Position Statements: Basic Informed Consent
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Medicine has undergone a revolution from the paternalistic approach where the doctor was considered to know best and expected to make decisions on behalf of the patient to the contemporary approach where the patient's viewpoint or autonomy is respected. Doctors have to acknowledge and carry out the value-based preferences of their patients. The principle of respect for autonomy obliges us not only to respect but also to facilitate the self-determination and choices of autonomous persons. It is now realised that under normal circumstances patients are best equipped to make decisions on behalf of themselves, based on their own values and beliefs. From a moral viewpoint it is clear that for patients to actualise self-determination, doctors have to take informed consent from their patients explaining the diagnostic, therapeutic and prognostic reasoning.

Informed consent is a paradigmatic example of the principle of respect for patient autonomy. The concept of informed consent prior to intervention is now not only a moral obligation, but has become a professional necessity and legal imperative.

The taking of consent for screening tests such as cervical cytology, "routine" obstetric ultrasound or mammography are included in this moral and legal imperative for informed consent.

A structure for informed consent is given below and consists of:

  1. Threshold elements
    1.1 Voluntariness: Any decisions made should be free of undue pressure.
    1.2 Decision making capacity: The patient should have the mental capacity to understand and make a decision about the procedure for which consent is being taken, as well as the ability to communicate their decision.

  2. Informational elements
    2.1 Disclosure of information: Legally the doctor has to exercise due care by giving the necessary information. Morally the doctor has to give the information necessary for the patient to make an autonomous decision.
    2.2 Recommendations: The doctor should give his/her interpretation of the beneficence-/nonmaleficence- based recommendations.
    2.3 Understanding: Prior to accepting a patient's authorisation the doctor should ascertain whether the patient has a substantial understanding of the salient facts.

  3. Consent elements
    3.1 Decision: The patient makes a decision based on the information disclosed. The decision is made according on the patient's own value system. The patient may decide to consent or decline the intervention.
    3.2 Authorisation: If the patient decides to consent to the intervention authorisation is given. Should the patient decline the intervention it would probably be prudent to note this in contemporaneous notes.
Once one has accepted that informed consent is mandatory, the basic structure of taking informed consent should be understood and followed. As can be seen the taking of informed consent is a process and does not revolve around the acquisition of an authorisation. The threshold requirements must be met prior to the informational elements, these are then followed by the consent elements.

As regards the taking of informed consent for screening tests there are two potentially troublesome areas. The first is the potential to interfere with a patient's voluntariness, based on the routine-ness of the test. The patient may have the impression from the doctor that the test is routine and thus it is expected of them to have the test. The second area that may be problematic revolves around the information that should be disclosed. The General Medical Council in the United Kingdom has given guidelines with respect to obtaining informed consent from patients undergoing medical procedures, including screening or diagnostic tests - remembering that consent is often incorrectly omitted for these procedures.

  1. The purpose of the test and whether it is a screening or diagnostic test and the distinction between the two.

  2. The likelihood of a positive and negative test.

  3. The concepts of sensitivity, specificity, false- negative and false positive findings.

  4. The uncertainties and risks of the screening.

  5. The significant medical, social or financial consequences of screening.

  6. The significant medical, social or financial consequences of not being screened.

  7. Follow up plans, including counselling and support services.

Compiled By: Prof Graham Howarth
Edited by Prof Gerhard Lindeque
August 2002