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.

If you suffer any injuries or complications as a result of a Breast Cancer Trials (BCT) research study, you should contact the study team as soon as possible and you will be assisted with arranging appropriate medical treatment.

If you are eligible for Medicare, you can receive any medical treatment required to treat the injury or complication, free of charge, as a public patient in any Australian public hospital.

BCT as the Sponsor for certain trials in Australia and New Zealand holds appropriate insurance. In the event of loss or injury, if deemed necessary, compensation procedures will be based on principles consistent with the ‘Guidelines for Compensation for Injuries Resulting from Participation in a Company-sponsored Clinical Trial’ published by Medicines Australia.

No claims will be considered if the agreed protocol has not been followed, or medical negligence (a failure of medical staff to take reasonable care or steps to prevent loss or injury to a person taking part in the study) is found.

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