Informed consent is currently a widely accepted practice. It is a concept that arises as Beuchamp and Childress put it in ‘Principles of Biomedical Ethics’ from the ethical principle of patient autonomy. There are of course also views that it also arises from the principle of basic human rights.
Is it Important to Disclose Information to the Patients?
Disclosing information to the patients by hook or crook has not been the original or the longest practice in the clinical process. This is because the Hippocratic Oath demonstrates that it is the doctor’s duty according to their “ability and judgement” to consider for the benefit of their patients. Further, Hippocrates has placed more emphasis for doctors to conceal information from their patients and the advice was to turn the patient’s attention “away from what is being done to him…revealing nothing of the patient’s future and present condition.”
In some instances from centuries ago consent was deemed necessary such as in the case of Slater v Baker(1767) whereby the court held that it should not only be a professional conduct for a doctor to seek consent before re-fracturing the patient’s leg, it is also important so that the patient would “take courage and put himself in such a situation as to enable him to undergo the operation.”
However, it was not until the twentieth century that the idea that doctors must disclose as much information as possible to the patients came about. This is mainly to allow the patients to have control on their own hands to some extent so as to give effect to the growing idea of patient autonomy. Moreover, it is also opined that disclosure of information could bring a balance between the doctor-patient relationships.
As Michael Jones puts it in ‘Informed Consent and Other Fairy Stories’ (1999), “part of imbalance between doctor and patient is due to the patient’s lack of information, and, on one view, it is the function of the law to redress the imbalance by providing patients with the ‘right’ to be given that information, or perhaps more accurately imposing a duty on doctors to provide it.”
The idea of disclosing information to the patient has therefore developed through the years, and in many cases the courts have improved the legal position regarding this matter. Hippocratic model was then replaced with partnership model. The rationale was, apart from respecting patient autonomy; allowing patients to decide as to what they want to be done to their bodies have become more possible with the advances in medical technology.
Is the Consent Legally Valid?
In order for consent to be legally valid, the patient must give the consent validly, have the capacity to give the consent and thirdly they must understand the nature of the treatment in question. The idea of “informed consent” is one that is derived from the third of these requirements. All three of these requirements have to be proved in order to establish consent, and failure to prove this would hold the medical practitioner in question to be liable under battery. In fact, in R v Brown [1994], Lord Templeman treated consent as a defence to battery.
Although obtaining an informed consent has often regarded as an ethical obligation, the English Legal System has been active in asserting that it is also a legal obligation, through the various case laws that have been decided before the courts.
One of the cases is Chatterton v Gerson [1981]. In this case, the court established that the information required for there to be a valid consent is largely similar to that of battery.
Justice Bristow in the Queen’s Bench Division stated that in order to succeed in trespass, the claimant or rather the patient has to show that there has been a lack of real consent, but if the patient has been “informed in broad terms of the nature of the procedure which is intended, and given his consent, that consent is real.”
This case has also seemingly emphasised that a mere fact of signing the consent form does not establish a complete consent, making the provision of information a more important factor to determine consent.
It is also important to note that it is sufficient so long as the claimant has understood the nature of the procedure in broad terms in order to consent to the procedure, to have derived the information for a source other than the doctors themselves. Therefore, an action in battery would only be applicable where the doctor has treated the patient against her will. This is along with the statement by Lord Diplock in Sidaway v Bethlem Royal Hospital [1985], that consent to what would otherwise be a battery is “a state of mind personal to the victim of the battery.”
What Happens when the Consent is Invalid?
What happens when the information used is intended to mislead the patients into giving consent? Many criminal cases held that apparent consent will be invalid if a person is misled about the “nature and quality” of a treatment or procedure, sometimes even the identity of the medical practitioner.
For example, in Appleton v Garret [1996] a dentist conducted a large scale, unnecessary treatments on patients, and was found liable under battery on the grounds that his patients’ consents were not real, because had they known the true intentions of the dentist, they would not have consented to the treatments.
Apart from battery, performing medical procedures on an inadequately informed patient may also lead to an action in negligence, upon the establishing of the duty of care, breach of the duty and causation. One question that is significant in this regard is “What information must a doctor disclose to avoid liability in negligence?”
Justice McNair in Bolam v Friern Hospital Management Committee [1957] applied the same standard of care to the claim of failure to disclose the risks associated with a procedure as he did to a claim that involved negligence by the defendants in the administration of a treatment, the standard of care required off a reasonable man.
However, in Sidaway v Bethlem Royal Hospital [1985], although other judges were prepared to apply the Bolam test with Lord Bridge and Lord Templeman slightly modifying it, Lord Scarman however was not prepared to apply the Bolam test. The case involved Mrs Sidaway who had been partially paralysed by an operation to remove recurrent pain in her arms and shoulders, which carried a risk of injury to the nerve root or her spinal cord of one to two percentages. Mrs Sidaway claimed that had she been informed of this risk, she would not have consented to the operation; however, the majority Lordships dismissed her appeal stating that the risk was too little that many reasonable neurosurgeons would not have warned her of it anyway.
Lord Scarman however was of the view that instead of looking at what a reasonable medical practitioner would have disclosed, the attention should be drawn to what “a reasonably prudent patient” would want disclosed, subject only to “therapeutic privilege”, where a doctor could still rely on a reasonable believe that disclosure of a risk would prove psychologically damaging to a patient.
