Skip to main content
Finance

Breadcrumb

  1. Finance Department
  2. Sections
  3. Insurance
  4. Policy Information
  5. Clinical Trials

Clinical Trials

The University holds two types of insurance to cover claims arising from its involvement in clinical trials: liability (Public Liability) and no-fault (Clinical Trials). 

The liability policies cover the University's legal liability to third parties, including subjects and sponsors. The no-fault policy is intended to provide compensation to subjects, regardless of liability, in the event of their suffering a significant and enduring injury (including illness or disease) which, on the balance of probabilities, is directly attributable to their involvement in the trial. 

The Public Liability policy covers harms to individuals which arise from their participation in a clinical trial where the University is shown to be liable. The limit of indemnity under this policy is £50m. 

This policy carries an endorsement which means that is does not cover legal liability arising from actual drug studies, nor those requiring non-fault compensation cover. Cover for these types of studies is provided under a separate Clinical Trials extension. It carries a limit of indemnity of £10m per trial, £12.5m in aggregate per annum. 

Any clinical research requiring a Clinical Trials authorisation from the Medicines and Healthcare Products Regulatory Agency under the Medicines for Human Use (Clinical Trials) Regulations 2004 is classified as a Clinical Trial. 

Cover for clinical trials excludes the following five:

  • Clinical trials or other intervention studies which aim to enrol pregnant women
  • Clinical trials or other intervention studies where subjects are under five at the time of entry to the study
  • Clinical trials or other intervention studies with international sites
  • Interventional trials which enrol more than 5,000 research subjects
  • Covid trials
  • Therapies targeting the brain, blood-brain-barrier or cerebrospinal fluid
  • Cell/gene therapy, including gene editing

In addition, insurers expect drug trials to be conducted in accordance with the Association of British Pharmaceutical Industry Guidelines. This means that where the trial is sponsored by a pharmaceutical company, that company should issue the standard ABPI form of indemnity and offer no-fault compensation. 

Claims from sponsors for the University's negligence in the conduct of a study is covered under the Professional Negligence policy. This carries a limit of indemnity of £10m per claim and in aggregate. 

The policies do not cover medical and dental practitioners while working a professional capacity. It is the responsibility of the individuals concerned to obtain insurance in their own name through an appropriate medical defence organisation.

It is essential that students acting as investigators are supervised by an employee of the University. 

Local CT policies [PDF 491KB]

Back to top