A recent Supreme Court judgment introduced the concept of 'informed consent' to the law of negligence. Dr Udvitha Nandasoma reviews the ethical and legal challenges in the complex area of consent, which is central to the provision of medical treatment.

What is consent?

Usually, we think of consent in the context of surgery or major medical interventions, but consent underpins even 'routine' interactions.

A patient may give their consent expressly (verbally or in writing), or their consent may be implied, as is often the case in routine examinations or procedures - for example, when a patient holds out an arm to have their blood pressure measured or gets on to the examination couch.

Disputes about the adequacy of consent often arise in clinical negligence claims some time - even years - after the event. While written consent is rarely required by law, it is for this reason that the MDU recommends that consent is confirmed in writing for all procedures where there is more than a minimal degree of risk.

Challenges to obtaining consent

The central challenge for doctors on a day-to-day basis is how to ensure that arrangements for signed consent are in place and can be implemented in a busy clinical environment.

There is no simple answer to this but, while clichéd, it is the case that consent is a process rather than simply a signature on a form. Each point in the pathway of clinical care is an opportunity to enhance the quality of consent by providing information and discussing the nature and risks of the procedure. The burden does not have to fall to a single consultation.

Information for patients - an evolving legal picture

For many years, the law considered that the adequacy of information provided to a patient would be assessed by reference to a responsible body of medical opinion - the 'Bolam' principle. The case of Sidaway made clear that the view of the responsible body of medical opinion must nonetheless be a reasonable one.

In practice, many doctors would think carefully as to what a prudent patient (and the patient in front of them) might wish to know, and would understand that a rare but recognised complication might have particular significance to an individual patient. For example, the risk of nephrotoxicity of a given drug to a patient with pre-existing renal impairment.

In addition to considering how a court might view the adequacy of the consent process, a doctor must also consider the stringent GMC requirements as to what information must be shared with a patient (see GMC guidelines below).

The guidance emphasises the information which must be shared with patients when seeking consent. Maximising opportunities to share information in a controlled way, using written information, procedure leaflets and online resources where appropriate, could make this a much easier task.

Informed consent - recent legal judgment

For the last few years, it seemed that the regulatory standards expected of a doctor in seeking consent exceeded what was considered in law to be valid consent.

However, the recent Supreme Court decision in Montgomery v Lanarkshire Health Board [2015 UKSC 11] made clear a doctor is under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in proposed treatment, and of reasonable alternatives.

The court ruled that a risk is 'material' if a reasonable person in the patient's position would be likely to attach significance to it, or if the doctor is or should reasonably be aware that their particular patient would be likely to attach significance to it. The concept of consent is now judged from the patient's, rather than the doctor's, perspective.

The court made three further points:

  1. The assessment of whether risk is material is no longer an issue of a percentage possibility of it arising. The significance of a risk to a particular patient reflects, for example, the nature of the risk, the effect it would have on the life of the patient if it were to happen, the importance to the patient of the benefits of the treatment, and alternative treatments and the risks associated with them.
  2. The doctor's role is to talk to the patient to ensure the patient understands the seriousness of the condition, the anticipated benefits of the proposed treatment and the risks it carries, and any reasonable alternatives. Information provided to the patient must be comprehensive, but not so technical that the patient could not reasonably be expected to understand it, and would therefore not be properly informed.
  3. There is a therapeutic exception to providing comprehensive information when the information would be seriously detrimental to the patient's health, or when treatment is required in circumstances of necessity. This is a limited exception and should not be abused, the court warned.

Making detailed records of what information you give to, and discuss with, the patient is likely to be even more important in view of the judgment.

The social and legal developments which we have mentioned…point towards…an approach to the law which, instead of treating patients as placing themselves in the hands of their doctors (and then being prone to sue their doctors in the event of a disappointing outcome), treats them so far as possible as individuals who are capable of understanding that medical treatment is uncertain of success and may involve risks, accepting responsibility for the taking of risks affecting their own lives, and living with the consequences of their choices.

Judgment in Montgomery v Lanarkshire Health Board [2015] UKSC 11, paragraph 81

Photo credit: Newscast

GMC guidelines

The GMC requires you to give patients the information they want or need about:

  1. the diagnosis and prognosis
  2. any uncertainties about the diagnosis or prognosis, including options for further investigations
  3. options for treating or managing the condition, including the option not to treat
  4. the purpose of any proposed investigation or treatment and what it will involve
  5. the potential benefits, risks and burdens, and the likelihood of success, for each option; this should include information, if available, about whether the benefits or risks are affected by which organisation or doctor is chosen to provide care 
  6. whether a proposed investigation or treatment is part of a research programme or is an innovative treatment designed specifically for their benefit
  7. the people who will be mainly responsible for and involved in their care, what their roles are, and to what extent students may be involved
  8. their right to refuse to take part in teaching or research
  9. their right to seek a second opinion
  10. any bills they will have to pay
  11. any conflicts of interest that you, or your organisation, may have
  12. any treatments that you believe have greater potential benefit for the patient than those you or your organisation can offer.

