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The University has established a block "Clinical Trials" insurance policy to indemnify the University against risks associated with design of protocol and where required with treatment and site risks associated with University clinical research studies. To be registered for this cover specific application must be made to the Insurance Section and where extra premium applies this must be paid by the research project concerned.

Negligent harm

Standard liability at law where the person alleging injury must prove that the other party has been negligent in observing their duties at law. The party being sued can defend themselves by showing that they have taken all reasonable precautions to avoid injury to the person or property of another. Cover arranged on this basis would require the injured research participant to sue the University for damages and to prove negligence. The cover will always respond to claims for negligent protocol design but will only respond to claims for negligent execution of the protocol where the University is sole sponsor for the study.

Non-negligent harm

Compensation provided where only the likelihood of fault needs to be shown. In this case it is not necessary for the injured research participant to prove negligence: they must simply show that on the balance of probability injury was caused by the other party. In the case of a research study participant bringing a claim against the University it would only be necessary for the subject to show that their health had deteriorated during the period of the trial. Where a claim is bought on a non-negligent harm basis the cover includes the option for the claimant to sue on a negligent harm basis rather than asking for compensation. So where you have applied for and received a letter stating the availability of insurance for non-negligent harm it can be stated that cover is available and can be arranged if Ethics approval is granted for both negligent harm and non-negligent harm on the application for NHS Ethics Committee approval.

Protocol risks

University clinical trials insurance is primarily concerned with claims for negligent protocol design. The designer of the Protocol is usually a qualified medical practitioner. The substantive employer of the protocol writer is responsible for providing insurance for the Design of Protocol. Whether the research is jointly or solely sponsored by the University, University employed Principal Investigators (PIs) are responsible for arranging insurance for Design of Protocol, for each study, with the University insurance office.

Medical Defence Union Membership (MDU)

Whilst the policy will respond to protocol risks, cover under the policy excludes the clinical treatment risks of physicians, surgeons and dentists. So for studies solely sponsored by the University, physicians, surgeons and dentists should arrange personal medical malpractice cover with their MDU.

Please refer to Appendix A for further explanation of the Terminology that you may encounter with Clinical Trials Insurance.