The legalities around consent are relatively complex and dependent upon a variety of factors.  This article addresses some common questions that arise from the issue of consent.

Who can give consent?

Adults with sufficient mental capacity to understand the nature, purpose and risks of the treatment proposed can give consent to treatment on themselves.  They also have the right to refuse treatment.

No family member can give consent to treatment of another adult, which is a popular misconception not least by many NHS Trusts.  I have heard from many people about how they were required by the treating doctors to give consent for their husband or wife to have a particular form of treatment, usually when their spouse is unconscious or so unwell that they are not capable of giving informed consent.  This is legally incorrect and can cause significant problems.  I have a client whose husband was requested to give his consent for her leg to be amputated.  During her rehabilitation, the client could not help but blame her husband for allowing this to happen to her, even though rationally, she knew that he didn't really have much choice.  However, the situation should not have arisen in the first place. 

If an adult does not have capacity to give consent themselves for example, if they are unconscious or have a mental impairment meaning they cannot sufficiently understand the nature and purpose of the treatment proposed, doctors are able to take the decision to treat on their behalf if they believe that the treatment is in the best interests of the health of the patient.  Ideally this should happen following discussions with the patient's family, but ultimately the decision lies with the treating doctor.

Older children are also often able to give consent if it can be established that they have adequate understanding of the issues involved.  This is presumed in children over the age of 16 without mental impairment.  In these circumstances the wishes of the child will usually outweigh the wishes of their parents, and the treating doctors.  The content of discussions where it has been determined that a child is able to give consent should usually be documented.  Where there is a difference of opinion between the child and the treating doctors, careful assessment of the child's level of understanding needs to be undertaken.  Determinative factors will include the child's age, level of intelligence and comprehension of the longer term impact of their decision.  A Court order may be sought in these circumstances.

Where younger children are concerned, or where the child is deemed not able to give informed consent, parents or legal guardians are able to give consent to treatment on their child's behalf.

Occasionally parents may refuse treatment for their child that is recommended by treating doctors.  An often quoted example is when a Jehovah's Witness parent refuses to consent to their child receiving a blood transfusion.  A more unusual, but extremely distressing example, is the separation of Siamese twins.  If the proposed treatment is believed to be life-saving, doctors are able to treat without parental consent.  If the proposed treatment is likely to have significant potential benefit to the child's physical and mental health, then the NHS Trust concerned may make an application to the Courts for a Court order allowing them to perform the treatment.  If the courts agree with the Trust, then the wishes of the parents can be overridden.  This will only happen in relatively rare circumstances and it is always preferable if the consent of the parents can be obtained.  

What type of consent must be obtained?

Treating doctors are required to obtain informed consent from their patients.  This means that the patient should understand the nature of the treatment, its intended purpose and the main risks associated with the treatment.  The type of risk that should be explained to a patient is something that I am contacted about frequently.  The general rule is that the greater the extent of harm that could be caused, the more important it is that this risk is explained to the patient.  This means that risks such as pulmonary embolism and myocardial infarction (heart attack) are often listed on consent forms, even though the risk of these events occurring may be very small.  Frequently occurring risks should also be discussed with the patient, so that they are able to make an informed decision and weigh up the risks of the treatment concerned as against the expected benefits.  As an example, I would usually expect risks such as infection, bleeding and nerve and vascular damage to be mentioned on the vast majority of surgical consent forms.  However, not every possible risk has to be discussed with a patient.  If the frequency of a risk happening is less than 1%, it would not usually have to be discussed with a patient ahead of treatment.

A major difficulty that I often come across is one of communication.  For example, surgery on the lower back often carries with it the risk of spinal nerve damage.  Should this inadvertently occur, there is the potential for the nerves controlling the bladder, bowels and erectile function to be damaged, which could result in permanent incontinence and loss of sexual function.  The doctor may have discussed the possibility of nerve damage with the patient and noted this on the Consent form, therefore believing that they have fully explained the risks and obtained the patient's consent.  The effect of this type of nerve damage however, has not necessarily been explained to the patient.  The patient may have understood the phrase 'nerve damage' to cover effects such as pins and needles or numbness.  On many occasions I have had clients say to me: "If I had known that I could have ended up like this, I would not have had the surgery.  No-one told me that I could end up having to use a catheter and not control my bowels properly."  Whilst in these circumstances the surgeon may well be able to establish that informed consent was obtained, this situation is clearly far from ideal and is an issue that I, my colleagues and the medical experts that we work with, frequently highlight in the hope that communication between the doctor and patient improves and the impact of any potential risk is fully explained during the consent process.

