The primary role of an ethics committee is to protect the welfare and rights of registry participants. Australian Human Research Ethics Committees (HRECs) are generally comprised of people with and without a health research background who, as a group, will only approve a project if it is conducted with integrity and respects the welfare of participants. The Monash University HREC oversees the conduct of the ABDR.
The ABDR is ethically reviewed and monitored in accordance with the Australian Government’s National Health and Medical Research Council’s (NHMRC) National Statement on Ethical Conduct in Human Research (2007) (updated in 2015 to include opt-out consent).
The ABDR complies with the clinical quality registry standards and operating procedures outlined by the Australian Commission on Safety and Quality in Health Care Operating Principles
The ABDR must also comply with state-based Privacy Acts, such as the Victorian Privacy and Data Protection Act 2014.
We are regularly in contact with HRECs in participating hospitals and health service operators, reporting updates on procedures and other issues of ethical relevance.
Why is the ABDR an 'opt-out' registry? What does that mean?
In 2012, a senate enquiry into the use of medical devices following the recall of PIP breast implants, recommended establishing an opt-out registry for breast implants as a priority. The ‘opt-out’ approach will facilitate a high data capture rate and ensure the registry achieves (as close as possible to) full population coverage.
The ABDR has ethics approval to be an ‘opt-out’ registry. An ‘opt-out’ approach means that if your surgeon/clinician is contributing to the ABDR, he/she forwards details of your surgery on this form for inclusion in the registry. They will have informed you of their involvement in the ABDR and provided you with a ABDR Patient Leaflet about the registry prior to surgery. You are able to contact us to advise if you do not want to participate and we will withdraw you (opt out) from the database.
It is important to note that the health information provided to the ABDR relates to breast devices, such as implants and tissue expanders and acellular dermal matrice (or similar). Your contact details are needed to validate the information (internal use only) and under no circumstances will be publicly available. This information is kept in a secure database. Contact details will also enable you to be contacted, eg by your health care provider, in the event of a hazard alert.
Participation in the registry is entirely voluntary and your involvement will in no way affect your relationship with health professionals or health service.
If you permit your data to be included on the registry you are not required to do a thing, although you are most welcome to stay in touch and update your contact details with us.
To opt out of participating in the ABDR, please call 1800 998 722 (freecall) or (03) 9903 0205 or email on email@example.com
Which human research ethics committees (HRECs) oversee conduct of the ABDR?
HRECs supervising the ABDR include:
- Alfred Hospital HREC (overarching)
- Bellberry HREC
- Calvary Health Care ACT HREC
- Central Adelaide Local Health Network HREC
- Macquarie University Hospital HREC
- Menzies School of Health Research HREC (NT)
- Monash University HREC
- Royal Brisbane and Women’s Hospital HREC
- Royal Perth Hospital HREC
- South Eastern Sydney Local Health District HREC
- St Andrew’s Hospital HREC
- St John of God Health Care HREC
- St Vincent’s Health & Aged Care (SVHAC) HREC
- St Vincent’s Hospital Melbourne HREC
- Uniting Care Queensland HREC
- University of Tasmania HREC
Who can I contact if I have concerns about the ABDR?
You are most welcome to discuss any aspect of the Australian Breast Device Registry with a member of the ABDR team on Tel. (03) 9903 0205 or via email: firstname.lastname@example.org
If you would like to speak to someone outside the registry or you have questions about being a research participant in general, you may contact the Monash University Human Ethics Office on Tel. (03) 9905 2052. You will need to quote the following project number: CF15/1452 – 2015000701