Human participant research (including clinical trials)

The University of York has insurance in place to protect its legal liabilities arising out of research or studies involving human participants and also for clinical trials, subject to certain exclusions.

Research, studies or trials that are covered automatically

Cover is automatic if the research is within the UK and limited to the following activities:

• questionnaires, interviews, psychological activity including CBT
• venepuncture (withdrawal of blood)
• 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).

If you require confirmation of the cover for the above activities please contact insurance-enquiries@york.ac.uk.

For all other research please contact insurance-enquiries@york.ac.uk with an outline of the study including the protocol, patient information sheet and patient consent form (if applicable).

Research, studies or trials that are not covered automatically

Cover is not automatic if the research, study or trial includes any of the following:

• Pregnancy
• Participants under 5 years of age
• Cell and Gene Therapy, including Gene Editing
• Therapies targeting the brain, blood-brain-barrier or Cerebrospinal fluid
• any Trial undertaken outside of the UK

If the research, study or trial involves any of the above please contact insurance-enquiries@york.ac.uk as soon as possible to discuss and arrange cover before commencing the research/study/clinical trial.

For the purpose of indemnity/cover 'clinical trial' means: an investigation or series of investigations conducted on any person for a medicinal purpose.

'Medicinal purpose' means:

• treating or preventing disease or diagnosing disease
• ascertaining the existence degree of or extent of a physiological condition
• assisting with or altering in any way the process of conception
• investigating or participating in methods of contraception
• inducing anaesthesia
• otherwise preventing or interfering with the normal operation of a physiological function.
  

Chief Investigators are reminded of the need to consider pregnancy in the inclusion/exclusion criteria.