Respect for patients’ autonomy is expressed in consent law; to impose care or treatment on people without respecting their wishes and right to self-determination is not only unethical, but illegal.
For consent to be valid:
- The patient must be competent – mental capacity is decision-specific. 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:
- An explanation of the investigation or treatment being proposed.
- An explanation of the probabilities of success or failure of the proposed intervention.
- Detailed information about the risks of the proposed investigation or treatment.
- Information about other potential options for investigation or treatment including the risks and benefits or non-intervention.
The patient should be given the opportunity to ask questions.
Montgomery V Lanarkshire Health Board
The law on informed consent has changed following this recent Supreme Court judgment. Doctors must now ensure that patient are aware of any "material risks" involved in a proposed treatment, and of reasonable alternatives. This is a significant change to the previous "Bolam test" which asks whether a doctor's conduct would be supported by a responsible body of medical opinion. This test will no longer apply to the issue of consent.
This is a move towards the "reasonable patient" standard of consent which is already prescribed in the GMC consent guidelines. Patients should be informed of any risks that a reasonable person in the same position would attach significance to. This includes rare but potentially serious complications.
It is only appropriate to withhold information if you believe that giving it would cause the patient 'serious harm'. In this context, 'serious harm' means more than the patient may become upset or decide to refuse treatment.
- The patient must be able to give his/her 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.
Patients who lack capacity
Patients who lack capacity should not be denied necessary treatment simply because they are unable to consent to it. The principle of proxy decision making on behalf of children is well established. The Adults with Incapacity Act 2000 allows other people to make decisions on the behalf of incapacitated adults.
In the absence of a proxy decision maker, either because there isn’t one or because the proxy cannot be reached before emergency treatment is required, the principle of necessity justifies treatment of an incompetent patient without consent. In all these circumstances any decision that is taken on behalf of an incompetent patient must be taken in his or her best interests.
Verbal or written consent?
There are very few occasions where the law specifically requires written consent – for example, in relation to the storage and use of gametes and embryos in fertility treatment. But in the main, a 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 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 and alternatives brought to the attention of the patient. Any particular fears or concerns raised by the patient should also be noted.
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 the GMC’s advice on consent can sometimes result in charges of professional misconduct and action by the GMC on the doctor’s registration.