Protocol for Obtaining Informed Consent for health care procedures or treatment

Guideline number: QH-HSDPTL-032-6

Effective date: 13 December 2024

Review date: 13 December 2027

Supersedes: Version 1.0

On this page:

1. Purpose
2. Scope
3. Protocol
4. Supporting and related documents
5. Authorising Health Service Directive
6. Definitions of terms
7. Approval and implementation
8. Human rights
9. Version control

1. Purpose

Obtaining informed consent for health care procedures or treatment is important to the delivery of safe and high-quality care. The purpose of this protocol is to contribute to patient safety outcomes by ensuring patients are able to make informed decisions about their care.

This protocol should be read in conjunction with the Patient Safety Health Service Directive and Guide to Informed Decision-making in Health Care.

This protocol is not intended to alter an individual health professional’s duty of care to ensure their patients are able to make informed decisions about their care, as this will be shaped by the specific circumstances.

Please note: this protocol is only intended to cover consent for certain health care procedures or treatment consistent with the definitions in part 6 of the Protocol.

2. Scope

This protocol applies to all Hospital and Health Services.

3. Protocol

Informed consent must be obtained from patients (this includes their substitute decision-maker(s) or a parent/legal guardian, if applicable) for health care procedures or treatment.

Who can obtain informed consent?

Informed consent must be obtained by an experienced health professional. An experienced health professional is someone who:

1. Is able to competently provide a patient (with interpreter/translator/cultural support as required) with sufficient information about their health care procedure or treatment, including discussing risks, benefits, potential outcomes, complications and alternatives, so that they may make an informed decision about the specific health care.
2. Holds appropriate professional registration under the Health Practitioner Regulation National Law (Queensland) or a professional membership:

• (a) medical practitioners – but does not include interns with ‘provisional’ registration, or where conditions are imposed on any medical professional’s registration pertaining to consent or the relevant health care procedure and/or treatment;
• (b) other registered health professionals – who do not have conditions imposed on their professional registration pertaining to consent or the relevant health care procedure and/or treatment (e.g. dentists / dental specialists; registered nurses / nurse practitioners, midwives / endorsed midwives, Aboriginal and Torres Strait Islander health practitioners, physiotherapists, occupational therapists, psychologists);
• (c) other self-regulated health professionals – who must hold, or be eligible to hold membership with their relevant professional bodies (e.g., speech pathologists, social workers, dietitians).

3. Is credentialed to perform the health care procedure or treatment within their professional scope of practice.

Delegated informed consent

Where a health professional meets requirements one and two above but is not able to meet requirement three, i.e. they are not credentialed to perform the health care procedure or treatment within their professional scope of practice, they may still obtain informed consent from a patient in certain circumstances. This is referred to as ‘delegated informed consent’.

Delegated informed consent applies to :

• junior and senior medical staff (excluding interns with ‘provisional’ registration);
• dentists / dental specialists;
• registered nurses / nurse practitioners;
• midwives / endorsed midwives;
• Aboriginal and Torres Strait Islander health practitioners; and
• allied health practitioners.

Delegates must be supervised and supported by a suitably qualified senior health professional. Delegates may decline the task or the request to obtain informed consent, by notifying their senior health professional.

Obtaining informed consent

Informed consent must be obtained, confirmed and documented in-line with the requirements in this Protocol.

Complex health care procedures and treatment where multiple disciplines are involved, may require multiple consent processes to ensure the patient has all of the information they require to make an informed decision. A multidisciplinary approach to a single informed consent process should also be considered (but will not always be necessary) for the optimal patient experience. These matters will need to be determined on a case-by-case basis by the treating health professionals.

If the consent process is undertaken in conjunction with another health professional, the health professional(s) delivering the relevant health care must satisfy themselves that informed consent has been obtained from the patient and is documented.

How can informed consent be given?

Informed consent may be given either in writing or verbally, with an interpreter/translator/cultural support person/s where relevant.

A patient may change their mind or withdraw consent at any time. For example, they may want to delay all or part of their treatment. Declining or withdrawing consent can be done verbally or in writing. A decision to decline or withdraw consent may be made for any reason, including religious, cultural or other personal beliefs.

In circumstances where an adult patient lacks capacity to provide consent, and an Advance Health Directive (AHD) is not in place, consent may be given by a substitute-decision-maker (i.e. a Tribunal appointed guardian, Enduring Power of Attorney or Statutory Health Authority) on behalf of the patient.

Where the health care pertains to a child or young person under the age of 18 years who does not have capacity to give their own consent (Gillick competent), a parent or legal guardian may provide informed consent on behalf of the child or young person.

Additionally, there are certain types of special health care that require the consent of a Tribunal or Court to be given on behalf of an adult without the capacity to make a decision e.g. sterilisation of an adult.

Documenting informed consent

All personnel responsible for discussing health care with patients, including obtaining informed consent, must keep contemporaneous records documenting these discussions. Any member of the treating team may document the informed consent process.

As part of this process, a suitably qualified member of the treating team (i.e. as per Section 3 in this Protocol) will still need to obtain, review and sign the consent, in-line with the requirements in this Protocol.

A review of the patient’s consent to the specific health care is required whenever the patient’s care plan is reviewed, changed or updated. A new consenting process is required when there is a change in the risks or benefits of health care or the options available.

Consent should be reiterated and confirmed with a patient in the same detail as it was initially if a reasonable period of time has elapsed between first obtaining the consent and the specific health care being performed. What is a reasonable period of time should be considered on a case-by-case basis taking into account the complexity of the health care being provided and the seriousness of the risks for the patient.

Generally, informed consent (for a single health care matter such as a procedure or a course of treatment to treat a specific health care matter) has a maximum validity of 12 months only if the following applies:

• the consent is for the same health care procedure/treatment;
• the patient remains able to recall the information surrounding their health care procedure/treatment and confirms their consent;
• the risks, benefits and alternatives of the health care procedure/treatment for the patient have not changed;
• the patient’s health status has not changed;
• there is no significant change in the nature of intended health care or outcome;
• the patient has not withdrawn their consent for the health care procedure/treatment and does not question their decision;
• there is no awareness of any new information, technology, treatment or guidelines that would impact the patient’s choices;
• the patient's substitute decision maker who provided the initial consent has not changed (if relevant); and
• the patient retains capacity to make decisions.

A Queensland Health consent form and patient information sheet should be used wherever available.

4. Supporting and related documents

The Guide to Informed Decision making in Health Care is published by Queensland Health and contains best practice guidelines to assist health professionals when obtaining informed consent (the Guidelines).

The Guidelines do not form part of the mandatory requirements of this protocol or the Patient Safety Health Service Directive.

5. Authorising Health Service Directive

• Patient Safety Health Service Directive QH-HSD-033

6. Definition of Terms

7. Approval and implementation

Protocol custodian:

Executive Director, Patient Safety and Quality, Clinical Excellence Queensland.

Approving officer:

Director General, Department of Health.

Approval date: 09/10/2024

Effective from: 09/10/2024

8. Human rights

Human rights have been considered in the drafting of this protocol and the contents are considered to be compatible with the Human Rights Act 2019 Human Rights Act 2019 - Queensland Legislation - Queensland Government).

9. Version Control