Insurance and indemnity

Insurance and indemnity is required for all clinical research and is the responsibility of the sponsor.

A clear statement of who is providing cover, and under what circumstances, should appear in the study protocol, the participant information sheet and ethics application form.

For studies sponsored by Oxford University Hospitals the following form of words should be used:

NHS bodies are legally liable for the negligent acts and omissions of their employees. If you are harmed whilst taking part in a clinical trial as a result of negligence on the part of a member of the study team this liability cover would apply.

Non-negligent harm is not covered by the NHS indemnity scheme. Oxford University Hospitals NHS Foundation Trust, therefore, cannot agree in advance to pay compensation in these circumstances. In exceptional circumstances an ex-gratia payment may be offered.

If your study is sponsored by a commercial company or other non-commercial organisation, they will be responsible for providing indemnity and provide appropriate wording as applicable.