All research proposals are to be submitted to the ABMDR via email to ABMDR.Research@abmdr.org.au.
Ethical assessment is conducted by the Australian Red Cross Blood Service Ethics Committee.
Why is ethical review important?
Some research may be considered as LNR research. Review the National Statement on Ethical Conduct in Human Research (specifically Chapter 2.1 – Risk and Benefit) for further details or contact the ABMDR.
For LNR projects, the following should be submitted to the ABMDR for evaluation:
- a research proposal (including a summary of the research in non-technical language)
LNR applications can be submitted at any time. LNR projects are to be managed by researchers in the same way as projects that have undergone full approval with regard to amendments, reporting requirements and record keeping (see below for details).
Applying for ethical approval (full review)
All research that involves more than low risk must be reviewed by the full Ethics Committee.
Human Research Ethics Application (HREA)
From 1 January 2018, the Blood Service Ethics Committee will only accept applications submitted via the NHMRC’s Human Research Ethics Application (HREA). The HREA was designed to be a concise application to facilitate efficient and effective ethics review for research involving humans. The application should assist researchers to consider the ethical principals of the National Statement on Ethical Conduct in Human Research (2007) in relation to their research, rather than focus on requirements for approval.
The Human Research Ethics Application is available here. The HREA can be accessed as a guest or as a registered user. Registering an account enables researchers to save applications in the system and to share applications with collaborators. General support, including a Getting Started Guide, a detailed How To Guide and FAQs, can be found here.
Providing the relevant supporting documentation is an important part of your application. Ensure the signatures of all researchers are recorded and the application is free from typographical and grammatical errors. Your application with the ABMDR must contain the following documents:
- Research Protocol
- Participant engagement email and telephone scripts
- Copy of approval from researchers’ own institution’s Ethics Committee
- TGA clinical trial notification (if required)
The ABMDR welcomes research proposals from transplant and donor centre members of the World Marrow Donor Association (WMDA). Requests from international centres to access donors or donor samples through the ABMDR must contain:
- A letter of request in English outlining the planned research and what is required from the ABMDR and its donors
- A copy of the research protocol or a summary of the research proposal (in English if available)
- Donor information and consent in English
- Evidence of ethical approval from local committees, in English
Managing your projects
If you are modifying any aspect of your study, you must request an amendment. This includes extensions of ethics approval, addition/removal of investigators or other personnel, new funding arrangements, and changes to recruitment procedures, methodology, or documents (e.g. Participant Information and Consent Forms, and any other recruitment materials).
Requests for amendments, including a description of the changes and any ethical implications, should be submitted in writing to the ABMDR National Executive Officer via the firstname.lastname@example.org email address.
Initial ethics approval is for a period of three years, contingent on meeting the reporting requirements. While your project is in progress, you must complete a progress report annually. Once the project is finalised, a completion report must be submitted. If you require an extension of ethics approval for your project, an amendment request must be submitted before the end of the approval period. If htese reporting requirements are not met, approval for the project will lapse and a new application will be required.
For more information, please contact ABMDR.Research@abmdr.org.au.