on to express what he held to be the suitable relationship between a doctor and his patient, â€Å"There is room in our law for a legal duty to warn a patient of the risk inherent in the treatment proposed†. He went on to consider the doctrine of informed consent and its relevance in the Canterbury case, â€Å"I think the Canterbury propositions reflect a legal truth which too much judicial reliance on medical judgment tends to obscure† Lord Scarman acknowledged the patients rights and that the prudent patient principle made the doctors much more accountable for their actions. As such he rejected the current medical practice that a patient will be informed if he needs to be, as opposed to if he wants to be. Doctors, in Lord Scarmans view, should be liable where the risk is such that in the courts view a prudent person in the patients situation would have regarded it significant. He appears to suggest that the onus proof rests on the doctor to satisfy the court as to the reasonableness of any non-disclosure and therefore suggesting a support for informed consent. However, it must be noted that he did not find in favour of Miss Sidaway, on the basis that she failed to establish that the less than one per cent risk was such that a reasonable patient would consider significant. 2.7 In spite of this the speech of Lord Scarman has stood as a symbol of hope to those who argue for informed consent to be introduced into English law. Lord Diplock rejects Lord Scarmans scrutiny, as he maintains that the Bolam test covers all aspects of the doctors duty to care to his patient. However, he distinguished from the position where a patient asks a question about treatment, by stating â€Å"if the patient in fact manifested this attitude by means of questions the doctor would tell him whatever it was the patient wanted to know.† This illustrates that while Lord Diplock believed doctors were not be required to inform the patient of risks, he does not fully discount the patients rights. Lord Bridge also rejected the notion that a patient should be warned of all risks, yet â€Å"when questioned specially by a patient of apparently sound mind about risks involved in a particular treatment proposed, the doctors duty must, in my opinion, be to answer both truthfully and as fully as the question requires.† This gives the patient the option of asking for information from the doctor and if the doctor failed to do so then his duty of care could be in breach. However, Lord Templeman, expressed that this is not clear cut, as â€Å"the court will be slow to conclude that the doctor has been guilty of a breach of duty owed to the patient merely because the doctor omits some specific item of information.† It was important that Lord Scarman recognised the doctrine of informed consent and that the remaining four judges recognised the meaning of a patients ability to enquire and the doctor responsibility to notify. 2.8 It seemed that English legal system was initially hesitant to adopt informed consent into medical law. However, the approach taken in the case Gold v Haringey Health Authority contradicts that expressed by their Lordships in Sidaway. The claimant, in this case, indicated that she did not wish to have any more children and was advised to undergo a sterilisation operation after the birth of her third child. The operation was carried out but the claimant later became pregnant and gave birth to her fourth child. The Judge at first instances applied his own analysis as to what information the doctor should have given and found the defendant negligent. Upon appeal, Lloyd L.J held that the Bolam test should be strictly applied and he dismissed the view of the judge prior to him. He asserted that for the purposes of establishing the test as to the duty of care owed by a doctor to a patient no distinction needed to be made between advice given in a therapeutic and non-therapeutic context. In reference to Sidaway he stated, â€Å"the House of Lords could have adopted the doctrine of informed consent favoured in United States of America and Canada, but the House of Lords decided not to follow that path.† It seems clear from the Sidaway judgement that the nature to inform is more extensive than that of the Bolam test where no information is required. The decision in Gold repealed any progress been made towards informed consent and the judgement seemed to convey patient autonomy to be rather trivial 2.9 The view of Diplock in Sidaway has been regarded as the authoritative statement regarding the extent of the doctors duty. There has been a move away from the Diplock approach as seen in the case Pearce v. United Bristol Health Care NHS Trust which altered the analysis of a doctors obligation. Mrs Pearce, who was expecting her sixth child, was two weeks past her due date of delivery. She discussed the possibility of induction with her obstetrician who warned her of the risks of induction and caesarean surgery, but did not tell her that there was a 0.1 to 0.2 per cent risk of stillbirth associated with non-intervention. Mrs Pearces child was stillborn and she alleged that failure to warn her of the full risks was negligent. Lord Woolf, in this case, held that the patient had the right to know and stated the doctor should normally inform a patient of â€Å"a significant risk which would affect the judgment of a reasonable patient.