Informed Consent in Radiology: A Technologist’s Guide
Informed Consent in Radiology: A Technologist’s Guide
An overview of informed consent, who can get it, who can give it, and what information should be provided to patients during the process.
Patients today are becoming increasingly well-informed and are demanding more involvement in decisions related to their medical care [1] [2]. To make a sensible decision concerning his or her treatment, a patient needs clear and appropriate information. This makes informed consent an integral part of patient involvement in their healthcare. It underpins the trust patients place in their healthcare providers and their confidence in the process of their care [2]. In the radiology department, informed consent presents something of a challenge, especially because of the shared responsibility between the referring doctor, who manages the overall care of the patient, and the radiologist reviewing the medical imaging examination [3]. In this article, we’ll provide an overview of the process of obtaining informed consent in radiology, including who can obtain it, who can give it, and what information should be given to the patient.
- What is informed consent in radiology?
- Who can obtain informed consent?
- What information should be given to the patient in the radiology department?
- Documentation of Informed Consent and Required Elements
- Who can give informed consent?
- Consent Given on Behalf of Someone Else
- Patients with an Intellectual Disability
- Patients with Reduced Mental Competency
- Emergencies
- Refusing Consent
- Obtaining Informed Consent
- Conclusion
- References
What is informed consent?
Informed consent is when a healthcare provider explains to his or her patient the risks and benefits of and the alternatives to, a proposed procedure or intervention. This is more than listing, though. It’s closer to educating. And in order to give informed consent after receiving all of this information from their healthcare provider, the patient must be competent and able to make a voluntary decision about whether or not to have the procedure or intervention performed. Informed consent is an ethical and legal obligation for healthcare practitioners stemming from a patient’s right to control what happens to their body [2] [4].
It is important to note that consent given by a patient is only considered valid if the patient has been given enough relevant information to allow a reasonable person put in the patient’s place to make an informed decision [3].
The gist: Informed consent in healthcare is a process of communication between a healthcare physician and a patient in which the patient’s agrees to undergo a specific medical intervention after receiving sufficient information about the risks, benefits, and alternatives [5].
Who can obtain informed consent?
In modern medicine, a patient’s care and treatment is often shared by several healthcare providers. The overall responsibility for obtaining patient informed consent in these circumstances remains with the healthcare provider responsible for making a medical intervention.
In the case of radiology departments, the radiologist bears the responsibility of obtaining informed consent. However, the tasks associated with obtaining consent can be delegated by the radiologist to other members of the medical imaging team under protocol, and frequently fall to technologists, especially for low-risk or run-of-the-mill procedures. But since as the actual obligation of obtaining informed consent remains with the healthcare provider responsible for making a medical intervention, the radiologist should always be available to give patients any information they ask for that the designated team member wasn’t able to provide [3].
The gist: The healthcare provider responsible for making the proposed medical intervention bears the responsibility for obtaining informed consent, but the tasks can be delegated to another remember of the team, usually the technologist in radiology departments.
What information should be given to the patient in the radiology department?
A patient must be given every opportunity to understand the potential benefits and risks of undergoing a medical imaging exam, the potential risks and benefits of not having the procedure, and they must be able to ask questions of their healthcare providers [6]. The amount of information that should be given to a patient will vary, depending on the nature of their condition, the complexity of and risks associated with the examination, the patient’s temperament, health, and their wishes, and the circumstances surrounding the exam. Whatever amount of information need to be given, it all should be given to the patient in plain language they can understand—avoid doctor-speak—and it should be appropriate for the patient’s age, level of education, and cultural background [3].
Below, we’ve provided a guide to the range and types of information that may be provided by the radiologist (or by his designee), depending on the type of exam. How much information to give to a patient is left to the discretion of the radiologist responsible for the medical imaging exam, and will be change depending on the level of complexity and risk associated with the exam and the factors related to individual patients laid out above.
- The nature of the exam: how invasive it is; whether it will be painful; how long it will take; how they will feel before, during, and after the procedure; the expected benefits; whether the proposed medical procedure is critical, essential, elective, or discretionary; and how certain of any diagnosis the exam will allow the doctor to be
- Other options for investigating, diagnosing, and treating the condition
- Who will perform the proposed exam, including their status and the experience they have
- How much the exam will cost
- Whether the exam is part of a clinical trial or other research project
- Any significant long-term and/or short-term physical, emotional, mental, social, and/or sexual side effects associated with the proposed exam
- The potential consequences of the proposed exam, including:
- common side-effects and complications, contraindications, and possible harms (as well as the likelihood and degree of severity of those harms)
- uncommon side-effects, an indicating those which may of particular concern in the patient’s case
- the consequences of not undergoing the proposed medical imaging or an alternative procedure
- how long will a patient will needed for recuperation and/or rehabilitation after the exam [3].
Documentation of Informed Consent and Required Elements
- the nature of the procedure
- the risks and benefits and the procedure
- reasonable alternatives
- risks and benefits of alternatives
- assessment of the patient’s understanding of elements 1 through 4 [5]
Important note: Certain medical imaging examinations expose patients to a significant radiation dose, so when obtaining consent, the issue of radiation risk must be addressed with patients [7].
Who can give informed consent?
