Patient consent
Introduction
The General Medical Council (GMC) requires written consent to be obtained in the following circumstances (GMC 2008):1
• The investigation or treatment is complex or involves significant risks
• There may be significant consequences for the patient’s employment, or social or personal life
• Providing clinical care is not the primary purpose of the investigation or treatment
• The treatment is part of a research programme or is an innovative treatment designed specifically for their benefit.
The three components of consent are: voluntariness, information and capacity. For consent to be valid consent must be voluntarily given, the patient must have information regarding the treatment concerned and must be competent to do so.
Voluntariness
It is useful to create a suitable environment to facilitate voluntary consent taking. It is good practice to take consent prior to the patient entering the operating room, as this environment places the patient under pressure and may invalidate consent.2 Suitable environments, which allow privacy and sufficient time for the patient to understand the information provided and to ask questions, include outpatient clinic and ward quiet rooms.
Patients may occasionally withdraw consent during a procedure. Should this occur, the doctor should immediately stop the procedure (even temporarily) and explore the patient’s concerns. Medication or pain may affect the patient’s capacity at this time. However, if the patient wishes the procedure to end and there is no possibility of immediate harm, the patient’s wishes should be accepted as a withdrawal of consent and the procedure halted.2
Information
Who?
The person providing care should take consent for the procedure. If this responsibility is delegated, the individual taking consent should have sufficient knowledge of the procedure.3 Confirmation of consent, done at the time of the procedure, remains the responsibility of the doctor performing the procedure.2
When?
For non-urgent procedures consent should be taken at least 24 hours prior to the procedure to allow the patient to consider the options available to them and change their mind if they wish to.4 There is no specific time limit on consent as long as the information provided to the patient has not changed with the passage of time.
What?
The GMC recommends the following information be provided to the patients prior to any procedure (GMC 2008):1
• The diagnosis and its prognosis
• Treatment or management options for the condition, including the option not to treat
• The purpose of any proposed investigation or treatment and what it will involve
• The potential benefits, risks and burdens, and the likelihood of success, for each option; this should include information, if available, about whether the benefits or risks are affected by which organization or doctor has chosen to provide care
• Whether a proposed investigation or treatment is part of a research programme or is an innovative treatment designed specifically for their benefit
• The people who will be mainly responsible for and involved in their care, what their roles are, and to what extent students may be involved
• Their right to refuse to take part in teaching or research
• Their right to seek a second opinion
• Any bills they will have to pay
• Any conflicts of interest that you, or your organization, may have
• Any treatments that you believe have greater potential benefit for the patient than those you or your organization can offer.
The GMC advises that doctors discuss these matters with patients, encourage them to ask questions, listen to their concerns and ask for and respect their views.