There are a number of conditions and principles based on the GCP Directive that apply to all Clinical Trials one of which is that ‘provision is made for insurance and indemnity to cover the liability of the investigator and sponsor, which may arise in relation to the clinical trial.’ The same can apply to all research that is conducted on human subjects taking part in a research project, namely that adequate insurance and indemnity is provided to safeguard participants during the research.

Adequate and appropriate insurance cover is the responsibility of the sponsor organisation and should cover the design, conduct and management of the research project. NHS indemnity will apply if the research is sponsored by an NHS Trust, designed by and NHS employee and conducted in an NHS setting. NHS bodies are liable for clinical negligence and other negligent harm to individuals covered by their duty of care. However, NHS indemnity does not offer no-fault compensation for non-negligent harm and NHS bodies are unable to agree in advance to pay compensation for non-negligent harm. They are able to consider an ex-gratia payment in the case of a claim.

When a research project is sponsored by an organisation or institution that is not an NHS organisation then separate arrangements should be made to provide adequate insurance cover to meet the potential legal liability of harm arising to an individual taking part in a research project.

Oxford Health NHS Foundation Trust will indemnify OHFT staff conducting research in an NHS environment through the NHS Litigation Authority (NHS LA).  Those researchers that are employed via other organisations will require indemnity to be provided by their employing organisations and access to OHFT be authorised via the Research Passport Application process (administered by the R&D department).  Those OHFT NHS employees conducting research as part of an educational programme and outside the Trust will require to source their own indemnity arrangements.