Informed Consent and Capacity Assessment (BC)

Consent and Capacity are two central tenets in modern medicine and critical to patient autonomy, the respect for personal dignity, and the delivery of ethical care by physicians. This page focuses specifically on legislation and laws in the province of British Columbia, Canada. The basic principles can be applied throughout Canada, because of the 2003 Supreme Court ruling (Starson v. Swayze) but please be aware of your own jurisdiction's specifics.[1]

All mental disorder and psychiatric treatments are covered under the BC Mental Health Act, while non-psychiatric treatments are governed under the Health Care (Consent) and Care Facility (Admission) Act (HCCCFAA) (BC).

Obtaining Informed Consent is the process of getting permission from a patient before conducting a healthcare intervention (e.g. - prescribing a medication or a surgical procedure). Only a health practitioner (i.e. - usually the most responsible provider, or MRP) who has the knowledge to answer a person’s questions about the treatment can carry out the process of obtaining informed consent to the treatment. For a patient to provide consent to a treatment, they must be capable (i.e. - able to “understand” and “appreciate” the nature of a treatment - see Capacity section below). There is no specific age requirement to consent (but obviously one must factor that a 4-year-old will not have the same understanding of any treatment compared to a 40-year-old).

When a physician obtains informed consent, it must:

  1. Be related to a treatment or treatment plan
  2. Be informed (the nature of treatment, risks, side effects, expected benefits, alternatives, likely consequences of refusing are discussed)
  3. Be voluntary (not under coercion, or under duress)
  4. Not be obtained through fraud or misrepresentation (by the physician)

Consent is Also Required Before You Disclose Patient Information!

Separate from treatment consent, communication/disclosure consent must also be obtained from patients prior to divulging personal health information to the patient's family or friends.

The key components of obtaining informed consent from your patient includes discussing the following:

  1. Nature of the treatment
  2. Expected benefits of the treatment
  3. Material risks of the treatment
  4. Material side effects of the treatment
  5. Alternative courses of action (i.e - alternate treatments including non-pharmacological)
  6. Likely consequences of not having the treatment
  7. Likely consequences of having the treatment

What Are 'Material' Risks and Side Effects?

Material risks or side effects of treatment include:
  • Those which are probable or likely to occur
  • Those which are possible if they carry serious consequences
  • Those which a reasonable person in the patient’s specific circumstances would want to know in order to make a decision to give or refuse consent

Sample Documentation for Informed Consent for a Medication Class

Class Documentation
Antipsychotics Consent was obtained to start the antipsychotic. The benefits of treatment were discussed, including reduction of psychotic symptoms, improved insight, judgment, and reduction in maladaptive behaviours. We also discussed the likely possibility of worsening symptoms and the clinical course without treatment. The rare risk of death/CVA, NMS, parkinsonism, involuntary movements due to EPS were also discussed. We discussed possible side effects including falls, sedation, metabolic syndrome, and QTc prolongation/arrhythmia. We also discussed the importance of ongoing monitoring for metabolic syndrome and side effects such as hyperlipidemia, and elevated glucose.
Antidepressants Consent was obtained to start an antidepressant for the patient. We discussed the common side effects, including nausea, headaches, sexual dysfunction, and increased anxiety, and that most of these side effects will self-resolve 1 to 2 weeks into treatment. Rare but serious side effects, including serotonin syndrome, hyponatremia, elevated bleeding risk, anti-depressant-induced mania/hypomania, and increased risk of suicidal ideation were also discussed.

Sample Documentation for Informed Consent for a Specific Medication

Medication Documentation
Clozapine[2] Consent was obtained to start clozapine for the patient. We discussed the risks and benefits of treatment with clozapine, including side effects such as agranulocytosis, myocarditis, weight gain, hypersalivation, as well as metabolic side effects. We also discussed the benefits of treatment, including reduction in symptoms of psychosis. We also discussed the role of ongoing blood work and monitoring involved.

In British Columbia, there are several situations where consent is not required. This is different than other jurisdictions in Canada (such as Ontario):

  1. When urgent or emergency health care is required, adult is incapable (e.g. - apparently impaired by drugs or alcohol or is unconscious or semi-conscious for any reason), and there is no committee, representative, Advance Directive or TSDM available;
  2. Involuntary psychiatric treatment is needed under the Mental Health Act
  3. For preliminary examinations such as emergency department triage or assessment

Capacity is the ability to understand and appreciate the consequences of a treatment. The approach to capacity (especially for psychiatric reasons) has become more nuanced in the last few decades. Capacity is no longer a one-time assessment that applies globally to everything. Instead, capacity can fluctuate, and also is specific to the type of treatment being offered.

