informed the workers, before they agreed to participate, of any risks inherent in the vaccine to be administered. This is the doctrine of ‘informed consent’ and it is part of the law of negligence. In Sidaway v. Board of Governors of the Bethlem Royal and the Maudsley Hospital (1985) it was held by the majority in the House of Lords that the Bolam test should be applied to issues of consent and that health professionals, when seeking consent, must give the patient the information which a reasonable health professional would give. However, the law was changed by the Supreme Court in Montgomery v. Lanarkshire Health Board (2015). The claimant was a woman of short stature who was diabetic. She was pregnant and under the care of a consultant obstetrician employed by the Health Board. There was a risk of a larger than average baby and of shoulder dystocia if delivered vaginally. The risk of a serious injury in that event was small, around 0.2 per cent. The doctor did not warn the mother of this possibility nor advise her of the available alternative of delivery by caesarean section since the risk was small and she held the opinion that caesarean sections are not in general in the mothers’ interests. Shoulder dystocia occurred during labour and the baby was deprived of oxygen, resulting in cerebral palsy and a brachial plexus injury. The Supreme Court rejected the Bolam test in the context of consent to treatment. They held that a patient should be given the information that a reasonable patient would want to know, rather than what a reasonable doctor would tell them.
The judgment summarised the law as follows:
An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.
Assessment of materiality of risks cannot be reduced to percentages but depends on a number of factors including the circumstances of the particular patient and the seriousness of the risk. The doctor should engage in a discussion with the patient giving information in a form which the patient is able to understand. It is only exceptionally that the doctor is entitled to withhold from the patient information that might be psychologically damaging (therapeutic privilege). The doctor must allow the patient to make an informed choice even if it is arguably contrary to their best interests. And, of course, the signing of a consent form is not conclusive. There must be documented evidence of a discussion with the patient before the signature is obtained. In 2019 the GMC engaged in consultation about the revision of its guidance on consent.
The consent of an individual to the taking of blood will prevent it from being either a criminal or civil battery, unless he was misled by false information as to the purpose of the test. It is a breach of the data protection legislation to use the results of a test taken for one purpose for a different purpose (Chapter 3).
Where a health care worker has suffered a needlestick injury and has been exposed to the blood or body fluids of a patient who is unconscious or otherwise incompetent, there is doubt about whether an HIV test may lawfully be performed on blood already obtained from the patient for other purposes. Under the common law and the Mental Capacity Act 2005, procedures can be undertaken without consent in the patient’s best interests where a patient lacks capacity. The problem is that such a test would be undertaken to protect the health care worker, not the patient. Where there is a likelihood that the patient is HIV‐positive, post‐exposure prophylactic drugs may be administered to the health care worker as a precautionary measure, but these drugs carry serious side effects and it would obviously be preferable if they could be avoided. The legal position has become even more uncertain since the Human Tissue Act 2004 became law (the law is different in Scotland, where the Human Tissue (Scotland) Act 2006, under review, does not cover tissue removed from living people, other than for transplantation). Under the Act, appropriate consent is needed to be able to retain blood or tissue from a living individual. If the patient has not been told that retained blood may be tested for blood‐borne viruses and given consent, such a test is in apparent breach of the Act. In addition, if a conscious patient is asked to agree to a test and refuses, the test cannot lawfully be performed. One option that has been suggested is to offer the patient a test, but to undertake that a positive result will not be recorded. However, in that event it would surely be negligent not to offer treatment to the patient. Anti‐retroviral drugs have been very successful in prolonging the lives of those living with HIV. The Faculty of Occupational Medicine’s Ethics Guidance for Occupational Health Practice (2018) states at paragraph 3.53 that currently there is no exception to the need for consent to test source patient samples. However, in Aintree University Hospitals NHS Foundation Trust v. David James (2013), the Supreme Court advised that where there is evidence, probably from relatives, that a patient who currently lacks capacity would, if they had capacity, have been willing to agree to a medical procedure for the benefit of others, the doctor may be entitled to authorise the procedure in the patient’s best interests. In 2016 the BMA published detailed guidance: Needlestick injuries and blood‐borne viruses: decisions about testing adults who lack the capacity to consent.
In CM v. Executor of the Estate of EJ (deceased) and HM Coroner for the Southern District of London (2013) the issue was the legality of taking blood samples from a dead body. CM was a doctor who went to the assistance of a woman lying seriously injured in the street. She attempted emergency first aid but this was unsuccessful and the woman died at the scene. On returning home the doctor noticed that she had various abrasions on her hand. She commenced a course of post‐exposure prophylactic (PEP) antiviral medication to reduce the risk of HIV infection but was suffering bad side effects. She asked the coroner to authorise the taking of a blood sample from the dead body. The Human Tissue Act provides that where the patient is dead, consent must be obtained from a person with a qualifying relationship with the deceased. The problem was that the patient was a foreign national who only had one relation in the UK, a cousin of her mother. On application to the High Court, the judge held that the cousin was sufficiently close to have a qualifying relationship and authorised the blood test. It showed that the deceased was not carrying a blood‐borne virus and the doctor was able to stop taking the PEP drugs.
The testing of anonymous samples, such that the donor cannot be made aware of the result because the tester does not know his identity, is lawful, whether or not it is ethical. Testing of identified samples without the knowledge of the donor is not anonymous; the tester can identify the samples. It is the latter kind of procedure which could lead to an action in negligence, because the employee has not given informed consent.
It should be noted that when a statute provides for obligatory medical examination of workers it does not mean that they can be physically examined without their consent. Such statutes commonly provide that the worker has a statutory duty to present himself for a test, e.g. Regulation 35(5) Ionising Radiations Regulations 2017:
An employee … shall when required by his employer and at the cost of the employer, present himself during his working hours for such medical examination and tests as may be required … and shall furnish the employment medical adviser or appointed doctor with such information concerning his health as the employment medical adviser or doctor may reasonably require.
If the employee refuses, the doctor must respect that decision although the employer will then be justified in taking disciplinary action, since the employee will be in breach of the law.
Increasingly, health care workers are required by their employers to be vaccinated against communicable diseases like measles and chicken pox so as to protect patients from possible infection. Comprehensive guidance can be found in Immunisation against infectious disease: the green book (Department of Health and Social Care,
