Accessing and using data
Data are valuable products in research. Data may be collected directly by a researcher or accessed via secondary sources, in both cases a well-developed plan is essential.
Researchers should develop a plan of how they will extract, capture, and manage data before commencing a project. They should also explain why the volume of data requested is required, and therefore consultation with a statistician may be necessary for assistance with sample size calculations.
Nomenclature is also important when data are considered, definitions for data types can be found here. For example, whether data are confidential, sensitive, identifiable, or anonymous need to be made clear from the outset. Terms such as de-identified and anonymous are not interchangeable, although they can be confused. Researchers may find this guideline from the Office of the Information Commissioner Queensland useful when considering their access to data and what de-identification means.
Collecting data directly from a participant via informed consent is considered by many as the gold standard for data collection in research. In this case an individual explicitly consents to the use of selected data for a research project. People may also consent to the use of their data for future projects, or in the case of parents and guardians, the use of other peoples' data.
How researchers plan to manage their data can be overlooked, but it is integral to protecting the researcher, the organisation and importantly, the participants and their data. Detailing who will have access, where it will be stored, how it will be destroyed (and when) should be considered at the start of a project. Further details, including examples, are available here on the importance and the practicalities of developing a robust data management plan. A comprehensive data management plan is required for all research project proposals submitted to Gold Coast Heath.
Data management throughout the research activity must be in accordance with the National Statement on Ethical Conduct in Human Research (2007) – updated 2018, noting in particular Chapter 3.1, Element 4: Collection, Use and Management of Data and Information.
All research projects should have a well-developed data analysis plan prior to submission for ethics approval. The data analysis plan should be detailed in the protocol, and be written in a way that others could replicate. Taking the time to formulate a data analysis plan before commencing their study will ensure researchers can best answer their research question. Gold Coast Health has biostatistician services available to assist staff plan and execute their projects.
Access to existing Queensland Health data
The type, volume, personnel involved, and the purpose for the data should be explicitly described in the research protocol. In all cases, it is good practice to seek approval from a Data Custodian when performing research during the planning phase. eHealth Queensland have provided a checklist for researchers to complete prior to applying for data access, available here.
Extracting data from other sources, e.g., patient records, can also be approved via other mechanisms. Access to data held by Queensland Health is protected under the Information Privacy Act (2009), the Hospital and Health Boards Act (2011), the Public Health Act (2005), the Guardianship and Administration Act 2000 (Qld), and the Coroners Act 2003 (Qld). A comprehensive list of requirements and items for Queensland Health researchers to consider regarding the secondary use of data are available here.
Queensland Health provides information on research and reports for current research projects, ethics and governance, intellectual property, available data sets, including how to request data through various avenues (open data, clinical, hospital and patient data, and Public Health Act (2005)).
Data Custodians manage and maintain data throughout each stage of its lifecycle.
Researchers are strongly encouraged to engage with Data Custodians during the design phase of their project to determine which data can be used for research purposes.
The Data Custodians can advise researchers which data are readily available and which will require more time-intensive processes, e.g. a medical chart review. They can approve or decline the access to data prior to ethics submission and allow researchers to determine whether their project is feasible. The members of the research team and the type of study conducted are factors a Data Custodian must consider when access to data is requested.
The list of Data Custodians across Queensland Health is available here (accessible on the QH network only).
If data were collected for another purpose e.g., medical records, they generally cannot be used for research without permission. Although clinicians access medical records for patient care, and may access them for quality assurance projects, their use for research will in most cases require ethical approval and authorisation by the relevant Data Custodian.
When conducting research, unless specifically advised, researchers should not access data themselves, instead they should request datasets from their relevant Divisional Analytics & Reporting Team or Data Operations. In addition to providing the data, these teams can advise researchers which data are available, who holds them, and whether manual extraction (chart review) is required. Researchers can also be advised how the data can be provided to them, including whether they can be de-identified or anonymised for use.
The use of ieMR data is commonly requested by researchers at Gold Coast Health. The Data Custodian for this dataset can be accessed by emailing GCHHIM@health.qld.gov.au. But there are many other sources of data that can be accessed, find the list of Queensland Health Data Custodians in the box above. To enquire about the availability and permission to access data for research, the pre-submission data access request form can be completed by the researcher and the relevant Data Custodian. This can be completed prior to ethics application and may provide researchers with reassurance that the data they need are available to them and their team. Once completed, it can be submitted as part of their ethics application.
To use confidential health information without consent some research projects require application under Section 280 of the Public Health Act (2005), commonly called a ‘PHA application’. Further information about this process is available here.
A waiver of consent can be requested by researchers – this may be for projects considered either low- to negligible-risk through to medium-high risk. In either case, a waiver of consent must be justified against the criteria listed in the National Statement (Chapter 2.3.10), so researchers will need to detail why their request should be approved. It is a requirement to publish the list of projects with approved consent waivers. These are available here.
Access and use of data outside of Queensland Health e.g., from the Australian Bureau of Statistics is suitable for some research questions. Researchers may also find collaborating with our research groups will enable access to data elsewhere.
The NHMRC have published Principles for access and using publicly funded data for health research and the Australian Research Data Commons provides a range of resources for researchers on using and handling data.