Implied and express consent
Patients undergoing invasive procedures will normally give express consent – either by signing a consent form or stating that they agree to go ahead with treatment.
Written consent should be taken where:
- “The treatment or procedure is complex or involves significant risks and/or side effects;
- Providing clinical care is not the primary purpose of the investigation or examination;
- There may be significant consequences for the patient’s employment, social or personal life;
- The treatment is part of a research programme.”32
However, consent is often implied by the patient’s compliance, an obvious example being when a patient rolls up a sleeve so that a blood sample can be taken. Nevertheless, patients should be told about the nature and purpose of any examination, investigation or procedure beforehand.
Any discussions with patients about the risks and benefits of a proposed procedure or treatment should be documented in the medical record.
Recording consent and consent forms
The presence of a signed consent form does not in itself prove valid consent to treatment – the important factors will always be the quality, extent and accuracy of the information given beforehand. Being able to demonstrate this afterwards depends on contemporaneous notes recording the key points discussed and relevant warnings given to the patient.
There are statutory forms of written consent required for certain procedures, interventions and circumstances – eg, sterilisation and termination of pregnancy. The Regulations deriving from the Children’s Act also specify the form that minors’ written consent to various interventions should take.
Patient information leaflets
Numerous studies have shown that patients retain comparatively little information given to them during a consultation, particularly if they are anxious or in pain. Many patients find it helpful if they are given written information as a reminder of the key points discussed.
However, written information is not a substitute for detailed discussion with patients and must be seen as an adjunct to, not a replacement for, that discussion. If information leaflet are used to augment discussion with a patient, this should be documented in the patient’s notes.