Enhancing Data Sharing Ethics and Governance in Clinical Research

Data sharing has the potential to accelerate medical research and improve healthcare outcomes. Researchers can share data and combine existing datasets to gain new insights without having to collect the data all over again, saving time, money, and lessening the research burden on people. However, research institutions often struggle to identify appropriate ethical and governance arrangements for sharing data and end up with different approaches, which can delay and potentially hinder valuable new research.

The Australian Research Data Commons (ARDC) is excited to announce a new project aimed at addressing the ethical and governance challenges related to sharing health and medical data. This project seeks to improve efficiency and quality in the application of requirements for sharing clinical research data among Australian researchers, human research ethics committees (HRECs), and governance offices. It also aims to bring a more consistent approach to research data governance across different institutions.

This project is being established within the Health Studies Australian National Data Asset (HeSANDA) program as part of the People Research Data Commons. It will support researchers and research institutions that contribute to Health Data Australia, a national catalogue established through HeSANDA of Australian health data for researchers to discover and request access to data for research. The resources developed through the project will also be valuable for the broader clinical research community.

Dr Kristan Kang, HeSANDA Program Manager, ARDC, said, “We’re working with CT:IQ, whom we partnered with previously on the successful ‘InFORMed’ Project, which addressed research participant consent for data sharing. The new project builds upon this effort by providing guidance to researchers, research governance, and ethics officers regarding the legal and ethical aspects of data sharing.”

One of the advocates for the new project is Martijn Oostendorp, Associate Director Trial Operations at the NHMRC Clinical Trials Centre of The University of Sydney. The NHMRC Clinical Trials Centre is a partner in the HeSANDA program and a founding member of CT:IQ. 

Martijn said, “Responsible and appropriate sharing of clinical research data requires consideration to complex ethical, regulatory, legal and institutional requirements. This project will enable data sharing stakeholders to confidently navigate these considerations. It will facilitate clinical research data sharing, which in turn will maximise learnings and minimise research waste in our shared mission to improve on health outcomes.”  

Sara Gottliebsen is the Senior Manager, Research Governance at Health Translation Queensland, another HeSANDA program partner. She said, “The sharing and reuse of data is an important tool for Australia to be competitive and keep up with other countries in health research. Funding bodies are starting to request details on the sharing and reuse of data. We therefore need to be providing researchers with information and guidance on how to ensure their project is set up for data reuse, alongside ethical and governance arrangements that are nationally consistent.”

Dr Lisa Eckstein, Director, CT:IQ, said, “CT:IQ was established to implement recommendations to improve the impact, quality, and efficiency of clinical trials in Australia. The opportunity to collaborate with HeSANDA on this project is an exciting opportunity to meet this objective by providing guidance and resources to promote trustworthy and responsible data sharing practices. This should allow for a more trustworthy, but also more efficient, data sharing ecosystem in Australia.”

Learn more about the new project, Clinical Research Data Sharing Frameworks and stay up to date with the project, please register your interest in the People Research Data Commons.

The ARDC is enabled by the National Collaborative Research Infrastructure Strategy (NCRIS) to support national digital research infrastructure for Australian researchers.