Advisory DI21/05: Clarification of consent requirements

Advisory details

Purpose

To advise diagnostic imaging practices of the requirements for Diagnostic Imaging Practice Standards (DIPS) Standard 2.2: Consumer Consent and Information Standard. Specifically, the consent requirements for:

• The administration of radiopharmaceuticals for nuclear medicine imaging procedures
• Transvaginal and transrectal ultrasound procedures

Issue

The purpose of Standard 2.2 Consumer Consent and Information is to outline the consent requirements for diagnostic imaging services.

There has been confusion about what form consent should take for nuclear medicine, transvaginal and transrectal ultrasound procedures.

Background

All procedures require informed consent. Ensuring informed consent is properly obtained is a legal, ethical, and professional requirement on the part of all treating health professionals and supports person-centred care. Good clinical practice involves ensuring that informed consent is validly obtained, appropriately timed and documented.

Standard 2.2 Consumer Consent and Information Standard states prior to a diagnostic imaging service being rendered, except in cases of emergency, the diagnostic imaging practice must ensure that:

1. Patients have access to information about the diagnostic imaging procedure
2. Risks are advised to the patient or substitute decision maker
3. Practice staff obtain and record relevant information about the patient’s health status and individual patient risk factors
4. Consent for each diagnostic imaging procedure is obtained from the patient or the substitute decision maker
5. Patient consent requirements reflect the risk attached to the diagnostic imaging procedure.

For there to be informed consent a patient must have enough information about their condition, treatment options, the benefits and risks relevant to them, and alternative options for them to make an informed decision to consent. This includes the opportunity to ask questions and discuss concerns.

A person can give informed verbal or written consent. Consent must always be in writing when required by law or by the policies of the state, territory, or healthcare organisation where the person is receiving care and treatment.

The most appropriate form of consent will depend on the degree of risk and complexity of the treatment for that person. Considerations include:

• The degree of significance of the treatment, procedure or intervention in terms of outcomes for the person
• The potential risks and benefits
• The shorter and longer-term consequences for the person
• The complexity of the treatment, procedure, or intervention
• The characteristics of the person giving consent.

Requirements

The diagnostic imaging practice must implement a policy on consumer consent and information that includes:

• Assessing individual patient risk
• Obtaining informed consent
• Documenting consent (for verbal and written consent).

For each patient, the diagnostic imaging practice must:

• Determine the level of risk associated with each diagnostic imaging procedure for the individual patient
• Conduct an informed consent process
• Regardless of the type of consent required, document the patient’s consent in the patient’s healthcare record

Nuclear Medicine Imaging Procedures

Obtain informed consent in writing for nuclear medicine imaging procedures that are high-risk based on the patient's circumstances.

For most patients, administering a radiopharmaceutical for a nuclear medicine imaging procedure is not high-risk when performed in line with appropriate professional standards.

The insertion of an intravenous cannula does not of itself present a significant risk that would require a patient to give written consent.

Transvaginal and transrectal ultrasound procedures

Verbal informed consent is sufficient for low-risk transvaginal and transrectal ultrasound procedures.

The diagnostic imaging practice must obtain written consent for all high-risk procedures, such as those which use transvaginal or transrectal scanning for interventional procedures (including biopsies) or are determined to be high-risk for the individual patient.

For more information

For more information on informed consent is available at:

• Informed Consent webpage

Informed Consent - Fact sheet for clinicians

2020

Fact sheet or brochure

For guidance on evidentiary requirements for Standard 2.2, see the DIAS User Guide for Practices Applying for Accreditation.

Diagnostic Imaging Accreditation Scheme – User guide for practices applying for accreditation

2022

Guide, user guide or guidelines