Consent to medical treatment and information requirements for a valid consent for medical treatment.

Consent to medical treatment and information requirements for a valid consent for medical treatment.

                                     Dr KS Dhillon LLM

‘Every human being of adult years and sound mind has a right to determine what shall be done with his body; and a surgeon who performs an operation without his patient’s consent, commits an assault’...Benjamin Cardozo, Supreme Court justice, USA

It is trite law that a consent must be obtained from a person with capacity before any examination, test or treatment can be carried out [1]. There is detailed jurisprudence in English law as far as consent to medical intervention  is concerned.The question is whether the patient is asked to consent to physical intervention or to the risks associated with that intervention [2]. Hence there are two types of consent, the ‘real consent’ and an informed consent.

The Tort of Battery and ‘Real’ Consent

A doctor commits a legal wrong of battery or assault if he subjects a patient to physical intervention without valid consent or alternative legal justification.
Legally, for consent to the physical intervention, all that the patient needs to know is, what that physical intervention will involve. Broadly there are three category of situations which can lead to a charge of battery. The most common situation is when a patient is subjected to treatment against his/her will [3]. Sometimes it may involve a situation where a procedure other than the one consented to is carried out [4] or where a patient is deliberately and fraudulently misled [5].
The information provided when obtaining a consent has to be relevant and the information need not be elaborate. The Court in Chatterton v Gerson [6] pointed out that ‘once the patient is informed in broad terms of the nature of the procedure that is intended, and gives her consent that consent is real’. Hence the patient only needs to understand the general nature of the operation for the consent to be valid and therefore the law terms it as ‘real’ consent.
The standard for deciding what information needs to be disclosed to the patient to make the patient ‘broadly aware’ of the nature of intervention and obtain a ‘real’ consent to prevent action in battery is determined by the medical profession [6].
For ‘real’ consent there is no requirement to provide information about risk involved and about other options available. For these reasons ‘real’ consent is easily obtainable.
Informed consent to medical procedure is a more complicated matter.

The Tort of Negligence and ‘Informed Consent

None disclosure of a non-negligent risk associated with an intervention by the clinician, could be actionable in negligence if the risk eventuates since valid consent to those risks was not obtained. Such a consent is known as informed consent. There is a definite difference between ‘real’ and ‘informed’ consent and the information required for informed consent is therefore very different. When giving an informed consent not only information about the the nature of the procedure is needed but also information about the risks associated with the said procedure is needed. Having to consent to possible risk raises the question of alternative procedures and their corresponding risk and also the possibility of non-intervention.
In English law it is evident that doctors have a duty to inform the patient of alternative treatment which have lower risk [7]. Even if the risk is not lower it is duty of doctors to inform the patient of alternative interventions [8].
A failure to disclose the risk and benefits of a procedure and alternative intervention does not render a ‘real consent’ invalid but it would mean that the doctor has not obtained an informed consent.
Action of battery is regarded as inappropriate for interventions without informed consent because the law believes that doctors act in good faith and in the interest of the patient when they carry out medical treatment [6]. Battery on the other hand is associated with bad faith and it is usually carried out intentionally [9]. Therefore, the Courts believe that the doctor must have inadvertently failed to disclose a risk and could not have battered a patients in whose best interest they are acting.
The courts are usually reluctant to entertain a tort of battery in medical cases even when a wrong intervention is performed. A claim in negligence, can in principle, be sought in such cases. Bristow J in Chatterton v Gerson [6] however, felt that trespass would be the appropriate cause of action in such a case.
The level of information required to avoid a charge of battery when obtaining a ‘real consent’ is low. All that is necessary is to make the patient  ‘broadly aware’ of the nature and purpose of the action by reference to the reasonable doctor’s view of what is relevant. The same however is not true as far as informed consent is concerned.
Till 2015, the English Courts used to take a similar position to setting standards, as for ‘real consent’, where a reasonable doctor’s view prevailed, when taking an informed consent.
In Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [10] relying on the Bolam test [11] the House of Lords held that a patient would be considered to have been adequately informed about the risks if the doctor had disclosed risks which the medical profession thought was reasonable to disclose.
However, in 2015 this reliance on the reasonable doctor’s view changed. In  Montgomery v Lanarkshire Health Board, the Supreme Court  departed from Sidaway in how standards are set by declaring that information
about risks and alternative treatments should no longer be based on Bolam.
The court held that the doctor is:
‘under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, 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’ [8].
Hence, when obtaining informed consent the level of information that needs to be disclosed has to be referenced to the patient’s perspective, and not that of the doctor.
Though the law of informed consent has been quite clear over the last 30 years, there still remains lack of clarity about the standard used to judge whether a consent is properly ‘informed’ or not. There appears to be significant differences between what the doctor and the patient views as relevant information for medical treatment.  The large numbers of high profile legal challenges concerning non-disclosure of medical risk information, in English law, bears testimony to this fact [12].

