Action 2.04

Informed consent is a person’s voluntary decision about their health care that is made with knowledge and understanding of the benefits and risks involved.¹

Ensure that the organisation has effective processes in place to:

• Inform patients (and, if applicable, their carers and substitute decision-makers) about the risks, benefits and alternatives of a treatment, including any fees and charges associated with treatment and referrals
• Determine patient preferences for treatment
• Document patient consent to treatment.

This includes processes for consent relating to transfusions of blood or blood products (Action 7.03), and specific situations that require informed consent for treatment with a medicine (Action 4.11).

Effective processes may include policies and procedures to guide and support the clinical workforce towards good standards of practice that meet legal and ethical requirements.

Review current informed consent processes

Informed consent processes should comply with legislation and best practice. The following are best practice principles for informed consent systems ¹ :

• Provide information to patients in a way that they can understand before asking for their consent – for example, provide an accredited interpreter to help with communication, or adapt information into accessible formats (such as translation into community languages, or providing audio or visual information); other strategies for tailoring communications to the diverse needs of the patient population are provided in Action 2.08
• Obtain informed consent or other valid authority before undertaking any examination or investigation, or providing treatment (except in an emergency)
• Document consent appropriately, and provide guidance on what to do if there are concerns about a patient’s capacity to provide consent
• Meet the common law and legal requirements of the relevant state or territory relating to
  • providing information about treatment
  • obtaining consent to treatment, including the requirement to disclose all risks
• Nominate a manager who is responsible for maintaining the integrity of the consent system and its continuous improvement
• Support informed consent through safety and quality systems across all areas of the organisation that ensure that
  • no treatment is provided without the patient’s informed consent (or, if applicable, that of their substitute decision-maker)
  • specific consent requirements established by state or territory legislation – such as mental health Acts, guardianship and administration Acts, and human tissue Acts – are complied with
• Support informed consent through education and training for all members of the clinical workforce in
  • effective communication to underpin good clinical practice
  • the legal, ethical and practical foundations of requirements for patient consent and engagement in clinical decision-making
  • the organisation’s consent policy and procedures
  • understanding how individual health literacy levels and the health literacy environment can act as barriers to understanding during the consent process
• Incorporate protocols for receiving, investigating and managing complaints about consent processes
• Link informed consent to the organisation’s open disclosure policy and the state or territory consent policy (if applicable).

If an organisation’s informed consent processes do not meet the best-practice principles outlined above, adapt the policies and procedures accordingly.

Some states and territories have developed informed consent templates or identified appropriate consent strategies for use in that state or territory. Adopt or adapt these if available; otherwise, develop processes for the health service organisation.

The Queensland Health Guide to Informed Decision-Making in Health Care provides guidance on how to implement the principles of informed decision-making in clinical practice.

Monitor design and performance of informed consent processes

Periodically review the design and performance of informed consent processes to evaluate whether they comply with best-practice principles. This will support effective clinical governance, including risk management.

For private sector organisations where informed consent may be obtained in a process separate from the health service organisation, it is not intended that visiting medical officer practices are monitored. Rather, the health service organisation takes a risk management approach and confirms with patients on admission, or at the commencement of an episode of care, that they understand why they are there and what treatment they will receive.

Informed consent is a person’s voluntary decision about their health care that is made with knowledge and understanding of the benefits and risks involved.¹

If the day procedure service is part of a larger or networked group that has informed consent policies and procedures, ensure that the service has adopted these.

If no such policies or procedures exist, the day procedure service should develop and implement effective processes to:

• Inform patients (and, if applicable, their carers and substitute decision-makers) about the risks, benefits and alternatives of a treatment, including any fees and charges
• Determine patient preferences for treatment
• Document patient consent to treatment.

This includes processes for consent relating to transfusions of blood or blood products (Action 7.03), and specific situations that require informed consent for treatment with a medicine (Action 4.11).

Have a process in place to ensure that informed consent has been obtained, including by maintaining a copy of the signed consent form. In some instances, the patient may have given informed consent to the referring clinician before being admitted to the day procedure service. However, the day procedure service should not assume that consent has been obtained before admission.

Effective processes may include policies and procedures to guide and support the clinical workforce towards good standards of practice that meet legal and ethical requirements.

