Insurance, indemnity and compensation

Insurance is required to be held by the Australian sponsor throughout the study. Some Australian states have specific requirements regarding the level of insurance cover and some sites require a copy of the sponsor’s certificate of insurance before commencing a trial.

Medicines Australia, an organisation representing the interests of the pharmaceutical industry, publishes Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored Clinical Trial and a Form of Indemnity for Clinical Trials. A standard Medicines Australia Form of Indemnity must be signed off by the Australian sponsor and the institution where the trial activities will be performed.

When considering a trial proposal, the Human Research Ethics Committee (HREC) needs to be satisfied that trial participants will be adequately compensated for the costs of any injury suffered as a result of participation in the clinical trial. HRECs verify compensation arrangements to ensure that they satisfactorily protect the interests of participants and the trial site. Terms of the available compensation should be explained to all prospective trial participants.

Clinical Trial Research Agreements

It is also useful to be aware that Australia and New Zealand have streamlined the contracting process between Sponsors and Sites. In Australia all states have agreed to using the Medicines Australia CTRA form.  This form cannot be amended generally but has provision under schedule 7 for mutually agreed deviations/changes to be noted.

Furthermore, New Zealand has also recently agreed and adopted a national form of agreement.