In emergency situations, the consent process often has to be rushed through as a matter of necessity. However, if the patient is being admitted for planned elective treatment on the NHS the consent process should take place earlier, so that the patient has time to properly consider the information. Their consent should be confirmed on admission for the treatment itself.  Perhaps for financial reasons, this does not always seem to happen in the case of private treatment, although the practice is becoming more widespread.

If there are alternative treatment options available that have different risks and benefits attached, these should in most circumstances also be discussed with the patient, although a doctor is not required to discuss or offer all possible options.  This obligation arises particularly if there is a less invasive treatment option, or one with lower risk factors, even if the doctor considers that the benefits are unlikely to be as substantial.  A prudent doctor will also make sure that these discussions are documented in the patient's medical records.

Although in most circumstances it is desirable to have given signed written consent, there are occasions where verbal consent is normal and sufficient, such as for an episiotomy during delivery. There may also be cases where consent is deemed to have been given through the actions of a patient.  This would include when an arm is given for blood to be taken, or when a patient lies back and opens their mouth in a dental chair.  

If I suffer injury from a risk that I was made aware of, does this mean there is nothing I can do?

Not necessarily.  Risks that should be discussed whilst obtaining informed consent are generally those that can sometimes inadvertently occur, despite the patient receiving an acceptable standard of skill and care.  However, this does not mean that the patient necessarily received an appropriate standard of care, should that risk materialise.  As an extreme and rather obvious example, scarring is a recognised risk of shoulder surgery.  However, if the patient suffers some form of chemical or maceration burn to the forearm, which leads to scarring, this is not an 'accepted' risk of the surgery. Bladder and often ureteric damage is a recognised risk of gynaecological and abdominal surgery. However, if a patient suffers damage to both ureters during the surgery, this is more likely to be indicative of a substandard surgical technique.  Spinal nerve damage is a risk of lower back surgery, but if the patient suffers this damage because the surgeon fails to notice and act on symptoms occurring after the surgery, caused perhaps by bleeding from the surgical site, this would not be considered an acceptable standard of care.

In summary, if a patient suffers an injury that is noted as being a recognised and accepted risk of the surgery, it may be more difficult to establish that this was in fact caused by substandard care, but it is not impossible.  Each case will turn upon its own facts.

I don't think that I gave informed consent.  What can I do?

Treatment or surgery that is given without any consent having been obtained from a competent adult is thankfully rare,  although incidents such as the removal of the wrong limb or kidney would fall into this category.  More often a patient considers that they did not give informed consent because they were not warned about a particular risk that could foreseeably occur (with a frequency of over 1%) and that risk has inadvertently occurred.

A claim for clinical negligence by reason of lack of informed consent is difficult, but not impossible, to bring.  Case law requires that in these circumstances, had the patient been properly warned of the risks, they would have declined the surgery at that time, and that ultimately, on the balance of probabilities, the injury would have been avoided.  The more urgent the need for the treatment or surgery to protect the health of the patient in the first place, the more difficult this is to establish.  This is particularly so if the patient has been advised of, and consented to, more serious risks.  It will be difficult for example to show that a patient who has consented for a coronary artery bypass procedure, with the attendant risk of suffering a heart attack or even death during the surgery, would not have gone ahead with the surgery, if the risk of nerve damage to his arm during harvesting of the radial artery to perform the graft, had been explained.  I was however able to agree settlement of such a case because the gentleman in question was a carpenter requiring full use of both of his arms in order to be able to return to work,.  Tthere were alternative graft sites that could have been used and there were questions about the standard of surgical technique during the harvesting of the artery itself.

The law does recognise the importance of the consent process and the right to autonomy.  However the burden of proving that the patient has suffered an injury that they would not have sustained had they been properly advised of the risks remains with the patient.  The patient needs to be able to show that if the risks had been properly explained to them, they would not have undergone the treatment at all and therefore would not have sustained the injury, or, that if they had undergone the surgery at a later point, the chances of them suffering the same inadvertent injury would have been less.  If a patient is able to establish all of these points through witness evidence of fact and expert medical evidence, then it is possible for them to bring a clinical negligence claim by reason of lack of informed consent.      




If you require any further information or wish to discuss treatment that you have undergone, please contact Kym Provan, Senior Solicitor, or any other member of Blake Lapthorn's Clinical Negligence team. 
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