Researchers wishing to access biological samples and/or data will not be permitted to until they have obtained approval from the national A3BC Access Committee, which includes project approval through the appropriate HREC. The applicant’s Sample and Data Access Application Form and Agreement will be assessed on the scientific merit of their proposed studies and other criteria.
The A3BC access application process will be entirely on-line via the A3BC website, with all communications relating to each application retained in a comprehensive file. The A3BC access process can be summarised by the following 4 steps:
- Registration of approved researchers (1 week):
- The identity of applicants is verified through the online system and the National Biobank Director registers them as an approved A3BC researcher.
- Each applying user only needs to be registered once and then simply confirms (or amends) their details for future application(s).
- Preliminary (pre-HREC) application (2-4 weeks):
- The approved researcher completes an online EOI form regarding the samples and/or data they wish to access.
- The Consortium Committee (CC) assess the type and number of samples and/or data sought, based largely on resource sustainability, logistics and cost.
- The CC provide preliminary approval for the approved researcher to proceed to main application (based on agreed sample/data types/numbers), firstly through their HREC.
- Main (post-HREC approval) application (2-4 weeks):
- The approved researcher submits their full application online to the A3BC Access Committee, comprised of a brief A3BC Application Form and HREC-approved application.
- To reduce duplication and potential document disparity, the A3BC prefers HREC-approved application content be submitted as the main A3BC access application.
- Our preference is that approved researchers use the NHMRC’s Human Research Ethics Application (HREA; https://hrea.gov.au/).
- The HREC-approved application (HREA) information should include the Curriculum Vitae of the Principal Investigator (two pages maximum), Project Description/Protocol (including approved ethically defensible plan), HREC Approval Letter(s) and Modules for all institutions where the research will be conducted.
- MTA and Access Fees (2-4 weeks):
- The approved applicant works with the A3BC to execute the Material Transfer Agreement (MTA) and finalise all access fees before the release of any samples or data.
The A3BC will grant academic researchers a free of charge, non-transferable, revocable, non-exclusive, worldwide licence (without the right to grant sub-licences) to use the data. An A3BC manual describing data collection and management processes is continually being updated. Only de-identified patient data may be made available to any third party (academia and industry) and all A3BC research staff are trained appropriately and sign confidentiality agreements. Where industry is involved in the research, they will be required to partner with one of the A3BC’s academic collaborators. While the A3BC receives some funding through unrestricted grants from pharmaceutical companies, they have no rights to directly access the data.
Deidentified data can be provided in two ways:
- Virtual Online Laboratory: Partnering with the Secure Unified Research Environment (SURE) – an online environment that draw together research data, models, analysis tools and workflows for collaborative research. The data cannot be copied, downloaded or transmitted by email or other means. Researchers can take their analyses from SURE but not the original data.
- Secure File Transfer Protocol (SFTP): In order to transfer files in accordance with the Health Records Act (2010) and Privacy Act (1988), the A3BC uses a SFTP. SFTP is considered to be a secure method of file transfer. It offers end to end security, with transfer via encrypted channels. SFTP works whereby each recipient of transferred data receives a username and password to access an online server. The data from uploaded folders is picked up and screened. Files will only exist in the folder for a limited time period.
Data generated from A3BC research will be fall into the following categories of ownership:
- Data generated by internal A3BC system/investigator analytics:
- Owned by the A3BC Consortium Committee investigators
- Data generated by external research approved to use the A3BC:
- Owned by external researchers (as per MTA terms and conditions)