A person is able to give informed consent if they are able to comprehend the information given to them about the proposed procedure and weigh the risks and benefits of it. A patient who does not legally have capacity—such as a child, a patient with an intellectual disability or with reduced mental capacity, and patients in certain emergency situations—cannot give valid consent. We’ll take a look at some of these instances below.
Consent Given on Behalf of Someone Else
Patients over the age of sixteen are generally able to give informed consent to or refuse most medical imaging examinations, as they ae—generally speaking—able to understand the nature, purpose, and possible consequences of having or not having the exam. However, if a patients over the age of sixteen lacks this level of competence, then they may not be capable of giving informed consent. In this case, a radiologist would be advised, whenever possible, to seek the consent of a parent or guardian.
Patients with an Intellectual Disability
Intellectual disabilities vary greatly, and each individual patient should be assessed in order to decide if they are capable of giving informed consent. If a patient is considered incapable of giving informed consent, the healthcare physician should approach the patient’s legal guardian in order to obtain informed consent.
Patients with Reduced Mental Competency
Radiologists may face challenges in obtaining informed consent from patients with reduced mental competency. Each patient should be individually assessed according to their specific clinical situation. If the patient’s ability to give informed consent is at all in doubt, the radiologist should contact the appropriate guardianship authority in their state for advice.
Emergencies
When informed consent cannot be obtained in emergency situations, the proposed radiological procedure should be performed for any patient who needs it, so long as the procedure is limited to what is necessary in the immediate moment to save the patient’s life and avoid any significant deterioration of their health. In situations such as these, the patient’s best interests are most important.
Refusing Consent
If a patient is capable of giving informed consent, they are also capable of refusing to consent. Disagreeing with their doctor does not necessarily mean that the patient does not understand the information they have been given. Patients may refuse to consent to procedures for a variety of reasons that are unrelated to lack of understanding of the information, such as decisions based on quality of life choices or religious convictions. If a patient refuses to give consent, it should be clearly noted in the patient’s records. Whenever possible, the patient’s reasons for refusing and other relevant details of the discussion should also be documented [3] [6].
It is also important to note that a patient can withdraw their consent at any time—even after they have signed the consent form or even after the procedure has begun [6].
Obtaining Informed Consent
Obtaining informed consent in healthcare settings is process that should include: (1) a clear description of the proposed intervention in language the patient can understand, (2) an emphasis on the patient’s role in deciding what happens to their body, (3) a discussion of alternatives to the proposed intervention, (4) a discussion of the risks posed by the proposed procedure, and (5) an indication of the patient’s choice (usually by signature) [8].
- Preparation: Get to know your patient. Familiarize yourself with their labs and social history or cultural background. Find out if they need an interpreter.
- Introduce Yourself: State your role in the patient’s medical care, and include whether you’re a physician or not. Encourage the patient to actively participate and talk about his or her goals and what they are hoping for as results.
- Core: Explain the proposed procedure. Tell the patient who will do it, how long it will take, how it will be done, what the risks and benefits are, and whether there will be any pain. Be sure to use plain language the patient can understand. Avoid technical medical terminology whenever possible, or if you must use a term, explain what the term means in a simple manner for the patient.
- Review: After the discussion, go back through the information to check that you and the patient are on the same page and they have understood the information you have given them. Read through the written consent form with the patient to be sure they understand what it says and means [2].
Conclusion
Actively engaging patients is a key method of enhancing communication and ensuring patient safety and understanding, and providing patients with comprehensive information to allow them to give informed consent to their own medical care is of utmost importance [4][1]. Informed consent is more than just the signing of a form; it is about a thorough and deliberate process of communication between patient and their healthcare providers and patient involvement and participation in the decision-making process of their own health [6].
- Make sure you know which radiology exams and procedures you are qualified to get informed consent for, and if in doubt, refer to your supervisor
- Be sure you choose the appropriate consent form to use
- When possible, try to gain informed consent before to the day of the procedure
- Remember to explain:
- The procedure
- Its risks and benefits
- Alternative procedures
- The risks and benefits of doing nothing
- Avoid the use of medical jargon
- Do not rush patients into a decision [1]
References
- Anderson, O. A., & Wearne, I. M. J. (2007). Informed consent for elective surgery—what is best practice? Journal of the Royal Society of Medicine, 100(2), 97–100. [Link]
- Jackson, Whitney L. (2015, December 9). Radiologist’s guide to informed patient consent. Diagnostic Imaging. [Link]
- The Royal Australian and New Zealand College of Radiologists. (2019). Medical imaging informed consent guidelines. [Link]
- The Joint Commission, Division of Healthcare Improvement. (2016). Informed consent: More than getting a signature. [Link]
- Joint Commission International. (2017). Joint Commission International accreditation standards for hospitals. [Link]
- National Health Service (2019). Consent to treatment. [Link]
- Shyu, J. Y., & Sodickson, A. D. (2016). Communicating radiation risk to patients and referring physicians in the emergency department setting. The British Journal of Radiology, 89(1061), 20150868. [Link]
- Shah, P., Thornton, I., Turrin, D., & Hipskind, J. E. (2021). Informed Consent. In StatPearls. StatPearls Publishing.
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