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The Perils and Pitfalls of Documenting Consent: Practices that Minimize your Risk of Liability PDF Print E-mail

Lydia Wakulowsky
McMillan Binch
Toronto, ON

Introduction
The doctrine of consent to medical treatment is fundamental to Canadian law, and is readily comprehensible to physicians and patients alike. Yet, this doctrine is one issue that frequently arises in medical malpractice litigation. As a result, the process of obtaining a valid consent, and of properly documenting this consent, continues to raise numerous questions in the minds of physicians. This article briefly sets out: (a) the legal requirement of consent to treatment; (b) the criteria for a valid consent; and (c) a discussion of how to establish practices that minimize your risk of liability.  

 

The Legal Requirement of Consent to Treatment

The Rule

It is a fundamental rule of Canadian law that medical treatment may only be provided where the consent of the patient has been obtained. In the case of Ciarlariello v. Schacter, the Supreme Court of Canada set out the common law rule:

It should not be forgotten that every patient has a right to bodily integrity. This encompasses the right to determine what medical procedures will be accepted and the extent to which they will be accepted. Everyone has the right to decide what is to be done to one's own body. This includes the right to be free from medical treatment to which the individual does not consent. This concept of individual autonomy is fundamental to the common law…

In addition to this common law rule, a number of provinces have passed legislation that sets out very clear, and in some cases, strict requirements for obtaining consent to medical treatment.

Exceptions to the Rule

There are only two exceptions to the consent requirement. Medical treatment may be administered without the consent of the patient in the following circumstances:

(a) where a physician is faced with a true medical emergency; for example, where: (i) the patient is at risk of serious bodily injury or death without prompt medical intervention; (ii) the patient is unable to give or withhold consent; and (iii) no legally authorized representative is available to provide consent on behalf of the patient; or

(b) where a legislative provision mandates treatment regardless of lack of consent; for example, in the case of mental health legislation and public health legislation (i.e. to prevent the spread of communicable diseases).

Consequences of Failure to Obtain Consent

Battery

The tort of battery protects individuals from intentional and unauthorized physical acts. A physician faces liability in battery when he or she provides medical treatment of any kind without consent. This includes liability for all of the direct consequences of the treatment, whether or not those consequences were foreseeable. This is the case even where the treatment is in the patient's best interest or has saved the patient's life. The tort of battery also covers situations where consent has been obtained by fraud or duress, or where the treatment goes beyond the consent that was given. The onus of proof of consent rests with the physician, and damages may be awarded even if no physical injury is suffered. This onus underscores the importance of properly documenting consent.

Negligence

A physician faces liability for negligence where a patient has voluntarily consented to treatment, but has done so on the basis of incomplete or inaccurate information. Thus, it is possible for a physician to provide treatment to a patient without negligence, but still face liability for negligence if the patient was not adequately informed. Liability for negligence is limited to those damages that were reasonably foreseeable. The onus of proof of adequate disclosure, once again, rests with the physician.

The Criteria for a Valid Consent

Consent is a Process, Not a Form

Physicians have attempted to shield themselves from liability by having their patients sign standardized consent forms as evidence of having obtained consent. These forms may offer some protection to physicians, but this protection is not without limits. The forms may, in fact, offer physicians a false sense of security. This is because a signed consent form is not conclusive proof that the patient has consented - it is only one piece of evidence of the consent process. The consent process involves far more than simply completing a consent form and having a patient sign it - it involves effective on-going communication between a physician and the patient over a period of time. When assessing whether a patient has given informed consent, one must consider the information and understanding that the patient actually had regarding the medical treatment.

Criteria for a Valid Consent

A patient may give consent to a particular medical treatment, and sign a consent form to this effect, but this consent will only be valid if all of the following criteria are met:

- The patient has the capacity to consent. Capacity is the ability of a patient to understand the information presented, to appreciate the potential consequences of a decision, and to provide free and informed consent to the treatment. This ability may vary according to the choice being made, the circumstances surrounding the decision, or the time in question. The law provides that a physician is entitled to presume that a patient is capable of authorizing treatment, unless there is something in the patient's history or behaviour that makes the physician believe that the patient's capacity to consent is questionable.

- The patient is legally competent to consent. A physician may presume that a patient is legally competent to consent to the treatment unless the presumption has been overridden by court order (i.e. the patient is under a guardianship order that removes the right to consent to health care) or by compulsory treatment legislation.

- The consent relates to the proposed treatment. A physician must refer to the specific treatment for which consent is being requested. Consent to a particular treatment may cover additional procedures that are a necessary or usual extension of the proposed procedure. A physician may not administer treatment beyond what was specifically authorized by the patient, however, except in the case of an emergency.

- The consent relates to the physician. Consent to treatment must refer to the physician who will carry out the procedure. If the physician proposes to engage the services of others in any aspect of the procedure (i.e. other physicians, residents or assistants), this information should be conveyed to the patient.

