Defining informed consent
Informed consent ensures that a person agreeing to treatment is given all the information available about risks, benefits, reasonable alternatives (if they exist) and the consequences of not having the treatment. When they consent (or refuse consent) it must be done voluntarily, without influence or pressure from others.
The NHS provides a definition of informed consent related to health.
In order to be able to give consent, a person must have capacity, which means they can understand the information they’ve received, retain the information in order to use it to make a decision and communicate their decision.
The law in the UK
The “Bolam” test was created from case law in 1957 and, until recently, was accepted practice around informed consent to treatment, including medication.
In 2015, the case of Montgomery versus Lanarkshire Health Board led to fundamental changes in law around informed consent. The law now requires patients to be given information about risks, including medicines risks, that are material to them and to be offered reasonable alternatives to the treatment being discussed.
Application in medicine
The advent of patient-centred care has been fundamental to the change in law concerning the duty of doctors to disclose information in relation to risk. An update to the change in law was published in the British Medical Journal to help medical practitioners navigate the changes, with commentary on the how this applies in medical practice. The General Medical Council provides their registrants with updated guidance and a summary of case law relating to informed consent.
Application in pharmacy
The General Pharmaceutical Council has produced updated guidance on informed consent to support registrants’ practice.