Protecting Personal Data in Epidemiological Research: DataSHIELD and UK Law

Wallace, Susan; Gaye, Amadou Thierno; Shoush, Osama; Burton, Paul R.

doi:10.1159/000360255

Cited by 21 publications

(17 citation statements)

References 21 publications

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“…64 It is claimed that under DataSHIELD personal data re-use, linkage and analysis is enabled in accordance with legislation and guidance in the United Kingdom, primarily because no identifying or sensitive information is returned to the researcher. [65][66][67] Significant challenges however need to be overcome in the implementation of this initiative. 64 WAYS FORWARD OUTSIDE THE CONSENT OR ANONYMISE PARADIGM An alternative approach is to search for ways forward outside the consent or anonymise paradigm, by creating another legal basis than consent for the processing of sensitive personal data for medical research purposes.…”

Section: Adapting Consentmentioning

confidence: 99%

Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach

et al. 2015

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Medical research is increasingly becoming data-intensive; sensitive data are being re-used, linked and analysed on an unprecedented scale. The current EU data protection law reform has led to an intense debate about its potential effect on this processing of data in medical research. To contribute to this evolving debate, this paper reviews how the dominant 'consent or anonymise approach' is challenged in a data-intensive medical research context, and discusses possible ways forwards within the EU legal framework on data protection. A large part of the debate in literature focuses on the acceptability of adapting consent or anonymisation mechanisms to overcome the challenges within these approaches. We however believe that the search for ways forward within the consent or anonymise paradigm will become increasingly difficult. Therefore, we underline the necessity of an appropriate research exemption from consent for the use of sensitive personal data in medical research to take account of all legitimate interests. The appropriate conditions of such a research exemption are however subject to debate, and we expect that there will be minimal harmonisation of these conditions in the forthcoming EU Data Protection Regulation. Further deliberation is required to determine when a shift away from consent as a legal basis is necessary and proportional in a data-intensive medical research context, and what safeguards should be put in place when such a research exemption from consent is provided.

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Section: Adapting Consentmentioning

confidence: 99%

Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach

et al. 2015

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“…DataSHIELD offers a new approach to data sharing and is currently being tested in real-life epidemiological projects, including the Healthy Obese Project of the BioSHaRE project [11]. In our previous paper led by Susan Wallace [12], we concluded that DataSHIELD was in compliance with UK standards of protection for the sharing of biomedical data. Here, we demonstrate that DataSHIELD can also address a number of commonly encountered ethics-related data-sharing concerns.…”

Section: Resultsmentioning

confidence: 99%

“…In our previous paper led by Susan Wallace [12], we suggested that the summary statistics processed in DataSHIELD are anonymous data which could potentially be shared without referral to European data protection principles, thus opening for pan-European use of the data. A similar analysis could indicate whether DataSHIELD can cross internal national borders (i.e.…”

Section: Discussionmentioning

confidence: 99%

“…In a previous paper, we investigated whether DataSHIELD could appropriately protect participant confidentiality according to UK legal standards [12]. That paper concludes that DataSHIELD reaches UK standards of protection for the sharing of biomedical data and calls for further investigation of DataSHIELD to determine if it satisfies other legal and ethics review requirements, also outside of the UK.…”

Section: Introductionmentioning

confidence: 99%

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DataSHIELD: An Ethically Robust Solution to Multiple-Site Individual-Level Data Analysis

Budin‐Ljøsne

Burton

Isaeva

et al. 2014

Public Health Genomics

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Background: DataSHIELD (Data Aggregation Through Anonymous Summary-statistics from Harmonised Individual levEL Databases) has been proposed to facilitate the co-analysis of individual-level data from multiple studies without physically sharing the data. In a previous paper, we investigated whether DataSHIELD could protect participant confidentiality in accordance with UK law. In this follow-up paper, we investigate whether DataSHIELD addresses a broader range of ethics-related data-sharing concerns. Methods: Ethics-related data-sharing concerns of Institutional Review Boards, ethics experts, international research consortia and research participants were identified through a literature search and systematically examined at a multidisciplinary workshop to determine whether DataSHIELD proposes mechanisms which can address these concerns. Results: DataSHIELD addresses several ethics-related data-sharing concerns related to privacy, confidentiality, and the protection of the research participant's rights while sharing data and after the data have been shared. The data remain entirely under the direct management of the study that collected them. Data processing commands are strictly supervised, and the data are queried in a protected environment. Issues related to the return of individual research results when data are shared are eliminated; the responsibility for return remains at the study of origin. Conclusion: DataSHIELD can provide an innovative and robust solution for addressing commonly encountered ethics-related data-sharing concerns.

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“…34 Other approaches allow a limited amount of information to be shared in response to queries made by the users, 35 although their use may be yet limited to specific models of data access. Given the alternative models are not yet widely established, the current model of data sharing seems here to stay for the foreseeable future, as some of our respondents noted.…”

Section: Discussionmentioning

confidence: 99%

Who should have access to genomic data and how should they be held accountable? Perspectives of Data Access Committee members and experts

2016

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Facilitating the responsible access to genomic research data is an emerging ethical and scientific imperative. Data Access Committees (DACs) assess the ethical footing and scientific feasibility of the data access requests and evaluate the qualification of applicants to ensure they are bona fide researchers. Through semi-structured interviews, we explored the opinions and experiences of 20 DAC members and experts concerning the users' qualification criteria and mechanisms to hold users accountable. According to our respondents, such evaluation is necessary to ensure applicants are trustworthy, meet a certain level of expertise or experience and are aware of the rules and the associated concerns with genomic data sharing. The respondents noted, however, that the qualification criteria are fragmented or are poorly delineated at times. Thus, developing qualification criteria seems vital for an objective, fair and responsible access procedure. Similarly, the access review will benefit from using common ways of verifying the users' affiliations. Furthermore, some DAC members expressed concern over the uncertain oversight of downstream data use, in particular where data are shared across borders. DAC members and experts did not consider current sanctions and enforcement procedures to be crystal clear. Therefore, data sharing policies should address this gap by establishing proportionate sanctions both against data producers and data users' non-compliance. Users' home institutes will need to have an active role in keeping oversight on the downstream data uses, considering their ultimate responsibility if wrongdoings happen.

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Protecting Personal Data in Epidemiological Research: DataSHIELD and UK Law

Cited by 21 publications

References 21 publications

Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach

Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach

DataSHIELD: An Ethically Robust Solution to Multiple-Site Individual-Level Data Analysis

Who should have access to genomic data and how should they be held accountable? Perspectives of Data Access Committee members and experts

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