GMC, 'Consent: doctors and patients making decisions together' (2008), paragraph 9

When to give information

These increasingly stringent requirements mean that we must consider the issue of consent when looking at pathways of care and identify appropriate points at which information relevant to consent is shared.

Giving patients information before a procedure allows them time to consider it and raise questions in advance, and lessens the risk of it being suggested that the consent was given under duress or that the option to consider alternatives was limited. This might be the case if, for example, the detailed discussion about the procedure and alternatives only takes place when the patient is in the procedure room with the team standing by and other patients waiting.

It is also important to explain what other options are realistically available to a patient and, indeed, the pros and cons of having no treatment at all. This might be particularly relevant where a procedure is being considered for cosmetic or lifestyle reasons.

Patients must also now take ever more complex decisions about treatments or participation in screening programmes where the risks and benefits are controversial or finely balanced. All clinicians face a difficult task in communicating such risks objectively, particularly when the subject matter is emotive. There have been some efforts to try and make information sharing in this context more systematic.  See http://www.optiongrid.org/ for more information.

Consent and capacity

In order to provide valid consent a patient must have the requisite capacity.

The Mental Capacity Act 2005 (MCA) sets out a statutory test for capacity. This states a person lacks capacity if they are unable to make a decision for themselves in relation to a matter because of an impairment of, or a disturbance in the functioning of the mind or brain. To be able make a decision, the patient must be able to:

  • understand the information relevant to the decision
  • retain that information for long enough to be able to use or weigh it as part of reaching a decision, and to
  • communicate their decision effectively by any means.

The MCA makes it clear that we must begin with a presumption of capacity - a patient must be presumed to have the requisite capacity unless it can be established, on the balance of probabilities, that they do not. It must also be remembered that capacity is decision-specific and that a given diagnosis does not automatically render the patient incapable.

With that in mind:

  • Ensure that you have information leaflets about procedures that are accessible to patients with a range of impairments. For example, think about how you might give information to a patient who cannot read or has visual difficulties or is hearing impaired.
  • Think about how you can make information more understandable - this might be simply using plain English or providing material in an appropriate language, or in an appropriate format for patients with impaired vision.
  • When you are treating patients who have learning difficulties, properly constructed information, along with support to understand it, may make the difference between a person being able to decide for themselves or not.
  • Think about how you will help maximise their decision-making ability and what support they might need to do this. This might range from visual aids to more time to consider their decision.

Where a patient lacks capacity, healthcare decisions must always be taken in their best interest. The MCA introduced a statutory framework for reaching such a decision. While responsibility for a decision remains with the decision-maker, those close to the patient, including their family and those involved in caring for them, must ordinarily be consulted when reaching that decision about what represents the patient's best interests. When there is nobody other than paid professionals to be consulted, then an Independent Mental Capacity Advocate (IMCA) or, in Scotland, a Welfare Attorney, must be consulted for all serious medical treatment.

Lasting power of attorney (LPA)

A person with capacity can confer the power to make decisions on their behalf by creating Lasting Power of Attorney relating to health and welfare. This would only become relevant should that person lose capacity. When caring for people who lack capacity it is important to clarify whether there is a relevant and valid Lasting Power of Attorney in place that deals with the issue at hand.

The MCA also gives patients power to make advance decisions to refuse treatment. These do not compel a practitioner to provide a particular treatment but do allow a patient to refuse treatment in specific circumstances. These can be expressed orally but, amongst other things, must be in writing where they relate to life-sustaining treatment.

This can be a complex area and it is important to take advice when there is any doubt as to the validity of, or capacity to make, an advance decision. Even where the advance decision is perhaps not precisely valid and applicable to those circumstances, it may form part of the picture that should be taken into account when reaching a decision with regard to the best interests of an incapacitated patient.

Summary

Rather than a one-off event, obtaining a patient's consent should be approached as a process involving providing information, answering the patient's questions and, where circumstances allow, giving the patient time to consider their decision to undergo the procedure or treatment. Allegations of lack of informed consent arise regularly in clinical negligence. Care and attention to the consent process can help reduce this risk.

This page was correct at publication on 13/04/2015. Any guidance is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.