Have you ever been handed a form in a doctor’s office or hospital room? Chances are, it was an informed consent form. It might have felt like ordinary paperwork at the time, but it’s actually a very important part of modern healthcare, as it helps to ensure that you are fully informed about what medical examination or procedure you’re about to undergo. It also fosters mutual trust and respect between the patient and the medical professional.
What Is Informed Consent?
As a general rule, a healthcare professional must obtain informed consent from a patient for medical examination, treatment, service or investigation.
Informed consent is where the patient has enough relevant information to be able to understand what is proposed and what are the potential risks and benefits. Only then is he or she able to fully decline or consent to what’s about to take place.
A patient should be appropriately counselled about material risks. A consent form which only contains generic risks where there is a specific material risk for a particular patient could be considered inadequate.
Exceptions to this Rule
An obvious example is in the case of an emergency: if medical treatment is required urgently in order to protect or save a patient’s life, there may be no time or ability to procure full consent. In that case, the medical practitioner may be obliged to carry out whatever treatment will best serve the patient’s interests.
In rarer cases, court orders may direct that medical treatment be carried out without the patient’s informed consent. Such cases might include those relating to serious brain injuries, for example. There may also be instances where medical treatment will be carried out in the interests of national health.
Types of Consent
Generally speaking, consent can be expressed or implied.
Expressed consent is usually given by the patient verbally or in writing. While it doesn’t have to come in the form of written consent, this should be the preference for any serious investigations, treatments or procedures.
Implied consent is when a patient has implied that they have consented to a medical treatment or procedure. They might do this in their conduct, by rolling up their sleeves to receive an injection, for example.
What is Valid Consent?
For medical informed consent to be valid, the person/patient must:
- Have received sufficient information in a comprehensible manner about the nature, purpose, benefits and risks of an intervention or treatment.
- Be acting voluntarily, not subject to any sort of threat or pressure from others.
- Have decision-making capacity, with the ability to understand, retain knowledge and make a considered choice.
The Health Service Executive (HSE) has published a detailed booklet on the ‘National Consent Policy’ in Ireland. They note that “the validity of consent does not depend on the form in which it is given”. People may indicate their consent:
- Verbally
- Non-verbally
- In writing
- By implication (such as where a person holds out their arm for a blood pressure reading
What Is Sufficient Information?
The Irish Medical Council’s Guide to Professional Conduct and Ethics For Registered Medical Practitioners says that its members “must give patients enough information, in a way that they can understand, to enable them to exercise their right to make informed decisions about their care. Consent is not valid if the patient has not been given enough information to make a decision.”
There are a number of factors that can decide how much information is sufficient, including the nature of the condition, investigation or treatment and the risk associated.
As a general rule, sufficient information about the material risk(s) is what a reasonable person in the patient’s situation would expect to be told or would consider significant.
Whether in a written medical informed consent form or a verbal conversation, this would include:
- Adequate communication of diagnosis and prognosis
- Options for treating or managing the condition
- Options not to treat and the associated risks of taking no action
- The purposes of any proposed treatment
- The potential benefits and risks and likelihood of a proposed intervention as well as any available alternative
- Possible side effects, material risk or complications of a treatment
- Likelihood of success as a proposed treatment
It’s very important that the information in a consent form is given in a clear, comprehensible manner. If medical jargon must be used, its plain English meaning should be explained too so that patients understand the information. Risks shouldn’t be outlined in a generic way — the discussion should be subjective and the medical information tailored to the patient’s circumstances, particularly if there is an increased material risk of injury due to a complicated medical history.
What is Failure to Warn?
The HSE notes that “a risk is significant where a reasonable person in the person’s position would consider it to be significant. Healthcare workers must disclose such risks to the person. This is the legal standard applied by the Irish Courts.”
