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Clinical trials

ECU is involved in research activities which can include clinical trials.  ECU has a duty to our insurer, Unimutual, to notify them of ECU's involvement in any clinical trials prior to the clinical trial commencing.

Early notification of clinical trials ensures that insurance protection is afforded to both the University and the researchers during the clinical trial period.  Whilst Unimutual provides Medical Malpractice Protection (Medical Treatment Liability) to the University, this cover does not automatically extend to clinical trials.  As such, a separate protection must be applied for all “clinical” trials.

The following clinical trial definition is used by Unimutual.  The definition helps provide clear understanding and clarity to researchers and support staff as to what constitutes a clinical trial.

A clinical trial is:

A study or research involving humans:

  • To test a drug, or a surgical, therapeutic, preventative or diagnostic procedure or device 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
  • Requiring an invasive procedure to be undertaken by a registered medical practitioner or other registered qualified health service provider.

For the purpose of this definition, invasive procedure means any procedure involving:

  1. Penetration of the skin (other than taking of blood samples);
  2. Biopsy or any taking of or extraction of tissue samples; or
  3. Penetration of the bodily orifices (other than ears or mouth) or insertion of diagnostic or other device within the bodily orifices (other than ears or mouth).

However, research or study involving humans where the research or study:

  • Involves evaluating outcomes of established health care management or treatment relating to the condition or illness from which the participants are suffering.
  • Only involves the participants completing questionnaires or interviews;

Will not be deemed to be a clinical trial.

If you are participating in a clinical trial activity as outlined above and have not advised ECU Insurance, you may be refused insurance cover in the event of a claim.

All research activities that include a clinical trial should undertake a Risk Assessment.  As part of the notification process to Risk and Assurance, you must have completed a Risk Assessment.  You must email and include “Clinical Trial Notification” as the title.

Your email should include the completed Clinical Trial Application form above, any applicable contract and acompleted risk assessment before ECU can submit the information to Unimutual for notification and acceptance.  If this has not occurred, insurance cover will not apply for the clinical trial.  Please allow up to fifteen (15) working days for the notification to be reviewed and response or confirmation provided.

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