Clinical Research Data Sharing Frameworks

The Challenge

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 Response

The project set out 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 has addressed this through the development of practical guidance to support trustworthy sharing of clinical research data in Australia, including a data sharing toolkit.

This project was 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 the ARDC and CT:IQ to address patient and research participant consent for data sharing.

The project achievements included:

• running activities with Australian HRECs to understand and benchmark their current practices regarding secondary sharing of clinical research data
• the development of 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
• supporting researchers who wanted 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.

Who Will Benefit

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

Outcomes

In collaboration with the clinical research sector, this project has produced:

• a consultation report on current challenges and practices regarding ethics and governance approval for data sharing. Read the report, 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.
  • Read the executive summary of the CT:IQ and ARDC Ethics Review Body Benchmarking Activity. This summary highlights key findings from a national exercise exploring how Australian ethics review bodies assess proposals for the secondary use of clinical trial data.
  • Read the Report on Findings of the Clinical Research Data Sharing Frameworks Ethics Review Body Benchmarking Activity.

It has also produced:

• a clear statement of the principles and regulations relevant to sharing clinical research data 
• a practical suite of governance resources to facilitate trustworthy and efficient data sharing

View all the project outputs in the Toolkit for Clinical Research Data Sharing Frameworks.

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

The Partners

• CT:IQ: a collaborative of stakeholders, all interested and involved in clinical trials
• HeSANDA nodes and partners
• ARDC

Get Involved

To get involved, please contact CT:IQ.