What is informed consent?

Informed consent is a two-way dialogue between patient and their healthcare practitioner whereby the practitioner provides adequate information necessary to enable the patient to make an informed decision about the risks, benefits and alternatives of a given procedure, treatment or intervention.

Informed consent or informed decision-making?

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. Therefore, the informed consent process is best described as “informed decision-making”. This is an ongoing process.

What you should know

• The onus is on the practitioner

The manner in which information for consent is conveyed by a practitioner to a patient is of cardinal importance, especially because of cultural, racial, socio-economic, language and educational differences in South Africa. The onus is on the practitioner to ensure not only that sufficient information has been imparted, but also that the patient has fully understood all the relevant implications and risks.

• What patients need to know

Section 6 of the National Health Act 61 of 2003 requires users of healthcare services (i.e. patients) to have full knowledge of:

• Their health status
• The range of diagnostic procedures and treatment options generally available
• The benefits, risks, costs and consequences associated with each option
• The user’s right to refuse health services and the implications, risks, and obligations of such refusal

• Don’t overestimate a patient’s ability to understand

It is advisable for a practitioner, without being condescending or paternalistic, to underestimate rather than overestimate the patient’s intelligence and comprehension of what is being imparted. When a patient has difficulty understanding the information being imparted, the practitioner must have the patience and care to repeat, perhaps in simpler terms, the necessary facts to ensure that they are properly understood.

• The simpler, the better

All information must preferably be communicated in an unambiguous manner, with as little medical jargon as possible and in non-technical terms. In the final analysis, the practitioner is obliged to explain the procedure or treatment until he or she is satisfied that the patient (or his or her family), understands the procedure and its possible consequences and outcomes.

How to obtain informed decision-making

1. Introduction

• Use simple language when explaining the patient’s condition
• Avoid technical medical terminology

2. Explain the procedure and material risks

• Discuss options for treatment, including non-operative care and no treatment, together with the potential benefits and risks of each option
• Make use of anatomical drawings
• Discuss possible complications
• Discuss potential follow-up treatment
• Allow an opportunity for questions and answers
• Provide further sources of patient information
• Invite the patient to contact you if additional questions arise prior to the planned procedure

3. Explain the costs involved in the procedure

• Ensure the patient knows the procedure required so that they can ascertain from their medical aid, what will be covered
• Explain your payment terms if available

4. Obtain written consent

• Ensure that you have your own appropriately worded consent form (do not rely on the hospital “confirmation of consent” form as they are not sufficient)
• Include the description of the patient’s condition
• Include the surgical procedure to be performed
• Include the proposed date of the treatment, if appropriate
• Include a list of the most recognised complications or risks associated
• with the procedure or treatment
• Ensure the patient signs the consent form
• Ensure the patient includes the correct date
• Provide any relevant patient information resource to the patient during the consultation
• Ensure that you countersign the consent form
• Attach any relevant patient information sheet to the consent form
• Be sure to include a discussion regarding conditions and risks specific to covid-19
• Allow the patient to take a copy and keep one copy for the practice file

At EthiQal, we are committed to protecting our doctors and keeping them in practice. Our in-house team of experienced medical and legal professionals will assess your situation and provide you with appropriate assistance and support.

If you require any assistance with your informed consent process, or if you require any assistance and information regarding our other medico-legal services, please contact EthiQal today. You can contact us on www.ethiqal.mobi, send an email to claims@ethiqal.co.za or call our claims and medico-legal support line on 021 007 4527/44.