Consent in care: the essentials

Quick guide:

• A consent discussion is required for many reasons and at many times throughout the patient care journey – not just before a procedure.
• A consent process involves more than just signing a form. The discussion should be an ongoing shared decision-making process, which aims to understand the patient’s particular situation and concerns and to clarify their expectations.
• Legal issues can arise including whether the patient has decision-making capacity, is making the decision voluntarily and has been given enough information to make an informed decision. Good documentation of your discussion will be invaluable if you need to respond to any issues.

Consent is a process, not a form 

Patient consent is required for all medical treatment, except in emergency situations. Obtaining consent involves more than simply explaining risks or working through a checklist. It requires a meaningful discussion that leads to a mutual understanding of the proposed treatment and a shared decisions about how to proceed. Our data shows that complaints and claims involving consent are less often about whether the consent process occurred, and more often about the quality of the conversation.  Effective consent is built on clear communication, patient understanding and genuine engagement in decision-making.

Shared decision making

As with many aspects of healthcare, expectations around the consent process have evolved. Patient-centred care requires clinicians to actively engage patients in shared decision-making about their treatment options. Consent is not about presenting a decision for a patient to simply agree to, nor is it about overwhelming them with information and expecting them to determine the best course of action on their own.

At its core, effective consent involves understanding a patient’s goals, values and concerns, and addressing these through your clinical experience and knowledge.

Informing patients means providing the context they need to understand the potential outcomes of a proposed treatment or procedure, whether positive, negative or neutral, and what those outcomes may mean for them personally. The patient then gives consent based on that understanding.

The consent process may take place over more than one consultation.  Consider offering patients additional time to reflect on the information provided and return for a further discussion before they decide. You could also encourage the patient to involve a family member, friend or other support person in subsequent conversations.  As a general rule, the more complex, invasive or elective a treatment or procedure is, the more detailed and extensive the consent discussion should be.  

Ask yourself the following key questions:

Capacity – Is your patient able to make this decision?

Capacity refers to a patient’s ability to make a decision about their health care. It is specific to the decision being made. A patient has capacity to make a decision if they can do the following with the information provided:

• Understand - the information and consequences relevant to the decision
• Retain - hold the information and recall the details
• Weigh - use and evaluate the information throughout the decision-making process
• Communicate - relay their decision and understand.

Voluntariness – Is your patient making this decision freely?

Patients must give their consent freely. Some patients may be vulnerable to undue influence from others, including family members, carers or even the treating team. Your role is to provide information in a clear and accessible way that enables the patient to make their own voluntary decision.

Patients have the right to choose between the treatment options presented to them and may withdraw consent at any time. They also have the right to refuse treatment or seek a second opinion. If this occurs, respect the patient’s decision and ensure you document the discussion thoroughly, including the information provided and any explanation of the potential risks of not proceeding with treatment.

Information – Does your patient have enough?

Patients need enough information about their condition and the available treatment options to make an informed decision. Consider using diagrams, written resources and decision aids to support these discussions. Research suggests that these tools can improve understanding, provide clarity and help patients feel more confident about their decision.

Consent should be obtained for a specific treatment or a procedure. This can become more complex when treatment occurs over an extended period or involves multiple stages. Patients should understand each step of the proposed plan before it begins and as it progresses. If the treatment plan changes, this should be discussed with the patient so they can consider the new information and provide informed consent for the revised approach.  

The information you provide should be tailored to the patient’s specific needs, particularly when discussing the risks of treatment options. The following issues should be covered:

• Condition – the possible or likely nature of their injury, illness, or disease.
• Proposed approach – to investigating, diagnosing or managing the patient’s condition, including what the treatment or procedure involves. Discuss the available evidence supporting the effectiveness of the proposed treatment and whether it is considered conventional practice or an experimental approach. Patients should also be told who will perform the procedure and consent to their involvement. For example, if some or all of the procedure will, or may, be performed by an assistant, registrar or other member of the healthcare team, this should be discussed as part of the consent process.
• Benefits – that can be expected from treatment but also discuss the degree of uncertainty about the therapeutic outcome.
• Risks – including risks that are material to the patient as well as the general risks of the treatment or procedure (discussed further below).
• Common outcomes and side effects – including any significant long-term outcomes that may be associated with the proposed treatment, including physical, emotional, mental, sexual, or social outcomes. It is also important to discuss the likely timeframes involved, including any recovery time.
• Alternative options - of treatment and diagnosis. It is important to inform patients of the consequences of not choosing the proposed procedure or treatment, or of not having any procedure or treatment at all.
• Costs – including any out-of-pocket costs. The patient needs to give informed financial consent to any treatment or procedure performed.

Explaining risks and managing expectations

As well as disclosing the general risks of the proposed treatment or procedure, you must also discuss risks that are material to the particular patient. This forms part of your duty of care. Failure to disclose material risks may result in a complaint or legal claim, even if the treatment or procedure itself was performed at an acceptable standard.

Material risks are different for each patient depending on their individual circumstances.  A risk that may seem minor to you, or to another patient, may be highly significant to someone else because of their occupation, family circumstances, lifestyle, medical history or personal values. Understanding what matters most to your patient is therefore a critical part of the consent process.

You should also discuss what would happen if any of these risks occurred. This will help your patient to consider the options and make an informed decision, including what plans they made need to make if any of those risks did occur.

These conversations will also clarify what the patient expects from the treatment or procedure. This can help inform your conversations and manage the patient’s expectations. Not achieving what the patient expected can lead to a complaint or claim.

The patient should also be given ample opportunity to ask questions.

Documenting consent

Although consent is about more than a form, it is essential to document the consent discussion. Your hospital or practice may require a specific form to be used. You may also need to make additional contemporaneous notes in the clinical records documenting your discussion with the patient.

It is particularly important to keep a record of:

• information provided about the procedure or treatment, including the aims, and expected outcomes
• your discussion about specific risks and those material to the patient's circumstances
• any other procedures explored
• any patient aids or diagrams provided (make sure you keep a copy of the version of any printed materials), and
•  that your patient had the opportunity to ask questions, and specifically any issues or questions raised by them and your response.

Certain types of procedures, including most surgical interventions, blood transfusions and chemotherapy, require written consent under legislation, hospital policy or both.  Also, hospital policies may require specific consent forms to be used, so check your organisation’s requirements.  Any signed consent forms should be retained as part of the patient’s medical record. However, it is important to remember that a signed form does not replace the consent discussion. The form should document and support a consent process that has already occurred, rather than serve as evidence of consent in isolation.

There are many other situations where written consent is not a requirement and patient consent is implied, such as offering an arm for a blood test, or verbal, such as agreeing to take a new medication. The circumstances will depend on the situation and your clinical judgment. It is prudent to document in the patient's clinical records if they have verbally agreed to something.

How long does consent last?

Consent remains valid until it is withdrawn by the patient or until their circumstances change in a material way. However, if a considerable time has passed since the original consent was obtained, it is best to update and document your discussion with the patient. If you work in a hospital, you should check if it has a policy on the length of time a signed consent form is considered valid.