Medical Imaging Informed Consent Guidelines

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Approved by: Eli Faculty of Clinical Radiology Council gi bil Date of approval: ity 26 June 2019 ABN 37 000 029 863

Copyright for this publication rests with The Royal Australian and New Zealand College of Radiologists ® Ra of The Royal Australian and New Zealand College of Radiologists

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TABLE OF CONTENTS

1. Introduction 3 2. What is Informed Consent? 4 3. What Information to Give? 4 4. Who can Obtain Informed Consent? 6 5. Obtaining Informed Consent 6 6. Who is Capable of Giving Informed Consent? 7 7. References 8

Medical Imaging Informed Consent Guidelines © The Royal Australian and New Zealand College of Radiologists® June 2019 Page 2 of 8 1. INTRODUCTION

1.1 Purpose

This document has been developed by the Standards of Practice and Accreditation Committee (superseded by the Safety Quality and Standards Committee) of The Royal Australian and New Zealand College of Radiologists and is designed to provide general guidance to radiologists, their medical imaging team members and medical imaging service providers on the principles and requirements of obtaining informed consent for medical imaging examinations.

Obtaining informed consent is the process by which a health care provider informs a patient of their options regarding available medical interventions to address a particular clinical problem, the associated risks and benefits, and supports them to make a decision about their care including, where possible, in emergencies.

These guidelines will be reviewed by the Committee from time to time.

1.2 Scope

In preparing this document, the College has reviewed general guidance material addressing patient consent1 2 3 4, and obtained legal advice to ensure that the guidance set out in this document is consistent with relevant legal principles.

This document does not provide risk data for individual imaging examinations or procedures, nor does it give directives regarding when and how informed consent must be taken, but aims to provide general guidance on how radiologists may address the issue of patient consent in the medical imaging context.

1.3 Disclaimer

The information provided in this document is of a general nature and is not intended as a substitute for medical or legal advice. It is designed to support, not replace, the relationship that exists between patient and doctor. Whilst every effort is made to ensure the accuracy of the information contained in this document, the College, its Board Members, Faculty of Clinical Radiology Councillors and employees assume no responsibility for its content, use or interpretation. Each person should rely on their own enquiries before making decisions that touch their own interests. If a clinician has questions or concerns they should seek advice from their medical defence organisation.

1.4 Definitions

In this Medical Imaging Consent Guideline:

ALARA means As Low As Reasonably Achievable

ARPANSA means Australian Radiation Protection and Nuclear Safety Agency

College means The Royal Australian and New Zealand College of Radiologists

Committee means The Standards of Practice and Accreditation Committee

Medical Imaging Examination includes all medical imaging examination, procedures and treatments

Member means a member of the College.

Medical Imaging Informed Consent Guidelines © The Royal Australian and New Zealand College of Radiologists® June 2019 Page 3 of 8 1.5 College Mission

As a fellowship-based organisation, The Royal Australian and New Zealand College of Radiologists sets, promotes and continuously improves the standards of training and practice in radiology and radiation oncology, for the betterment of the people of Australia and New Zealand.

2. WHAT IS INFORMED CONSENT?

2.1 General Concepts

Patient informed consent is the agreement of a patient to treatment by a health care provider.

Obtaining patient informed consent is the process by which a health care provider informs a patient of their treatment options, the associated risks and benefits, and supports them to make a decision about their care including, where possible, in emergencies.

Patient informed consent must be voluntary, specific to a treatment and be given by a patient that fully comprehends what has been explained to them.

2.2 Application to Medical Imaging

The relationship between doctor and patient involves a great deal of trust. In recent times the trend is for patients to want more information about the level of risk versus the potential benefits of medical interventions; patients seek and expect to be provided with comprehensive information and to be actively involved in the decision-making process before giving informed consent for medical interventions, including medical imaging examinations. However, the expectations around informed consent provide something of a challenge in the context of medical imaging.

There is a shared responsibility to provide information to the patient between the referring doctor, who is primarily responsible for the clinical management of the patient, and the radiologist who is responsible for the imaging examination. A radiologist is best equipped to provide information specific to the imaging examination, while the referring doctor is best placed to provide information on the overall clinical context of the examination.

As such, the communication between the referring doctor, who manages the overall care of the patient, and the radiologist performing the medical imaging examination, is of utmost importance in ensuring that the patient receives comprehensive information to enable them to provide informed consent to their medical care.

