All amendments to approved data linkage projects require Data Integration Service Centre (DISC) approval before they are submitted to the AIHW Ethics Committee. You should allow a minimum of 3 weeks for DISC review and approval for project amendments.
For amendments, the following forms must be completed and submitted to DISC:
- Amendment request form: The amendment request form is required for all changes to approved data linkage projects. The form will not be accepted if it is incomplete.
- Updated Technical Assessment: All technical assessment forms must be provided in Microsoft Word format. All updates must be marked with track changes against the most recent technical assessment submitted to the AIHW Ethics Committee. If your project does not have a technical assessment, please contact DISC to discuss the requirements for your proposed amendments.
Please ensure communication begins with the Ethics Secretariat on your amendment as soon as possible. The Ethics Secretariat should be aware of the amendment prior to DISC sign off.
Please refer to applying for ethical (HREC) review for further information.
1. Public Interest Certificate
A Public Interest Certificate (PIC) is required to be signed by a delegate of the Minister for Health for the purposes of paragraphs 130(3)(a) of the Health Insurance Act 1973 and 135A(3)(a) of the National Health Act 1953. The PIC certifies that it is necessary in the public interest to divulge the requested data from Medicare (Medicare Benefits Schedule or Pharmaceutical Benefits Scheme), or some other data collections, to the Principal Investigator.
An application for a PIC to be issued by the appropriate government department will be made by the AIHW on behalf of the Principal Investigator once AIHW Ethics Committee approval has been obtained.
2. AIHW Approved Secure Access Environment
Where a project requires Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, Centrelink, or certain other data, it is a data custodian requirement that the linked dataset must be stored and analysed within an AIHW approved secure access environment (SAE).
Currently, the only AIHW-approved SAE for external researchers is the Sax Institute's Secure Unified Research Environment (SURE). AIHW is scoping the addition of more SAEs to the approved list.
It is recommended that researchers make enquiries about arranging a workspace within SURE as soon as possible. There are costs associated with establishing SURE workspaces. Please do not establish the workspace without confirming with DISC first.
The AIHW is a member of the Population Health Research Network (PHRN), an Australian Government collaboration that has built a nationwide data linkage infrastructure capable of securely and safely managing health information from around Australia. This includes Australian Government and state and territory government data.
For linkage projects involving more than one linkage team, you may choose to manage the project through the PHRN data linkage online application system. The PHRN will support researcher requests to access linked data by facilitating feedback and assisting with relevant approvals by the linkage teams, rather than you contacting each linkage team separately.
For prospective studies or where it is possible to contact participants, the AIHW Ethics Committee expects that, where feasible, researchers will seek written consent from participants to access their Medicare Benefits Schedule or Pharmaceutical Benefits Scheme data from Services Australia.
Please contact Services Australia to obtain their preferred consent form.
If this pathway is taken for studies that require only Medicare Benefits Schedule or Pharmaceutical Benefits Scheme data, there is no requirement for AIHW Ethics Committee approval. These projects are instead approved by Services Australia's External Request Evaluation Committee (EREC).
Visit the AIHW’s Australian Cancer Database (ACD) for information about this collection.
To access ACD information, researchers must seek approval from data custodians in each state and territory. Some jurisdictions also require additional ethics approvals.
Please contact DISC to obtain details of the ACD data custodian approval requirements. The approval process can take more than six months, so make sure you allow plenty of time.
If other collections also need to be linked, work can begin while ACD data custodian approvals are finalised.
As the Repatriation Pharmaceutical Benefits Scheme (RPBS) is part of the Pharmaceutical Benefits Scheme (PBS), prescription information relating to Defence personnel and veterans is routinely captured in PBS data requests.
Where data about Defence personnel or veterans are to be analysed or reported separately, approval must also be sought from the Departments of Defence and Veterans’ Affairs Human Research Ethics Committee (DDVA HREC).
Please note that for studies that are not approved by the DDVA HREC, PBS extracts provided to researchers will be recoded to ensure that prescription information cannot be attributed to Defence personnel or veterans.
Advice to researchers on requesting comparison group records
If, in addition to your sub-population of interest, you are looking to gain access to records for comparison purposes there are a number of issues you should address in your application.
Under the Beneficence underpinning of the National Statement on the Ethical Conduct in Human Research, the National Health and Medical Research Council requires the balancing of risk with benefit. (See Sections 1.6, 1.7, 2.1.3 and 2.1.4 of the National Statement.) Providing more data than is required to achieve the goals of an analysis could unnecessarily increase risk (for example increase the risk of re-identification or the level of harm should a breach occur).
To this end, Applicants need to provide justification as to why they require access to the data in question. Information relevant to this justification includes:
- a statement of the research question(s) of the study. This will include details of any comparisons to be made and the importance of these comparisons to the study;
- a full description of the population of interest, along with how it is defined;
- a full description of any comparison population, along with how it is defined; and
- the data required to address the research question.
The volume of data that makes up any comparison group should not be larger than is required to meet the objectives of your study.
When designing your analysis and considering your control/comparison group you should adhere to the following principles:
- the group should be no larger than required;
- the group should be chosen to meet the requirements of the planned comparison;
- the group should be chosen to minimise the re-identification risk inherent in the control/comparison group. This will at times conflict with principle 2.
In determining the required comparison sizes the following approaches may be considered (based on Ury, 1975 and Foppa and Spiegelman, 1997):
- where the number of records for the population of interest is less than 10,000 then the control/ comparison group can contain up to 4 times the number of records in the population of interest
- where the number of records for the population of interest is 10,000 or more and less than 1,000,000 then the control/comparison group can contain up to 2 times the number of records in the population of interest
- otherwise the control/comparison group can contain up to the same number of records as the population of interest.
There may be studies where these rules will not be sufficient to meet the requirements of the planned comparison (Principle 2). In these cases, you will be required to provide information justifying the need for access to additional data.
One such justification would be to demonstrate the number of control/comparison records needed to achieve the study aims. To do this, first of all determine the statistic and the statistical test that you will use in your analysis. Then consider the power required. That is, determine the size of the difference between the study and control/comparison groups that you want to detect and the level of confidence with which you want to detect it.
Once the required power is determined, along with how the two groups are to be selected and which statistic and statistical test will be used, it is usually possible to calculate the sample size required. One piece of information required to perform this calculation is the variance of the property of interest in the comparison/control group. If the variance can’t be calculated from the data in question then an alternate estimation or approximation is required. This can come from historical data, other data sources or (at worst case) an educated approximation.
In the case that there is more than one property of interest it is necessary to choose one or more design variables that the selection is designed around. These can be selected by importance to the analysis, availability of information about the property (including variance), expected high variance / low power or a combination thereof.
You would include the power requirements and calculations in your technical assessment to support your justification for access to more control/comparison records than indicated by the general rule.
If you need assistance with this aspect of your application the AIHW may be able to help. The availability of assistance will depend on AIHW resourcing levels and would be charged on a cost recovery basis.
Ury, H.K. 1975. Efficiency of case-control studies with multiple controls per case: continuous or dichotomous data. Biometrics 31(3), 643-649.
Foppa I. & Spiegelman D. 1997. Power and sample size calculations for case-control studies of gene-environment interactions with polytomous exposure variable. American Journal of Epidemiology 146(7):596-604.
Please contact the AIHW Data Integration Services Centre to request a quote, or if you have any questions about data linkage services.