What is informed consent in health care?
- Informed consent is the process where a capable patient or an incapable patient's SDM makes a decision about whether to agree to the decision to the treatment or plan of treatment proposed by health care practitioner.
- In Ontario, informed consent can only be obtained from a person. Health Care Practitioners cannot take direction (or accept as consent) from a document such as an advance directive or a level of care form.
- Informed consent is required before any treatment is started. The only exception this rule is certain emergency situations where the delay required to obtain consent would result in serious bodily harm. For example initiation of life saving treatment in an unconscious patient who arrives in the emergency department without an SDM. treatment. (HCCA, s.Shed.A,s,25(1-3))
- The discussion and documentation of that discussion is more important than the signing of a consent form.
What does this mean?
- Consent cannot be “general”. It must be specific to a particular treatment. One cannot get consent to "anything that the health practitioner may order” while a patient is in the particular health facility. This is not a valid consent.
- The consent must be voluntary and not “required” as a condition of admission into a health facility or of continuing right to receive treatments at that health facility or from that health service. For example, requirements that a person agree to a “no CPR order” as a condition of admission into a long term care home is not a voluntary consent as that requirement would be a breach of the Long Term Care Homes Act.
- The consent must not be obtained through misrepresentation or fraud. This means that patients cannot be told that the treatment is for one particular health condition when it is for another about which they are not told. Health practitioner may not tell a patient that there are no risks to a treatment when in fact there are risks that a reasonable person would want to know about before making a decision about that treatment.
What does informed mean?
- For consent to be informed, the patient or SDM must be provided with enough information to make the decision.
- Information must be provided to the person in a way that gives them the best chance of understanding (avoid medical jargon, using communication aids and translator in cases where there is a language barrier)
- This includes information about:
- the nature of the treatment,
- the expected benefits of the treatment,
- the material risks of the treatment,
- the material side effects of the treatment,
- alternative courses of action and,
- the likely consequences of not having the treatment. (HCCA s.11(3))
- The person or the SDM must also be given the opportunity to ask and have their questions answered regarding any of the above information. information (HCCA, s.11(2))
Healthcare practitioner's responsibilities in informed consent discussions
Determine the health decision maker – the patient or the SDM? (by assessing the person's capacity to make that decision).
- If the patient is found to be incapable, they must be informed of this finding and given rights advice on how to dispute this finding
- Explain to the SDM their requirement to make decisions following prior capable wishes and then best interests of patient
- Provide the necessary information to the patient or their SDM and take steps to ensure that it is understood.
- Provide information at their health literacy level and in a language (through an interpreter if required)
Answer any questions they have
Ideally, consent discussions occur following a Goals of Care discussion which includes:
- Helping the patient /SDM understand the patient's illness
- Helping patient/SDM understand information about the treatment options (risks, benefits, side effects, alternatives, and what happens if refuse treatments offered - elements of an informed consent discussion)
- Discussing patient's values, goals, fears and worries
Get the informed consent/ refusal and document this in the patient chart. It is important to document what was discussed as part of the discussion including what information was provided
What does this mean?
- to be considered mentally capable of making a healthcare decision, the person must meet both parts of the legal test for capacity (defined above).
- The "understand" part means that the person must be able to explain back to you, the information you first provided. For example, if they have diabetes and being asked to consent to starting insulin, the would need to be able to understand that diabetes is a problem with high sugar in their blood and that insulin is meant to help control sugar levels.
- "Appreciating" means that they are able to understand how the situation applies to them. With the diabetes example, they would need to understand that controlling sugar levels is important to prevent them from developing blindness, kidney damage and loss of feeling in their legs that could lead to amputation.
- A person may state a series of accurate statements but unless they are able to relate it to their own situation, they fail to meet the requirements for capacity.
What else do I need to know about capacity?
A healthcare practitioner can assume that the person has capacity for making treatment decisions, unless the health practitioner has reasonable grounds to believe otherwise. (HCCA, 1996 s. 4(2)and (3))
Health practitioners should not assume that a patient lacks capacity to make a decision solely because of their age, disability, appearance, behaviour, medical condition (including mental illness), their beliefs, their apparent inability to communicate, or the fact that they make a decision that the health practitioner disagrees with.
Capacity is time and decision-specific
Capacity and the health care provider's responsibility
- Capacity is assessed by the healthcare practitioner who is proposing the treatment and asking for consent.
- For example, a surgeon would assess capacity to consent for the surgery they are proposing, an oncologist would assess capacity for decisions about chemotherapy, a speech language pathologist would assess capacity to consent to a swallowing study.
- A psychiatrist may be involved if there is concern about mental illness, but capacity to consent to medical treatments is assessed by the healthcare practitioner who has the most knowledge about the treatment being offered.
- Healthcare providers must give the person the best chance of succeeding at a capacity assessment. This means choosing a time when the person is most alert, communication barriers have been addressed and information has been provided at a level the person can understand.
- Healthcare practitioners must inform the person that they are assessing their capacity, and similarly inform them of any finding of incapacity
For more information on assessing capacity click here.