3. WHAT INFORMATION TO GIVE?

3.1 Type of Information

A patient must be given every opportunity to understand the potential benefits and risks of a medical imaging examination, the potential risks and benefits of not having the procedure and be able to ask questions. Consent is only valid if the patient has been provided with sufficient information to enable a reasonable person in the place of the patient to make an informed decision. The amount of information to provide will vary, depending on the nature of the condition, complexity of, and known risks associated with, the examination, the patient’s temperament, health and own wishes, and the surrounding circumstances.

Information should be in plain language, commensurate with the person’s age, education and cultural background.

Medical Imaging Informed Consent Guidelines © The Royal Australian and New Zealand College of Radiologists® June 2019 Page 4 of 8 Following is a guide to the range and types of information that, depending on the examination, may be provided by the radiologist. How much information to provide is at the discretion of the individual radiologist performing the medical imaging examination and will be relative to the level of complexity and risk associated with the examination and to the factors relevant to individual patients as set out above.

Such information may address:

(a) the nature of the medical imaging examination, for example: how invasive it is; whether it will be painful; how long it will take; how the patient will feel before, during and after the procedure; the expected benefits, whether the proposed medical procedure is critical, essential, elective or discretionary, and the certainty of any diagnosis;

(b) other options for investigation, diagnosis and treatment;

(c) who will undertake the proposed medical imaging examination, including their status and the extent of their experience;

(d) the financial cost of the medical imaging examination;

(e) whether the proposed medical imaging examination is part of a clinical trial or other research project;

(f) any significant long term and/or short-term physical, emotional, mental, social, sexual or other outcome which may be associated with the proposed medical imaging examination;

(g) the potential consequences of any proposed medical imaging examination, including:

(i) common side-effects, common complications, contraindications and possible harms, including their likelihood and degree;

(ii) uncommon side-effects to which a particular patient may be exposed or which are of particular concern to a particular patient;

(h) the consequences of not proceeding with the proposed medical imaging examination or any alternative;

(i) the time involved in the medical imaging examination, including how long will be needed for recuperation and/or rehabilitation.

3.2 Radiation Risk

Certain medical imaging examinations require significant radiation dose. When obtaining consent the issue of radiation risk will need to be addressed for these examinations. Inside Radiology5 (www.insideradiology.com.au) is recommended as a source of comprehensive information about specific diagnostic and interventional medical imaging examinations as well as ionising radiation and stochastic risk in general (radiation risk information).

The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) also provides information that may be of assistance in explaining radiation risk www.arpansa.gov.au. The following two fact sheets have been developed by ARPANSA in relation to paediatric patients undergoing CT scans:

CT Scans for Children: Information for Referrers

What Parents Should Know about CT Scans for Children

Medical Imaging Informed Consent Guidelines © The Royal Australian and New Zealand College of Radiologists® June 2019 Page 5 of 8 4. WHO CAN OBTAIN INFORMED CONSENT?

In modern medicine treatment of a patient is often shared by several health care providers. This includes situations where a patient might be attended to by a general practitioner who then refers the patient to a radiologist (or another specialist medical practitioner or health care provider).

Each of these persons may administer treatment to the patient. However, it is unlikely that each will incur an obligation to inform the patient about the treatment administered (although it is possible that more than one of these persons will incur such an obligation).

The overall responsibility for obtaining patient informed consent in these circumstances remains with the health care provider responsible for making a medical intervention; in the case of medical imaging, this is the radiologist. While the tasks associated with obtaining consent can be delegated by the radiologist to other members of the medical imaging team under protocol, as the actual obligation remains with the health care provider responsible for making a medical intervention the radiologist should always be available to provide any information that the patient requests that the delegated medical imaging team member is unable to provide.

5. OBTAINING INFORMED CONSENT

5.1 Methods of Recording Informed Consent

Patient consent is where, after being provided with adequate information, the patient clearly states their agreement to the medical imaging examination or treatment. This may be implied, verbal or in writing.

When obtaining patient consent at the time of the examination, the form of consent and the manner in which consent is recorded will differ depending on the type of examination, the degree of risk and, in emergencies, whether the imaging is time-critical. The more complex the medical imaging examination or the greater the risks, the more important it is to have formal documentation of the consent process. However, the way in which consent is recorded is left to the individual radiologist’s judgement. The requirements of any relevant legislation should always be borne in mind by the individual radiologist in making this judgement.

5.1.1 Implied Consent

Implied consent is given when, after being provided with adequate information, the patient indicates their agreement to the medical imaging examination through their actions or by complying with the health care provider’s instructions.

