Requesting Data from the ANZFFR

Access to data collected and collated by Australia and New Zealand Fragility Fracture Registry (ANZFFR) is guided by privacy, confidentiality, and ethical principles. Provision of data to the Registry is governed by the study protocol, which has been approved by Human Research Ethics Committees in each jurisdiction, and the relevant Research Governance Offices of participating sites. This document outlines the principles that ANZFFR will apply to requests for access to registry data and the procedures for applicants to follow when making a request to access data.

The ANZFFR holds identified data about people aged 50 years and older who have suffered a fragility fracture. The registry holds the data submitted by participating sites, and it is important that the privacy of this information is maintained. This policy is intended to protect the privacy and confidentiality when considering requests for access to the data from third parties.

The ANZFFR Steering Committee encourages the use of its accumulated data for appropriate academic research, clinical review, planning or scientific investigation of issues to do with fragility fractures. Parties interested in accessing ANZFFR data are encouraged to make informal enquires to the FFR National Manger in the first instance: [email protected]

1. People accessing ANZFFR data are responsible for ensuring appropriate security for the storage of any material, confidential or otherwise, held in any format including on computing systems.
2. A date for data disposal must be included in any request for access to data.
3. In accessing de‐identified data, no attempt will be made to re‐identify individuals in the data provided by the ANZFFR.
4. For research proposals, ethics and governance approvals must be provided prior to the release of data. In New Zealand institutional ethics committee approvals will be accepted (University or Hospital) and applications to the National Health and Disability Ethics Committee will not be necessary.
5. For non-research proposals, compliance with relevant privacy and data governance legislation should be demonstrated.
6. For all proposals, a schedule for the reporting and dissemination of results must be included in the submitted project outline.
7. Applicants must provide an annual report on progress with data use and a final report when analysis completed.

Using Statistical Process Control and quality tools on existing data will provide insights into Registry performance that will spur improvements - Ian Hutchby, Dr Roger Harris.

Nil

1. The ANZFFR Steering Committee shall be the final approver of data access requests except Basic Summary Data and Site Data.
2. Requests for data access will be referred to the ANZFFR Data Management Committee (DMC) which will consider each application in detail. This committee may request further information and clarification from the applicant. The Data Management Committee will forward a recommendation about each application to the Steering Committee for final review.
3. The Data Management Committee will consider:
   o Whether the project meets appropriate standards of scientific merit and/or public health importance.
   o Whether the ANZFFR data requested is of a sufficiently high level of quality as has previously been reported on as part of the annual reporting process.
4. All requests for data must take timeframes into account as data requests are considered along with other ANZFFR tasks. ANZFFR Steering Committee meetings are held quarterly, and data will not be extracted until Steering Committee approval has been given.
5. It is a condition of use of the data that the data source is acknowledged, with a statement that the analysis and interpretation of the data are those of the author(s) and not the ANZFFR.
6. The Steering Committee must review any results before submission for intended publication, presentation, or other public release. The Steering Committee should be given at 15 working days to comment on any material.
7. Data requests must be lodged in writing on the Registry application form.
8. Data is released for the specific purpose(s) set out in the submitted application. The use of the data for any other purpose without prior approval is not permitted.
9. Applicants will be required to complete a confidentiality undertaking prior to the release of data.

1. Site data. Participating sites may have ad hoc access to their own patient level data and comparisons to ANZFFR benchmarks on demand. This may be used for quality improvement and other analysis but must not identify individual participants. This access does not require review by the Data Management or Steering Committees.
2. Basic summary data. This is data that is in an aggregated form and does not directly or indirectly disclose information concerning individual participant. Where this is requested, a formal application will still be required. This level of data access can be approved by the Data Management Committee. A record is kept of all applications, and this is reported to the Steering Committee.
3. Aggregate de-identified data. Requests by researchers or other third parties that include de-identified participant level data, are required to make a formal application, and this must be accompanied by ethics committee approval. (Note: in New Zealand an institutional (University or Hospital) ethics committee approval will be accepted.) Each application will be reviewed in detail by the Data Management Committee.
4. Identified data for linkage.
   a. Individually identifiable unit record data (such as name, address, date of birth, NHI) will not be provided directly to an applicant.
   b. Individually identifiable information would only be made available to third parties (such as data linkage centres) for the purpose of linkage to other data collection(s). No clinical or health information would be provided for the purpose of data linkage.
   c. Separate ethical approval would be required for research or projects involving data linkage and the third party conducting the linkage must have a data governance and data security plan in place.
   d. If a research or other project requires individual data for linkage, the individual data will not be provided directly. A data linkage plan will be developed with each new applicant with the overarching requirement that the privacy of individual sites and participants is maintained.