Clinical Research

Research Insurance

It is a requirement of any organisation undertaking research with human participants that they hold appropriate insurance to cover the eventuality of an individual coming to harm, as a result of the research, and making a successful legal case for damages. The insurance protects participants, by ensuring that any damages awarded can be paid, as well as financially protecting the University.

The majority of human-participant research is covered by the University's Public Liability Policy - in most cases, it is not something that you would need to interact with.

Exceptions to the Public Liability Policy

If you will be recruiting participants to an active interventional study

•  which is not a study in a health or social care setting (see below)

•  which is not limited to the following activities: Questionnaires, interviews, psychological activity including CBT, Data-only studies; Venepuncture (withdrawal of blood); Muscle biopsy; Measurements or monitoring of physiological processes including scanning; Collections of body secretions by non-invasive methods; Intake of foods or nutrients or variation of diet (other than administration of drugs)

•  and which involves any of the following: More than 5,000 research subjects; Children under the age of 5; Pregnant research subjects; Conception / contraception; Genetic engineering; Investigation of an interventional substance designed or manufactured by the University; Trials undertaken outside the UK; Research into hepatitis/HIV/AIDS/LAV/CJD

then additional cover may need to be arranged. If that is the case, please contact research-governance@bristol.ac.uk to discuss.

Health and Social Care Research

If you are conducting research in a health or social-care setting and are required to complete an IRAS form, you will require proof that the University has appropriate insurance.

Research of this nature, that is Sponsored by the University, is covered by our Clinical Trials Insurance. (Note, in this context "Clinical Trial" does not relate to any of the other established definitions of the phrase - this policy applies to all health/social-care research).

As part of your IRAS application, you will need to answer questions relating to Insurance. Please refer to our IRAS Insurance Guidance. Note, this guidance is new as of 2022 - please do not copy from previous applications.

You will also be required to include information relating to insurance in Patient Information Leaflets. Please refer to our PIL Insurance Guidance. Note, this guidance is new as of 2022 - please do not copy from previous applications.

Clinical Trial Insurance Exceptions

This policy applies to all health/social-care research unless you are recruiting participants for an interventional study and it involves:

•  More than 5000 participants

•  Participants under 5 years of age

•  Pregnant participants

•  Overseas sites

If this is the case, additional cover may need to be arranged. Please contact research-governance@bristol.ac.uk to discuss.

Third Parties

Both the Public Liability and Clinical Trial policies cover liability arising from the design or oversight of the study and the actions of anyone acting under the direction of the research team. However, it does not cover any harm arising from individual negligence. Essentially, if someone working for a third-party conducts a trial procedure in accordance with the relevant protocol or work-instruction, and someone comes to harm, the University's insurance will apply. However, if they did not conduct the procedure in accordance with the relevant protocol or work-instruction then the University's policy will not apply - they will be reliant upon their employer's policy or their own professional/clinical negligence cover.

Non-Fault Insurance

Neither policy covers non-fault / non-negligent harm as standard. If this is required by a funder or partner, contact research-governance@bristol.ac.uk to discuss.