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Consent – The basics

27 Jun 2017

Summary

It is important to respect patients’ autonomy and seek their consent to treatment; to impose care or treatment on people without respecting their wishes and right to self-determination is unethical and goes against medical principles.

Recent case law and revisions to the SMC Ethical Code and Ethical Guidelines have placed a legal and professional obligation to move to a patient-centred approach when providing information and advising of risks and treatment options.

Key principles

Following a landmark decision by the Court of Appeal (Singapore Court of Appeal in Hii Chii Kok v Ooi Peng Jin London Lucien [2017] SGCA 38), the Bolam test (with Bolitho addendum) no longer applied to advice provided by doctors. This has been replaced by a Modified Montgomery Test, which obliges physicians to provide sufficient information to enable patients to exercise their autonomy and make informed decisions with regards to their care.

The Test has been framed as a 3-stage test that the Courts will apply when considering whether a doctor has been negligent in his advice. Under the Test:

  1. the patient must show that the information the doctor failed to disclose was information that would be relevant and material to a reasonable patient situated in the particular patient’s position, and information that the physician knew would be important to the particular patient in question.
  2. If the patient successfully shows this, the Court will determine whether the doctor was in possession of the information.
  3. Finally, if the doctor was in possession of the information, they must show that they were justified in withholding the information, otherwise there would be a breach in the standard of care.

In practice this means that it is essential to recognise that when advising a patient and providing them with information, you consider the individual requirements of that particular patient, and what is material to them. What does he or she need to know, taking into account his or her particular circumstances and concerns? What do the questions they are asking suggest is important to them? Are there any pre-existing conditions which give rise to peculiar risks? Does the patient’s job or current circumstances make a risk more material, or give rise to more serious consequences for them?

While this standard applies to the provision of information generally, it goes right to the heart of consent, ensuring that a patient is sufficiently informed of the risks and reasonable treatment options, including non-treatment if that is a reasonable option. Your discussion cannot simply be based on a matter of percentages or probabilities, but rather must be sensitive to the characteristics of the particular patient, with consent focused on what is important and material to them.

This approach involves understanding your patient’s individual needs and circumstances more than ever before, and building this in to your consenting process, so that the patient is appropriately informed. As always, it is crucial that you document your discussions and ensure that you and the patient are comfortable that he or she is equipped as an individual to make the decision about their care. 

To help this process, in addition to discussions with your patient, it may also be useful to supply pre-treatment literature or signpost them to online material, for them to read and reflect upon at their leisure. This additional information can be used as a starting point for further consent discussions, focusing on the particular patient in front of you.
The revised SMC Ethical Code and Ethical Guidelines (that came into effect on 1 January 2017) state that: ‘You must ensure that patients are made aware of the purpose of tests, treatments or procedures to be performed on them, as well as the benefits, significant limitations, material risks, (including those that would be important to patients in their particular circumstances), and possible complications as well as alternatives available to them.’ 

The role of the doctor

You should ensure that patients have adequate information to make informed choices about medical management, by communicating clearly and in a language understood by the patient. You should respect a patient’s choice of accepting or rejecting advice, providing that they understand the consequences of their choice.

Verbal or written consent

In the main, verbal consent is just as valid as written consent. Consent is a process – it results from open dialogue, not from getting a signature on a form.

Completed consent forms provide some evidence that consent was obtained, but mean little beyond that – it is important to realise that they do not constitute proof that the consent was valid. If there is any dispute over whether valid consent was obtained, the key issue will not be whether the patient signed a form or not, but whether they were given all the information they needed to make a considered decision. It is, therefore, crucial that the essential elements of discussions with the patient are documented in the patient’s medical record.

The notes do not need to be exhaustive, but should state the nature of the proposed procedure or treatment and itemise the risks, benefits, possible complications and alternatives brought to the attention of the patient. Any particular fears or concerns raised by the patient should also be noted. 

Clinical trials

The care and safety of patients in clinical trials must be the foremost consideration for doctors. Informed consent must be obtained from any patient involved in a clinical trial. You must ensure that the trial is approved by an ethics committee and conforms to the Good Clinical Practice Guidelines. You should also be aware of the requirements of the Medicines (Clinical Trials) Regulations in relation to obtaining consent of trial subjects.

Prescription medicines

Patients should be appropriately informed about the purpose of prescribed medicines, contraindications and possible side effects.

Complementary medicines

You should only practise complementary medicine if you are adequately trained and registered by the proper authority to do so. The patient must be informed and should consent to be treated by complementary medicine.

Failure to obtain valid consent

A significant proportion of clinical negligence claims are settled simply because valid consent was not obtained. In theory, where harm has befallen the patient and consent was not obtained, this could also give rise to claims for assault or battery and, in extreme cases, criminal charges, but fortunately this is exceptionally rare.

Disregarding advice on consent can sometimes result in charges of professional misconduct and the SMC taking action on a doctor’s registration.

Further information