The majority of health care interventions are routine and low risk, and involve implied consent. For example, the health professional may assume that consent has been given when the patient co-operates during treatment e.g. presentation of the arm for venepuncture. It is not usually necessary to document a patient’s implied consent.

There are certain procedures and treatments where the health professional should seek verbal consent. These may include non-routine interventions or interventions that require intimate examinations. When a health professional believes it necessary to seek verbal consent from the patient, evidence of this should be clearly documented in the patient’s clinical notes.

With specific exceptions (e.g. infertility treatments) it is not a legal requirement to seek written consent. It is good practice to do so where any of the following circumstances apply:

• The treatment or procedure is complex or involves significant risks (the term “risk” is used to mean the potential for any adverse outcome, including those which some health professionals describe as “side-effects” or “complications”).
• There may be significant consequences for the patient’s employment, social or personal life.
• It is mandatory to obtain written consent if the treatment is part of a project or programme of research approved by NHS Ayrshire & Arran.

Whichever form of consent is used, it is important that both the patient and health professional understand what has been agreed. It is good practice for the health professional to document clearly within the patient’s health records or on the consent form, the verbal information that was provided. This should include a record of any information leaflet provided, including the version number and/or date.

In NHS Ayrshire & Arran, when a patient (or parent/guardian) is capable of consenting, written consent must be obtained for the following procedures and interventions:

• procedures involving general or regional anaesthesia, or sedation
• electroconvulsive therapy
• major dental surgery
• major podiatric interventions
• pregnancy and newborn screening
• childhood immunisations
• video, photographic and audio recordings.

There is no requirement for separate written consent for anaesthesia. The anaesthetist should explain the anaesthetic choices at the time of pre-operative assessment, and any relevant discussion should be clearly recorded in the medical notes, dated and signed. Provision of supporting information leaflets would be good practice. For more interventional anaesthetic procedures, a separate written consent form should be used.

Traditionally, written consent was not sought for procedures performed on wards, such as central line insertion, chest drain insertion or lumbar puncture. Increasingly, there is a move towards seeking written consent for these procedures, recognising the degree of risk associated. Departments should have a clear policy on which procedures are expected to have written consent obtained. For procedures performed across multiple departments, it may be appropriate for that policy to be decided at divisional level or above.

Some medical therapies carry as much or more risk than surgical interventions. Conventionally, written consent is not sought, however. The principles of fully informed consent still stand, and the medical record must reflect any discussion about the therapy, risks, benefits and alternatives.