Informed consent
Informed consent is a process that ensures patients understand the benefits, risks and alternatives before they agree to a medical treatment, test or procedure.
Informed consent is a process that helps ensure patients understand the benefits, risks and alternatives before they agree to a medical treatment, test or procedure.
It’s about a person’s right to make decisions about their own health and wellbeing and helps to ensure care respects their needs and preferences.
Health professionals have a legal, ethical and professional responsibility to make sure consent is properly obtained.
What is informed consent?
Informed consent is a person’s agreement, given voluntarily, to a medical treatment, procedure or other intervention.
This requires the provision of accessible, accurate and relevant information about the intervention, and the expected outcomes, benefits, risks and alternative options, relevant to that person, including:
- doing nothing
- watching and waiting
- and/or lifestyle interventions.
Why is informed consent important
Informed consent is a key safety and quality issue and must be validly obtained and appropriately timed.
When done well, informed consent helps people understand the risks, benefits, alternatives, potential consequences and costs of health care.
Informed consent is integral to the right to information in the Australian Charter of Healthcare Rights, and recognised in Professional Codes of Conduct.
The National Safety and Quality Health Service Standards require all hospitals and day hospitals to have informed consent processes that comply with legislation, lawful requirements and best practice.
Supporting patient participation
Informed consent is best approached through a process of shared decision making.
This involves understanding the person’s goals, concerns, needs, and preferences, as well as discussing:
- what are the options? (including wait and watch)
- what are the possible benefits and harms of those options?
- how likely are each of those benefits and harms to happen?
Many factors may influence a person’s understanding. These include health literacy, cultural differences, disability, spoken language, and neurodiversity. It is important not to make assumptions about a person and to use strategies to tailor communication to patient needs.
Checking patient understanding and encouraging questions are an important part of these conversations.
Decision-making ability, capacity and supported decision-making
- All adults are presumed to have capacity to decide if they wish to receive health care and should be included in decision-making and supported to fully participate.
- A person’s skill and ability to participate in decision-making can change over time and depend on their underlying health condition, acute condition and the type of decision being made.
- If there are still concerns a person is unable to participate after supports have been optimised, a clinical assessment of their decision-making ability may be required, noting that capacity may be decision-specific and change over time.
- Where a person’s physical, emotional or behavioural state means they do not have the ability to make a particular decision, the framework for obtaining substitute consent that applies in each state or territory must be used. This involves the healthcare professional engaging substitute decision-makers or nominated persons, in line with legislation.
- The legal test for whether a person has capacity to decide varies depending on the state or territory in which they are receiving health care.
- Where a person other than the patient is legally appointed as a decision maker, they may only act in line with the authority outlined in the instrument of appointment.
- People may be able to make some decisions with support from a family member, friend or healthcare professional; this is called supported decision-making.
- A supported decision-making process provides the patient with information in a way they can understand and ways of communicating their will and preferences in response.
- In some situations, a person may be supporting the patient to decide, while in others, they may be deciding on their behalf as a substitute decision maker. This is because decision making ability can change, including based on the type of decision being made.
- The patient should remain at the centre of the decision-making process, and their current wishes, values and preferences should be sought and respected wherever possible, even if a substitute decision-maker is involved.
Resources for health professionals
Our fact sheet for clinicians describes the key principles of informed consent and provides information about the importance of key conversations, decision-making capacity and what support patients may need to participate in those conversations.
We have an online education module that supports clinicians in developing and refining their skills in communicating effectively about the benefits and risks of treatment options with consumers.
A better way to care provides guidance for health professionals on how to safely and respectively gain informed consent from people with cognitive impairment or at risk of delirium.
Resources for consumers
We have a fact sheet for patients and a fact sheet for substitute decision makers which can help them to understand their healthcare rights, what to expect during informed consent processes and provide tips for preparing and taking part in key conversations.
We also have a dedicated page for consumers on informed consent and making informed choices.