The issue of consent is based on the principle of patient autonomy (Hope et al, 2003). Informed consent is a way of actualising the notion of negative liberty (see autonomy) by protecting the patient against unwanted interference from the doctor (e.g. medical paternalism).
Lidz et al (1984) have analysed informed consent using three principal components and two subsidiary components.
- The three principal components for valid consent (informed, competent, voluntary)
- The two subsidiary components (understanding and deciding) can be seen as elements of competence.
Faden and Beauchamp (1986) have criticised this analysis as being too centred on the provision of information. It is too easy to provide extensive information and claim that the doctor had carried out their duty to the patient. They argue that while such an approach is legally safe, it is not ethically right. A distinction should be made between consent and assent. Assent may be mere submission to the doctor’s authoritative order. True informed consent requires the patient specifically authorising the doctor to initiate the medical plan: The patient assumes responsibility for the decision-making then voluntarily transfers that responsibility to the doctor.
Other ethical considerations
- The notion of informed consent assumes the patient is a fully rational and autonomous, and after being fully informed can freely agree (or disagree) to the intervention. However, many patients fall sort full autonomy (e.g. young, unconscious, mentally impaired,…). Simply being ill makes individuals vulnerable and further reduces capacity to exercise autonomy.
For competent adults
Valid consent requires that the following information has been provided:
- Nature of the procedure: including actions taken in the event of complications (this protects against an accusation of battery. Refer to case of Chatterton v Gerson (1981) below.
- Risks and benefits: the law does not give specific guidance for what risks need to be disclose and recognises that doctors will need to use their judgement. However, the Bolam test is widely used in cases where doctors are accused of negligence: a doctor is not guilty of negligence if they “reach a standard of a responsible body of opinion”.
Two main areas of law concerned with consent: battery and negligence”
- Battery is legally defined as unconsented touching. Unlike negligence, there is no need to prove that the person touched has suffered harm for damages to be awarded in the event of a crime of battery. Refer to case of Schloendorff vs Society of New York Hospital (1914).
- Negligence (as relates to consent) is the failure to provide relevant information before the patient agrees to a procedure. Refer to case of Sidaway v Bethlem (1985) below.
Capacity of the patient
- Competent adults have the legal right to refuse treatment or demand the withdrawal of treatment even if this refusal results in death or permanent injury. Refer to case of Re C (1994).
- Incompetent adults should be treated in their best interests and doctors (and other people) can make decisions on their behalf.
- Capacity to consent/refuse may persist even in a patient suffering from a mental disorder, provided he/she understands what is proposed.
- Buchanan and Brock (1989) propose three central capacities needed for competence:
- Understanding and communication (patient can become informed and express a choice)
- Reasoning and deliberation (person has the intellectual capacity to make a decision)
- The person must have a ‘set of values or conception of the good’ (person is able to evaluate particular outcomes as beneficial or harmful and assign weight or importance to them)
- Capacity is ‘functionally specific’: A person is not globally competent or incompetent – they can only be competent with regard to a particular thing. See case Park v Park (1953) below.
- Standard of proof for establishing capacity or lack thereof is ‘the balance of probabilities’ as opposed to ‘beyond reasonable doubt’.
Other legal considerations
- The consent form has no legal force: Consent can be written or spoken – the form just ensures consent has been obtained. It is useful to inform other members of the healthcare team that consent has been obtained already. Also useful as evidence.
- Consent can be implied: If you ask to take a patient’s pulse and they roll up their sleeve offering their wrist, that is implying consent.
- Cases where the the doctor does not know what is necessary until the procedure is performed can be a grey legal area. See cases Marshall v Curry (1933) Devi v West Midlands (1980) below.
- Alder Hey (1988-1995), UK: Unauthorised removal, retention and disposal of human tissue, including children’s organs. Similar events at Bristol Royal Infirmary. Defence from the hospitals was that parents had signed a form consenting to the removal of tissues for research purposes, but the parents didn’t understand what they were signing. This led to the passing of The Human Tissue Act, 2004.
- Park v Park (1953), UK: Mr Park got married in the morning to the woman who had been caring for him and in the afternoon he made a new will leaving everything to her. Children challenged his competence to make these decisions. Judged ruled that he had the capacity to understand getting married but not changing his will which is a more complex decision.
- Schloendorff v. Society of New York Hospital (1914), USA. Patient consented to abdominal examination under anaesthetic but not to operation. The surgeon removed a fibroid. Judge ruled that the surgeon’s action amounted to assault. This case has been absorbed into English common law.
- Sidaway v Bethlem (1985), UK: Doctor failed to inform the patient that there was a less than 1% risk that the cervical cord decompression operation she would undergo might result in paraplegia. Court rejected the patient’s claim for damages, stating that consent did not require an elaborate explanation of remote side effects. However, one of the Law Lords stated that if there is a “significant risk which would affect the judgement of a reasonable person, it is the responsibility of the doctor to inform the patient of that risk.”
- Chatterton v Gerson (1981): Doctor failed to warn patient of the risk of losing sensation in one of her limbs following the operation. Judge found consent was valid and doctor was not guilty of battery.
- Marshall v Curry (1933), Canada: Doctor removed diseased testicle during hernia operation on the grounds that removal was necessary for hernia repair and the gangrene threatened patient’s life. Judge upheld surgeon’s action.
- Devi v West Midlands (1980), UK: Patient went in for minor operation on womb, but doctor discovered womb was ruptured and sterilised patient on grounds that future pregnancies would put her at risk. Judge ruled in favour of the patient.
- Re C (Consent and Partial Mental Competence) (1994), UK: C was a paranoid schizophrenic who injured his leg. As the wound became gangrenous, doctors advised below knee amputation to avoid death. C refused and sought an injunction to prevent the doctors doing this. The injunction was granted.