Authorising the Release of Data without Consent for Health Research: The Role of Data Custodians and HRECs in Australia.

In Australia, access to administrative data for research without consent invokes a plethora of governance requirements. Whether these requirements are met is assessed by at least one human research ethics committee (HREC) and each of the custodians of the relevant data collections. In this article, we examined and compared the decision-making processes of data custodians and HRECs. These processes were investigated using three case studies and qualitative interviews with data custodians around Australia. The investigation demonstrated that there was significant overlap and duplication in the review of applications for access to data without consent between HRECs and data custodians. This was the result of overlapping requirements in the relevant legislation and policies with those in the National Statement for Ethical Conduct in Human Research 2007 (updated 2018) as well as confusion about the distinct roles of HRECs and data custodians.