What is Informed Consent?

What is Informed Consent?

Informed consent is something that arises frequently in clinical negligence claims. Some patients may feel they have undergone a medical procedure they did not need, or that has resulted in an outcome or complication they did not expect.

Simply put, ‘informed consent’ means giving a patient all of the information they need to understand a procedure or treatment that is being offered to them, in order to help them make a decision about whether to agree to that treatment or decline it.

However, what actually constitutes informed consent is not always as straightforward as it sounds.

The basic principles of informed consent

What is the purpose of informed consent? Essentially, everyone has the right to choose what happens to their body, and that includes the right to decide what medical treatment they have. A person is entitled to accept or refuse any treatment they are offered, but when making that decision they should know what it is they are accepting or refusing.

A patient should be told, in a way that they can understand:

  • what the procedure or treatment involves
  • what the treatment aims to achieve
  • what the outcome might be in terms of further treatment ongoing – for example, if a period of physiotherapy will be required, or a second surgery
  • what the material risks and complications of the treatment might be
  • which reasonable alternative treatments are available and how the options might compare – for example, if one treatment carries more risk than another.

What this means in practice, and exceptions to the basic principles

It’s not always mandatory that a patient be told absolutely everything about a proposed treatment.

The law only requires that a patient is informed about the risks that are “material” to the treatment that is being recommended. In fact, a doctor can withhold information about a risk from a patient, if they believe that it would be detrimental to the patient’s health to inform them of a risk. But, these scenarios are rare.

What is a material risk?

What counts as a “material” risk will vary from case to case, but the Courts have defined it as a risk which a patient would attach significance to; if it would potentially affect their decision to have treatment.

How this is assessed can be patient-specific and fact-sensitive, but it is still measured against what a reasonable person in those circumstances would consider important to them.

How does a patient give informed consent?

It is common for patients to be given a form to sign prior to any physically invasive procedure, such as surgery. The form will set out in writing the details of the procedure, the risks and potential outcomes.

Although a patient may sign the form, this does not necessarily mean they have given their full informed consent. This is because relevant information may still be missing from the form. It is important that doctors talk through the treatments and make sure patients understand what is expected to happen and what the risks are, rather than simply asking a patient to sign a consent form without explaining what everything means.

It is important to note that consent is not always required in writing, even in circumstances where that might be considered best practice. It would likely be impractical if written consent was required for any and all treatment, no matter how minor. A patient can give verbal consent, or even imply that they consent through their actions, following an appropriate discussion with their doctor.

What if a patient cannot give informed consent?

There may also be situations where a person cannot legally give consent, for example if they lack mental capacity (within the meaning of the Mental Capacity Act 2005) to make such a decision, or if they are not yet an adult.

In those cases it will usually be up to the parent, guardian or next of kin to make the decision regarding treatment. In situations where a person cannot consent to treatment – say they are unconscious after a serious car accident – and there is no one else who can make decisions on their behalf, then medical staff can make treatment decisions themselves provided it is in the patient’s best interests.

What constitutes a lack of informed consent?

If it can be shown that a patient has not been informed of material risks or reasonable alternatives, and none of the exceptions above apply, then it is likely that the patient has not given their informed consent to the treatment.

Has the lack of informed consent caused an injury?

For a clinical negligence compensation claim to succeed in this context, a patient must prove that they’ve suffered an injury from the treatment.

There is no standalone claim simply for lack of informed consent.

The patient would need to prove that they would have made a different decision, had they received the appropriate information beforehand.

Example

If, for example, a patient was not informed about the risk of an infection after surgery, and went on to suffer an infection, then they could be eligible to claim for a failure to obtain informed consent.

However, if the patient would have agreed to the surgery anyway even if they had been told that it carried a risk of infection, then in theory nothing would have changed – they would have had the surgery and suffered the same infection.

Proving a patient would have made a different decision

Establishing that a patient would have done something different had they known of the risks can be difficult.

In reality, judges tend to consider that a patient who is suffering with pain and experiencing a negative impact on their daily life is likely to accept some relatively small risk to undergo treatment that stands a good chance of improving or resolving their symptoms.

The challenge is that a Court must be convinced that, if a patient had been given all of the information beforehand, and was making their decision without the benefit of hindsight knowing the treatment went wrong, that they would still have decided against having the treatment.

In circumstances where the benefits of having the treatment greatly outweigh the risks, convincing a Court that a different decision would have been made and the injury avoided can be a difficult hurdle to overcome.

Did you give informed consent?

If you believe you have suffered an avoidable medical injury because you did not give informed consent to treatment, then you should seek expert legal advice to see if you have a potentially successful medical negligence compensation claim.

As part of the claims process, your solicitor will be able to investigate many of these issues and establish the risks involved in your particular situation, and the information you should have been given. It is important to have a clear and detailed discussion with your solicitor to determine which decisions you would have made with the correct information, and how a successful claim can be pursued.

Get in touch with our clinical negligence solicitors today if you feel you may be eligible to make a claim. Call us free on 0808 164 0808 or request a call back, and one of our experts will call you at a time that suits.

About the Author

Mark Jackson

Mark Jackson

Chartered Legal Executive - Medical Negligence

Mark joined Lime in 2013, and moved to the Clinical Negligence team as a Chartered Legal Executive in 2020, drawing on over 10 years’ experience in personal injury law and litigation. He is a graduate of Nottingham Law School, a Fellow of the Chartered Institute of Legal Executives and a Member of the Association of Personal Injury Lawyers (APIL).