† It was decided, however, that while a doctor is under an obligation to warn, the 0.1 to 0.2 per cent risk of stillbirth was not classed a significant risk. While the Pearce judgment did not go so far as to fully accept the doctrine of informed consent, it adopted elements of the reasonable test. The judgement goes a certain distance to reconcile the approaches of Lord Scarman, Lord Bridge and Lord Templeman in Sidaway. It isolated Bolam, which by Professor Margaret Brazier,who has wrote many publications on issues of medical law, was considered good as Bolam was â€Å"out of control and out of context, it came close to acquiring democratic status in some quarters.† The test for duty to warn was now suggested to be that the reasonable doctor must tell the patient what a reasonable patient wanted to know. The judgement signified a more patient-friendly approach and made greater demands on the level of disclosure. Chapter 3: Further development towards the doctrine of informed consent 3.1 The medical professional has taken steps to further achieve the full introduction of informed consent into the medical world. The General Medical Council (GMC) produced comprehensive guidance to, doctors on seeking the patients consent in Seeking Patient Consent: The Ethical Considerations February 1999 (appendix I). These guidelines make particular reference to the requirement on doctors to attain informed consent, a doctrine which a few years earlier was alien to English law. Since 1992 Professor Sir Ian Kennedy LLD, a former member of the GMC, has been arguing that doctors need specific guidelines on what constitutes good practice. At that time he was the voice of the minority, however due to dramatic change in the doctor-patient relationship the GMC recognised guidelines needed to be established. The standard adopted in these guidelines resembles elements of the prudent patient test specifically that of the judgment made by Lord Scarman in Sidaway. Guidance from the GMC directs doctors to†¦take appropriate steps to find what patients want to know and ought to know about their condition and its treatment. Andrew Hockton believed that the guidelines, â€Å"should now be considered to amount to more an ethical obligation: they provide at least, a starting-point for measuring the extent of a doctors duty of care to patients† It appears that the guidelines are considered to be a benchmark for doctors to monitor their legal duty of care, to which the Bolam test fails to create. This dissertation professes that perhaps this is the responsible body of medical opinion and it seems the medical profession are setting a higher standard for both themselves and the patient. 3.2 It must be noted the development of the Human Rights Act 1998, has extended the doctrine of informed consent in medical treatment. Incorporation of the European Convention of Human Rights under the Human Rights Act encourages the courts to focus more on the patients rights. This area of law includes Article 2 (the right to life), Article 3 (prohibition on inhuman or degrading treatment) and Article 8 (the right to respect for private and family life which includes the right to bodily integrity). The case R(on the application of Wilkinson) v Broadmoor Hospital illustrates how the introduction of the rights affected certain aspects of medical law. A mental patient appealed concerning a decision to administer treatment without his consent and under restraint. He claimed it infringed his rights under the European Convention of Human Rights 1950, Art.2, Art.3 and Art.8. The judge allowed the appeal stating that under the 1998 Act, it was no longer appropriate to forcible treat detained patients without a court judgement granting so. While the decision in this case would not have been so without the introduction of the Human Rights Act, it had little effect on the majority of medical consent cases. The Act was expected to have a great impact upon issues of medical consent, however it does not seem to have made a dramatic difference on the Courts decision making. 3.3 The most recent case that has dealt with the issue of informed consent is Chester v Afshar, where the claimant underwent surgery and suffered nerve damage leading to paralysis. The surgeon failed to warn Miss Chester of the inherent risk in surgery and the House of Lords decided that the risk was of sufficient quantity to determine the defendant had inadequately warned. The case is considered to show the importance the courts attached to the principle of autonomy, as Lord Hope reiterates when he states, â€Å"the duty to warn has at its heart the right of the patient to make an informed choice as to whether and if so when and by whom to be operated on.† The claimants evidence verified had she been warned of the risk she would not have agreed to surgery without at least seeking a second opinion on the necessity and risks of surgery. Therefore, a causation link was adopted by the courts to further prove negligence by the doctor. 