- The consent is informed. The patient must receive information that a reasonable person in the same circumstances would require in order to make an informed decision regarding the treatment. This information includes:

  • the diagnosis;
  • the nature of the proposed treatment;
  • the physician's experience with the treatment;
  • methods to be used;
  • the expected benefits of the treatment;
  • the "material and special risks" of the treatment;
  • the alternative courses of action to the treatment; and
  • the likely consequences of not having the treatment.

- The consent is given voluntarily. Consent must be obtained without undue influence, manipulation or coercion. Persuasion is permissible, provided no attempts are made to overcome the patient's own decision. If possible, a patient's consent should not be taken after the administration of medication, or while the patient is under the influence of drugs or alcohol.

Getting to Know the Patient

In sum, the doctrine of consent to medical treatment requires physicians to invest some time in getting to know their patients. In this regard, a physician must:

  • take the time to consider a patient's education, age, language, culture and special needs to ensure that information is communicated to the patient in a manner and using language which the particular patient can understand;
  • take the time to consider the patient's special needs to identify what may be important or special considerations for the particular patient;
  • take the time to assess the patient's understanding of the nature and consequences of the treatment by promoting dialogue and encouraging the patient to ask questions about the proposed treatment; and
  • take the time needed for the patient to synthesize the information provided.

Once these steps have been undertaken, a physician may proceed to obtain the patient's consent. To minimize exposure to liability, the physician must take detailed notes of all physician-patient communications and must document the consent obtained.

The Perils and Pitfalls of Documenting Consent

Evidence of free and informed consent should ordinarily be obtained in writing. This is because if the validity of a patient's consent is challenged after medical treatment is administered to the patient, a physician must prove that a valid consent was obtained. Oral consent is difficult to establish, particularly when the court action is taking place long after the event when memories have faded. The most common form of documenting consent is by using a consent form signed by the patient. In fact, in some circumstances, provincial legislation or institutional policy requires the patient's signed written consent.

A significant peril in using the consent form is that one may confuse the "process" of consent with the format in which the authorization is recorded. It bears repeating that consent is a process and not a form. The fact that a patient has signed a consent form does not necessarily mean that consent has been given, that the consent was valid, or that the procedure that was performed was the procedure for which consent was obtained. When considering whether a valid consent was obtained, a court will examine all relevant circumstances, and not just the written form. Notwithstanding this fact, there is a proper role for consent forms in the documentation process.

The Do's And Don'ts of Documenting Consent: Establishing Practices that Minimize Your Risk of Liability

1. Be familiar with your province's laws regarding consent, as well as with any relevant institutional requirements.

2. Invest a certain amount of time to get to know your patient. Pinpoint important factors or special considerations to the patient.

3. Do not obtain consent from a patient who is under the influence of medication, as this may affect the patient's capacity to consent.

4. Ideally, obtain the consent yourself and do not delegate this task to others. This way, you can solicit necessary information from the patient and answer any of the patient's questions about the treatment.

5. Inform the patient if others, such as residents and assistants, will perform any aspects of the procedure. Answer any questions the patient may have in this regard and ensure that a note of this discussion is recorded in the patient record.

6. Provide your patient with an opportunity to ask questions and to receive understandable answers.

7. Provide your patient with sufficient time to synthesize treatment information.

8. Draft the consent form to fit the specific circumstances at hand. Ideally, a consent form sets out the patient's condition, the alternative courses of treatment available, the proposed treatment and its expected results as well as its material and special risks.

9. Make sure that the consent form is complete before the patient signs it.

10. Do not make any additions, deletions or alterations to the form after the patient signs it.

11. Have the consent form signed by the patient at the time the risks and benefits of the treatment are explained.

12. Do not have the consent form signed until the consent process has been completed.

13. Avoid using imprecise language or broadly worded consent forms that purport to authorize a vast array of treatment or "any further procedure as may be found necessary or advisable". Such forms will not protect you from liability, but will only give you a false sense of security.

14. Make a note in the patient's file confirming the date, time and general nature of the discussion with the patient regarding consent to treatment. In particular, make note of any special concerns raised by the patient, particular to his or her circumstances, and the manner in which you addressed those concerns.

15. Obtain a new consent for a new course of treatment if there is a change in the plan of care.

16. Have your consent forms reviewed by legal counsel, particularly when there is a change in legislation that affects the consent process.

17. Most importantly, do not view the consent process as a one-time activity. View it as a continuing obligation to ensure that the patient, at all times, is making decisions based on a full understanding of the risks and benefits of on-going treatment.

Conclusions

Notwithstanding the perils and pitfalls associated with the use of consent forms, these forms can serve a useful function in the documentary aspect of the consent process - so long as they are understood to be no more than a written account of what actually transpired between a physician and a patient.


This article provides only a summary of issues related to informed consent. Readers are cautioned against making any decisions on the basis of this material alone. Instead, a qualified lawyer should be consulted.

Lydia Wakulowsky is a member of McMillan Binch's Health Law Group. For further information on this or other health law matters, please contact her directly at This e-mail address is being protected from spambots. You need JavaScript enabled to view it

 

Last Updated on Sunday, 11 June 2006 06:38