Understanding the Basic Steps to Obtaining Informed Consent
Taking the time to obtain proper informed consent is one of the most effective ways to avoid medico-legal challenges. Other than building the doctor-patient relationship, it ensures that patients do not encounter unpleasant surprises on their care journey which may result in unnecessary anger and blame.
Informed consent is a process where you provide information sufficient to enable the patient to make an informed decision relating to their healthcare. Although the signature of a consent form often constitutes completion of the consent process, a signature on a consent form without a balanced discussion does not constitute informed consent.
Informed consent is both a legal and ethical requirement. The National Health Act gives patients the right to be informed of the various treatment options available, and the benefits, risks and costs of each treatment option. It also gives patients the right to participate in decisions regarding their treatment and the right to consent before any treatment is given unless it is an emergency and they aren’t able to consent. From an ethical perspective, informed consent has two main objectives, firstly to respect and promote patients’ autonomy and secondly, to protect patients from potential harm. Medical intervention with a patient’s body is potentially an infringement of the constitutional right to bodily integrity and is legally wrongful unless there is a ground of justification. One such ground of justification is patient consent.
- Knowing your patient will help focus the discussion during the informed consent process. Enquire about your patient’s personal circumstances, expectations and fears, and assess their understanding of medical concepts and ability to make decisions.
- Use simple language and avoid technical terminology when discussing medical facts.
- Ensure your patient understands their medical condition and its natural history before discussing treatment options. This lets them know what to expect without treatment.
- List the range of diagnostic procedures and treatment options generally available. For each, highlight potential benefits and risks, including recognised complications and any potential follow-up treatment.
- Explain the possible need for emergency management of unforeseen conditions that may emerge.
- Discuss cost implications and payment responsibility. This considers medical aid coverage, any out-of-pocket costs, the cost of the different procedures, as well as any complications.
- Allow an opportunity for questions and answers. Encourage your patient to ask questions. Test your patient’s understanding. Let patients contact you prior to the planned procedure, if they have more questions or concerns.
If a patient has specified that they would rather a procedure didn’t go ahead in the event of certain clinical findings, the patient’s decision must be recorded and respected.
If the patient decides to consent to an intervention, obtain their signed written consent. The patient’s details, health status, the treatment options discussed and the procedure to be performed must be entered into your consent form.
Document complications that have a reasonable likelihood of occurring and/or which are likely to be of importance to your patient, considering personal circumstances.
For example, an abnormal sense of touch after carpal tunnel syndrome surgery may affect a practising dentist more significantly than a retired librarian.
- Ensure that your consent form documents that no guarantees or promises have been made regarding the outcomes of the procedure and the patient has a right to refuse the procedure.
- Your consent form must include any discussions relating to financial consent, the use of anaesthesia and blood products and the need for emergency management in the event of unforeseen complications.
- Check that the patient initials the document and signs with the correct date. Countersign and date the consent form. Attach any relevant patient information sheet to the informed consent form and allow the patient to take a copy and keep one for the practice.
Consent remains valid until it is withdrawn by the patient or until their circumstances change in a meaningful way. However, if significant time has passed since the original consent was obtained, you may need to update and document your discussion with the patient. Additions or corrections to the consent form must be dated, timed and signed by both parties.
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