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Advance directives

An advance directive is a statement made by a competent adult in anticipation of a time in the future when he or she may lack the capacity to make healthcare decisions. Such statements usually take the form of advance refusal of specified treatments, but may also contain information about the patient’s values and beliefs.

The HPCSA states: “Where a patient lacks the capacity to decide, health care practitioners must respect any valid advance refusal of treatment.”25

It further recommends encouraging patients with terminal conditions to appoint a proxy to make decisions on their behalf in the event of their losing decisional capacity. Moreover, patients should be given the opportunity to write a directive setting out their wishes regarding their future care to guide those who will be tasked with deciding what is in their best interests.26

If there is any doubt about the validity or applicability of an advance decision (eg, there is reason to believe that the patient might have had a change of mind since drawing up the directive, or the current circumstances do not correspond to those specified in the directive), the patient should be provided with care to secure his/her best interests while the issue is resolved, if necessary by reference to the courts.


All decisions to withdraw or withhold treatment, either with or without the patient’s consent, should be fully and clearly documented in the patient’s medical record and accessible by all those involved in the patient’s care. Such documentation should include:

  • The relevant clinical findings
  • Discussions with the patient and others
  • Details of “treatment or other significant factors which may affect future care”.27

Clinical trials and research

“Everyone has the right to bodily and psychological integrity, which includes the right

(a) to make decisions concerning reproduction;
(b) to security in and control over their body; and
(c) not to be subjected to medical or scientific experiments without their informed consent.”

Source: Constitution of the Republic of South Africa 1996, section 12(2)

The Department of Health specifies that participants’ verbal and written consent must be obtained before research may begin.28 To be valid, such consent must be given freely, without coercion and it must be based on comprehensive information about the nature of the proposed research. The Medical Research Council (MRC) stipulates that all the information listed in Box 9 must be disclosed – and presented in a form the individual concerned can understand, giving due regard to his or her culture and language. A patient’s care should not be compromised in any way by his or her refusal to articipate in research (see Box 10).

Box 9: What patients should know before agreeing to participate in clinical trials

All clinical research must be approved by an accredited research ethics committee. The Medical Research Council’s guidelines regarding participants’ consent is set out below.

i. “The precise nature, scope, purpose and duration of the proposed research project. That is, whether it is therapeutic, non-therapeutic, invasive, observational, a pilot study, controlled, randomised, single blind, double blind, triple blind or quadruple blind, and whether or not placebos are involved;

ii. the nature, scope and consequences of the proposed research intervention;

iii. the anticipated benefits and disadvantages compared to those expected from available standard therapy;

iv. the foreseeable prognosis and all foreseeable and additional risks, dangers and complications, as well as the possibility of unforeseen risks, dangers and complications, irrespective of whether the proposed research is therapeutic or nontherapeutic;

v. personal benefits, including financial benefits, that may accrue from the research to participants, investigators and anyone giving proxy consent. Moreover, the research participant, or the articipant's proxy, should be informed that participation is voluntary and that he or she is:

1. under no obligation to consent to the research procedure and that a refusal will not adversely affect future treatment;
2. free to withdraw consent at any time without adverse consequences and without having to state a reason.”

Source: MRC, Guidelines on Ethics for Medical Research: General Principles (2006), para