What are the elements of full informed consent?

Following the decision by the Supreme Court in Montgomery it has become important that the patient is given an opportunity to be an informed participant in his/her health care decisions. The following points have to be taken into consideration and discussed when obtaining an informed consent:

• The nature of the procedure or intervention has to discussed and the patient should be made to understand what is involved
• The patient has to be made aware of reasonable alternatives to the proposed intervention which are available
• All the relevant risks, benefits, and uncertainties related to each alternative has to be discussed with the patient
• The doctor has to make sure that the patient comprehends the information provided. The discussion should be carried on in layperson's terms
• The patient must be willing to accept the intervention proposed by the doctor

This gives rise to the next question.

How much information is considered "adequate"?

In the past the reasonable physician standard was used to determine how much information has to be provided. That would mean that the doctor would decide how much information to provide the patient about the intervention based on the common practice among doctors. The courts have found that this standard is inadequate since it has become apparent that doctors do not provide a lot information. In the reasonable physician standard the focus is on the doctors rather than on the patient and is inconsistent with the concept of patient autonomy and with the goals of informed consent.
Currently most jurisdictions use the reasonable patient standard for informed consent. It involves providing information which an average patient would want to have to participate in the decision making process.
Patients have to be given sufficient information about the condition, investigation and treatment options, benefits, possible side effects or complications, and the likely outcome if treatment is not undertaken, so that they can make an informed decision to undergo treatment, procedure or operation.
There is a legal duty for the doctor to warn the patient about material risk inherent in the proposed treatment or intervention. ‘Material’ risk was defined in Rogers v. Whitaker  [13]. A risk is ‘material’ in a given circumstance if a reasonable person in the patients position, if warned of the risk, is likely to attach significance to it or if the doctor is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. Known risks that are common though their detriment is slight and those that are uncommon but their outcome is severe should be disclosed. It is also important to know whether knowing about a risk is likely to influence a patient’s decision. Failure to disclose these risks may be a breach of the doctors duty of care to the patient and this could give rise to legal action for negligence.

Pre-prepared material/brochure and informed consent

Prepared patient information forms and brochures (translated when necessary) are sometimes used in hospitals before obtaining informed consent. These material can be useful for the patient to stimulate discussion about the procedure and its risks and it helps the doctor to guide the direction of the discussion. This material however cannot be used as a substitute to ascertain that the patient has understood the nature and risk of the procedure. Providing this material does not discharge the legal duty of the doctors when obtaining an informed consent. The doctor still has to make sure the patient is aware of the intervention planned and all material risks involved. The doctor has to ask the patient if any of the information provided is unclear. It is the doctor's duty to make sure that the pre-prepared material is up to date, accurate and appropriate for the patients. An inadequate or inaccurate information sheet would mean that that the patient was inadequately informed and this could have legal implication if litigation ensues. When additional information is provided to the patient it should be specifically noted by hand on the information sheet. Interpreters have to be used when there are language problems. In some countries professional interpreters are used when dealing with non-English speaking patients [14].

When can the duty to inform be breached?

The duty to inform the patient cannot usually be breached. However there are two situations where the duty to inform may be breached.

