Some Commonwealth data custodians require approval from a Human Research Ethics Committee (HREC) for a data integration project prior to the release of data. HREC approval is sometimes a legislative requirement (see Example 2 on the ‘Examples of Legislated Authorisation‘ page). Use of ethics committees is aimed at balancing the benefits of projects with any risks that the project may cause harm, inconvenience or discomfort to individuals. HREC approval does not guarantee that the data custodian(s) will give approval for data release.
HRECs review research proposals that involve people, their data or their tissue. Their job is to protect the welfare and rights of individuals by ensuring that the proposed project is ethically acceptable and accords with relevant standards and guidelines. There are more than 200 HRECs in institutions and organisations across Australia. Ethics committees will consider a number of aspects before granting approval, including whether projects:
- have research merit and integrity;
- select participants fairly;
- minimise the burden imposed;
- respect the privacy of participants; and
- respect the confidentiality of the information.
For more information on ethics committees, including a list of registered HRECs, see the Overview of HRECs on the National Health and Medical Research Council website http://www.nhmrc.gov.au/
The Privacy Act 1988 permits the handling of health information for health and medical research purposes in certain circumstances, where researchers are unable to seek the consent of individuals. Two sets of legally binding guidelines, issued by the National Health and Medical Research Council and the Australian Privacy Commissioner, are produced under sections 95 and 95A of the Privacy Act 1988. Researchers and Ethics Committees need to follow these guidelines when dealing with personal and health information for health and medical research.
HREC approval for a project (if required), must be obtained before data custodians can give final approval for the project to proceed. This process may be facilitated by the appointed integrating authority.
For more information about the authorisation to release identifiable data see:
- Examples of Legislated Authorisation
- Human Research Ethics Committee Approvals
- Informed consent
- Public interest determinations
For more information about steps in finalising project details see:
- Outsourcing or working in partnership
- Human Research Ethics Committee approvals
- Privacy Impact Assessments
- Data management
- Drafting project agreements