Data Safe Havens and Trust: Toward a Common Understanding of Trusted Research Platforms for Governing Secure and Ethical Health Research

Lea, Nathan; Nicholls, Jacqueline; Dobbs, Christine; Sethi, Nayha; Cunningham, James A.; Ainsworth, John; Heaven, Martin; Peacock, Trevor; Peacock, A.; Jones, Kerina; Laurie, Graeme; Kalra, Dipak

doi:10.2196/medinform.5571

Cited by 42 publications

(47 citation statements)

References 31 publications

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“…Researchers as part of their host institution have to sign a Data User Agreement before they are allowed to access NHS-linked data. Linked eHealth data is released for clinical academic research via NHS approved safe havens, or held in a secure network environment [55]. Samples are stored in four separate laboratories in Scottish University Medical Schools, catalogued through a central laboratory information management system [56].…”

Section: Resultsmentioning

confidence: 99%

Balancing the Local and the Universal in Maintaining Ethical Access to a Genomics Biobank

Heeney

Kerr

2017

Preprint

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Background: Issues of balancing data accessibility with ethical considerations and governance of a genomics research biobank, Generation Scotland, are explored within the evolving policy landscape of the past ten years. During this time data sharing and open data access have become increasingly important topics in biomedical research. Decisions around data access are influenced by local arrangements for governance and practices such as linkage to health records, and the global through policies for biobanking and the sharing of data with large-scale biomedical research data resources and consortia. Methods: We use a literature review of policy relevant documents which apply to the conduct of biobanks in two areas: support for open access and the protection of data subjects and researchers managing a bioresource. We present examples of decision making within a biobank based upon observations of the Generation Scotland Access Committee. We reflect upon how the drive towards open access raises ethical dilemmas for established biorepositories containing data and samples from human subjects. Results: Despite much discussion in science policy literature about standardisation, the contextual aspects of biobanking are often overlooked. Using our engagement with GS we demonstrate the importance of local arrangements in the creation of a responsive ethical approach to biorepository governance. We argue that governance decisions regarding access to the biobank are intertwined with considerations about maintenance and viability at the local level. We show that in addition to the focus upon ever more universal and standardised practices, the local expertise gained in the management of such repositories must be supported. Conclusions:A commitment to open access in genomics research has found almost universal backing in science and health policy circles, but repositories of data and samples from human subjects may have to operate under managed access, to protect privacy, align with participant consent and ensure that the resource can be managed in a sustainable way. Data access committees need to be reflexive and flexible, to cope with changing technology and opportunities and threats from the wider data sharing environment. To understand these interactions also involves nurturing what is particular about the biobank in its local context.

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Section: Resultsmentioning

confidence: 99%

Balancing the Local and the Universal in Maintaining Ethical Access to a Genomics Biobank

Heeney

Kerr

2017

Preprint

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“…The new ISO document on anonymisation carefully shows the trade-offs between various anonymisation techniques and theirdin shortdusability for research purposes [18]. Anonymous data to the highest standards without any residual risk for re-identification lose their value for nuanced research [19,20]. Methods such as 'datashield' [21] or VIPAR [22] claim to bring the questions to the data and hence be able to avoid the complexities of data protection rules.…”

Section: Personal Datamentioning

confidence: 99%

Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate

Veen¹

2018

European Journal of Cancer

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Insights into the incidence and survival of cancer, the influence of lifestyle and environmental factors and the interaction of treatment regimens with outcomes are hugely dependent on observational research, patient data derived from the healthcare system and from volunteers participating in cohort studies, often non-selective. Since 25th May 2018, the European General Data Protection Regulation (GDPR) applies to such data. The GDPR focusses on more individual control for data subjects of 'their' data. Yet, the GDPR was preceded by a long debate. The research community participated actively in that debate, and as a result, the GDPR has research exemptions as well. Some of those apply directly; other exemptions need to be implemented into national law. Those exemptions will be discussed together with a general outline of the GDPR. I propose a substantive definition of researchdabsent in the GDPRdwhich can warrant its special status in the GDPR. The debate is not over yet. Most legal texts exhibit ambiguity and are interpreted against a background of values. In this case, those could be subsumed under informational self-determination versus solidarity and the deeper meaning of autonomy. Values will also guide national implementation and their interpretation. The value of individual control or informational selfdetermination should be balanced by nuanced visions about our mutual dependency in healthcare, as an ever-learning system, especially in the European solidarity-based healthcare systems. Good research governance might be a way forward to escape the consent or anonymise dichotomy.

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“…A graphical method was used to map required information flows within a limited number of privacy zones [22]. We nominated privacy zones as Care Zone, Non-care Zone and Research Zone [23] but additionally incorporated a use-case driven Trustworthy Research Environment [24] for data analytics. The Trustworthy Research Environment (commonly abbreviated to TRE) is a fullyimplemented system supporting secure, regulated (authenticated researcher) access to datasets and tools.…”

Section: Consistent Matching Of Information Governance Requirements Tmentioning

confidence: 99%

GDPR Compliance Challenges for Interoperable Health Information Exchanges (HIEs) and Trustworthy Research Environments (TREs)

Conley¹,

Pocs²

2018

ejbi

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and processors once it comes into force in the spring of 2018. Fundamentally, GDPR aims to provide a set of standardized data protection laws across EU countries. This is intended to make it easier for EU citizens to understand how their data is being used and to raise any complaints. For implementers, it has potential to reduce fragmentation and administrative burdens where business activities flow through local, regional, national and international data exchanges. A full treatment of the data protection principles that drive compliance to the GDPR is beyond the scope of this paper, but an abundance of introductory resources is available on the Internet.

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Data Safe Havens and Trust: Toward a Common Understanding of Trusted Research Platforms for Governing Secure and Ethical Health Research

Cited by 42 publications

References 31 publications

Balancing the Local and the Universal in Maintaining Ethical Access to a Genomics Biobank

Balancing the Local and the Universal in Maintaining Ethical Access to a Genomics Biobank

Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate

GDPR Compliance Challenges for Interoperable Health Information Exchanges (HIEs) and Trustworthy Research Environments (TREs)

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