These are the key points to consider regarding capacity:

  1. An individual is capable until proven otherwise
  2. Capacity can fluctuate (i.e. - someone may be capable at one time regarding a treatment and incapable at another)
  3. Capacity is task-specific (i.e. - capacity for finances is different than capacity for admission to a long-term care facility)
  4. Capacity is treatment-specific (i.e. - antipsychotics vs. mood stabilizers, diabetes management vs. chemotherapy for cancer, neurosurgery for brain cancer vs. acetaminophen for a headache)
  5. Capacity is functional
 (i.e. - just because someone is diagnosed with a mental disorder does not mean they are incapable)
  6. Disagreement or refusal with medical recommendations does not equate to incapacity
  7. Acquiescing to treatment does not prove capacity
  8. The best interests of the person are not relevant to the question of determining capacity

Capacity in Children

Although controversial, it is generally assumed that an individual < 6 years of age not capable, age 6-13 can have partial capacity, and over age 13 can be capable but with variability.

Supreme Court of Canada 2003 Ruling

While a patient need not agree with a particular diagnosis, if it is demonstrated that he has a mental “condition”, the patient must be able to acknowledge the possibility that he is affected by that condition…As a result, a patient is not required to describe his mental condition as an “illness”, or to otherwise characterize the condition in negative terms… Nonetheless, if the patient’s condition results in him being unable to recognize that he is affected by its manifestations, he will be unable to apply the relevant information to his circumstances, and unable to appreciate the consequences of his decision.

– Justice John C. Major, Starson v. Swayze, 2003 Supreme Court of Canada 32, [2003] 1 S.C.R. 722

It is important to recognize that the final decision about capacity is made by the courts. The role for physicians is to provide an opinion (hence a physician documents their “opinion” about an individual's capacity).

Use the Aid To Capacity Evaluation (PDF) as a template when assessing capacity.

A Capacity Assessment involves assessing two branches: (1) the patient's ability to understand the information that is relevant to making a decision about the treatment, and (2) the patient's ability to appreciate the reasonably foreseeable consequences of a decision or lack of a decision. Incapacity occurs when, on a balance of probabilities, the patient fails either one or both branches of the capacity test. Furthermore, this must be documented appropriately in the patient's chart.[3]

When doing a capacity assessment for treatment with medication, you should to discuss treatment options in terms of classes of medications (i.e. - antipsychotics, antidepressants, etc.) This gives you broader coverage to change antipsychotics without needing to do repeat capacity assessments. You cannot obtain capacity/consent beyond a class of medications (i.e. - you cannot do a capacity assessment or obtain consent for all forms of psychiatric medications!). If you deem a patient incapable, you have to ask yourself: the patient is incapable to what specific treatment? There is no such thing as “global incapacity.”

The Two Branches of Capacity

Understanding Appreciation
Description Is the person is able to understand the information that is relevant to making a decision about the treatment? Do they have the cognitive ability to attend to, comprehend, retain and process relevant information? Are they able to appreciate the reasonably foreseeable consequences of a decision or lack of decision. An individual fails this test if they are unable to recognize the possibility that they are affected by the manifestations of the condition you describe to them and cannot appreciate the consequences of the decision being made.
Factors • What information has been given to the patient?
• What is the patient's response to this information?
• Discuss what you think are the reasonably forseeable consequences from treatment, or lack of treatment.
• Are they able to apply the relevant information to their own circumstances and to weigh foreseeable risks and benefits?
Examples of failing this branch • Individuals with a cognitive condition (e.g. - dementia, traumatic brain injury) that impedes their ability to retain and or process the information.
• There is a very high threshold to actually fail this branch of the test (and most patients will pass it)
• A patient diagnosed with schizophrenia is able to understand the information about the illness, and that it can affect some people, but does not believe that he/she has that illness, in spite of a two-year history of symptoms consistent with schizophrenia, hospitalization and treatment.
• A patient diagnosed with anorexia nervosa is able to understand and intelligently discuss the nature and consequences of the illness and readily acknowledges that people have to eat or that they may die. In spite of this, the patient is not able to eat and maintains that he/she will be fine.
Documentation

A finding of incapacity need to be documented on the medical record.

Sample Documentation for Capacity Assessment

A capacity assessment was done today. [Patient] agreed/disagreed with a provisional diagnosis of [mental disorder]. [Patient] agreed/disagreed that they had a mental disorder. [Patient] was able/unable to understand the side effects of treatment with an antipsychotic such as paliperidone. When asked how these medications relates to the diagnosis of psychosis/schizophrenia, [Patient] could not apply it to their own situation. Furthermore, when asked in detail about what would happen if they were to stop taking medications, they said [patient quote].

[Patient] was unable to appreciate the foreseeable consequences of taking antipsychotics or lack of taking antipsychotic medications. [Patient] COULD NOT apply the relevant information provided to them to their own circumstances or weigh foreseeable risks and benefits. In particular, they could not appreciate that their non-adherence to medication would likely lead to [symptoms of disorder]. Based on this assessment, [Patient] fails the SECOND BRANCH of the capacity test.