3.4 In this case it was sufficient for her to prove that, if properly warned, she would not have consented to the operation. Dr Afshar was found to violate her right to choose, which meant she was unable to seek further advice or alternatives. Therefore, a claimant pursuing a claim in this area must prove if the information had been given, their decision as to the treatment would have caused extra consideration. Lord Steyn asserted that individuals have a right to make important decisions affecting their lives for themselves†¦in modern law paternalism no longer rules. This case was a ground breaking decision by the House of Lords, as it introduced fully informed consent and it addressed the purpose and rationale behind a doctors duty to warn. 3.5 Historically the law as taken the view that doctors are honourable and true, essentially allowing the medical profession themselves to dictate the duty to disclose. As a result of the decision made in Chester v Afshar this outlook has changed somewhat and it appears to provide a new dawn for patients rights. It has created a remedy for patients who have received insufficient information, where previously the majority of case had failed to provide such a remedy. The days of Lord Denning are long gone, meaning the doctor-friendly Bolam principle has practically been condemned worthless. While the judgement can be seen to address the reality of responsible expectations of society, it seems the judgment leaves the court with a difficult job determining who, between the patient and the doctor, is effectively legitimate when it comes to what information is disclosed. More specifically the outcome is likely to be met with distaste from doctors and there is already evidence of growing concern from within the profession. Despite the doctors concern the law of informed consent has moved on considerably from the reality where the majority of cases would fail to offer a remedy for those who had not been completely informed. As was stated by Sarah Devaney in a Medical Law Review, that back then, â€Å"It did not matter whether or not doctors were wearing the flak jackets of consent, as patients wishing to make claims about lack of information were in any event carrying unloaded guns. However, after cases, time and the materialization of certain events the doctrine of informed consent began to take effect in English law. Chapter 4: The Degree of Sufficient Information 4.1 Informed consent is based on the requirements of appropriate information to allow patients to make an informed choice. The law fails to formulate a standardize figure which can be consider significant and therefore it can only be gauged on previous cases and what the accepted amount has or has not been within these circumstances. More specifically, as no clear indication has been articulated, the judgement will be dependant on the individual facts of the case, as long as this coincides with the authoritative case law. What is clear is that failure to advise sufficiently as to the nature and purpose of the procedure may give rise to an action against the doctor. If the patient is given inadequate information, then how they able to make an informed decision and therefore be said to have given real consent? 4.2 The leading case Chester v Afshar (as discussed above) contradicted any previous beliefs of the court and that of the medical profession. The case prior to Chester was Pearce v United Bristol Health Care (as discussed above) where Lord Woolf stated that the doctor should normally inform a patient of a significant risk which would affect the judgement of a reasonable patient. It considered the balance of percentages and whether this balance would have effected the patients decision to have the treatment. The risk of 1-2 per cent in this case was not considered to be sufficient to represent a significant risk. The decision in Chester made it clear that a 1-2 per cent risk was an adequate percentage for the doctor to warn the patient. Even though, the doctor appropriately informed according to the Pearce decision and the GMC standards, Chester v Afshar brought a new way of thinking to the table. 4.3 Chester disregarded the concept of what a reasonable patient would want to know and instead looked at what each individual patient wanted to know for themselves. This meant it was more plausible for the doctor to consider the patients personality, concerns and wants and information given must be relevant to the patients decision. The involvement of the causation link enabled patients to assert their rights over decision not only on the surgery itself, but in addition on the circumstances in which it was under, for example the time, place and in whose hands the operation should be performed. The causation link made it easier for patients to receive a remedy at law, as long as they could prove that had they been sufficiently warned of the risks they wouldnt have undergone the treatment. This does not mean they need to prove that they would not have had the operation at any time, just not at that moment in time in which they did. The doctor needs to make acknowledgment to both warn of a significant risk and risks which a patient would consider relevant, even if not below significance. It left the doctors with the delicate job of determining what information individual patients wanted to know. This contemporary approach sent shock waves through the medical profession and the GMC had to amend their guidelines, as they now failed to reach a high enough standard. The new guidelines can be found In Good Medical Practice 2006. (see Appendix II) 