What is Free and Informed Consent?

Under review

Consent is “an explicit or tacit manifestation of will by which a person approves an act to be undertaken by another”. In recognizing the patient’s right to consent, we necessarily and implicitly recognize the patient’s right to refuse.

The need for consent is clearly spelled out in Article 11 of the Civil Code of Québec:

“No person may be made to undergo care  of any nature, whether for examination, specimen taking, removal of tissue, treatment or any other act, except with his consent. If the person concerned is incapable of giving or refusing his consent to care, a person authorized by law or by mandate given in anticipation of his incapacity may do so in his place.”

The patient’s right to consent and the health professional’s consequent obligation to obtain this consent before undertaking any investigation or treatment is in keeping with the right to inviolability of the person protected by the Canadian and Québec charters of rights and freedoms and the Civil Code of Québec. Without the consent of the person, or his legal representative, a  professional may not treat or undertake an investigation of that person, except in situations that are exceptional. This concern is also reflected in the Code of Ethics of Physicians of Québec (ss. 28-31) and in the Act respecting health services and social services (sec. 9).

To be valid, the consent to investigation and/or treatment, as well as the refusal, must be free (voluntary) and informed.

For a  consent to be free (voluntary), it must be obtained without pressure, threat, duress or promise of any kind on the part of  the physician, the family or significant others. It must also be obtained without threat of reprisal, for example, without threatening to suspend support or assistance should the patient not consent to the proposed treatment or investigation. To give such a consent, the person or his legal representative must be capable of giving consent and be in full possession of his faculties; consequently, the person’s mental faculties must not be weakened by, among other things, alcohol, sedatives or any other drug.

The consent must also be informed. Legal texts make the distinction between “free” and “informed”, even if, in everyday language, the two notions are inseparable. One cannot be considered “free” to decide without being adequately informed. Freedom to decide, therefore, goes hand in hand with being informed. 
Before obtaining the patient’s free and informed consent, the following information must be given to the patient:

  • the diagnosis;
  • the nature of the treatment;
  • the procedures to be performed;
  • the benefits and risks associated with the procedures;
  • the consequences of refusal or not intervening;
  • other treatment options.

While the benefits sought after by the patient and the physician may be mentioned first and be given special attention with the view to obtaining consent, they are not the
only items of information required.

Indeed, the risks must also be disclosed and must take into account the patient’s particular situation. Serious and infrequent  risks (for example, paralysis) must be
disclosed, but only in terms related to the patient’s precise situation. Frequent risks must also be mentioned, even those considered minor, inasmuch as they may have a
particular impact on the patient. For example, a surgical procedure on a finger will not have the same impact on a security guard as it will on a professional pianist. Presenting the benefits and risks of the procedure will allow the patient to judge the situation, based upon the most accurate  information, and make the best possible decision in the circumstances.

Other treatment options are also part of the information given to the patient. The physician must therefore present all options to the patient, including what would
happen if the patient refused the investigation or treatment.

But it is not enough to explain all the possible benefits and risks. The physician must also ensure that the patient has understood what was said and grasped the extent of its impact on his life. For this reason, the physician must present the information in terms that are simple and comprehensible to the patient. The patient in turn must be given an opportunity to ask questions and to obtain satisfactory answers before giving his consent.

The physician’sobligation to inform the patient is therefore not uniform; indeed, it varies with the circumstances. The extent of the obligation changes notably according to the care,defined in three broad categories: emergency care, medically required care and care not medically required. When a patient’s life is threatened if treatment is not given immediately, and consent cannot be obtained in due time, the physician is relieved of this obligation. As for medically required care, the extent of the obligation increases with the prevalence and gravity of the complications; on the other hand, care not medically required entails a much greater obligation (Civil Code, Art. 13-25).

The Civil Code of Québec in fact requires that written consent be obtained for care not medically required, experimentation, and organ donation (Art. 24). Care not medically required includes cosmetic surgical and medical treatments, among others. In this field, it is essential that the physician present to the patient not only the probable risks of the treatment, but also the possible risks, even if they are rare COLLÈGE DES MÉDECINS DU QUÉBEC, « L’information médicale avant la prise de décision. » Le Collège, Vol. XL, No. 1, May-June 2000. The Civil Code of Québec goes as far as to prohibit all experimentation involving a serious risk to minor or incapable patients (Art. 21). The Organization and Management of Establishments Regulation (ROAE) provides for a written consent to the anesthesia and the surgery  (ROAE, sec. 52.1). It also stipulates that the user’s record must contain a document attesting that consent was obtained for the care and services provided, as well as for the taking of photographs, the making of  films or other documents, if applicable (ss. 53-57). Generally, a written consent is considered necessary for the following procedures:

  • anesthesia;
  • surgical procedure;
  • care given in an institution;
  • the taking of photos, the making of films or video documents;
  • organ donation;
  • experimentation;
  • non-therapeutic care.

But let us be clear: a free and informed consent is much more than a simple signature on an authorization form. And while it is often required, the signed form does not
necessarily mean that consent has been freely given after having received all of the relevant information. In practice, the consent may be implicit or explicit. In both cases, the decision to accept or refuse the proposed care is up  to the patient. Furthermore, the physician must be able to demonstrate that the  patient has been adequately informed, by entering the appropriate note in the patient’s medical record. This note must reflect the exact nature of the information given,  the questions asked by the patient and the discussion on the other treatment options. In case of litigation, a well-kept medical record is the best means of clarifying the facts.

But how long is the consent, even the written one, valid? There are no provisions in the Civil Code of Québec or in the Act respecting health services and social services
(LSSSS) with respect to the duration of the validity of the consent. This explains the validity, albeit limited, of “living wills.” It is reasonable to believe that the consent to a
procedure of short duration is valid for the entire duration of the procedure. However, for long-term treatments (chemotherapy, radiation therapy, use of immunization
schedule), it is reasonable to believe that the consent given at the start of treatment may be withdrawn, even verbally, at any time. Consent is an evolving process. Therefore, a patient may always change  his decision, based on new information or new developments.

Consent to care given in training facilities or in a research context requires special attention. Patients must be informed if  medical residents are part of the treatment team. And the consent to treatment given as part of a research protocol must meet very specific requirements. COLLÈGE DES MÉDECINS DU QUÉBEC,  Le médecin et la recherche clinique : guide d’exercice, Montreal, Collège des médecins du Québec, July 2007.

Ms. Lise T. refuses the proposed procedure. Yet the procedure is urgently required. You check whether Ms. T. knows the consequences of her refusal. Ms. T. clearly states that she would prefer to die rather than have surgery. Checking with her spouse reveals that the decision dates back to a period before her illness. Furthermore, you do not perceive any particular coercion or outside influence compelling her to refuse.
What do you do?