The majority of research involving human participants has an element of risk and therefore it is essential that appropriate insurance arrangements are in place.
Under the umbrella of the University’s Public and Products Liability Insurance Policy sits our Clinical Trials Cover.
The definition of a Clinical Trial according to the University’s current insurers is as follows:
"Anything requiring general anaesthetic, any surgical procedures, implants, or anything requiring injection or ingestion of drugs and/or chemicals."
A caveat to this is that blood tests that are the sole clinical activity of a trial are agreed as Non-Invasive provided that none of the exclusions below apply.
Exclusions to the Clinical Trials Cover policy are as follows:
- Legal liability under agreement:Any liability for injury which attaches solely because of an agreement or contract
- Research participants that are pregnant: Any injury to any Research Subject who is known to be pregnant at the time of the Clinical Trial
- Research participants under the age of 5 years: Any Injury to an Research Subject who is under the age of 5 years at the time of the Clinical Trial
- Specific Clinical Trials: Any Clinical Trial
- In which the medical purpose is either assisting with or altering in any way the process of conception, or investigating or participating in methods of contraception.
- Involving genetic engineering other than a Clinical Trial on which the medicinal purpose is treating preventing or diagnosing disease.
- Where the substance under investigation has been designed and / or manufactured by the University.
- Hepatitis:Any claims arising from Hepatitis or any condition directly or indirectly caused by or association with Human T-Cell Lymphotrophic Virus Type iii (HTVL iii) or Lymphadenopathy Associated Virus (LAV) or the mutants derivatives or variations thereof or in any way related to Acquired Immune Deficiency Syndrome or any other syndrome or condition of a similar kind however it may be named.
- Creutzfeldt -Jakob disease:Any claim arising from any condition directly or indirectly caused by or associated with Creutzfeldt - Jakob disease (CJD) variant Creutzfeldt - Jakob disease (vCJD) or new variant Creutzfeldt - Jakob disease.
- Contracts:the failure of the University to fulfil its obligations under any contract entered into with the Research Subject.
- Overseas Trials: including trials where international sites are involved, trials where any of the research participants are non UK nationals or reside outside of the UK.
University’s additional criteria for referrals:
In addition to the exclusions above, R&IS also refer the following:
- Trials involving medicinal products, whereby a University employee has written the protocol, irrespective of co-sponsorship, as the liability for the design lies with the University.
- Trials involving participant recruitment targets of >1,200. The current limit of compensation for a project is £2 million in any one case, which leaves a risk of being under-insured.
- Medical Devices and/ or substances that have been manufactured and/ or designed by the University.
- Any Clinical Trial which involves the transfer of insurance coverage from one institution to another
The CI or a member of the project team should provide R&IS will the following information so that the trial can be assessed by R&IS and referred to the insurers as deemed necessary:
- The Protocol
- Patient consent forms and ethics application.
- Any terms and conditions
- Duration of the trial
- Staff involved in the project and the activities they will undertake.