COMPLAINTS AND COMPENSATION

Complaints and Compensation During a Clinical Trial

If you feel uncomfortable with any part of taking part in a research study, its conduct, or the research personnel managing your care, you have the right to lodge a complaint.

You can choose to speak with either the human research ethics committee (HREC) responsible for reviewing the research study, or the local complaints contact person for the site at which you are taking part. Contact details are found on the Information Sheet for the study.

In an emergency, you should call 000 or go to the emergency department at your nearest hospital. If your injury is not urgent, you should contact your study team. They can help you organise medical care.

Breast Cancer Trials (BCT) as a sponsor of clinical trials in Australia and New Zealand holds proper insurance. BCT follows the compensation process set out in Medicines Australia’s ‘Guidelines for Compensation for Injury Resulting from Participation in a Company-Sponsored Clinical Trial’.

Under these Guidelines, you should be paid damages if you have significant injuries from taking part in a clinical trial. BCT will decide whether to pay compensation to you and how much you will get. You may also be able to take action through the courts. You may wish to seek independent legal advice. If you are eligible for Medicare, you can receive the treatment you need to treat the injury free of charge as a public patient in any Australian public hospital.

Claims against BCT’s clinical trials insurance will not be considered if:

• Procedures in the approved protocol have not been followed; or
• Medical negligence (medical staff have failed to take reasonable care or steps to prevent loss or injury to a person taking part in the trial) is found.

You will be covered by the treating doctor’s or hospital’s medical indemnity in the unlikely event of this happening.

A copy of the Medicines Australia guidelines can be obtained from your study team upon request or can be accessed here.