4.4 Professional guidelines now go further and state the doctor must do his best to discover the patients individual needs and priorities to analysis what information that individual may require. When consenting to treatment patients should be aware of certain factors such as, diagnosis, prognosis, various treatment options, probabilities of success and possible side effects. This was the situation in the case Smith v Tunbridge Wells Health Authority, where a claim was brought against a 28 year old man who was not warned of the risk of impotence inherent in rectal surgery. His claim succeeded despite the risk being considered significantly low, as the judge found failure to warn such a patient of a risk of such importance to him was neither reasonable nor responsible. The doctor needed to have balanced the small risk of importance against the importance it possessed on his life. 4.5 The most effective way of obtaining consent that is currently in the English medical system is consent forms. Consent forms place emphasis on the patients rights; it gives them a sense of control and perhaps recaptures some of the faith that is said to have disappeared between doctors and patients. There is no requirement in English law that consent forms should be in writing, however the Department of Health have recommended the use model consent forms (see appendix III). The most prominent aspect is the fact it does not shy away from informed consent and instead seems to embrace it. It attempts to ensure that patients are aware that they are entitled to ask questions and expect explanations do with the medical treatment they receive. Unfortunately this way of operating is time consuming and is limited to operations and major procedures. It would not be viable for such things as checking a patients throat or examining a patients stomach, as these everyday occurrences are too frequent and considered to be too minor. Some see the consent form as purely evidential yet other believes them to signify fairness to both the patient and the doctor. It creates patient awareness of the fact that they have the right to know and for this right to be attained the patient needs to make it aware what they specifically want to know. This does not extinguish the doctors duties, he must still follow the guidelines set out in obtaining informed consent, for example, explaining the treatment and its implications. In the case Abbas v Kenny the judge stated the obligation is not placed upon the patient and it simply reaffirms their rights, yet it is still the doctors responsibility to â€Å"take into account the personality of the pati ent and the likelihood of misfortune.† 4.6 Even if a warning is given, it can not be consider a suitable warning if it is insufficiently clear to the patient and affects their ability to make a decision on information they fail to comprehend. The doctor must take responsible steps to ensure that advice is understood by the patient. To what extent is it the doctors duty to make sure the patient understands? Chapter 5: A Patients Capability to Understand 5.1 There is a rebuttable presumption that adults have capacity to consent to or refuse treatment. Therefore to make consent valid they must possess the capacity to understanding the method, consequences and benefits. If one fails to understand the information given and the inherent risks of treatment then it can not be regarded as informed consent. Care must be taken to not automatically presume those with learning difficulties are incapable; it is important for doctors to not underestimate a person from their faà §ade. Capacity is not a question of decree of intelligence or maturity of the person concerned, it incorporates elements of ability and belief. 5.2 There are different functions of what must be understood. The must frequently cited case in this context is Re C (Adult: Refusal of Medical Treatment) in which, Thorpe J, held that the person must understand the nature, purpose and effect of the procedure. In other words, sufficient knowledge constitutes the general functions of treatment. Another function that capacity can occupy is that held in Re T (Adult: Refusal of Traetment) where Lord Donaldson referred to knowledge in broad terms of the nature and effect of the procedure to which consent was given. The level of understanding was made important in this case and that this will differ according to the gravity of the decision. More specifically, the more serious a decision the greater capacity required and accordingly patients may have capacity to make some decisions but not others. 5.3 Assessment of a patients capacity is determined by reference to the Thorpe. Js three stage test in Re C it states the courts will assess the patients ability: to take in and retain treatment information; to believe it; to weigh that information, balancing risks and needs. In this case, a sixty-eight-year old patient was being detained in a special hospital, as he survived from schizophrenia. Despite this, the Judge ruled that the patient remained capable of understanding what he was told about the proposed treatment and the proposed risks involved. By satisfying the three points, a patient can verify that information can be given by the doctor, thought through and decided on and therefore the doctrine of informed c