Following the Supreme Court decision in Montgomery v Lanarkshire Health Board (2015) the law relating to informed consent has been redefined. Before the change, it was down to the clinician to decide how much information to give a patient (providing that decision would be considered reasonable by a responsible body of medical opinion, the Bolam test).
Post Montgomery, clinicians must ensure that their patient is fully informed about any potential risks to the proposed treatment, and of any alternative treatment options.
Background to ‘Montgomery’
Mrs Montgomery was pregnant. Despite having diabetes, she was not informed of the small risk of injury to her baby as a result of shoulder dystocia. The clinician was concerned that if she did advise Mrs Montgomery of the risk she would opt for a caesarean which, in the opinion of the clinician, was not in the maternal interest. Unfortunately the risk materialised and Mrs Montgomery’s baby was severely disabled. Mrs Montgomery argued that, had she been told of the risk of injury to her baby she would have opted for a caesarean and the injury would not have occurred; it was not for the clinician to decide what information to give her regarding any risk.
The Bolam test
The case of Sidaway confirmed that it was for the clinician to decide how much information to give the patient, which must be backed up by a responsible medical body (known as the Bolam test). The Bolam test dealt with the standard of care required by health professionals. If the health professional in question could show that another health professional would have taken the same action (i.e. advised the same treatment) then the duty of care would not be considered as breached. The Bolam test was modified by the case of Bolitho which held the practice or treatment had to be reasonable. In simple terms this means even if a responsible body of health professionals would pursue the same course of action as the health professional in question, the practice also needs to be considered reasonable i.e. logical; it is simply not enough that another health professional supports the practice.
Material risks are bespoke to the individual
Following Montgomery the law has shifted. Clinicians must 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.’ Material risk is not defined, and will depend on the circumstances of the individual patient – some patients will attach more significance to information about risk than others. Had Mrs Montgomery known of the risks attached to a natural delivery she would have opted for a caesarean; in her case the risks of natural birth were significant. The law in relation to informed consent is now bespoke to the individual.
It is important to note that you must not only legally prove you were not given sufficient information to consent to a procedure, or treatment, but you must also prove that, if you had have been provided with all the information, you would have chosen an alternative procedure or treatment, and that procedure/treatment would have altered your outcome for the better.
For example in Montgomery if the clinician had provided Mrs Montgomery with information relating to the risks of natural delivery, Mrs Montgomery would have opted for a caesarean. However, if there was evidence (i.e. medical notes) to show that Mrs Montgomery would never have opted for a caesarean (unless in an emergency) then it would be difficult to prove that, even if Mrs Montgomery had of been told of the risks of injury in a natural delivery, she would have opted for a caesarean and this would have prevented the injury to her baby.
New guidelines relating to elective treatment
The Royal College of Clinicians (RCS) has issued new guidelines (which relate to elective treatment only and not emergency treatment). The key changes to the law regarding informed consent include:
- Providing the patient with all the information relation to that procedure, however small the risk may be. The key here is that it is not for the clinician to decide what information a patient receives about a procedure, it is for the patient to have all the information and make their own informed decision.
- Once the procedure has been explained in full, including all risks however small, written information regarding diagnosis and treatment options should be given to the patient. Ideally this would be in the form of a booklet, although details of a website will suffice. A copy of what information (booklet/website) has been given to the patient should be included in their notes, along with the consent form.
- To ensure the clinician who is explaining the procedure and any associated risks is suitably qualified and has sufficient knowledge to be able to provide all information regarding the procedure and risks. Ultimately it is the responsibility of the clinician carrying out the treatment to ensure proper informed consent has been provided.
- Ensuring patients have sufficient time to digest the information they are given in order to make an informed decision. The amount of time considered to be sufficient is likely to depend on the type of treatment. For example, a patient would probably need more time to consider the information relating to a more invasive and risky treatment, compared to that for a routine, low risk operation.
- Ensuring a consent form is signed as soon as a decision is made. A copy should be filed with the patient’s notes and, if possible, a copy given to the patient, to allow time for reflection.
- The clinician should make notes of the discussions regarding consent and keep all documents relating to the decision-making process.
The law in relation to informed consent is evolving to recognise that patients are capable of understanding the risks involved with their medical treatment, and should be given the right to make an informed decision. It is important that you as a patient feel involved in the decision making so you are fully aware of the risks and intended outcome. If you have any concerns regarding the information, or lack of information, you have been given about any medical treatment, it is important you seek legal advice as soon as possible.