individual is not cleared to perform EPPs is sensitive because it clearly implies that they are infected with a blood‐borne virus. For that reason such information should be confined to OH and to managers and others who need to know of the person’s EPP status. If a patient notification exercise is undertaken, care must be taken to limit the disclosure of the identity of the infected HCW to as few people as possible. In H (a health care worker) v. Associated Newspapers (2002) a HCW performing EPPs was found to be HIV positive and a patient notification exercise was proposed by the health authority. The HCW obtained a court order against a newspaper that his identity, his specialty and the identity of the health authority should not be published, but he was ordered to disclose to the health authority the records of his private, as well as his NHS, patients.
Patient notification exercises
These may be advised where it is discovered that a HCW has been performing EPPs, either not being aware of a BBV infection which has subsequently been diagnosed, or deliberately concealing it. Patients who have been put at risk are entitled to be made aware of this and to be offered a test in order to establish their status. A risk assessment is needed to establish, if possible, the likely period when the HCW was infectious. The full employment history of the HCW during that period must be compiled. Also, it will be important to establish the nature and history of the HCW’s clinical practice. Research may be needed into whether it is likely that the infected HCW was the source of iatrogenic transmission to a patient. The patient identification process will require the assistance of the medical records officer to identify patients treated by the HCW. It is recommended that in the first instance patients who have undergone relevant EPPs by a HIV infected HCW during the previous 10 years be identified. For PNEs involving HCV or HBV infected HCWs there is no specified time limit. Other factors which may be relevant are whether there is evidence of the HCW’s poor clinical practice or a physical or mental impairment which might have affected their standard of practice. UKAP can provide expert advice on the need to undertake a PNE but the responsibility lies with the local public health team. As these exercises are complicated and expensive to undertake, and cause damaging publicity and distress to patients, the decision is a difficult one to make. In practice, where there is no evidence of transmission of the virus to a patient, the decision whether to commission a PNE depends on an assessment of the degree of risk posed by the particular HCW in the particular circumstances.
2.12 Professional indemnity
Those who work for others rather than themselves often assume that any legal liability falls on the employer alone. This is definitely not the law. The primary liability for negligence lies with the person who commits the negligent act. Sometimes there is no alternative defendant. An independent consultant is the only possible defendant if he makes a careless mistake. If he is in partnership, his partners are also liable. Where the health professional is an employee, the employer is vicariously liable: they are both responsible. If the employer is in financial difficulty and uninsured, or claims a contribution or indemnity from the employee, or where the claimant out of revenge chooses to pursue the employee instead of or as well as the employer, damages and costs may threaten. The OH professional may be involved in a HSWA prosecution in which he may need legal advice and representation (it is not possible to insure against a criminal fine). For these reasons, every professional should be covered by professional liability insurance, despite the lack of a legal obligation to insure, and the guidance of the regulators is that they have an ethical duty to do so. In the past, nursing staff commonly insured through membership of the Royal College of Nursing (RCN) or a trade union. After the RCN in 2014 withdrew cover for its members who are directly employed and therefore included in their employer’s insurance, nurses were advised to check whether they were protected through an employer’s insurance or whether, if they were in the position of an independent contractor, they needed to take out and pay for their own professional liability insurance. Doctors usually obtain professional indemnity through a subscription to the Medical Defence Union or the Medical Protection Society. The latter are not, strictly speaking, insurance companies, because they have a discretion whether to indemnify (Medical Defence Union v. Department of Trade (1979)). In 2019 a Clinical Negligence Scheme for General Practice was introduced in England and Wales providing indemnity for all staff working in NHS General Practice. The Faculty of Occupational Medicine advises that in his own interest and that of his patients, the doctor should obtain adequate insurance or professional indemnity cover for any part of his practice not covered by an employer’s indemnity scheme.
Nurses are often troubled that they are not covered if they undertake ‘extended role’ tasks without proper authority. Because essentially the proper role of a nurse rests on custom and practice, it is impossible to lay down a definitive list of nursing tasks. The RCN in its guidance notes for the occupational health nurse advised that each OH department should draw up an agreement about the tasks which the nurse is expected to perform. No nurse should undertake any procedure for which she is not trained and competent. The RCN was reluctant to draw up lists of duties which could be regarded as a restriction on the development of the OH nurse’s role in a true professional sense. On the other hand, OH nurses need to recognise those areas of expertise which rightly belong to other professions, such as medicine, radiography or physiotherapy. The emphasis is on demarcation agreements, especially with doctors who carry the ultimate clinical responsibility, and on training to enable the nurse to extend her role competently.
2.13 The conduct of research
Research on humans is of two kinds: clinical research on ill patients (therapeutic) and research on healthy volunteers (non‐therapeutic). (Research on animals is regulated by completely different laws.) In law both need the informed consent of the subjects. In the case of a healthy volunteer who will reap no benefit from the research, it is likely that a court would expect maximum disclosure of risk.
Ethical rules are laid down in the Declaration of Helsinki 2000. The Helsinki Declaration demands that every subject:
must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and the potential risks of the study and the discomfort it may entail … the doctor should obtain the subject’s freely given informed consent, preferably in writing.
The 2000 amendments to the Declaration insist that therapeutic and non‐therapeutic research should be subject to the same controls. Department of Health guidelines have had to be substantially amended to allow for the changes brought about by the Clinical Trials Regulations 2004. The Research Governance Framework for Health and Social Care (Department of Health, 2001) indicated a need for review of NHS ethics committees and this was done under the umbrella of the Central Office for Research Ethics Committees (COREC). In 2007 the National Research Ethics Service was created. This body became the responsibility of the Health Research Authority (HRA) which was established in England in 2011 to coordinate the regulation of health and social care research. Similar bodies were created in Scotland, Wales and Northern Ireland. The HRA now comes under the Care Act 2014 as an executive non‐departmental public body. Governance Arrangements for Research Ethics Committees (2018) (GAfREC) describes the principles, requirements and standards for research ethics committees including their remit, composition, functions, management and accountability. Any research done on NHS premises, or using NHS records or patients, must first be submitted to an NHS ethics committee for approval. Application to all NHS research ethics committees is via the Integrated Research Application System (IRAS). Outside the NHS, ethics committees have been set up by, for example, universities, private hospitals and companies engaged in the testing of pharmaceutical products. NHS employees who fail to obtain ethics committee approval for a research project would be subject to disciplinary action. The professional bodies would be likely to regard a failure to obtain ethical approval as professional misconduct. Prior ethical review, however, is not needed for audit designed to examine the value and effectiveness of a system of care.
On 1 May 2004 the Medicines for Human Use (Clinical
