Obtaining informed consent is a legal and ethical necessity before treating a patient. It derives from the principle of autonomy; one of the 4 pillars of medical ethics: (Autonomy, Beneficence, Non-maleficence and Equality - as described by Beauchamp and Childress1). Touching/treating someone without permission could be considered assault or battery under criminal law and civil law, even if the person was helped by your actions.
For consent to be valid it must be informed consent. For this to be the case it must be:
- Given voluntarily (with no coercion or deceit)
- Given by an individual who has capacity
- Given by an individual who has been fully informed about the issue.
Consent can be written, verbal or non-verbal/implied. A written consent form is not the actual consent itself, but evidence that consent has been given (most forms include sections to record the important aspects of the procedure the patient has been informed of). Implied consent is an action such as offering your arm for blood samples. It can be unreliable as a patient may argue that their actions were misunderstood and they did not actually wish to consent.
Sidaway vs Bethlem Royal Hospital Governors 19852 - a case where a patient was left with paralysis after an operation to relieve a trapped nerve. In the court of appeal, the patient claimed negligence as she had not been informed of the risk of this outcome. The judge rejected the appellants claim as a respectable body of medical opinion agreed that it was not necessary to warn a patient of every risk (Bolam test - see below). The case did however establish in English common law that a doctor has a duty to provide to their patients sufficient information for them to reach a balanced judgement. Patients must be informed how necessary a procedure is, any alternatives, and any common or serious consequences of it. (There remains some debate of what constitutes "common" or "serious".)
If a patient is not properly informed and suffers harm as a result of the procedure, the doctor will be liable for negligence.
The Bolam test is important in cases of negligence. In Bolam vs Friern Barnet Management Committee 1957 a patient suffered severe injuries as a result of receiving Electro Convulsant Therapy without muscle relaxants. The judge ruled taht the doctor had not been negligent and noted that "A doctor is not guilty of negiligence if he has acted in accordance with with a practise accepted as proper by a responsible body of medical men skilled in that particular art." The doctor can still be found to be negligent if common practise is thought to be unreasonable by the court.
Children aged under 16 can be judged to have capacity to consent on a case by case basis if they can fully understand what they are consenting to ('Gillick competent'3). This means that they must understand not only the medical aspect but also the moral and ethical ones too. If a child is not competent to consent, a proxy with parental responsibility can make decisions in the child's best interests (these can however be overruled in court if they are decided not to be in the child's best interests). The parents can consent to a treatment even if their child has refused. The courts can also consent on behalf of a child. The court can overrule a refusal to consent given by the child and the parents and this has happened in several cases where a family of Jehovah's Witnesses have refused consent to a life saving blood transfusion. The courts have also overrulled refusal to give consent to life saving treatment in Gillick competent children. Although this seems to go against individual autonomy the courts tend to take a paternalistic "best interests" approach to children choosing to die.
- Beauchamp and Childress. 1979 The Principles of biomedical ethics.
- Sidaway v. Bethlem Royal Hospital (1984) All Engl Law Rep. Feb 23; 1:1018-36.
- Gillick v West Norfolk and Wisbech Area Health Authority. 19884 All Engl Law Rep. 1984 Nov 19-Dec 20 (date of decision);1985(1):533-59.
- General Medical Council (UK). Ethical guidance: Confidentiality. October 2009.
- Beauchamp TL, Childress JF. Principles of biomedical ethics, 5th edn. Oxford: Oxford University Press 2001.
- W v. Egdell. All Eng Law Rep. 1989 Nov 9; 1:835-53.
- Her Majesty's Stationery Office (UK). The Data Protection Act (1998). 1998
- General Medical Council (UK). Confidentiality: Protecting and Providing Information. September 2000 .