It is important to advise Finance & Insurance Officer, Financial Services on (02) 4221 5236, of any claim notification or of a situation that may give rise to a possible claim as soon as possible.
General Clinical Trials Protection provides the University with insurance for legal liability to pay damages or compensation as a result of any claim or claims made by research subjects for bodily injury caused by any act, error or omission in connection with clinical trials approved by the University’s Ethics Committee and undertaken by the University within the Commonwealth of Australia after 21st May 1997.
Protection is subject to certain terms, exclusions, conditions and limitations.
You must notify Financial Services of ALL trials you are planning to undertake. Failure to do so may result in your trial not having adequate insurance cover. Financial Services, along with the provider of the University’s protection, will decide if your trial falls within the below definition, and if so, will arrange protection. Unfortunately, this is not a decision that the Researcher is able to make.
The definition of a clinical trial is as follows:
“Clinical Trial" means:
(a) a study or research involving humans:
(i) to find out whether an intervention, such as treatments or diagnostic procedures, which is believed may improve a person's health, actually does so; or
(ii) to test a drug, a surgical or other therapeutic or preventative procedure or a therapeutic, preventative or diagnostic device or service;
where the nature of the study or research is such that it requires the investigator or an assistant to be a registered medical practitioner or other registered qualified health service provider; or
(b) research involving humans requiring any invasive procedure to be undertaken by a registered medical practitioner or other registered qualified health service provider. For the purpose of this definition, "invasive procedures" means any procedure involving ingestion, application or admission of any substance or material onto or into a human’s body. Invasive procedure does not include:
(i) ingestion of drinks, food or fluids which are commercially available in the marketplace at the time of the ingestion; or
(ii) taking of blood samples.
Further information:
http://www.uow.edu.au/research/rso/ethics/human/
Clinical Trial Insurance Guidelines [pdf - 28kb]
To View Core Protections Outlining Clinical Trials
