Clinical Research Data Sharing Frameworks


Research sites and clinical research sponsors are entrusted with the storage of large amounts of clinical research data. Sharing clinical research data can allow a more efficient medical research ecosystem, but identifying the appropriate ethical and governance arrangements for sharing data can be difficult and can prevent valuable new research from proceeding.


The project seeks to improve the efficiency and quality of clinical research data sharing decisions by Australian researchers, human research ethics committees (HRECs), research governance offices and institutions.

It will do this through the development of practical guidance to support trustworthy sharing of clinical research data in Australia, including a data sharing toolkit.

This project is being established under the Health Studies Australian National Data Asset (HeSANDA) program as part of the People Research Data Commons. It expands on a previous partnership between CT:IQ and the ARDC to address patient and research participant consent for data sharing.

The project will:

  • provide informational resources to HeSANDA’s clinical trial partners and the broader Australian research community on the legal and ethical aspects of data sharing to support secondary use of clinical research data
  • run activities with Australian HRECs to benchmark their current practices regarding secondary sharing of clinical research data
  • support researchers who want to take advantage of Health Data Australia, a national catalogue of Australian health data for researchers to share, discover and request access to data for their research.


  • Australian clinical trials community and other clinical and health research areas


In collaboration with the clinical research sector, this project will produce:

  • a clear statement of the principles and regulations relevant to sharing clinical research data
  • a consultation report on current challenges and practices regarding ethics and governance approval for data sharing
  • a benchmarking report of HREC practices when reviewing applications for data sharing in the absence of specific consent
  • a practical suite of governance resources to facilitate trustworthy and efficient data sharing

The project’s outputs will be beneficial for the broader Australian clinical trials community, and much of the information provided will be extensible to other areas of clinical/health research.