Standard responses in the IRAS application form

The IRAS application form required for submission to an NHS Research Ethics Committee asks specific questions about insurance and indemnity. Applicants are asked to use the IRAS Q&A Insurance guidance, to complete these questions in the IRAS application.

Clinical Negligence

The NHS has a duty of care to all patients and participants of studies in a NHS clinical setting. If any patients/participants suffer harm due to the Trust or clinician failing in their duty of care, then the Clinical Negligence Scheme for Trusts will cover financial damages which may be payable once negligence is admitted or proven in a court of law.

NHS Indemnity Scheme

All NHS Trusts (including Foundation Trusts) and Primary Care Trusts (PCTs) in England currently belong to the Clinical Negligence Scheme for Trusts(CNST) although memembership of the scheme is voluntary, the scheme covers the trusts for clinical negligence claims once proven in court.

The Clinical Negligence Scheme for Trusts (CNST) is a scheme of risk pooling. It provides indemnity cover for NHS bodies in England who are members of the scheme against clinical negligence claims made by or in relation to NHS patients treated by or on behalf of those NHS bodies. In all cases the Trust has the capacity to provide financial cover for damages or compensation arising from negligent harm. Non-negligent harm carries no legal liability and it is beyond the power of NHS organisations to give indemnity for compensation in the event of non-negligent harm and therefore NHS organisations may not offer advance indemnities or take out commercial insurance for non-negligent harm. The NHS Indemnity Scheme does not provide financial cover as a general rule, in cases where the fault of the hospital or clinician has not been proven or admitted.

CNST asks each of its members to contribute a sum of money to a pool from which claims are settled. The contribution required of each member is based on the level of risk that that member poses. For example, hospitals performing high risk procedures such as obstetrics would be asked to contribute more than members that do not perform such procedures. CNST is a non-profit scheme run by the NHS for the benefit of its members and their patients.

The CNST exists to provide a fair and cost-effective means of handling clinical negligence claims against NHS trusts in England and also to provide risk management guidance, so that adverse incidents and hence claims are reduced in number. CNST contributions are significantly lower than the equivalent commercial insurance premiums.

CNST is administered by the NHS Litigation Authority (NHSLA) which assesses risk levels, sets contribution levels and manages claims on behalf of CNST members.

The Clinical Negligence Scheme for Trusts handles all clinical negligence claims against member NHS bodies where the incident in question took place on or after 1 April 1995 (or when the body joined the scheme, if that is later). While Independent Sector Treatment Centres cannot join the scheme in their own right, they can benefit from cover when treating NHS patients via the membership of their referring PCT.

Further information can be found on the NHS Litigation Authority website.