01.02.03. Informed consent
Informed consent is obtained or confirmed prior to initiating the procedure, test or treatment
What is informed consent?
- Informed consent is the patient’s right to be fully informed of their procedures, tests and treatment options, the benefits and risks for each, and the probability of success and failure.1,2
- Informed consent is a fundamental concept of contemporary healthcare practice emphasizing patient autonomy and collaborative decision-making between patients and healthcare professionals.3,4
- For informed consent to be considered valid and complete, the process must ensure the following1,5:
- Capability: The patient must be legally competent to provide their consent. The patient’s capacity to provide consent may change over time and there may be a need for consent reassessment.
- Voluntary: The patient must voluntarily provide consent. The patient must be free of any suggestion of duress or coercion (actions or words) by the healthcare professional obtaining consent or others involved in the process.
- Informed: The patient must receive full disclosure of all relevant information.
- The information provided must be accurate and relevant
- The information provided must be reflective of what would be reasonably discussed and expected in similar circumstances with other patients6
- The information must be communicated in a way that can be understood by the patient (e.g., plain language, commensurate with the person’s mental capacity, education and cultural background)7,8
- The patient must have an opportunity to ask questions and to receive answers that satisfy their understanding
- Specific: The consent request must be specific to the procedure, test or treatment being performed.
- Although a healthcare professional may have good intentions and change a procedure, test or treatment after consent is obtained, the healthcare professional must then explain the change(s) and obtain new consent to proceed.
- A lack of informed consent in clinical practice can have significant negative impacts, including but not limited to:
- The patient could receive a procedure, test or treatment that has significant risk which occurs but they were not aware of its potential9,10
- A healthcare professional who fails to obtain informed consent can be considered negligent under current Canadian Law which could result in legal and professional actions against them2,11
Who can consent?
- If a patient is deemed able to provide informed consent, they are able to determine what shall or shall not be done with their body. No other individual can provide informed consent on their behalf.1,2,12
- Only a healthcare professional who has the knowledge and permission to obtain informed consent is able to obtain it
- The ordering healthcare professional is the individual responsible for ensuring that informed consent is obtained initially
- To support patient autonomy, their healthcare decision-making rights include13:
- receiving assistance with communication
- obtaining support with decision-making, and
- obtaining a substitute decision-maker (SDM)
- If the patient is deemed incapable of providing informed consent, it is obtained from an SDM in accordance with legislation requirements.2
- An SDM will represent a patient if or when the patient is no longer able to make their own medical decisions. The SDM may speak on behalf of the patient with the same authority as if the patient were speaking. However, consent limitations for the SDM must be considered carefully and understood in full (e.g., limited consent directives, shared decision-making in divorced parents).
- For minors, determination of informed consent capacity has moved away from chronological age requirements in most provinces and territories in Canada; instead, it is derived through an evaluation of their physical, mental and emotional development.1
- Informed consent must be obtained in the patient’s own language if proficiency in either of Canada’s official languages is limited.1
- Language barriers can exist where the official language used by the patient is a minority language in the healthcare setting14
- Translating a consent form or use of translation technologies does not fully address the communication requirements for informed consent between the patient and healthcare provider15
- In decision-making processes, the healthcare professional collaboratively works with the patients to make healthcare decisions that align with patients’ goals, preferences and values. However, it is still the patient who must provide consent.4
- All patients have the right to consult with another health professional for any reason prior to providing informed consent1
- Informed consent is not required in an emergency situation when the patient or their SDM is unable to consent and there is demonstrable severe suffering or an imminent threat to life or health of the patient.1
- In these cases, a designated healthcare professional may give the order to proceed with the procedure, test or treatment without the patient’s informed consent; in most cases, this would be a physician
- Even when the patient is unable to communicate, the known wishes of the patient, by an advanced directive or other indicator, must be respected
- For ongoing or repeated procedures, tests or treatment, it is reasonable to obtain informed consent at the initial visit, and to interpret the patient’s conduct (i.e., showing up on their own for subsequent appointments) as continued consent.1
