Approval

Two different groups ensure regulatory requirements for linked data research are met

  • Data custodians
  • Human Research Ethics Committees (HRECs)

Researchers are required to submit a data request to the relevant Data Custodian(s) and a HREC application to the relevant HREC(s). There is substantial duplication in the information that is needed for a data request and a HREC application.

Data Custodians

Each request for data access is assessed by the Data Custodian, against the relevant legislation and privacy laws. These procedures are in place to protect personal information recorded in the dataset from breaches of privacy. 

The information you provide in your data application will enable the Data Custodian to:

  • ensure that it is legal to share the data for your research project; and
  • determine what records and data variables to extract for your project. 

Data Custodians will refer to the relevant authorising legislation to determine what data can be used, for what purpose, and by whom. Other factors the Data Custodian must take into consideration when deciding whether to share data varies depending on the relevant authorising legislation.

Human Research Ethics Committee

In the Human Research Ethics Committee (HREC) application you will be asked to demonstrate that you will conduct research with scientific merit and that you understand and have designed the project with the other three core ethical values at the centre of the research – justice, beneficence, and respect.

The default approach to demonstrate the value of respect is to ask each participant for their consent to use their data. Routinely collected population level datasets are often used for data linkage projects. The size and longitudinal nature of these datasets means that it is impracticable to ask each person for consent. Therefore, it is common for researchers to request a waiver of the requirement for consent (a waiver of consent).

If you are requesting a waiver of consent the HREC has an additional role in making the use of data lawful according to the relevant privacy act. For a waiver of consent, you must demonstrate to the HREC that your project meets all the criteria listed in 2.3.10 of the National Statement on Ethical Conduct in Human Research (2023).