How do you obtain and record informed consent under HPCSA Booklet 4?

Booklet 4 asks the practitioner to give the patient their diagnosis, the options, the benefits, risks, costs and consequences of each, and the right to refuse, then record the key elements of the discussion in the record or a consent form. Written consent is expected for complex or high risk procedures, for research, and where care is not the main purpose.

What consent must cover

Booklet 4 sets out that the National Health Act requires the patient to be told their health status, the range of diagnostic procedures and treatment options, the benefits, risks, costs and consequences of each, and their right to refuse.¹ Consent must be expressed, never implied, and a signed form alone is not sufficient evidence that a patient consented to every aspect of the treatment.¹ Rule 27A makes obtaining informed consent, except in an emergency, one of every practitioner's main responsibilities.⁵

How to record it

1. Write the procedure. The OHSC tool asks for a consent procedure covering emergencies, the information given, legal standing to consent and review of consent.
2. Explain and check understanding. Diagnosis, options, risks, benefits, success, costs, consequences and follow-up, in words the patient understands.
3. Choose the form. Written consent for complex or high risk procedures, research, and care that is not the main purpose, and recorded consent otherwise.
4. Record the discussion. Booklet 4 asks for the key elements, the information given, the patient's requests and the scope of the consent, in the record or on the form.
5. Review it before treatment. Check the decision again close to the procedure, especially if time has passed or anything has changed.

1. Patient ______ Procedure ______ Date ______
2. Diagnosis explained ______ Options discussed ______
3. Risks, benefits, costs and consequences given ______
4. Patient's questions and requests ______
5. Consent form, written or recorded ______ Scope of consent ______
6. Reviewed before treatment on ______ By ______

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Telehealth and the OHSC

Regulation 6(5) requires every health establishment to have a formal process for obtaining informed consent.³ The OHSC scores the consent procedure as an essential measure in line with section 3 of Booklet 4, and treats it as not applicable where no surgical procedures are done.² For telehealth, Booklet 10 accepts consent in writing or recorded orally, and asks that the consent cover the identities, the practice number, the transmissions and the security used, with a copy kept in the record.⁴

Questions

Is verbal consent enough?

Booklet 4 accepts consent recorded or in writing, and asks for written consent for complex or risky procedures, research, and care that is not the main purpose.

Can the patient's agreement be implied?

No. Booklet 4 says consent must at all times be expressed, and that a patient lying on a couch does not show they understood what is proposed.

Does a signed form prove consent?

Not on its own. Booklet 4 asks the practitioner to review the decision close to treatment and record the discussion.

Sources

1. 1Health Professions Council of South Africa, 2021Booklet 4, Seeking patients' informed consent, the ethical considerations, revised December 2021Read source
2. 2Office of Health Standards Compliance, 2025Regulatory General Practice Inspection Tool v1.1, Administration and Practice ManagementRead source
3. 3Office of Health Standards Compliance, 2018Norms and Standards Regulations applicable to different categories of health establishments, GNR 67, Government Gazette 41419, 2 February 2018Read source
4. 4Health Professions Council of South Africa, 2021Booklet 10, General ethical guidelines for good practice in telehealth, revised December 2021Read source
5. 5Health Professions Council of South Africa, 2023Ethical Rules of Conduct for Practitioners registered under the Health Professions Act, GNR 717 of 2006, as amended to BN 510 of 2023Read source

Written by the wai team from Health Professions Council of South Africa and Office of Health Standards Compliance guidance, checked on 16 October 2026. This is guidance, not legal advice. Neither the OHSC nor the HPCSA endorses wai or any software.