The patient should be advised of common, potentially minor side effects as well as rare, and potentially serious complications. The HSE notes that these include any risk of:
- Death
- Permanent disability (such as paralysis or blindness)
- Permanent disfigurement
- Chronic pain
- Need for continuing medication/treatment/medical equipment
Failing to warn a patient of these risks means that the patient is not fully informed and therefore, potentially unable to give valid consent. Where a patient undergoes an investigation, treatment or procedure without valid consent, they may have grounds to file a complaint or claim against the medical practitioner.
The Medical Practitioner’s Liability
If a person carries out healthcare procedures without informed consent, they run the risk of being charged, prosecuted and potentially convicted of assault. This type of case would typically be undertaken by the Director of Public Prosecutions.
Outside of the criminal courts, they could also be sued for civil damages by the patient. Medical professionals may also be sued for negligence and face disciplinary action by their medical council or other regulatory bodies.
For example, HOMS Assist recently brought a medical negligence action on behalf of a patient against the HSE and their agent/consultant, who allegedly did not provide full information to the patient to allow for informed consent to an elective surgery. Afterwards, the patient suffered long-term effects including chronic infection, pain and anxiety, and the team at HOMS Assist succeeded in securing a High Court settlement for the patient together with her legal costs.
When It May Not Be Possible to Obtain Valid Consent
It’s not always possible to obtain valid consent. As mentioned earlier, this can happen in emergency circumstances where treatment is necessary to preserve a patient’s life or health, but there isn’t sufficient time or the patient lacks the capacity to consent. This reflects public interest in ensuring that the preservation of life is prioritised at all times.
The important point here is the urgency involved, which naturally limits the practitioner’s ability to gain medical informed consent. At the other end of the scale is an elective treatment or procedure, which is normally planned in advance with plenty of time to consider the options available. The HSE policy notes that “The Irish Courts acknowledge a distinction between elective and emergency treatments. There is a greater duty to warn of potential negative outcomes the more elective the intervention is.”
That said, patients can and do lodge claims in respect of treatments or procedures carried out without consent in emergency situations. When it comes to medical negligence and informed consent, it’s best to discuss your individual circumstances with an experienced medical negligence solicitor.
How to Make a Claim If You’ve Not Received Informed Consent?
The first step in making a claim is to reach out to a law firm with a proven track record in medical negligence cases. It’s important that you do this as soon as possible, as the general rule is that proceedings must be issued within two years, less a day, of the date of the negligent act. There are exceptions to this, as sometimes injuries may take time to become noticeable. In this case, the courts rely on a ‘date of knowledge’, i.e. when you became aware of your injuries or harm suffered, or when you should have become aware of the alleged medical negligence .ie. a constructive date of knowledge.
Your solicitor will guide you through the next steps, from requesting a copy of your medical records to introducing you to medical experts, all the way to representing you in settlement negotiations or in court. You can find lots more information in our everything-you-need-to-know blog post on medical negligence.
Consent is a big issue in medical law and extends to the disclosure of information and sharing medical information without consent. In stressful situations, patients may consent to share medical information with family members, but this must be carefully conducted, in strict adherence with the patient’s wishes. If you feel that you have experienced disclosure of medical information without consent, you may be eligible to pursue legal remedies. Our qualified medical law team at HOMS Assist will be able to advise further.
How Can HOMS Assist Help?
At HOMS Assist, we have decades of experience with medical law cases of all types. If you feel you did not receive informed consent and have suffered an injury as a result, please do get in touch with us.
We will sit down with you to discuss your circumstances and work out the next steps. With your authority, we will take up a copy of your medical records and engage with our panel of medical expert witnesses to review your medical records and patient information. If the expert is of the opinion that negligence has occurred, we can proceed with an action on your behalf.
With over 50 years of expert legal experience advising patients, we are here to provide care and advice when you need it most. Call us today on 1800 207 207 or contact us online.
*In contentious business, a solicitor may not calculate fees or other charges as a percentage or proportion of any award or settlement.