Informed consent

More than a signature

Why and when do we need consent?

Male physician looking over chart with female patient
  • Patient autonomy — the right to make one's own health decisions
  • "Treatment" is more than surgery
The principle of patient autonomy applies to all treatment, whether medical, surgical, or investigative. Discussion with the patient and consent from the patient are needed for situations such as:
  • physical examinations (entails touching)
  • taking blood
  • injecting vaccines or other drugs
  • exposing the patient to radiation as a part of investigation
  • medications including interactions with other drugs

The doctor's role is to give good advice — it is the patient's right to accept or reject that advice.

Legal principles

Sample Statement of Claim form
  • Legal actions are usually based on claims of negligence (professional civil liability in Québec).
  • Allegations often include assertions that the consent discussion was inadequate.
Most legal actions
Civil legal action:  In medical-legal (civil) cases, the goal is to obtain monetary compensation for harm or injury suffered. Almost all Canadian medical-legal cases are civil and not criminal actions. Several different defendants, such as individual health professionals, hospitals/institutions, equipment manufacturers and pharmaceutical companies, may be named in a medical lawsuit. The cause of the action or central focus is usually an allegation of provider negligence, but allegations of lack of informed consent, assault and battery, breach of contract or breach of fiduciary duty are also possible causes. In civil actions, the plaintiff(s) is/are usually awarded monetary compensation if the cause of the action is admitted by the defendant(s) or proven in law. In the courts, these disputes are decided on the balance of probability. (See Damages; Lawsuit, stages of)
 involving physicians are based on claims of negligence
Negligence/faute professionnelle:  A legal concept. In all provinces/territories of Canada except Québec, to establish negligence by a physician, a plaintiff patient must prove to the satisfaction of a court that harm to the patient was caused by the failure to exercise a reasonable and acceptable standard of care by the physician. In the courts, the medical standard of care to determine negligence is not one of perfection but rather the standard of care that might reasonably have been applied by a colleague in similar circumstances.

In Québec, the concept of faute professionnelle is at the heart of civil liability. Every person has a duty to abide by certain rules of conduct or standards, and if a person does not, he or she has committed a fault. The plaintiff must demonstrate the physician committed a fault, that is, did not act as a reasonably prudent physician of similar training and experience would have under the circumstances. The plaintiff must also have suffered an injury as a result of the fault committed, and the plaintiff must establish the fault caused the injury.
 and often raise allegations about the adequacy of the consent discussion with the patient.

More than 20 years ago, the Supreme Court of Canada ruled that patients should be told what the doctor intends to do, as well as what the significant material risks are, as well as anything else that a reasonable person in that patient's condition would want to be told.

Reasonable patient standard

Collage of different types of shoes
  • Walk in the shoes of your patient.

The adequacy of consent explanations is judged by the "reasonable patient" standard, that is, what a reasonable patient in the particular patient's position would have expected to hear before consenting.

Patients can be their own best risk managers. If they have information on the reasons for a proposed investigation or treatment, as well as the risks, benefits, and alternatives which may include no treatment, they can participate in meaningful decisions about their own healthcare.

Learn more about Reibl v. Hughes — a landmark Canadian legal case
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Express and implied consent

  • Most patient care is based on implied consent.
  • Express consent can be verbal or written.

Consent is often implied either by the words or the behaviour of the patient, for example by volunteering a history, answering questions, or submitting without objection to physical examination. When the reason for examination may be misunderstood, as with rectal, vaginal, or breast examinations, it may be prudent to state the intention in advance.

When treatment may cause more than a little pain or carry significant risk, the patient should be asked to express their consent. A note in the patient's record may be adequate to document consent, but in some circumstances it may be wise to obtain written consent.