The University has protection which covers bodily injury of research subjects that results from the subjects participation in University clinical trials.
Clinical Trials are defined as:
A study or research involving humans:
- to test a drug, a surgical, therapeutic, preventative or diagnostic procedure or device where the nature of the study or study is such that it requires the investigator or an assistant to be a registered medical practitioner or other registered qualified health service provider; or
- requiring any invasive procedure to be undertaken by a registered medical practitioner or other registered quality health service provider.
For the purposes of this definition, invasive procedure means any procedure involving:
- penetration of the skin (other than taking of blood samples)
- biopsy or any taking of or extraction of tissue samples; or
- penetration of the bodily orifices (other than ears or mouth).
The definition of Clinical Trials does not include research or study
- involving evaluating outcomes of established healthcare management or treatment relating to condition or illness from which the participants are suffering; and/or
- only involves the participants completing questionnaires or interviews.
NB: Any knowledge of an event or which may give rise to a claim should be reported immediately to the Insurance team of the Risk and Assurance Unit. Failure to do so may limit or negate the insurance protection available to the University.