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Informed consent
Disclosure of information
For consent to treatment to be considered valid, it must be an “informed” consent. The patient must have been given an adequate explanation about the nature of the proposed investigation or treatment and its anticipated outcome as well as the significant risks involved and alternatives available. The information must be such as will allow the patient to reach an informed decision. In situations where the patient is not mentally capable, the discussion must take place with the substitute decision maker.
The obligation to obtain informed consent must always rest with the physician who is to carry out the treatment or investigative procedure. This obligation may be delegated in appropriate circumstances (to a PGY trainee for example) but before assigning this duty to another, the treating physician should be confident the delegate has the knowledge and experience to provide adequate explanations to the patient.
In special circumstances, an obligation of pre-treatment disclosure may fall to more than one physician involved in the care. For example, a radiologist carrying out an invasive diagnostic procedure would likely be seen as responsible for explaining how the test will be done and the risks attendant upon it. The physician who ordered the test might also be expected to tell the patient, in general terms, about the nature and purpose of the test and alternatives which might be employed.
The bottom line:
The patient must have been given an adequate explanation about the nature of the proposed investigation or treatment and its anticipated outcome as well as the significant risks involved and alternatives available.
The obligation to obtain informed consent must always rest with the physician who is to carry out the treatment or investigative procedure.
Standard of disclosure
Although obtaining a valid consent from patients has always involved explanations about the general nature of the proposed treatment and its anticipated effect, the Supreme Court of Canada, over two decades ago, imposed a more stringent standard of disclosure upon physicians. The adequacy of consent explanations is to be judged by the “reasonable patient” standard, or what a reasonable patient in the particular patient's position would have expected to hear before consenting.
The Supreme Court of Canada has set out in general terms the scope of the physician's duty in informing patients before treatment as follows:
“In summary, decided cases appear to indicate that in obtaining the consent of a patient for the performance upon him of a surgical operation, a surgeon, generally, should answer any specific questions posed by the patient as to the risks involved and should, without being questioned, disclose to him the nature of the proposed operation, its gravity, any material risks and any special or unusual risks attendant upon the performance of the operation. However, having said that, it should be added that the scope of the duty of disclosure and whether or not is has been breached are matters which must be decided in relation to the circumstances of each particular case.”
In a subsequent decision, the court extended the obligation of disclosure as follows:
“... a surgeon must also, where the circumstances require it, explain... alternative means of treatment and their risks.”
The foregoing does provide physicians with a general basis for deciding the nature and extent of the pre-treatment information which should be given to patients but it can be difficult to apply legal generalizations to specific clinical situations. Therefore, some comment about several of the points raised in these precedent-setting judgments may be helpful.
Throughout these and other legal judgments which have been rendered in more recent years, there is repeated reference to the need to disclose “material” risks to patients. However, there can be some understandable uncertainty as to what in fact does constitute a “material” risk. One court has defined it as follows:
“A risk is thus material when a reasonable person in what the physician knows or should know to be the patient's position would be likely to attach significance to the risk or cluster of risks in determining whether or not to undergo the proposed therapy.”
Thus the particular circumstances of the patient are an important determinant of materiality.
It is clear that the materiality of a risk is influenced as well both by the frequency of the possible risk and also by its seriousness should it occur. Generally speaking, the more frequent the risk, the greater the obligation to discuss it beforehand. Further, even uncommon risks of great potential seriousness should be disclosed. In this context the Supreme Court of Canada indicated that even if a risk is “a mere possibility” yet it carries with it serious consequences such as paralysis or death, it should be regarded as material and therefore requires disclosure.
The bottom line:
The adequacy of consent explanations is judged by the "reasonable patient" standard, or what a reasonable patient in the particular patient's position would have expected to hear before consenting.
Recent legal judgments repeatedly refer to the need to disclose "material" risks to patients. Generally speaking, the more frequent the risk, the greater the obligation to discuss it beforehand. Further, even uncommon risks of great potential seriousness should be disclosed.
Patient comprehension
It has been suggested that not only must the physician provide the necessary details about the nature, consequences and material risks of the proposed treatment in order to obtain informed consent, but also the physician has the duty to ensure the patient has understood the information. This interpretation of the case law goes too far and would place an unfair and unreasonable burden on the physician. In rejecting this obligation, the court, in a recent Scottish case, commented that such an onus upon the physician could only be discharged through “vigorous and inappropriate cross-examination” of the patient.
There is no doubt, however, that the physician does have a duty to take reasonable steps so as to be relatively satisfied that the patient does understand the information being provided, particularly where there may be language difficulties or emotional issues involved. What amounts to “reasonable steps” will very much depend on the individual facts and circumstances of the particular situation.
