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Patients and potential lack of informed consent to treatment – what does the GMC guidance require?

Posted: 16/06/2021

A significant number of the clinical negligence cases handled by the Penningtons Manches Cooper clinical negligence team involve issues of consent. Did the patient have all the appropriate information about their treatment options and the relative risks and benefits of each before consenting to treatment? Did they properly understand the likely outcome of the treatment proposed and the risks involved in proceeding with it?  

There has been much case law over the years on a clinician’s obligations in obtaining consent with the most significant case in recent years being that of Montgomery v Lanarkshire Health Board [2015] AC 1430. The emphasis of the case law has increasingly been on the fact that the patient needs to understand the risks and benefits before any consent provided is deemed to be ‘informed’. 

However, the Montgomery judgment made it clear that it was not imposing a new requirement or test but that the requirements it found to be applicable were effectively those embodied in existing General Medical Council (GMC) and other guidance for doctors on the issue of consent.

In considering therefore if a patient or potential claimant does have valid grounds to say that they were not provided with appropriate and sufficient information when consenting to treatment which has not had the outcome expected or has resulted in complications, it is worthwhile considering what the GMC guidance in fact says. This is particularly so as the GMC comprehensively updated this guidance at the end of 2020 for the first time in a number of years.  

A read through the new guidance reveals that it is very much aligned with the principles that the court in Montgomery thought should apply and the importance of involving patients in the decisions about their treatment.

The guidance on ‘Decision Making and Consent’ talks about the seven key principles below that clinicians should consider when deciding what information to provide to patients as part of the consent process. 

  • All patients have the right to be involved in decisions about their treatment and care and be supported to make informed decisions if they are able.  
  • Decision-making is an ongoing process focused on meaningful dialogue and the exchange of relevant information specific to the individual patient. 
  • All patients have the right to be listened to, to be given the information they need to make a decision, and the time and support they need to understand it. 
  • Doctors must try to find out what matters to patients so they can share relevant information about the benefits and harms of proposed options and the reasonable alternatives, including the option to take no action. 
  • Doctors must start from the presumption that all adult patients have the capacity to make decisions about their treatment and care. A patient can only be judged to lack capacity to make a specific decision at a specific time and only after assessment in line with legal requirements.
  • The choice of treatment or care for patients who lack capacity must be of overall benefit to them, and decisions should be made in consultation with those who are close to them or advocating for them. 
  • Patients whose right to consent is affected by law should be supported to be involved in the decision-making process, and to exercise choice if possible.

The guidance is applicable to all healthcare decisions made with and for patients that cover ‘treatments, procedures, interventions, investigations, screenings, examinations and referrals’. However, it makes clear that although these principles apply to all such decisions, every case is different and, in certain circumstances, the detail or information required may be reduced. 

In applying the principles above clinicians should consider the following five factors:  

  • The nature and severity of the patient’s condition and how quickly the decision must be made. Clearly in an emergency situation consent may not be possible or the delay in obtaining it would present a threat to the patient.
  • The complexity of the decision, the number of available options and the level of risk or degree of uncertainty associated with any of them.
  • The impact of the potential outcome on the patient’s individual circumstances.
  • What is already known about the patient, and what they already know about their condition and the potential options for treating or managing it. This includes considerations about patients who are unable to or will not make decisions about their treatment.
  • The nature of the consultation. This might include the resources available and who could or should be obtaining the consent.

The guidance makes clear that informed consent can only be provided (be that verbal or non- verbal) if there has been a dialogue between the clinician and the patient that:

  • helps the patient understand their role in the process, and their right to choose whether or not to have treatment or care;
  • ensures the patient has the opportunity to consider relevant information that might influence their choice between the available options;
  • tries to reach a shared understanding of the expectations and limitations of the available options.

The guidance goes into considerable detail about the approach clinicians should take when having this dialogue in terms of the information they need from the patient to assess their priorities and concerns and the information that they should be providing to the patient. 

In the context of clinical negligence claims, while consent cases are often about patients who were not aware of other options and/or the limits on what is likely to be achieved from proposed treatment, they are also often about risks.

For example, a patient may say that they were not advised of a risk known to be inherent in the treatment proposed and that if they had they known of that risk then that would have persuaded them not to go ahead with the procedure. Claims are often instigated because those very risks have materialised.

Risks and information to be provided are specifically addressed in the guidance and clinicians are advised that:

  • Clear and up-to-date information, based on the best available evidence, about the potential benefits and risks of each option must be provided. This must include the option to take no action. 
  • A clinician is not expected to share every possible risk of harm or potential complication but should tailor the discussion to each patient, taking into account what matters to that patient. 
  • As a general rule, the discussion about benefits and harm should usually include discussions about:
        • Recognised risks of harm that you believe anyone in the patient’s position would want to know. 
        • The effect of the patient’s individual clinical circumstances on the probability of a benefit or harm occurring. 
        • Risks of harm and potential benefits that the patient would consider significant for any reason. 
        • Any risk of serious harm regardless of how unlikely it is to occur. 
        • Expected harms including common side effects and what to do if they occur.

The guidance also considers other issues such as the importance of documenting advice and decisions but also of staying within what is agreed. Another common theme in clinical negligence claims is patients providing informed consent to a specific procedure only to discover that an alternative or more extensive procedure has actually been carried out. Clearly, in certain circumstances this may be unavoidable and in the patient’s best interests but, outside an emergency setting, clinicians should not do more or anything different to the treatment consented by the patient.

From a clinical negligence perspective, this guidance is both helpful and interesting. The Montgomery case has largely been helpful to claimants as it imposed high requirements on clinicians in terms of the amount of information to be provided to patients to satisfy the requirement of obtaining informed consent.

The GMC guidance effectively makes clear that this is not just what lawyers should be expecting of clinicians but that the key points about patients’ autonomy and the importance of providing sufficient information for them to provide informed consent are what is expected of clinicians in day-to-day practice.  

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