Consent - COVID-19 Vaccine

Off Label Use

As long as a patient can provide informed consent to the off-label use of a vaccination product, that consent can be verbal consent and does not have to be in writing.

The Saskatchewan Ministry of Health and/or the National Advisory Committee on Immunization (NACI) routinely approve the use of some vaccination products for “off-label” usage. Off-label use includes any use of a vaccine or drug that is not set out in the Product Monograph.

In administering a vaccination product as an off-label use, SHA healthcare providers should obtain express verbal consent. Consent to the off-label use of a vaccine does not have to be in writing but should be informed and then given explicitly. The consent should be voluntary and not coerced or obtained under pressure. The patient’s health record should be documented, including the information that was given to obtain consent. If an adult does not have capacity to provide consent, a substitute decision maker must provide consent in writing. For a child, if the parent is present, verbal consent is sufficient. If a parent is not present, a parent must complete a consent form in writing and send it along with the individual who is accompanying the child.