Often the risks involved with a medical imaging examination are very low. In these cases, it may be sufficient to rely on the patient’s implied consent through their actions. For example, in the case of an x-ray of a body extremity, such as the hand or foot, a patient may give implied consent by placing their hand or foot on the x-ray machine.

5.1.2 Verbal Consent

Verbal consent is given when a patient says they agree to the medical imaging examination. It is recommended from a medico-legal perspective that a contemporaneous note be made of the patient’s consent in the patient’s record.

Medical Imaging Informed Consent Guidelines © The Royal Australian and New Zealand College of Radiologists® June 2019 Page 6 of 8 5.1.3 Written Consent

Written consent is where the patient provides written evidence of their agreement to a medical imaging examination, for example, by signing a consent form. This written consent is to be held in the patient’s record. The signing of a consent form is not the same as following a proper process to gain a patient’s consent, it is merely written evidence. In other words, written consent is in addition to, and does not replace, the process outlined in paragraph 3 above.

Some examples of when written consent should be obtained are:

• When the medical imaging examination is complex or has significant risk and/or side effects (e.g. contrast administration)

• Interventional procedures: any procedure where the skin is breached other than IV cannula insertion

• When clinical care is not the primary purpose of the medical imaging examination

• There are significant consequences for the patient’s personal/work life

6. WHO IS CAPABLE OF GIVING INFORMED CONSENT?

A person is judged to be capable of giving informed consent if they are able to comprehend the information given to them about, and weigh the risks and benefits of, a medical imaging examination. A person who does not legally have capacity cannot give valid consent; this may include children, intellectually disabled patients and patients with reduced mental competence, as well as patients in some emergency situations.

6.1 Consent Given on Behalf of Someone Else

Patients over the age of sixteen are generally able to provide informed consent to most medical imaging examinations and may also refuse a medical imaging examination, as they are generally able to understand the nature, purpose and possible consequences of having, or not having, the medical imaging examination. However, if patients over the age of sixteen do not have this level of competency then they may not be capable of giving informed consent.

Patients under the age of sixteen may be able to consent to a medical imaging examination provided they are able to understand the nature, purpose and possible consequences of having, or not having, the medical imaging examination. State and Territory legislation generally has specific provisions for dealing with the ability of minors to provide informed consent and the relevant legislation should be considered. A radiologist would be advised whenever possible to seek the consent of a parent or guardian.

6.2 Intellectually Disabled

Intellectually disabled patients cover a spectrum of disability. Each individual patient should be assessed in order to decide if they are capable of giving informed consent. Where a patient is considered incapable of giving informed consent, the legal guardian, be that a parent or other legally appointed decision maker should be approached to provide informed consent. If further difficulties arise in obtaining informed consent an approach should be made to the appropriate State or Territory guardianship tribunal or authority.

6.3 Reduced Mental Competency

Patients with reduced mental competency may present a difficulty to radiologists in obtaining informed consent. Each patient should be assessed according to their individual clinical circumstances. If there is any doubt as to whether the patient is able to give informed consent, the radiologist should seek advice from the appropriate State or Territory guardianship tribunal or authority.

Medical Imaging Informed Consent Guidelines © The Royal Australian and New Zealand College of Radiologists® June 2019 Page 7 of 8 6.4 Emergencies

In an emergency when informed consent cannot be obtained the medical imaging examination should be performed for anyone who needs it, provided the examination is limited to what is immediately necessary to save life and avoid significant deterioration in the patient’s health. In these situations the best interests of the patient are paramount. If possible a second opinion should be sought. In less time-critical emergencies informed consent should be obtained if possible and, whenever possible, decisions should be made with the consensus of the next of kin or legal guardian.

6.5 Refusing Consent

If a patient is capable of giving informed consent, they are also capable of refusing consent. Disagreeing with a doctor does not mean, in itself, that the patient does not understand the information that has been provided. Refusing to give consent should be noted in the patient’s records. Where possible, details of the reasons and discussion should also be recorded.

A patient can withdraw consent at any time, even after signing a form or after a procedure has commenced.

7. REFERENCES

1 NHMRC, General Guidelines for Medical Practitioners on Providing Information to Patients, 2004 2Medical Board of Australia, Good Medical Practice: A Code of Conduct for Doctors in Australia, 2014 3The Royal College of Radiologists, Standards for patient consent particular to radiology, Second edition, 2012 4 American College of Radiologists, ACR-SIR Practice Guideline on Informed Consent for Image- guided Procedures, 2016 5 RANZCR, www.insideradiology.com.au

Medical Imaging Informed Consent Guidelines © The Royal Australian and New Zealand College of Radiologists® June 2019 Page 8 of 8