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R&D Approval - Indemnity Arrangements
Establish Indemnity Arrangements
The Clinical Trials Regulations that govern trials of medicinal products makes it a legal requirement for the sponsor and the lead investigator to ensure that adequate arrangements are in place to address insurance/indemnity for the trial.
A useful summary can be found
on the DH website. 'Research
in the NHS: indemnity arrangements'
This note summarises the current position on NHS indemnity for NHS bodies
involved in research. It is a guide to managing the risks associated with
research that involves NHS staff and/or NHS patients, including their organs,
tissues or data. These notes represent existing guidance as in 'HSG(96)48:
NHS Indemnity - Arrangements for handling clinical negligence claims against
NHS staff' and the associated good practice document.
Non-commercial clinical research on NHS patients - Arrangements for negligent harm
Indemnity arrangements within public bodies, especially the NHS, can address only negligent harm. This is the legal liability that arises from the NHS Trust's duty of care towards patients.
Where an individual is harmed in the context of R&D, and an individual or group of individuals can be demonstrated to have caused that harm because of their negligence through, for example, not following an agreed procedure according to set policy or protocol, then that would be deemed negligent harm.
Therefore if an NHS patient is harmed in the course of research as a result of negligent actions on the part of staff (including those working under Honorary Contracts) then the NHS Trust is liable or vicariously liable. In such cases, the NHS Trust would be responsible for dealing with claims arising against the Trust for the harm caused, according to the details of each individual case (but see below for comments on Independent Contractors).
The Trust NHS participates in the Clinical Negligence Scheme for Trusts (CNST), run by the NHS Litigation Authority, which pools the risk of clinical negligence claims.
The Trust will only extend NHS indemnity cover (for negligent harm) to its employees, both substantive and honorary, taking part in projects that have been approved by the R&D Department. The Trust can't accept liability for any activity that has not been properly registered and managerially approved.
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Non-negligent harm arises where an individual has been harmed in the context of R&D, through no fault of an individual or institution involved in the research and even though all the correct policies and procedures have been followed.
It is the role of ethics committees to decide whether or not a study can go ahead without a scheme of compensation for harm caused where there is no negligence.
NHS indemnity arrangements do not extend to non-negligent harm and NHS bodies cannot purchase commercial insurance for this purpose. NHS bodies cannot give advance undertaking to pay compensation when there is no negligence attributable to their vicarious liability.
The agreements
between research partners clarifying who holds the respective responsibilities
for the research, as well as the patient information leaflets, should specify
whether there are arrangements in place for non-negligent harm. Where
there are no arrangements in place for non-negligent harm, or where such
arrangements are limited to consideration of ex-gratia payments, this should
be clearly stated in the agreements between the research partners and in
patient information leaflets.
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Pharmaceutical companies act as sponsor of their own research and are expected to hold adequate insurance cover to indemnify the research.
For contract clinical research, the Trust expects standard Association of the British Pharmaceutical Industry (ABPI) (no fault) indemnity cover or equivalent (approved by the Research Ethics Committee) to be provided by the commercial company.
The R&D Department, on behalf of the Trust, and the commercial company must sign the indemnity agreement before the research begins.
A copy of the ABPI
Indemnity can be downloaded here:
ABPI
Indemnity 
(The sections
above are adapted from the National R&D Forum's ‘Indemnity Arrangements
for Primary Care' Jan 2005)
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Trials initiated by NHS employees, using marketed equipment, would be covered by NHS Indemnity for negligent injury to patients/volunteers.
In the case of trials of medical devices sponsored by manufacturers the company should provide ‘no fault' indemnity arrangements for non-negligent injury which are analogous to those provided for drug trials by the ABPI Guidelines.
The device being used should have a CE approval mark indicating that a product satisfies recognised standards and is safe for its intended use. If it hasn't, investigators should provide relevant safety details.
For further information
on the indemnity arrangements for the use of the equipment or medical device,
please see Research
Involving Medical Devices or contact the Medical Physics
Department Tel: 0113 39 23486
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