Informed consent (IC) arises from the principle that a person has the right to make decisions about what happens to her or his body. In healthcare, this involves two-way communication between a healthcare provider (HP) and a patient, resulting in the patient’s agreement (or refusal) to undergo a specific clinical treatment.
Frequent claims against physicians involve allegations that consent to treatment was lacking or inadequate. Physicians are not the only HPs who may neglect to provide adequate information about a proposed intervention. A signed consent form does not always confirm the patient’s understanding of the potential benefits and risks of the proposed treatment or alternatives to it.
Claims for lack of informed consent are based on the idea that a patient would not have undergone a treatment had he or she understood the risk of harm. If harm occurs, a patient may allege that an HP was negligent in informing him or her adequately about the benefits and consequences of a treatment. Claims for assault and battery can arise if the HP acts without consent or the scope of treatment goes beyond what was agreed to, such as administering a medication after the patient has specifically forbidden it.
To help healthcare facilities and practitioners minimize the potential liabilities associated with consent requirements, this blog will address the informed consent process, interventions or treatments requiring express consent and consent forms.
Implied versus Express Consent
Much of every HP’s practice is performed on the basis of a patient’s implied consent – actions that indicate the patient is giving the HP permission to do something. For example, it is implied that a patient has consented to have blood drawn when the patient rolls up their sleeve and holds out their arm.
Express consent (verbal or written) should be obtained when the treatment is “likely to be more than mildly painful, when it carries appreciable risk, or when it will result in ablation (removal or destruction) of a bodily function”. In these circumstances, the HP has an ethical and legal responsibility to communicate specific information about a proposed intervention or treatment and answer the patient’s questions so he or she can decide whether to proceed.
Requirements for Valid Consent
To defend against an allegation of negligence or assault and battery, an HP must ensure that consent meets the following requirements:
- It is voluntary, given without any suggestion of coercion or threat, and the patient is free to agree to or refuse treatment;
- The patient has the capacity to consent and a reasonable understanding of the proposed intervention or treatment, the effect of the intervention or treatment and its alternatives, and the consequences of refusing the intervention or procedure. In Canada, minors may give consent if they have the mental and emotional maturity to do so. (In Quebec, the established age of consent is 14 years old.) An individual who is unable to make certain decisions may still be able to make decisions about their medical care; and,
- The patient is fully informed and has been provided adequate information about the proposed treatment, including its expected benefits and significant risks as well as reasonable alternatives.
Elements of Informed Consent
In order for consent to be considered informed, a patient must be given sufficient information on the following:
- The nature of the proposed care, including a description of what it entails and why it is being proposed;
- The risks (expected consequences) and anticipated benefits of the proposed care;
- Reasonable alternatives and their risks, and why the proposed care is preferable to other options;
- The consequences of refusing the proposed care; and,
- The patient’s understanding of the above.
The patient must be presented information that is understandable, without the use of complex language and medical terminology.
The obligation to obtain consent rests with the HP who will carry out the procedure or intervention. This cannot be delegated to another professional such as a nurse or assistant.
Consent Forms Are Not Informed Consent
A patient’s signature on a consent form does not equate to informed consent. Patients are known to sign consent forms without understanding what they have agreed to. It is the two-way discussion between the HP and patient that is critical to the consent process. A consent form is the documentary confirmation that the patient has received and understands explanations about the proposed treatment and agrees to what is proposed.
The person who witnesses the patient signing the consent form, if not the proposer of the treatment, is only witnessing the patient’s signature. The witness is not confirming that the patient was informed of and understands the benefits and consequences of a treatment. If a patient states that he or she has questions about the proposed treatment, the patient should not sign the form and the treating HP should be notified.
When consent forms are used, they should be completed fully.
By implementing a sound informed consent process, healthcare facilities and providers help ensure that patients are consulted about decisions affecting their body, and that their questions are answered to minimize the possibility of litigation. What should this include?
- Being aware of and complying with any provincial regulation on consent and capacity.
- Complying with the relevant regulatory body’s standard/policy on consent.
- Asking patients to describe the treatment in their own words to confirm their understanding of the information.
- Developing consent forms that address the elements of consent as listed above.
- Ensuring that consent forms are fully completed with the specific treatment to be carried out, the name of the HP carrying out the treatment, the witness’s name and signature, and the patient’s name and signature.
- Documenting the consent discussion in the patient record. Suggested items in the documentation include:
- Major risks discussed;
- Minor but important risks mentioned;
- Any questions the patient asked;
- Answers given;
- The patient's apparent understanding (especially if it is a young person, or one whose mental capacity or competency might be questioned); and,
- Any handout materials provided to the patient.
CNA provides medical malpractice insurance to healthcare facilities and healthcare practitioners (except physicians, as all licensed Canadian physicians are members of the CMPA, which provides medico-legal assistance to physicians, including legal defence). Our industry expertise, customized services, and comprehensive coverage helps healthcare organizations successfully navigate the evolving landscape.
 CMPA. (2021.) Consent: A guide for Canadian physicians. https://www.cmpa-acpm.ca/en/advice-publications/handbooks/consent-a-guide-for-canadian-physicians.