One of the most critical aspects of receiving healthcare is informed consent, which is one of the most fundamental rights of a patient. Not only does it assist to foster the necessary trust between patient and healthcare provider, but it also ensures that a patient is fully aware of what is happening, why it is happening, and what the potential risks are. Providing clear and thorough information empowers patients to make educated decisions about their health.

What is informed consent?

Informed consent is a both legal and ethical requirement in healthcare, requiring healthcare providers to inform their patients the details of any proposed treatment or surgery. Such details include inter alia the purpose of the treatment or surgery, benefits, possible side effects, any risks involved and any available or possible alternatives. This information plays a crucial role in assisting patients to make educated decisions about whether or not to proceed with the proposed treatment or surgery.

Legal framework

In South Africa, informed consent is anchored in the Constitution, the National Healthcare Act 61 of 2003 (“the Act”), and guidelines from the Health Professions Council of South Africa (“HPCSA”). Healthcare providers are required stay informed about these law and guidelines to ensure that they meet the minimum standards required for informed consent, ensuring patients’ rights are respected and safeguarded.

Components of informed consent

The requirements for obtaining informed consent, as outlined by legislation and the HPCSA guidelines, involve several key components:

Comprehensive information: Section 6(1) of the Act provides that a healthcare provider must inform the patient of their health status, the range of available diagnostic procedures and treatment options, the benefits, risks, costs and potential consequences generally associated with each option. Additionally, in terms of the aforementioned section, the healthcare provider must inform person receiving treatment of their right to refuse the health services and explain the implications, risks and obligations of such refusal.

Effective communication: Healthcare providers must communicate clearly, allowing patients to ask questions and ensure that they receive clear and honest responses. Section 6(2) of the Act requires the healthcare provider, where possible, to relay all the aforementioned information in a language that the patient, also taking into account said patient’s level of literacy as well. Additionally, healthcare providers must ensure that the patient understands the information being relayed to them.

Voluntary decision-making: A patients must provide their informed consent without coercion, undue influence or pressure. Healthcare providers may make recommendations, but not coerce, unduly influence or place pressure on the patient.

Capacity to consent: informed consent will not apply where there is substantial evidence that the disclosure of a patient’s status to them would be contrary to their best interests, or where the patient lacks the capacity to provide informed consent. Lack of capacity may occur due to conditions such as unconsciousness, severe cognitive impairment, mental health conditions, or being a minor. If a patient lacks the capacity to provide informed consent, said consent may then be provided by a parent, a legal guardian, a spouse, closest family member, and in some instances the Courts through a court order. However, in emergency situations where consent cannot be obtained, the healthcare providers may proceed to provide treatment.

Consent forms and documentation: Informed consent is typically recorded through written consent forms, especially for treatments that carry significant risks or long-term consequences. These consent forms typically contain the information relayed to the patient and any discussions that follow, highlighting that the patient understands the information relayed and made and informed decision.

Informed consent is crucial to ensure that patients are fully aware of and agree to medical procedures, which is essential for ethical and patient-centred care. By following the HPCSA guidelines, healthcare providers support patient autonomy and help foster trust in the healthcare system.

Informed Consent: understanding your rights before Treatment and Surgery