NHS bodies' duty of care applies both when a health care professional employed by the NHS body is negligent in the course of their employment and when the negligent health care professional was contracted to an NHS body to provide services to people to whom the NHS body owed a duty of care.
In either case, if there is negligent harm, NHS bodies will accept full financial liability. They are not expected to recover costs from the health care professional. NHS Indemnity is the understanding that NHS bodies will provide for these liabilities. NHS bodies may carry this risk themselves, or spread it through the Clinical Negligence Scheme for Trusts (CNST). The CNST provides unlimited cover for this risk. If there is negligent harm during a clinical trial when the NHS body owes a duty of care to the person harmed, NHS Indemnity covers NHS staff, medical academic staff with honorary contracts, and those conducting the trial, under NHS employment.
The Medicines for Human Use (Clinical Trials) Regulations 2004 does not require no-fault compensation. It requires insurance or indemnity covering liabilities of the sponsor and investigator. No-fault compensation is compensation when there is no legal liability.
Ethics committees are responsible for considering provision for indemnity or compensation in the event of injury or death attributable to the clinical trial, and any insurance or indemnity to cover the liability of the investigator or sponsor. It is for the ethics committee to consider in each trial whether it is acceptable to seek consent without no-fault compensation, given the risks of the trial.
NHS Indemnity does not offer no-fault compensation. Public bodies, including the Department of Health, the Medical Research Councin and NHS bodies, are unable to agree to pay compensation for non negligent harm.
Whatever arrangements are in place it is vital that this be communicated to potential research participants during the consent process and therefore a full explanation should be included in the patient information sheet.
A section explaining the indemnity arrangements is also required in the protocol