Background
The Clinical Trials EU Directive 2001/20 makes it a legal
requirement that provision has been made for insurance or indemnity
to cover the liability of the investigator and sponsor before a
clinical trial using medicinal products may be undertaken.
The Research Governance Framework requires that financial
arrangements are in place to compensate anyone harmed as a result
of negligent or non-negligent harm.
The NHS cannot purchase advance insurance to cover indemnity
because it is backed by the resources of the Treasury.
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.
Negligent harm is where an NHS patient is harmed in the course
of research, 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. In such cases, the Trust is liable or
vicariously liable and would be responsible for dealing with claims
arising against the Trust for the harm caused.
The Trust 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, conducting
research projects that have been approved by the R&D
Department. The Trust cannot accept liability for any activity that
has not been properly registered and Trust approved.
Non-negligent harm
Non-negligent harm arises where an individual has been harmed in
the course of research, 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 clearly whether there
are arrangements in place for non-negligent harm or if there are no
arrangements in place for non-negligent harm.
If the principal investigator is employed by the University of
Hull, the University has the responsibility for providing financial
cover for damages or compensation arising from non-negligent harm
(where applicable).
Summary
Hull and East Yorkshire Hospitals NHS Trust has indemnity to
cover claims arising from negligent harm, but not non-negligent
harm.
If the principal investigator is employed by the University of
Hull, the University has the responsibility for providing financial
cover for damages or compensation arising from non-negligent harm
(where applicable).