The law of consent
Published in LaingBuisson Healthcare Markets August / September 2017
Consent is a fundamental principle in healthcare and it is essential that both clinicians and hospital providers are compliant with the regulatory guidance and case law. In association with Bevan Brittan, AIHO has now produced a Key Principles document for its members.
Consent is a fundamental principle. It represents an individual’s right to autonomy about what is or isn’t done to them, where they have the capacity to give it.
Therein lies the issue for any clinician undertaking an intervention or procedure for a patient. The legal system takes a dim view of treatment provided in the absence of consent where this should have been obtained. In the worst-case scenario, providing treatment without consent can amount to a criminal charge of assault or lead to a civil negligence action.
Effective communication is essential to the consent process and the law places a requirement on doctors to personalise information to suit individual patients.
The Supreme Court case of Montgomery v Lanarkshire Health Board in 2015 was a landmark decision for the doctor-patient relationship and the process of informed consent. It closed the gap between regulatory guidance and case law by shifting the focus of consent towards the specific needs of the patient:
- The aim of the discussion about consent is to give the patient the information they need to make a decision about what treatment or procedure they want (if any).
- The discussion must be tailored to the individual patient. This requires time to get to know the patient well enough to understand their views and values.
- All reasonable treatment options, along with their implications, should be explained to the patient.
- Material risks for each patient should be discussed. The test of materiality is two-fold: firstly, in the circumstances of the particular case, would a reasonable person in the patient’s position be likely to attach significance to the risk? And secondly, is or should the doctor reasonably be aware that the particular patient would likely attach significance to the risk in question?
- Consent should be written and recorded. If the patient has made a decision, the consent form should be signed at the end of the discussion. The signed form is part of the evidence that the discussion has taken place, but provides no meaningful information about the quality of the discussion.
- In addition to the consent form, a record of the discussion (including contemporaneous documentation of the key points of the discussion, hard copies or web links of any further information provided) should be included in the patient’s case notes. This is important even if the patient chooses not to undergo treatment.
Tests and dialogue
Montgomery is now the definitive authority on how clinicians obtain valid and informed consent from a patient to a procedure or treatment. The test is now patient centred and revolves around the concept of materiality of risk for the individual.
Statistics or percentages relating to risks are a relevant (but not of themselves decisive) measure of whether a matter should be discussed with the patient. A specific risk (however small) may be of significance to a patient whose life or livelihood would be especially adversely affected if the risk materialised, for example, the threat to fertility for a childless woman, damage to the voice for a singer, or to the finger of a concert pianist.
The concept of ‘therapeutic exception’ will in rare cases allow a doctor to avoid disclosure if he/she decides on reasonable and reasoned grounds that the patient is so psychologically fragile or otherwise vulnerable that disclosure would present a real threat to the patient’s mental health or stability.
Lack of time for adequate dialogue with the patient may seem an ever present and even insuperable problem. It must be overcome, because what is at issue is the patient’s most basic and fundamental right to decide for themselves, on adequate information, whether or not to submit to proposed treatment, or which alternatives to choose.
A doctor who is not good at communicating with patients, whether because inexpert or unwilling, must recognise the fact and take steps to acquire the necessary skills.
Fiona Booth, AIHO Chief Executive