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The five safes framework

ALSWH is funded by the Australian Government Department of Health and Aged Care as a research resource. The insights and new knowledge generated by the researchers using ALSWH data benefit all Australian women. Participant privacy is a priority at the ALSWH, and the study has a long history of compliance with its privacy and confidentiality requirements.

ALSWH staff are experienced in assessing and managing the risks associated with the use and sharing of study data. Data sharing means ALSWH gives approved researchers access to some study data in a controlled manner. ALSWH uses the Five Safes framework to manage this process at the two sites of the ALSWH, the University of Queensland and the University of Newcastle.

The Five Safes framework is an internationally recognised approach for assessing and managing the strategic, privacy, security, ethical and operational risks involved in data sharing. The Five Safes framework is used by Australian state and federal government agencies. Using the framework, ALSWH manages data sharing risks across five dimensions: projects, people, data, settings, and output.

Safe projects

ALSWH adheres to all current legal and ethical requirements for data use required by Human Research Ethics Committees.

Data is only released for projects approved by the ALSWH Data Access Committee.

ALSWH is funded by the Australian Government Department of Health and Aged Care in recognition of public benefit. From a data management perspective, ALSWH data is produced to be accurate and clearly understood, which is necessary for the public benefit. Extensive documentation is readily available from the ALSWH website to enhance this benefit.

Safe people

The ALSWH data management staff are qualified in data analysis and trained in security and confidentiality, and they keep up to date with developments in this area.

The data is released to researchers who have been vetted by the ALSWH Expression of Interest (EOI) process. The EOI process ensures that:

  • Applicants are genuine researchers who have prepared a sound analysis plan and that they understand how to appropriately use and store the data.
  • The project has nominated an ALSWH Liaison for the project to advise on data issues
  • Applicants sign the ALSWH Statement of Data Use, whereby they agree to comply with security and confidentiality protocols. Researchers are also subject to Institutional Codes of Research Conduct and Privacy Policies.
  • The researchers are contacted directly by the Data Management team when the data is made available. This discussion ensures they have a thorough understanding of the data and sound usage.

Safe data

The survey data is de-identified, meaning no identifiable information (for example, names, addresses, and dates of birth) is left in the data. Furthermore, other potentially identifiable information is removed from the data, for example, post codes and country of birth. All possible steps have been taken to ensure it is not possible to identify someone from the data.

When external administrative data (such as hospital data) are linked to the ALSWH survey data, an extra level of supervision is added. Researchers can only access these linked data in ALSWH offices or through the SURE facility at the Sax Institute. The linked data remains at these sites and is never removed. Also, new identifiers are produced and used for each linked data project to avoid any possible cross-comparisons with other ALSWH data.

Safe settings

The data is kept in secure university directories and backed up in secure university areas specially designed for secure data. When data are sent it is always via Australian-approved secure cloud-based services (to avoid US extraterritoriality laws.)

Researchers who are permitted to use survey data are instructed to use it only for the approved research and must adhere to ALSWH confidentiality and data use statements, as well as adhering to their own Institutional Codes of Conduct, Privacy and IT policies and procedures.

With regard to linked data, use by external researchers at ALSWH offices is monitored by a responsible officer and a security checklist is completed at the close of every session.

Safe output

ALSWH has oversight of research outputs (for example, papers, conference presentations and reports) before publication. Researchers using the data agree to this when signing the Expression of Interest. All output must be sufficiently aggregated, so it is not possible to identify individuals, small communities, health service providers, or health facilities.

For state-based linked data, outputs are also provided to data custodians for review before publication.