Abstract
In parallel with the advances in big data-driven clinical research, the data safe haven concept has evolved over the last decade. It has led to the development of a framework to support the secure handling of health care information used for clinical research that balances compliance with legal and regulatory controls and ethical requirements while engaging with the public as a partner in its governance. We describe the evolution of 4 separately developed clinical research platforms into services throughout the United Kingdom-wide Farr Institute and their common deployment features in practice. The Farr Institute is a case study from which we propose a common definition of data safe havens as trusted platforms for clinical academic research. We use this common definition to discuss the challenges and dilemmas faced by the clinical academic research community, to help promote a consistent understanding of them and how they might best be handled in practice. We conclude by questioning whether the common definition represents a safe and trustworthy model for conducting clinical research that can stand the test of time and ongoing technical advances while paying heed to evolving public and professional concerns.
Highlights
The Big Data DilemmaThe challenges of secure electronic health care records reuse and its trustworthiness are well recognized [1]
With reference to a series of case studies across the 4 nodes of the Farr Institute of Health Informatics Research, which spans the United Kingdom, we build upon the understanding that has developed around the data safe haven (DSH) paradigm and the need to apply a more developed and inclusive understanding of trust as it applies to different stakeholders
We have described the motivations behind developing the DSH paradigm to support the big data, epidemiological research drive
Summary
The challenges of secure electronic health care records reuse and its trustworthiness are well recognized [1]. While this armory of legal protections enforces the requirement of careful working practice and processing that should not undermine reasonable uses of health care data, it does not offer an immediate answer to information reuse dilemmas, nor does it alter the risks of re-identification in de-identified datasets. The DSH has been established within the School of Life and Medical Sciences at University College London as an identifiable data handling service, comprising a technical solution for the secure storage of identifying or pseudonymized data, and a service within which the technical solution is mapped that provides individual health research projects guidance on how to develop their own working practices and achieve Information Governance Toolkit compliance. The identifiable data handling service is considering the establishment of an ethics oversight committee to include a panel of researchers, clinical and legal expertise, and involvement from patient groups or members of the public to help consider any ad hoc collaborations across research projects or wider interventions
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