What is informed consent?

All medical professionals should obtain their patient’s informed consent i.e. agreement or permission, to undergo any type of medical intervention, including investigations, treatments or procedures. This applies to all GP practices, NHS and private hospitals, dental practices and clinics offering cosmetic/plastic surgery, laser eye surgery and non-surgical cosmetic treatments or procedures. This guide explores:

• What is informed consent
• Who can give informed consent 
• What to do if someone does not have capacity to give informed consent
• What information needs to be communicated for informed consent 

*’In this guide, ‘the patient’ refers to the person who is providing the consent i.e. a competent adult patient, the parent of a child patient or a patient’s lasting power of attorney etc.* 

What is informed consent? 

For a patient’s consent to be valid and informed, all of the following elements must be satisfied: 

• Voluntary: The decision to either consent, or not to consent, to medical intervention must have been made by the patient, and they must have not been influenced or pressured by medical staff, friends or family. 
• Adequate Information: The patient must be given all of the necessary information which is required for that individual patient to make an informed decision. This may include what the proposed intervention involves, any associated benefits and material risks, whether there are any reasonable alternatives, and what will happen if the proposed intervention does not go ahead. 
• Understanding: The patient must be capable of understanding the information which has been given to them, and any possible implications of their decision. 
• Capacity: The patient must have the required legal and mental capacity to make an informed decision. 

Who can give informed consent? 

In England and Wales, the Mental Capacity Act 2005 states that anyone aged 16 and over, is assumed to have capacity (until proven otherwise) and therefore, can provide their consent to medical intervention.  

This applies even where a patient wishes to refuse medical intervention. Providing an adult has the necessary capacity to make a voluntary and informed decision to refuse a particular treatment or procedure, their decision must be respected, even if refusing the treatment would result in their death, or the death of their unborn child.

What if the patient is under the age of 16? 

Where a patient is under the age of 16, they may be able to give consent themselves, so long as they’re believed to be ‘Gillick competent’, which means they have enough intelligence, competence and understanding to fully appreciate what’s involved in the proposed intervention, and any potential implications. 

Otherwise, someone with parental responsibility can provide consent on the child’s behalf, for example the child’s mother or father.

What if the patient lacks capacity? 

The Mental Capacity Act 2005 states that a person will be considered to lack capacity, “if at the material time, they are unable to make a decision for themselves, because of an impairment of, or a disturbance in the functioning of, the mind or brain.” 

For example, a person may lack capacity if they have a medical condition such as dementia, a significant learning disability, a severe mental illness or a brain injury.  

It is important to note, however, that a person’s mental capacity can change or fluctuate over time, as a result of various factors and conditions. For example, a usually competent person may experience a temporary or short-term lack of capacity due to intoxication, caused by drugs or alcohol, or a physical/mental condition which causes confusion or drowsiness. Whilst fluctuations in capacity are common in the earlier stages of dementia and certain mental health conditions, such as bipolar or schizophrenia. 

Similarly, a person may lack capacity to make some decisions, such as managing their finances but still have capacity to make other decisions, such as consenting to a medical procedure. 

In situations where it has been shown that a patient does lack the capacity to make a decision regarding their own medical care or treatment, consent will need to be obtained from the patient’s lasting power of attorney (‘LPA’).  

However, if they have not appointed a LPA, the treating medical professionals may be permitted to make the decision on the patient’s behalf, providing it is in their best interests. Though reasonable steps must also be taken to discuss the situation with the patient’s relatives, close friends or an independent mental capacity advocate beforehand.  

Moreover, even where a patient may not be able to provide consent themselves, they should still be involved in any discussions regarding their medical care or treatment, and the decision-making process, where appropriate.

What information should be communicated before obtaining a patient’s consent? 

The general rule is that a medical professional must give a patient, all of the information which they want or need, in order to make an informed decision. However, any discussions regarding medical intervention should be tailored to the individual patient, and the nature of the intervention which is being proposed.  

For example, the information provided before a minimally invasive, low risk intervention such as a blood test, will be significantly less detailed than the information provided before an invasive, high risk surgical procedure such as heart surgery.

Usually, a patient should be provided with information regarding: 

1. Diagnosis and prognosis, including the potential outcomes if left untreated 
2. Uncertainties about the diagnosis or prognosis, including options for further investigation  
3. All available treatment or management options, including the choice to not undergo any intervention 
4. The nature and purpose of each option, what would be involved, and the desired outcome  
5. The potential benefits, probabilities of success, any serious or common associated risks, including possible side effects or complications

In some situations, it may also be appropriate to provide the patient with information regarding how and when their condition and any side effects will be monitored or reassessed, following the proposed intervention and whether any proposed treatment or procedure is experimental. 

