Clinical Research

Details of insurance cover

Non-drug studies:

Liability to research participants in most research studies is covered under the University's Public Liability insurance.

Drug studies (CTIMPS and Medical Device Trials):

The University has a specific Clinical Trials policy to cover legal liability for injuries to participants in MHRA authorised clinical trials (basically drug or medical device studies).

Insurer: Zurich Municipal

Cover: £10 million any one claim/all claims in any one period of insurance

Help with completing an ethics form

To obtain confirmation of cover for an NRES application please send a copy of your draft ethics application form or protocol to insurance-enquiries@bristol.ac.uk so that the Insurance Officer can issue a letter confirming details of the insurance protection.

If your study requires no fault compensation (non-negligent harm) cover please let the Insurance Officer know as soon as possible and she will advise if it is available.

It is also important for you to let the Insurance Office know if your study will involve any of the following:

  • More than 5,000 research subjects
  • Children under the age of 5
  • Pregnant research subjects
  • Conception / contraception
  • Genetic engineering
  • Substances (the IMP) designed or manufactured by the University
  • Trials undertaken outside the UK
  • Research into hepatitis, HIV/AIDS/LAV/CJD
  • Other material fact (anything invasive or unusual that an underwriter will find pertinent to covering a risk)

Please use our Specimen answers (Office document, 37kB) for the indemnity questions on your ethics form.

Contact the Insurance Office if you need any help with the wording on indemnity on your participant information sheets or protocol.

For general guidance on research governance within the University please see the Research Governance website.

Please also see our Insurance Guidance for Medical Practitioners (Office document, 77kB)