B18b. Clinical Research Data Sharing: Towards Clear and Consistent Governance Frameworks

Tracks
Data, Technology and Informatics
Wednesday, June 4, 2025
2:45 PM - 3:45 PM
C2.5+C2.6

Chair & Speakers

Agenda Item Image
Dr Lisa Eckstein
Programme Director
CT:IQ

B18b. Clinical Research Data Sharing: Towards Clear and Consistent Governance Frameworks

Abstract

Secondary sharing of clinical research data can facilitate more effective and efficient medical research. However, identifying the appropriate ethical and governance arrangements can be difficult and can prevent valuable research from proceeding. In 2024, CT:IQ and the Australian Research Data Commons (ARDC) commenced a project to support clinical research data sharing in Australia, including through providing practical guidance to researchers, sponsors, ethics review bodies, and data custodians.

This presentation will report on preliminary outputs of this project, including:
- A draft Governance Framework outlining the multiple and often overlapping laws, and regulations relevant to sharing clinical research data in Australia as well as broader roles and responsibilities in data sharing.
- A Consultation Report on barriers and enablers to sharing clinical research data based on a series of focus groups with Australian research staff conducted in October 2023.
- An ethics review body benchmarking exercise to assess ethics review body practices when reviewing a dummy application for secondary data sharing, including variation in interpretations of criteria in the National Statement on Ethical Conduct in Human Research (2023). Attendee feedback will be sought on high-priority governance resources for the project team to develop to promote trustworthy, efficient, and effective data sharing practices in the future.

Biography

Dr Lisa Eckstein is the Ethics Specialist for Bellberry Ltd and the CT:IQ Programme Director. Her previous role was as a senior lecturer in the faculty of Law at the University of Tasmania, where she chaired the Tasmania Health and Medical Human Research Ethics Committee and published on the regulation of clinical trials, genomic privacy, and consent. Prior to academia, Lisa worked as a legal officer for the Australian Law Reform Commission and for state and federal health departments.
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