GUIDANCE NOTE ON RESEARCH GOVERNANCE AND NONNEGLIGENT HARM
In future, any research requiring the collaboration of the NHS or community care
services in Scotland must have an organisation willing and able to take on the
responsibilities of research sponsor, and the host care organisation is responsible for
making sure there is one. Where there is no external sponsor, there will have to be a
NHS care organisation willing and able to act as sponsor.
The Research Governance Framework emphasises the sponsor’s role in assuring the
quality of research. This includes ensuring the proposal respects the dignity, rights,
safety and well-being of participants, as well as making arrangements to review
developments that put the safety of individuals at risk and approve modifications in
the design of the research.
Ethics committees are responsible for advising whether the risk of non-negligent harm
calls for the sponsor to ensure that there are arrangements for compensation. The
sponsor is responsible for ensuring that agreement has been reached about the
provision of compensation in the event of non-negligent harm.
A no-fault injury could be a side-effect or some other unintended consequence of the
research. While there may then be no legal obligation to provide compensation, the
case for compensation may be stronger if there was a risk of injury that the protocol
was designed to minimise and manage.
Because the sponsor accepts responsibility for assuring the quality of a research
activity, it is likely to be the first port of call for a claim for compensation. If the
sponsor agrees formally with another body to rely on its monitoring systems (for
example), the other body may agree to share or take on the risk and be prepared to
consider claims for no-fault compensation.
In exceptional circumstances, (and within delegated limits), NHS bodies can consider
whether an ex-gratia payment could be offered. However, NHS bodies should not
offer advance indemnities or take out commercial insurance for non-negligent
harm and should not make ex-gratia payments for non-negligent harm if a nonNHS body is the research sponsor (see Clinical Negligence and Other Risks
Indemnity Scheme (CNORIS), MEL (2000)18).
Chief Scientist Office
November 2002