Clinical trials collect invaluable data and ideally the data should live on when the trial ends. Shared responsibly, the data can help answer new research questions, confirm earlier findings, and reduce the need for more patients to be recruited into future studies.
In Australia, ethics review bodies (ERBs) are a key decision maker for whether clinical data can be shared. ERBs are responsible for weighing up the public benefits of data sharing with potential harm to participants, such as breaches of privacy and consent.
However, the decisions made by ERBs are not always black and white. Different ERBs, looking at the same application, may reach different conclusions. One may approve the request, another may ask for significant changes, while a third may reject it outright.
So, how are ERBs making decisions about data sharing and reuse? What challenges do they face when doing so? And what support or guidance do ERBs and researchers need to improve the process?
These questions are at the heart of a new report from Clinical Trials: Impact and Quality (CT:IQ), supported by the Australian Research Data Commons (ARDC) under the HeSANDA program, which encourages researchers to share and access health data via Health Data Australia.
As part of the Clinical Research Data Sharing Framework project, the Ethics Review Body Benchmarking Activity [PDF] is the first study of its kind in Australia examining how Human Research Ethics Committees (HRECs) across Australia interpret requests to reuse clinical trial data.
The National Health and Medical Research Council (NHMRC) issues the National Statement on Ethical Conduct in Human Research, a series of guidelines that must be used to inform the design, ethics review and conduct of human research. It acts as a ‘rulebook’ for ERBs, highlighting what needs to be considered when reviewing research ethics applications.
The National Statement details several requirements for participant consent to the sharing of their research data, and the conditions under which data sharing may be permitted in the absence of consent. However, Dr Lisa Eckstein, an Ethics Specialist and Program Director of CT:IQ, said different ERBs interpret and execute the requirements in the National Statement differently.
“When the National Statement says, ‘it has to be impracticable for participants to be re-contacted,’ what does that mean?” Lisa said. “Does that mean it’s impossible to contact them? That it’s expensive to contact them? That it’s burdensome for researchers to contact them? We don’t know where the threshold is set by different ethics committees.”
These variations can lead to delays in research and erosion of trust in the ethics review process.
“If we have committees that are coming to different conclusions on the acceptability of the same applications, researchers, participants, and the community might feel like the system doesn’t mean very much. And that’s a problem,” said Lisa.
However, while it’s important to ensure that ERBs are operating from the same rulebook, Vanessa Warren, Senior Research Associate at CT:IQ, and one of the lead authors of the report, said that some degree of variation between ERBs is normal and to be expected.
“The purpose is not to flatten the ethics review space to make sure everybody approaches the exact same decisions in the exact same ways every time. You want some localised decision-making. You want cultural specificity. You want to be relevant to the context in which the research is occurring and where the ethical discussions are happening,” Vanessa said.
“But at the same time, you want to make sure that everybody is approaching it within the same ethical framework, within the same understanding of the legal space, and the same understanding of the National Statement.”
To explore this, CT:IQ contacted over 180 ERBs around Australia, including those based at public hospitals, private sites and universities, and invited them to participate in a study. As part of the study, the ERBs were asked to review a mock ethics application that requested data from a previous clinical trial to be shared for secondary research.
Dr Rebekah McWhirter, Director of Education at the Australian National University College of Law and another author of the report, explained that the mock application included a whole range of data from parents who had preterm babies.
“We asked to reuse the quality of life data relating to the parents,” Rebekah said. “It would have been individual-level participant data, which is potentially quite identifiable even once you take away names. So, there are ethical issues involved there. We wanted to see how the ethics committees addressed that issue.”
One health consumer highlighted this challenge, particularly in the context of rare diseases. “My son has IQSEC2-associated neurodevelopmental disorder – a gene variation. There’s about 20 cases in Australia, and 300 in the world. There’s a very small percentage with his specific gene variant, so I can see him in the studies.”
In total, 18 ERBs across Australia returned their deliberations, which were explored using descriptive statistics and qualitative content analysis to understand the processes used in their decision-making.
The study found that ERBs took very different approaches and had very different outcomes when assessing the same application.
“What we found was an astonishing array of diversity. Some [ERBs] approved the study, some rejected it outright, and quite a number of committees asked for further information or for revisions to be made,” Rebekah said. “While some committees were very positive about the way that the application had been written, others were very negative.”
“There was a huge range of issues that were raised by only one or two committees, suggesting that it might be difficult for researchers applying to multiple HRECs to get consistent advice. And that suggests that perhaps HRECs need some additional guidance and support in making their decisions,” Rebekah said.
The ARDC, Bellberry and CT:IQ recently held a joint event to share findings from the report and provide a platform for open dialogue.
“We had a number of stakeholders from a whole range of different industries and institutions and different parts of the research life cycle all in one room, which is such a rare and exciting opportunity to have this kind of conversation,” Vanessa said. “To have it all together in one place, and [be] in the room with people who have the capacity to […] shift policy or put pressure on where support and guidance need to be developed is a really fantastic opportunity.”
One health consumer who attended the workshop suggested that data management plans and consent for secondary use of data should be part of ethics applications from the beginning. “We need to think about it with the patient – the consumer – at the front of mind. Because at the end of the day, are we doing research to get our name on a paper? Or are we doing it to improve science and for the patient? Always bring it back to the patient.”
Overall, Lisa said that the participating ERB members valued the exercise as a chance to reflect and learn.
“People were really excited. They felt like they were part of something important. And I think it started some ongoing conversations between people, and opened up opportunities for continual learning,” she said.
With support from the ARDC, CT:IQ is now translating the benchmarking findings into practical tools to help ethics committees and researchers make clearer, more consistent decisions about data sharing.
“We are preparing an ethics submission guide for researchers and ethics committees that will provide step-by-step advice through the process, from developing a research project to a high-quality ethics review,” said Lisa.
Alongside this, the team are developing tools for clinical trial data sharing and governance, including guidance on data sharing agreements, de-identification of participant-level data, and data management.
Together, these efforts aim to provide tangible resources to help guide researchers and ERBs through the process of ethical data sharing, building the shared understanding and confidence in ethics review that is urgently needed.
This work is part of the efforts of the ARDC-led HeSANDA program to address culture and policy to enable health data sharing. HeSANDA is helping researchers access and reuse health research data safely and efficiently, maximising the impact of publicly funded research and strengthening Australia’s contribution to global health research.
The final outputs of this project are now ready. It includes a practical toolkit to guide ethical and effective sharing of clinical research data in Australia. Use these resources to understand requirements and apply best practice in your work. View the resources.
Find out more in the Benchmarking Activity report [PDF] and the executive summary of the report [PDF].
The ARDC is enabled by the National Collaborative Research Infrastructure Strategy (NCRIS) to support national digital research infrastructure for Australian researchers.
