Medical Imaging Informed Consent Guidelines Ex 1 P ar t the of C o m pl eti on Su & Ex 1 P ar t Ra the Name of document and version: Att to Medical Imaging Informed Consent Guidelines, Version 3 (This document was formerly titled A Doctor’s Duty to Warn) 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 Level 9, 51 Druitt Street C Sydney NSW 2000, Australia oll eg e Email: [email protected] Website: www.ranzcr.edu.au Telephone: + 61 2 9268 9777 Z Facsimile: + 61 2 9268 9799 ea la nd Disclaimer: The information provided in this document is of a general nature only and is not intended as a substitute for medical or legal advice. It is designed to support, not replace, the relationship that exists between a patient and Ne his/her doctor. an A us tr ali an Ro 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 INTRODUCTION 1.1 Purpose This document has been developed by the Standards of Practice and Accreditation Committee (superseded by the Safety Quality and Standards Committee) of The Royal Australian and New Zealand College of Radiologists and is designed to provide general guidance to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