1. Rarely a situation may arise, where the patient expressly directs the doctor to make the decisions and does not want any information that is being provided. In such situations the doctor should at least provide the  basic information about the diagnosis and treatment.
2. On other occasions the duty to inform may be breached when the doctor exercises “therapeutic privilege” and withholds the information, when he holds a reasonable belief that disclosure of the risks could prove damaging to the patient’s health. Here the doctor has to make a judgment call, on reasonable grounds, that the information provided could cause serious harm to the patient’s physical or mental health. Several factors govern therapeutic privilege and this can include the personality, temperament or attitude of the patient as well as their level of understanding. Other factors include the nature of the treatment to be provided and the likelihood and severity of adverse effects which can result from the treatment.

Exercising ‘therapeutic privilege’ denies the patient his /her right to participate in decision making and this privilege should be sparingly used. The scope of this privilege remains uncertain and consultation with other colleagues is useful when making a decision to exercise ‘therapeutic privilege’ [14].

What information should the doctor provide the patient when obtaining the informed consent?

When obtaining an informed consent the following points should be brought up in the discussion with the patient:

1. The possible or most likely illness that the patient has;
2. The planned approach to investigations and treatment, including what the approach entails
3. The expected benefits of the intervention
4. The common side effects and material risk associated with the intervention
5. Whether the procedure is experimental or is conventional and established
6. The person who would be carrying out the procedure
7. Are other options for diagnosis and treatment available
8. The degree of uncertainty involving the the diagnosis and outcome of the intervention
9. What is the likely outcome of not undergoing the intervention for diagnosis and or treatment
10. Long term physical and non-physical adverse effects associated with the proposed intervention [14].

Conclusion

From the legal point of view a consent must be obtained from a person with capacity before any examination, test or treatment can be carried out.
A legal wrong of battery or assault can easily be avoided by obtaining a ‘real consent’ by informing the patient in broad terms the nature of the procedure that is intended. The nature of information to be given to patient to obtain ‘real consent’ is determined by the medical profession.
Obtaining an informed consent on the other hand is more complicated. The law in this area has changed over the years. When obtaining an informed consent the level of information that needs to be disclosed has to be referenced to the patient’s perspective, and not that of the doctor as in the past. Patients now have to be given sufficient information about the condition, investigation and treatment options, benefits, possible side effects or complications, and the likely outcome if treatment is not undertaken, so that they can make an informed decision to undergo treatment, procedure or operation. It is now the legal duty of the doctor to warn the patient about material risk inherent in the proposed treatment or intervention.
Prepared patient information forms and brochures can be used to provide information to the patient. These forms, however, cannot be used as a substitute to ascertain that the patient has understood the nature and risk of the procedure. Providing this material does not discharge the legal duty of the doctors when obtaining an informed consent.
The duty to inform can very rarely be breached. Doctors should use ‘therapeutic privilege’ to withhold information from patients very sparingly, because it denies the patient his /her right to participate in decision making.
Although the law of informed consent has been quite clear over the last 30 years, there still remains lack of clarity about the standard used to judge whether a consent is properly ‘informed’ or not.

References

1. Mental Capacity Act 2005 s.
2. Chico V and Taylor MJ. Using and disclosing confidential patient information and the English common law: What are the information requirements of a valid consent? Medical Law Review, Vol. 26, No. 1, pp. 51–72.
3. Re B (Adult, refusal of medical treatment) [2002] 2 All ER 449; Re C (Adult, refusal of treatment) [1994] 1 All ER 819.
4. Devi v West Midlands RHA [1980] CLY 687.
5. Appleton v Garrett (1997) 8 Med LR 75.
6. Chatterton v Gerson[1981] QB 432, 443.
7. Birch v University College Hospitals NHS Trust [2008] EWHC 2237 (QB).
8. Montgomery v Lanarkshire Health Board [2015] UKSC 11.
9. Wilson v Pringle [1987] QB 237.
10. Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] UKHL 1.
11. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582.
12. Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] UKHL 1; Montgomery v Lanarkshire Health Board [2015] UKSC 11; Chester v Afshar [2004] UKHL 41; Al Hamwi v Johnston and another [2005] EWHC 206 (QB) and Pearce v United Bristol Healthcare NHS Trust [1998] EWCA Civ 865.
13. Rogers v Whitaker [1992] HCA 58; (1992) 175 CLR 479.
14. Policy Directive -- Consent to Medical Treatment - Patient Information. Ministry of Health, NSW, Australia at http://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2005_406.pdf accessed on 19/4/18.