Regulating big data research

The project was comprised of three phases. First, we reviewed existing national and international ethical and legal documents related to Big Data research involving digital and internet mediated data using classical analytical methods. Second, we investigated the attitudes, needs and concerns of involved stakeholders by conducting interviews with researchers, data protection officers and legal scholars. Finally, we carried out a thorough ethical and legal analysis of the issues identified during the interviews and literature review. We provided and disseminated best practices and recommendations to independent researchers and research institutions through scholarly articles and knowledge transfer initiatives (symposia, meetings etc.).

Research using Big Data has the potential to contribute to advance of knowledge and general improvements of society. But regulations governing research have not kept pace with technology. Research involving electronic health records or social media are but two prominent examples. This regulatory uncertainty could stoke public fears about privacy and confidentiality. Research issues related to informed consent and conflicts of interest thus urgently require careful ethical and legal assessment.

The absence of clear ethical guidance could lead to reduced sharing of data and hinder research in a way that affects the societal benefit of Big Data research. The primary goal of this study was thus to strive towards a sensible and efficient use of digital data for research. The project aimed to reduce ethical and regulatory uncertainty by providing ethical guidance for individual researchers and research institutions concerning the collection, storage, and analysis of large digital datasets.

This project has contributed to the local and international regulatory and ethical debate on the use of Big Data in research. In doing so, the project has helped to provide practical guidance for researchers and lead to better understanding of public fears about misuse of data. The project results provide recommendations to protect the privacy, confidentiality, and informed consent of those whose data are being used while maximising the societal benefits of this emerging research trend.

The project highlighted how the evaluation of the ethical issues of Big Data is still at its infancy. According to the results, Big Data is raising unpredictable ethical challenges including risk of harm for research participants – such as discrimination, invasion of privacy, possible misuse of their data and issues of consent. Researchers involved in Big Data research are aware of the ethical challenges, but they point to the lack of appropriate guidelines and regulatory practices to handle increasingly digital projects. The results also show that there is the need to implement ethical oversight and assessment of Big Data research projects. In this context, the role of ethics committees should be expanded in order to monitor the ethical soundness of research projects throughout the data lifecycle. Strategies to implement models of shared responsibility between researchers, ethics committees and other data stakeholders (the individuals whose data is collected and data holders) should be created. In the legislative context, Big Data exceptionalism (treating Big Data differently than other types of data) should be avoided especially in the Swiss context where emphasis is given to concepts such as consent and notice. In addition, experts in the legislative area share the perspective that the concept of ownership in the Big Data area is incompatible with today’s legal dogma. Indeed, this concept of ownership is regarded as contentious by lawyers and data protection officers.

Ethical and legal regulation of Big Data research – towards a sensible and efficient use of electronic health records and social media data [BigResearchEthics]