If a patient asks specific questions about the proposed intervention, the medical professional must also give full, honest and objective answers, whilst ensuring that they do not share their own personal views and beliefs.

Information about risks and alternatives 

It is important to note that when discussing potential risks, it is not reasonable to advise the patient of every possible risk of harm, side effect or complication. Nor is it always necessary to offer every alternative treatment or management option, if they are not appropriate for the individual patient. 

The guidance in relation to these issues comes from two leading cases: 

• Case law dictates that clinicians owe a duty to take reasonable care to ensure patients are informed of any material risks inherent in proposed treatment, as well as any reasonable alternatives. A risk is material if a reasonable person in the patient’s position would be likely to attach significance to it, or if the clinician knows (or ought to know) that the particular patient would consider it significant (Montgomery v Lanarkshire Health Board, 2015). 
• The case law on alternative options dictates that a clinician’s duty to discuss alternative treatments is limited to options that are reasonable and clinically appropriate in the circumstances. A doctor is not obliged to inform a patient of treatments which, in their reasonable professional judgment, are not indicated or are not supported by the clinical picture (McCulloch v Forth Valley Health Board, 2023). 

How should information be provided to the patient? 

In any event, the information, which is provided to the patient should be clear, accurate and up to date, and communicated in simplified non-technical language, wherever possible.  

Information should be provided in a way in which the individual patient is able to understand and retain it. Usually, information may be given verbally and then followed up in writing, such as in a letter sent to the patient following an appointment. 

Leaflets and online material may be used as a helpful starting point; however, medical professionals should not rely on these in lieu of a verbal discussion with the patient. Moreover, medical professionals must ensure that a patient has the necessary time and support they require, in order to understand and consider the information which has been provided. This should include the time to make any notes or ask further questions.   

Additional care must be taken when providing information and obtaining consent from patients whose capacity may be temporarily affected, due to the influence of strong pain relief or anaesthesia, for example. 

Throughout the consent process, patients should also be reminded that they have the right to seek a second opinion in regard to any proposed medical intervention, and that they are permitted to change their decisions at any time.

How can a patient give their informed consent? 

Informed consent can be given by a patient: 

• In writing e.g. signing a consent form for an operation 

• Verbally e.g. saying they’re happy to have an x-ray 

• Non-verbally e.g. holding out their arm for a blood test 

Again, the appropriate method for giving informed consent, will depend on the nature of the proposed investigation, treatment or procedure and the patient’s individual circumstances. 

Obtaining informed consent does not always need to be a formal, time-consuming process and for most quick, minimally invasive interventions such as a blood tests, verbal or non-verbal consent may be appropriate, providing the patient understands what procedure or treatment is about to take place. Whereas for more complex interventions or surgical procedures, only written consent may be appropriate. 

However, where consent is given verbally or non-verbally, this should still be recorded in the patient’s medical records.

When might consent not be required? 

There are, however, certain exceptions whereby medical intervention may take place without the person’s consent, even if they would otherwise be capable of providing their consent. 

For example, it may not be necessary to obtain consent: 

• Where the patient needs emergency treatment to save their life, but they’re unconscious 

• Where an additional emergency procedure is required during an operation under general anaesthetic  
• Where the patient has a severe mental health condition, such as schizophrenia or dementia, and lacks the capacity to consent to the treatment of their mental health. 

What might amount to a lack of informed consent? 

Informed consent can only exist where all four elements (voluntary, adequate information, understanding and capacity) were met, at the time when the patient’s consent was required. Therefore, if any of these elements were missing, the patient’s consent will not have been valid nor informed. 

Common situations whereby informed consent has not been obtained, may include where the patient: 

• Has not been given all of the necessary information which was needed for them to make an informed decision. For example, where they have not been told about certain material risks, or alternative treatment/management options.  
• Has been influenced, coerced or placed under undue pressure by a medical professional or relative to consent to a particular procedure or treatment option. For example, where the medical professional has not given the patient the choice of any appropriate alternative treatment options.
• Lacks the required mental capacity and understanding to make an informed decision about their treatment. For example, where the patient was suffering from dementia or a mental health condition at the time when their consent was required. 

Providing a patient with misleading information regarding their medical condition or the proposed intervention, may also mean that their consent was not valid or informed. 

It is important to note that where a patient has provided their consent, by signing a consent form for example, this does not necessarily prevent them from making a claim, providing they can demonstrate that their consent was not valid and informed.

Can I make a medical negligence claim for lack of informed consent? 

If you have any concerns about a consent process which you have experienced, or if you believe you did not provide your valid informed consent before undergoing a medical investigation, treatment or procedure and you have then suffered harm or injury as a result, please contact our specialist team today. 

At Fletchers Solicitors our dedicated team of solicitors have extensive experience and expertise in all types of medical negligence claims involving issues of informed consent. We can offer you a confidential, no-obligation conversation to discuss any concerns that you have and advise you as to your options. 

