Understanding Risks and Warnings

A signature on a form is not, of itself, a valid consent. For a valid, true, or real consent in law, the patient must be sufficiently well informed to understand that to which he or she is asked to give consent. The doctor must be satisfied that the patient is capable of the following:

1. He or she can comprehend and retain the relevant information.

2. He or she believes the information.

3. He or she can weigh the pros and cons to arrive at a choice (10).

To defend a doctor against a civil claim alleging lack of consent based on a failure to warn adequately, it is necessary to have more than a signature on a standard consent form. Increasingly, in medical negligence actions, it is alleged that risks were not explained nor warnings given about possible adverse outcomes. Therefore, it is essential for the doctor or any other healthcare professional to spend adequate time explaining the nature and purpose of the intended investigation, procedure, or treatment in terms that the patient can understand. Risks and adverse outcomes should be discussed. The patient's direct questions must be answered frankly and truthfully, as was made clear in the Sidaway case (11), and thus the discussions should be undertaken by those with adequate knowledge and experience to deal with them; ideally, the clinician who is to perform the operation or procedure.

English law differs from the law in other common-law jurisdictions (e.g., Australia, Canada, and the United States) regarding the nature of the information that must be imparted for the consent to be "informed" and, therefore, valid. Increasingly, worldwide the courts will decide what the doctor should warn a patient about—applying objective tests, such as what a "prudent patient" would wish to know before agreeing. For example, in the leading Australian case (12), the court imposed a duty to warn about risks of remote (1 in 14,000) but serious complications of elective eye surgery, even though professional opinion in Australia at the time gave evidence that they would not have warned of so remote a risk.

In the United States and Canada, the law about the duty to warn of risks and adverse outcomes has long been much more stringent. Many (but not all) US courts recognize a duty on a doctor to warn a patient of the risks inherent in the treatment proposed. In the leading case (13), the District of Columbia appeals court imposed an objective "prudent patient" test and enunciated the following four principles:

1. Every human being of adult years and sound mind has a right to determine what shall happen to his or her body.

2. Consent is the informed exercise of choice and that entails an opportunity to evaluate knowledgeably the options available and their attendant risks.

3. The doctor must therefore disclose all "material risks."

4. The doctor must retain a "therapeutic privilege."

A "material risk" was held to be one that a reasonable person, in what the doctor knows or should know to be the patient's position, would likely attach significance to in deciding whether to forego the proposed treatment—this test is known as the "prudent patient test." However, the court held that a doctor has a therapeutic privilege by which he or she is entitled to withhold from the patient information about risk if full disclosure would pose a serious threat of psychological detriment to the patient. In the leading Canadian case (14), broad agreement was expressed with the propositions expressed in the American case.

English law continues to allow the doctor discretion in deciding what information is to be imparted to the particular patient being advised. The practitioner is not required to make an assessment based on the information to be given to an abstract "prudent patient;" rather, the actual patient being consulted must be assessed to determine what that patient should be told. However, the Sidaway and Bolitho (15) cases make clear that doctors must be supported by a body of professional opinion that is not only responsible but also scientifically and soundly based as determined by the court.

The message for the medical and allied health care professions is that medical paternalism has no place where consent to treatment is concerned; patients' rights to self-determination and personal autonomy based on full disclosure of relevant information is the legal requirement for consent.

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