Review current informed consent processes

Informed consent processes should comply with legislation and best practice. The following are best practice principles for informed consent systems ¹ :

• Provide information to patients in a way that they can understand before asking for their consent – for example, provide an accredited interpreter to help with communication, or adapt information into accessible formats (such as translation into community languages, or providing audio or visual information); other strategies for tailoring communications to the diverse needs of the patient population are provided in Action 2.08
• Obtain informed consent or other valid authority before undertaking any examination or investigation, or providing treatment (except in an emergency)
• Document consent appropriately, and provide guidance on what to do if there are concerns about a patient’s capacity to provide consent
• Meet the common law and legal requirements of the relevant state or territory relating to
  • providing information about treatment
  • obtaining consent to treatment, including the requirement to disclose all risks
• Nominate a manager who is responsible for maintaining the integrity of the consent system and its continuous improvement
• Support informed consent through safety and quality systems across all areas of the organisation that ensure that
  • no treatment is provided without the patient’s informed consent (or, if applicable, that of their substitute decision-maker)
  • specific consent requirements established by state or territory legislation – such as mental health Acts, guardianship and administration Acts, and human tissue Acts – are complied with
• Support informed consent through education and training for all members of the clinical workforce
• Incorporate protocols for receiving, investigating and managing complaints about consent processes
• Link informed consent to the organisation’s open disclosure policy and the state or territory consent policy (if applicable).

If an organisation’s informed consent processes do not meet the best-practice principles outlined above, adapt the policies and procedures accordingly.

Some states and territories have developed informed consent templates or identified appropriate consent strategies for use in that state or territory. Adopt or adapt these if available; otherwise, develop a local system.

The Queensland Health Guide to Informed Decision-Making in Health Care provides guidance on how to implement the principles of informed decision-making in clinical practice.

Monitor design and performance of informed consent processes

Periodically review the design and performance of informed consent processes to evaluate whether they comply with best-practice principles and whether enough resources have been allocated. This will support effective clinical governance, including risk management.

For private sector organisations where informed consent may be obtained in a process separate from the health service organisation, it is not intended that visiting medical officer practices are monitored. Rather, the health service organisation takes a risk management approach and confirms with patients on admission, or the commencement of an episode of care, that they understand why they are there and what treatment they will receive.

Examples of evidence

Select only examples currently in use:

• Policy documents for informed consent that reference relevant legislation or best practice and consider issues such as
  • when consent should be obtained
  • when consent is not required
  • when written consent is required
  • requirements for valid consent
  • refusal of treatment or consent
  • obtaining consent from patients from culturally and linguistically diverse backgrounds
  • consent ages and consent for minors
  • guardianship or advocacy
• Training documents on informed consent processes
• Standardised consent form that is in use
• Audit results of healthcare records for compliance with informed consent policies, procedures or protocols
• Audit results of healthcare records to see whether patients are informed of the risks and benefits of treatment, and whether there is a record of consent
• Results of consumer and carer experience surveys, and actions taken to deal with issues identified about informed consent
• Patient information packages or resources about treatment and consent processes that are available for consumers in different formats and languages, consistent with the patient profile
• Feedback about the consent process from patients and carers after treatment.

MPSs or small hospitals that are part of a local health network or private hospital group should use the established informed consent policies and procedures.

Small hospitals that are not part of a local health network or private hospital group should develop or adapt effective processes to:

• Inform patients (and, if applicable, their carers and substitute decision-makers) about the risks, benefits and alternatives of a treatment, including any fees and charges associated with treatment and referrals
• Determine patient preferences for treatment
• Document patient consent to treatment
• Support the clinical workforce to meet legal and ethical requirements.

The following are best-practice principles for informed consent systems ^{1, 2} :

• Provide information to patients in a way that they can understand before asking for their consent – for example, provide an accredited interpreter to help with communication, or adapt information into accessible formats (such as translation into community languages, or providing audio or visual information)
• Obtain informed consent or other valid authority before undertaking any examination or investigation, or providing treatment (except in an emergency)
• Document consent appropriately, and provide guidance on what to do if there are concerns about a patient’s capacity to provide consent
• Meet the common law and legal requirements of the relevant state or territory relating to
  • providing information about treatment
  • obtaining consent to treatment, including the requirement to disclose all risks
• Nominate a manager who is responsible for maintaining the integrity of the consent system and its continuous improvement
• Support informed consent through education and training for all members of the clinical workforce in
  • effective communication to underpin good clinical practice
  • the legal, ethical and practical foundations of requirements for patient consent and engagement in clinical decision-making
  • the organisation’s consent policy and procedures
  • understanding how individual health literacy levels and the health literacy environment can act as barriers to understanding during the consent process

The Queensland Health Guide to Informed Decision-Making in Health Care provides guidance on how to implement the principles of informed decision-making in clinical practice.

Periodically review the design and performance of informed consent processes to evaluate whether they comply with best-practice principles. This will support effective clinical governance, including risk management.