In most situations, obtaining a patient’s valid consent to a procedure or treatment is a simple matter of following straightforward guidelines, but circumstances can occasionally develop in which conflicting principles must be resolved and this can pose a dilemma for clinicians. This booklet has been written as a guide to the ethical and legal principles that should be applied, both in straightforward and more challenging circumstances.
To treat competent patients without their valid consent is a violation of their constitutional rights and transgresses a fundamental principle of medical law. The basic rule is simple: no-one has the right to touch anyone else without lawful justification and if doctors do so it may well undermine patients’ trust as well as violate their rights to physical integrity. The only exception to this rule is when the patient lacks the capacity (by virtue of his or her lack of maturity or a mental impairment) to give valid consent, in which case someone else has to make decisions on the patient’s behalf.
Failure to respect a patient’s rights to bodily integrity may lead to a complaint to the HPCSA, civil or criminal proceedings for assault, or to a claim. It is important to remember that a well-taken consent is not based on a one-off event, but is an outcome of an ongoing communication process (see Box 1).
There are three components to valid consent:
Figure 1: Steps in the consent process
Obtaining a patient’s consent to treatment is not just a matter of asking for a signature on a consent form; it is a communication process.
Step 1: Threshold Elements
Assess the patient’s decisional capacity. Check that the patient is not under undue duress (ie, is able to make a voluntary decision) .
Step 2: Informational Elements (see Box 5)
Describe the proposed intervention. Discuss risks, benefits and consequences of the proposed intervention/including costs/no charge, and check that the patient understands the information and can make and communicate a rational decision based on that information.
Step 3: Consent Elements
The patient makes a decision. The patient communicates his/her decision and, if appropriate, signs a consent form (authorisation).
Step 4: Confirmation Elements
The patient is reminded that consent can be withdrawn at any time. If there has been a delay between authorisation and the procedure, the patient’s willingness to proceed is confirmed.