The House of Lords in Bolitho v City and Hackney Health Authority [1998] supported the test saying that it does not simply take into account any supportive expert’s opinions, but requires the medical opinion to have a logical basis. Further, Lord Woolf in Pearce v United Bristol Healthcare Trust (1999) supported Lord Bridge’s statement in Sidaway that a “significant risk” is something that is in the region of ten per cent, failing to consider a 0.1 to 0.2% risk of stillbirth to be significant enough.
Lord Steyn in Chester v Afshar on the other hand, stated that the patient has a prima facie right to be informed of even a small, but well established risk of serious injury that could result from a surgery.
Was the Reasonable Doctor’s Test Welcomed?
The reasonable doctor test was substantially criticised to place too much of a discretion on the medical practitioners and for its failure to place sufficient importance on the right to self-determination of patients. In fact, the Australia’s highest federal court in the case of Rogers v Whitaker (1992) has demonstrated its disagreement with the test as early as 1992, by applying the prudent patient test and finding the surgeon negligent for failing to disclose a risk that is only slightly greater than one in 14000, despite his action being supported by a body of medical opinion.
Although the Sidaway approach was endorsed by cases such Pearce v United Bristol and Gold v Haringey Health Authority [1988] (where the rule in Sidaway was applied to sterilisation for contraceptive purposes rather than restricted to therapeutic procedures), however, the current leading case on the disclosure of risks is Montgomery v Lanarkshire Health Board [2015], rejecting Sidaway and its endorsement of Bolam. This is because the reasonable doctor standard was gradually recognised to be too paternalistic and there is risks of medical opinions agree to the doctor’s conduct although the risk associated to it is significant.
The Prudent Patient Test
Further, the prudent patient test endorsed by Lord Scarman is uncertain especially to the medical practitioners as they will be expected to focus on finding out what the patients would like to know instead of focusing on disclosing the information they consider is important or significant. The prudent patient test may however be helpful in cases where there are other alternatives to a treatment that might carry lesser or no risks, as that can be seen in Birch v UCL Hospital NHS Foundation Trust [2008] where a doctor who had informed the patient of the significant risks was held liable for negligence nonetheless simply because there was an alternative procedure carrying fewer or no risks that the doctor failed to inform to the patient.
In Montgomery, the test articulated is “in the circumstances of the particular case, would a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.”
The case concerned Mrs Montgomery who suffered from insulin dependent diabetes mellitus. It was agreed between the parties that the risk of shoulder dystocia occurring during vaginal delivery was 9 -10% in the case of diabetic mothers. She was not told of the risk of shoulder dystocia, as, in the doctor’s opinion, the possibility of it causing a serious problem for the baby was very small. The doctor also suggested that advising of the risk would lead to most women electing for a caesarean section. During the vaginal delivery the umbilical cord was completely or partially occluded, thereby depriving the baby of oxygen. After his birth, he was diagnosed as suffering from dyskinetic cerebral palsy. It was the Mrs Montgomery’s case that had she been told of the risk of shoulder dystocia she would have elected for a caesarean section.
The Supreme Court in this case disagreed with the majority judgement in Sidaway and was of the view that Lord Scarman’s dissenting judgement was more favourable. It was held that the doctor was under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in proposed treatment, and of reasonable alternatives. A risk was “material” if a reasonable person in the patient’s position would be likely to attach significance to it, or if the doctor was or should reasonably be aware that their patient would be likely to attach significance to it. This is in line with the General Medical Guidance (GMC) 2008 whereby it was stated that doctors must “share with the patients the information that they want or need in order to make decisions.” They cannot simply make assumptions as to the information that the patients may want to know.
Lord Kerr and Lord Reed reasoned that an adult of sound mind is entitled to decide which, if any, of the available treatments to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. This is in favour of the patient autonomy argument. The patient must also be informed of the reasonable alternatives, especially when they carry fewer or no risk at all when compared with the proposed procedures.
Lord Ordinary was of the view that if only had the doctor discussed every details of the risk of the proposed procedure to Mrs Montgomery, with the alternatives available, Mrs Montgomery would probably have chosen the caesarean section, reducing the risk of the stillbirth.
Lady Hale was also somewhat of the same opinion, stating that the doctor should properly weigh the advantages and disadvantages of the vaginal delivery compared to a caesarean section and inform the patient about it.
The Practice of Patient Autonomy Principle
The new test established in Montgomery therefore places a significant emphasis on the patient autonomy principle, which not only is ethical, but also respects basic human rights of patients.
Other jurisdictions have long introduced this in practice. For example, Article 5 of the law on patient’s rights in Finland provides that “a patient shall be given information about his/her state of health, the significance of the treatment, various alternative forms of the treatment and their effects and about other factors in association with his/her treatment that are significant when decisions are made on the treatment given to him/her.” It should also be given in a manner the patient could understand. The similar is provided in Czechoslovakia, under Section 23 of Law No.20 of 1966 concerning the protection of public health. The right to information is heavily endorsed by any other jurisdictions, such as France (Article 37 of the Code of Deontology), Germany, Greece (informed consent must come without physical or psychological pressure), Hungary and Iceland (Article 1 of the Physicians’ Act of 1988).
In conclusion, not only in the English Legal System especially after the introduction of the new test in Montgomery, other jurisdictions too have adopted the view that informing the patient about the nature of a treatment, risks associated with it, the prognosis and potential consequences of not having the treatment, is important in order to respect the patient autonomy and their rights to bodily integrity.
Therapeutic privilege by doctors however may be required in some circumstances where the patient is illiterate and expects the doctors to make decision for him or her and also when the doctors think that the patient is so fragile that a full disclosure would overwhelm him or her. For example, it may be more acceptable to not inform a patient something that could trigger a dangerous anxiety reaction.
