Pay attention to the ethical aspects of data sharing

Frank van Wijck, science journalist 
 
Eline Bunnik is an associate professor at the Department of Medical Ethics, Philosophy and History of Medicine at Erasmus MC in Rotterdam – an ideal background for membership of the Data Access Board (DAB) of Hartwig Medical Foundation. She has fulfilled her role in the DAB for the last two years. 

Given her CV, it is no surprise that Hartwig Medical Foundation approached Bunnik two years ago to become a member of the DAB. Genetics had been an important area of interest to her for years, and she obtained her PhD with a thesis on the ethics of new genome technology. “From that time on, I was intensively involved in ethical issues in healthcare, especially in the field of genetics,” she says. “I immediately saw Hartwig Medical Foundation as an interesting group that could give an enormous boost to making genetics useful in oncology.” 

Bunnik therefore saw a clear role for herself in the DAB. “As an independent board, the DAB focuses on making the database with the clinical and genetic data of patients available in a responsible way,” she says. “Sharing this data while at the same time protecting the interests and privacy of patients is completely in line with my research work at Erasmus MC and my work in the center’s medical ethics review committee, in which we assess applications for clinical studies. That alone was a good reason to say yes. In addition, ethics was not yet represented on the Data Access Board at that time. I pay attention  to other aspects of data sharing than a lawyer does – for example, the societal goals of making data available to researchers. The other way around, I also learn from lawyers. For example, about sharing data with countries that have very different data protection laws.” 

Diversity in research applications  
 
Requests from researchers to make data available can be very diverse, Bunnik notes. “Research proposals can focus on fundamental research or applied research, such as validation of a predictive model for implementation in healthcare,” she says. “It can also relate to rare cancers or cancers for which there is no treatment yet. Other research aims at identifying patients for whom a particular treatment has no added value, so they would not need to be exposed to it. Opening up the Hartwig Medical Database makes all these types of research possible, and therefore has great scientific and societal value.” 

The DAB ensures that the purpose of the research is consistent with the consent given by patients when they make their material available, she says. “I always look at the significance of the research for healthcare and society. We also see data minimization as an important principle in the discussion about making data available for research. We only want to give researchers access to data if it is really necessary, and even then, as limited as possible and for as limited a time as possible. Researchers must therefore clearly justify which type of samples and how many samples they need. And if they apply for an extension after two years, they have to explain why this is necessary.”  

Researchers also must demonstrate they can achieve the purpose of their research with the requested data. In that respect, the DAB relies on the Scientific Council, which determines whether research can lead to results that are scientifically relevant. As members of the DAB, we look at the extent to which the data will be safe with the researchers. If we believe the answer is yes, we will approve the application. Hartwig Medical Foundation particularly appreciates that we always ask critical questions during this process. As the DAB, we are clearly taken seriously.” 

Trend towards sharing and reuse  
 
Researchers often acknowledge that Hartwig Medical Foundation has a unique dataset, without which they would not be able to conduct their research. “The number of samples in the database could be even greater if all patients whose data are sampled were included in the database,” says Bunnik. “Unfortunately, reusing genetic data for research is currently not standard procedure – something we want to move towards in the Netherlands. There is also movement in this direction at European level. There is a trend towards sharing and reuse of data for research. This has to be done carefully with sufficient attention for privacy. That’s where the tension lies. Genetic data is sensitive personal data. It is therefore not self-evident to share. However, this is necessary to better understand how cancer arises and can be treated. So the data is encrypted to protect it.” 

It’s not about the willingness of patients to share data for research – this is very high. “Almost all patients are willing to do it,” says Bunnik. “They do often indicate that they want to be kept informed about what happens with their data. I think there is still room for improvement in this respect. Apart from that, we may need to focus more on what can and cannot be done with the data. That means prevent abuse. But that lies within the sphere of influence of society, not of the researcher.” 

More information 

• Data Access Board 

• Interview Ele Visser, DAB 

• Interview Mariska Kool, DAB 

• Interview Warnyta Minnaard, DAB