Incapable individuals still require consent for treatment, this can be done through several different ways:

  • If for psychiatric treatment
    • Use the BC Mental Health Act (Form 5)
  • If for medical treatment
    • Use the Health Care (Consent) and Care Facility (Admission) Act (HCCCFAA), through a subsitute decision maker (SDM), the following order of hierarchy:
      • Committee of Person
      • Representation Agreement for Personal and Health Care Decisions (Personal/​Health Care RA7)
      • Representation Agreement for Personal and Health Care Decisions (Personal/​Health Care RA9)
      • Advance ​Directive ​for Health Care (Advance Directive)
      • Temporary SDM (TSDM)
  • If urgent treatment (i.e. - life or death emergency), no consent required

A substitute decision-maker (SDM) can be appointed or created in one of the following ways:

  1. A capable adult can name the substitute decision-maker(s) in an Advance Planning Document (e.g. - in a Enduring Power of Attorney, a Representative Agreement); or
  2. An incapable adult may have a guardian (called a Committee of the Estate or Committee of Person, or both) appointed by the courts (or by statute) to make decisions.
  3. The PGT may be appointed to make decisions by court order.

In British Columbia, SDMs go by the following order (highest to lowest):

  1. Committee of the Person and Estate (guardian “speaking” for the adult)
    • Act Involved: Patients Property Act
    • In other jurisdictions this is known as a “Guardian” or “Conservator”
    • This is the highest authority in British Columbia that someone can have over an incapable individual
    • A Committee is obtained through a court order
    • A Committee overrides/suspends any Power of Attorney or Representation Agreements
  2. Representation Agreement (RA) (adult “speaking” through chosen representatives)
    • Representation Agreements do not override a capable adult's decisions and rights
    • Always ask for a copy of the RA to review the scope of authority
    • Representation Agreement, Section 9 (Personal/Health Care RA9)
    • Representation Agreement, Section 7 (Personal/Health Care RA7)
  3. Advance Directive (adult “speaking” through a pre-defined document)
  4. Temporary Substitute Decision Maker (TSDM)
    • Act involved: Health Care (Consent) and Care Facility (Admission) Act (HCCCFAA)
    • The HCCCFAA provides for criteria, conditions, hierarchy, and responsibilities for someone to provide consent for health care when an adult is not capable of providing consent. The hierarchy is as follows:
      • The adult's spouse (may be married or cohabiting; may be same sex);
      • The adult's child (any, equally ranked);
      • The adult's parent (equally ranked and includes adoptive);
      • The adult's brother or sister (any, equally ranked);
      • The adult's grandparent (any, equally ranked);
      • The adult's grandchild (any, equally ranked);
      • Anyone else related by birth or adoption to the adult;
      • A close friend of the adult;
      • A person immediately related to the adult by marriage

Patients Must Have a Representation Agreement if They Want to Pick a Specific TSDM!

A patient cannot choose a TSDM on their own (i.e. - selectively pick people out of the TSDM hierarchy) – rather, the health care provider must choose a TSDM (following the order of the hierarchy) when the patient is incapable and a health care decision is needed. If the patient wants to pick a specific adult as the substitute decision maker (i.e. - child over their partner), instead of the health care provider choosing a TSDM, the patient MUST name a representative in a representation agreement while they remain capable of doing. Otherwise, the healthcare provider will go through the hierarchy in order to find the highest ranking TSDM![4]
  • If an individual is unable to consent to a healthcare procedure, a Temporary Substitute Decision Maker (TSDM) can make this decision for the individual
  • The TSDM always follows the hierarchy and the healthcare provider must follow this order when selecting the TSDM (unless there is a representation agreement).
  • To qualify as TSDM, a person must
    • Be at least 19 years of age;
    • Have been in contact with the adult during the preceding 12 months;
    • Have no dispute with the adult;
    • Be capable of giving, refusing or revoking substitute consent; and
    • Be willing to comply with the duties of a TSDM
  • The TSDM can give consent to major and minor health care but not to the restricted list
    • Major health care: any treatment requiring anesthesia and major investigative/diagnostic procedures
    • Minor health care: routine tests, routine dental care
    • The restricted list includes: radiation therapy, IV chemotherapy, dialysis, ECT (proposed by one physician), laser surgery
  • The physician writes this opinion on the patient's chart to carry it out the procedure
  • If there is dispute about who is to be chosen as TSDM, the physician must choose a person authorized by the Public Guardian and Trustee (PGT)
  • If an adult has a court-appointed personal guardian (committee of the person) or has named a representative in a representation agreement, a TSDM is not chosen unless the committee of the person or representative is incapable or unavailable.[5]
  • A committee, representative, or temporary SDM may be limited in their decisions depending on the scope of their authority under any applicable legislation, court order, or authorizing document.
  • Substituted decision making also does not apply to certain decisions such as those related to:
    • Psychiatric treatment of involuntary patients under the Mental Health Act
    • Non-therapeutic sterilization
    • Certain communicable diseases as set out in the law