- If a patient is capable of giving informed consent, they are also capable of refusing consent. The patient has the right to withdraw consent at any time before or during the procedure, test or treatment.1,12
- All relevant information is provided to the patient so that the decision to withdraw consent is informed
- If consent is withdrawn, the procedure, test or treatment must be stopped as soon as it is safe to do so
- Withdrawn consent must be documented in the patient’s clinical record
MRT's role in the consent process
- MRTs must be familiar with the informed consent policy and procedures at their facility as well as the relevant legislation in their jurisdiction.12
- MRTs must ascertain and ensure that informed consent has been granted by the patient to conduct the procedure, test or treatment that is to be performed.1,12
- If a signed form is required by the local facility, the MRT confirms that the appropriate document has been signed
- The signing of a consent form does not mean that consent has been obtained, and can never replace the dialogue that needs to occur between the MRT and patient to obtain confirmation
- The consent form is simply evidentiary, written confirmation of the explanations given and that the patient agreed to what was proposed at the time
- MRTs cannot assume that patients attending a department have previously provided informed consent as patients are often not aware of the exact nature and risks associated with the procedure, test or treatment they will undergo.16
- If the procedure, test or treatment has been explained by someone else, the MRT must verify informed consent was given by the patient.12
- If it is within their scope and competence, it may also be appropriate for the MRT to obtain consent from a patient (e.g., administration of contrast).12
- Consent is documented according to institutional and legislative requirements
- If the patient does not have adequate information to provide informed consent, and if it is beyond an MRT’s scope and competence to provide the information (e.g., information regarding alternative diagnostic tests or treatments), then the MRT must refrain from conducting the procedure, test or treatment and take appropriate action to resolve the situation.12
- The MRT should contact the healthcare professional who obtained the original patient consent and inform them of the situation
References
- CMPA. Consent: A guide for Canadian physicians. CMPA. Accessed December 8, 2021. https://www.cmpa-acpm.ca/en/advice-publications/handbooks/consent-a-guide-for-canadian-physicians#intro
- Government of Canada D of J. Section 7 – Life, liberty and security of the person. In: ; 1999. Accessed December 8, 2021. https://www.justice.gc.ca/eng/csj-sjc/rfc-dlc/ccrf-ccdl/check/art7.html
- Pietrzykowski T, Smilowska K. The reality of informed consent: empirical studies on patient comprehension—systematic review. Trials. 2021;22(1):57. doi:10.1186/s13063-020-04969-w
- Grad R, Légaré F, Bell NR, et al. Shared decision making in preventive health care: What it is; what it is not. Can Fam Physician. 2017;63(9):682-684.
- Cocanour CS. Informed consent—It’s more than a signature on a piece of paper. Am J Surg. 2017;214(6):993-997. doi:10.1016/j.amjsurg.2017.09.015
- Picard LE, Robertson GB. Legal Liability of Doctors and Hospitals in Canada. 5th ed. Carswell Thompson Professional Publishing; 2017. Accessed December 8, 2021. https://store.thomsonreuters.ca/en-ca/products
- Bester J, Cole CM, Kodish E. The Limits of Informed Consent for an Overwhelmed Patient: Clinicians’ Role in Protecting Patients and Preventing Overwhelm. AMA J Ethics. 2016;18(9):869-886. doi:10.1001/journalofethics.2016.18.9.peer2-1609
- Royal Australian and New Zealand College of Radiologists. Medical Imaging Informed Consent Guidelines, Version 3. Published online June 26, 2019. https://www.ranzcr.com/documents/2836-medical-imaging-consent-guidelines/file” t “_blank
- Canada. Supreme Court. Hopp v. Lepp. Dom Law Rep. 1980;112:67-83.
- Canada. Supreme Court. Reibl v. Hughes. Dom Law Rep. 1980;114:1-35.
- Lane AN. Medical imaging and consent: when is an X-ray assault? J Med Radiat Sci. 2016;63(2):133-137. doi:10.1002/jmrs.172
- Canadian Association of Medical Radiation Technologists. Member code of ethics and professional conduct. CAMRT. Published November 2015. Accessed June 23, 2020. https://www.camrt.ca/mrt-profession/professional-resources/code-of-ethics/
- James K. Health Care Consent with Physical Distancing: Understanding Decision-Making Rights in Canada. Canandian Centre for Elder law. Published May 11, 2020. Accessed December 9, 2021. https://www.bcli.org/health-care-consent-with-physical-distancing-understanding-decision-making-rights-in-canada
- Moissac D de, Bowen S. Impact of language barriers on quality of care and patient safety for official language minority francophones in Canada. J Patient Exp. Published online April 18, 2018. doi:10.1177/2374373518769008
- Bowen S. The Impact of Language Barriers on Patient Safety and Quality of Care. Published online August 2015. Accessed December 10, 2021. https://www.reseausantene.ca/wp-content/uploads/2018/05/Impact-language-barrier-qualitysafety.pdf
- Rosenkrantz AB, Flagg ER. Survey-Based Assessment of Patients’ Understanding of Their Own Imaging Examinations. J Am Coll Radiol. 2015;12(6):549-555. doi:10.1016/j.jacr.2015.02.006
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