It seems clear that by engaging in personal dialogue with the patient, the physician will be placed in the best possible position to be reasonably comfortable the patient understands the consent explanation. Personal attendance permits the physician the opportunity to observe the patient's reaction for signs of apparent comprehension or confusion. As well, the ability of the patient to ask questions will often assist the physician to assess the level of patient understanding.
The bottom line:
Physicians have a duty to take reasonable steps so as to be relatively satisfied that the patient does understand the information being provided, particularly where there may be language difficulties or emotional issues involved.
Consent disclosure in research and experimentation
The issue of consent merits careful consideration by those physicians who may become involved in any research work in which patients or human volunteers are asked to participate.
In terms of the extent to which risks must be disclosed, there is now less distinction between “therapeutic” and “non-therapeutic” research than in earlier years when requirements for informed consent were less stringent. These days, for any treatment or procedure that is innovative or that could be perceived as experimental, anything which may be interpreted as going beyond the need for prophylaxis, diagnosis or therapy, an element of “research” should be assumed. In such circumstances a standard of full disclosure may be applicable when obtaining consent. The concept of therapeutic privilege is inappropriate and no information about a project or clinical trial may be hidden from a patient on the ground that disclosure would result in undue worry or anxiety. As well, researchers must recognize the potential for what might later appear to have been duress or coercion. This is a particularly important consideration if the subject has a physician-patient relationship with a member of the research team.
A fair explanation must always be given about what is proposed, its risks and discomforts, what, if any, benefits might accrue and, if applicable, what appropriate alternative treatments or procedures might be offered. If a blind study is involved, patients must be aware they could stand to derive no benefit at all. Researchers should offer and make themselves available to answer enquiries about what is proposed and should emphasize to patients or subjects they are free to withdraw consent and discontinue participation in the project at any time without prejudice.
It might be argued that minors or adults with mental disability do not have the capacity to consent when research or experimentation figure to any significant extent in clinical management. Physicians should exercise a great deal of caution in dealing with such situations.
The bottom line:
When it comes to research and experimentation, a fair explanation must be given about what is proposed, its risks and discomforts, what if any benefits might accrue and, if applicable, what appropriate alternative treatments or procedures might be offered. If a blind study is involved, patients must be aware they could stand to derive no benefit at all.
Informed refusal
Our courts have reaffirmed repeatedly a patient's right to refuse treatment even when it is clear treatment is necessary to preserve the life or health of the patient. Justice Robins of the Ontario Court of Appeal explained:
“The right to determine what shall, or shall not, be done with one's own body, and to be free from non-consensual medical treatment, is a right deeply rooted in our common law. This right underlines the doctrine of informed consent. With very limited exceptions, every person's body is considered inviolate, and, accordingly, every competent adult has the right to be free from unwanted medical treatment. The fact that serious risks or consequences may result from a refusal of medical treatment does not vitiate the right of medical self-determination. The doctrine of informed consent ensures the freedom of individuals to make choices about their medical care. It is the patient, not the physician, who ultimately must decide if treatment — any treatment — is to be administered.”
However, difficulty may arise if it should later be claimed the refusal had been based on inadequate information about the potential consequences of declining what had been recommended. In the same way as valid consent to treatment must be “informed,” so it may be argued a refusal must be similarly “informed.” Physicians thus may be seen to have the same obligations of disclosure as when obtaining consent, that is, disclosure of the risk to be accepted.
When patients decide against recommended treatment, particularly urgent or medically necessary treatment, discussions about their decision must be conducted with some sensitivity. While recognizing an individual's right to refuse, physicians must at the same time explain the consequences of the refusal without creating a perception of coercion in seeking consent. Refusal of the recommended treatment does not necessarily constitute refusal for all treatments. Reasonable alternatives should be explained and offered to the patient.
As when documenting the consent discussion, notes should be made about a patient's refusal to accept recommended treatment. Such notes will have evidentiary value if there is any controversy later about why treatment was not given.
The bottom line:
Our courts have reaffirmed repeatedly a patient's right to refuse treatment even when it is clear treatment is necessary to preserve the life or health of the patient. Physicians must at the same time explain the consequences of the refusal without creating a perception of coercion in seeking consent.
Informed discharge
Although not strictly an element of the pre-operative consent process, the courts have recently elaborated on the duty or obligation of physicians to properly inform patients in the post-operative or post-discharge period. Thus a physician must conduct a discussion with a patient of the post-treatment risks or complications, even statistically remote ones that are of a serious nature. The purpose is to inform the patient of clinical signs and symptoms that may indicate the need for immediate treatment such that the patient will know to visit the physician or return to the hospital/facility.
The bottom line:
Physicians have an obligation to properly inform patients in the post-operative or post-discharge period, most specifically about clinical signs and symptoms that may indicate the need for immediate treatment.
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Some practical considerations
about informed consent
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