Clinical 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.

How do I obtain proof / confirmation of cover?

Details of Insurance Cover

The Research Governance Team should be contacted in the first instance to determine / confirm which category a study falls into.

Minimal Intervention Studies:

If the nature of your study intervention is limited to only the following activities:

          a.    Questionnaires, interviews, psychological activity including CBT, Data-only studies;
          b.    Venepuncture (withdrawal of blood);
          c.    Muscle biopsy;
          d.    Measurements or monitoring of physiological processes including scanning;
          e.    Collections of body secretions by non-invasive methods;
          f.     Intake of foods or nutrients or variation of diet (other than administration of drugs)

 

then it will be covered by our existing Public Liability Insurance

Other Non-drug studies:

Liability for negligent harm to research participants in more interventional studies is also covered under Public Liability unless it falls into one or more of the following categories:

  • 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

If your study meets any of these exclusions, the Research Governance Team will refer your study to the Insurance Team.  An additional premium may be required.

MHRA Approved Studies (CTIMPS and Medical Device Trials):

The University has a specific Clinical Trials policy to cover legal liability for injuries to participants in Clinical Trials of Investigational Medicinal Products and Clinical Investigations of Medical Devices.

However, these studies must be referred to Insurers.  The Research Governance Team will refer your study to the Insurance Team.  An additional premium may be required.

Non-Negligent Harm (No-Fault) Cover

The standard policy does not include No-Fault cover. (If your agreement with an NHS partner is via an OID, section 2.15 of appendix 1 should be deleted.) If a funder or collaborator require No-Fault cover, the Research Governance Team will refer your study to the Insurance Team.  An additional premium may be required.

Ethics form indemnity specimen answers:

Please use our  Specimen Answers (PDF, 64kB) ‌ for the indemnity questions on your ethics form.

Insurance guidance for Medical Practitioners:

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

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