Time limited for making a claim 

Where the claimant is over 18, they will usually have 3 years to bring a legal claim, either from the: 

• Date of injury; or  

• Date of knowledge, which is the date on which they first became “reasonably aware” that they may have suffered an injury, as a result of medical negligence. 

However, where the claimant is a child, a claim can be brought on their behalf, any time before their 18th birthday, regardless of when the injury occurred. Once the claimant turns 18, and providing they have mental capacity, they will then have a further 3 years in which they can bring their own claim (up to their 21st birthday). 

Though in cases where a claimant lacks the relevant mental capacity to conduct legal proceedings, a claim may be brought on their behalf at any time, with no limitations. 

What must be proven? 

In order to be successful in any medical negligence claim, there are three key elements which the claimant must prove: 

Was there a duty of care?  

The claimant must show that the medical professional or provider had a duty to provide them with a reasonable standard of care.  

In medical negligence claims, this duty will usually be presumed, as all medical professionals have a legal duty of care to their patients. This includes all GPs, doctors, midwives, nurses and dentists, but it also extends to certain ‘non-medical’ professionals such as A&E receptionists. 

Was there a breach of this duty of care? 

The claimant must show that the medical professional breached their duty of care, in that the care or treatment which the claimant received, fell below a reasonable standard, such that no responsible body of medical practitioners practising in that area would have acted in the same way.  

For example, if the medical professional failed to discuss all material risks, or alternative treatment options before obtaining a patient’s consent, this could amount to a breach of duty of care. 

However, a medical professional may have a defence, if it can be shown that a reasonable though minority body of medical practitioners would have acted in the same way as they did in the claimant’s case.  

For example, if a reasonable though minority body of medical practitioners, would have provided the claimant with the same information (as they actually received) during the consent process, it is unlikely that there will be a breach of duty.

Did the claimant suffer injury or damage, as a result of the breach of duty of care? 

Finally, the claimant must show that: 

1. They suffered injury or damage (physical, emotional or financial); AND 
2. That there is a more than 50% chance that the negligence i.e. breach of duty, caused or materially contributed to their injury or damage. 

It is important to note, however, that even if the claimant can show that the medical professional breached their duty of care in some way, the claimant is unlikely to succeed with a medical negligence claim, if they did not suffer any injury or damage as a result of such breach.  

In cases involving the issue of consent, this means that where there is a lack of informed consent because the claimant was not warned about all material risks before undergoing a procedure, for example and the claimant has then suffered harm as a result of that procedure, it will also be necessary to show that if the claimant had been warned of all material risks, they would not have consented to undergo the same procedure.  

Consequently, if can be shown that the claimant would still have consented to undergo the same procedure, even after being warned about all material risks, it is unlikely that the claimant would succeed with a medical negligence claim.

What evidence is required? 

Medical negligence claims involving a lack of informed consent can be particularly complex and tricky, and there may often be a difference in the recollection of the claimant and the medical professional(s), as to what may or may not have been discussed during the consent process.  

Therefore, when investigating these types of claims, key evidence will include: 

1. The claimant’s medical records and any other relevant documentation, such as any handwritten notes made by the claimant, or family members. 
2. Witness statements from the claimant, and/or anyone else who was present during the consent process, detailing their recollection of the consent process, what was or was not discussed etc. The claimant’s witness statement should also explain whether or not they would still have consented to the same medical intervention, had they been provided with all of the necessary information and their reason(s) for this.  
3. Expert reports from independent medical experts, providing guidance as to what information should have been given to the claimant during the consent process e.g. risks, alternative treatment options etc.  

In cases where there are concerns regarding the claimant’s capacity at the time their consent was obtained, it will also be necessary to gather evidence about the patient’s state of mind, mental functioning, both during the consent process and at the time that they provided their consent. 

How much compensation could I get? 

The amount of compensation awarded can vary significantly and will depend on the individual circumstances of each case. However, generally, compensation will include the following: 

• General damages for any pain, suffering and loss of amenity which you have experienced, as a result of the negligence i.e. any harm or injuries which you have suffered; and  

• Special damages for any out-of-pocket expenses or financial losses which you have suffered (past losses), or which you are expected to suffer in the future (future losses), as a result of the negligence. For example, travel expenses to and from additional medical appointments, private surgery costs, loss of income etc.

Start your journey with expert support  

If you or a loved one has suffered as a result of medical negligence, our team can guide you through tailored rehabilitation, legal support, and access to essential resources.  

Because recovery isn’t measured only in compensation, we combine specialist legal expertise with a strong focus on your recovery and long-term well-being, supporting you not just through a claim, but through life beyond it.  

We’re here to listen, support, and help you take the next step. Talk to us today