Consent – the basics
Correct as of February 2011
Treat patients with honesty, dignity, respect and consideration
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.
The Singapore Medical Council’s Ethical Code and Ethical Guidelines states that doctors should: “Treat patients with honesty, dignity, respect and consideration, upholding their right to be adequately informed and their right to self-determination.”
Key principles
A patient who is unable to make a decision about a complex proposal is not necessarily incapable of making any decisions at all
Valid consent is needed to ensure that the patient understands the treatment proposed. For consent to be valid:
- The patient must be competent – Assessment of a person’s capacity should be based on his/her ability to understand, retain and weigh in the balance the information relevant to a particular decision. The person must also be able to communicate the decision. A patient who is unable to make a decision about a complex proposal is not necessarily incapable of making any decisions at all, and may be perfectly able to consent where the issues are simpler. The starting point in the case of adults is always to presume that the patient has capacity until it is shown otherwise.
- The patient must have sufficient information to make a choice – Without adequate information, patients are unable to make decisions about their treatment. The information provided should include the benefits, risks and possible complications of the procedure, and any alternatives available. The patient should be given the opportunity to ask questions and to seek any further information they require.
- The patient must be able to give their consent freely – Pressuring patients into consenting to treatment invalidates the consent. To ensure that consent is freely given, patients should, where possible, be given time to consider their options before deciding to proceed with a proposed treatment. Be aware, too, that patients’ friends and relatives may also try to exert their influence and that this can be subtle but nevertheless powerful.
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
Consent is a process – it results from open dialogue, not from getting a signature on a form
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. If you are managing a patient’s treatment remotely, you should see them personally in the first instance. The SMC states: “No doctor–patient relationship can be established through electronic means and consequently no consultation fee may be received.”
Clinical trials
The care and safety of patients in clinical trials must be the foremost consideration for doctors
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 or because there was no eveidence in the medical record that this was the case. 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.
Aesthetic procedures
You should be particularly careful when obtaining consent for aesthetic procedures when the treatment is not for therapeutic purposes.
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