+ What is informed consent?
- The patient has the right to be informed regarding the procedure/treatment and its risks in a way that he/she can understand, and to have his/her questions answered in a similar manner.1
- Failure to obtain informed consent may be considered negligence under current Canadian Law, and could result in court action.2
- The standard of information provided to the patient is reflective of what a reasonable person would expect in similar circumstances3
- For consent to be valid, it must be ensured that:2,4
- The patient is legally competent to consent to procedure/treatment
- The patient receives a full and proper disclosure of information (including the risks and benefits for undergoing as well as not undergoing the procedure/treatment) from the caregiver5
- Consent is specific to the procedure/treatment being performed
- The patient has the opportunity to ask questions and to receive answers that satisfy his/her understanding
- Consent is obtained voluntarily, free of coercion or undue influence
- Informed consent is based on accurate representation of the relevant information
- As well as professional standards, MRTs should be familiar with the legislation in his/her jurisdiction.6
+ Who can consent?
- If the patient is capable based on the criteria set out (see "What is informed consent?" tab), then only the patient can consent to a procedure/treatment
- If the patient is incapable of giving consent, it is obtained from a substitute decision maker, according to provincial legislation. 2
- The patient’s physician or another member of the healthcare team can NOT give consent on the patient’s behalf.2
- Consent is not required in an emergency situation ONLY if the delay to find an interpreter or substitute decision maker will prolong suffering or will put the patient at risk of sustaining serious harm.2,4
- In these cases, a physician may give the order to proceed with the procedure/treatment without consent2,4
- The facts and circumstances surrounding the decision to proceed without informed consent are carefully documented7
- For ongoing or repeated procedures/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.2
- Consent is obtained in the patient’s own language if proficiency in English (or French) is limited.2
- The patient has the right to withdraw consent at any time before or during the procedure/treatment.2
- If consent is withdrawn, the procedure/treatment must be stopped
- Withdrawn consent is documented
- All relevant information is provided to the patient so that the decision to withdraw consent is informed
+ MRT's role in the consent process
- The MRT should be familiar with the facility consent policy and the legislation in his/her jurisdiction.
- Part of the MRT's role is to ascertain and ensure that informed consent has been granted by the patient for the procedure/treatment that is to be performed.8
- If the procedure/treatment has been explained by someone else, the MRT verifies that consent was given by asking the patient: “What has been explained to you? Do you understand? Do you have any questions or concerns?”9
- If a signed form is required by the local facility, the MRT confirms that a consent form has been signed
- 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)
- 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 refrains from administering the procedure/treatment and takes the appropriate action to resolve the situation.4
- In this case, the next step is to contact the radiologist, oncologist or referring healthcare professional
+ Documenting consent
- Consent is documented according to institutional and provincial requirements.
- Consent to treatment is an ongoing process, not a form. The signing of a consent form does not mean that consent has been obtained, and can never replace the dialogue that needs to happen between practitioner and patient.2
- The consent form is simply evidentiary, written confirmation of the explanations given and that the patient agreed to what was proposed2
- Rozovsky L. Canadian Patient’s Book of Rights. Toronto, ON: Doubleday Canada Limited; 1994.
- Rozovsky LE. The Canadian law of consent to treatment. 3rd Ed. Toronto, ON: Lexis Nexis Canada Inc.; 2003.
- Picard EI, Robertson GB. Legal Liability of Doctors and Hospitals in Canada. 4th Ed. Scarborough, ON: Carswell Thompson Professional Publishing, 2007.
- Health Care Consent Act. Ontario, 1996 (Amended 1998, 2000, 2002, 2004, 2006, 2010).
- The Canadian Medical Protective Association. Consent: A guide for Canadian Physicians. Available at:http://ocfp.on.ca/docs/collaborative-mental-health-care-network/consent---a-guide-for-canadian-physicians-(cmpa-1996)-.pdf?sfvrsn=2. Accessed November 18, 2015
- Videto v. Kennedy (1981), 33 O.R. (2d) 497 (C.A.)
- Sneiderman B, et al. Canadian Medical Law: Introduction for Physicians, Nurses and Other Health Care Professionals. 4th Ed. Scarborough, ON: Carswell Thompson Professional Publishing, 2013.
- Obergfell AM. Law and Ethics in Diagnostic Imaging and Therapeutic Radiology. Philadelphia, PA: W.B. Saunders Company; 1995.
- Lee CI, et al. Diagnostic CT Scans: Institutional Informed Consent Guidelines and Practices at Academic Medical Centers. Am J Roentgenol 2006; 187: 282-287.