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We conclude that the search for ways forward within the consent or anonymise paradigm becomes increasingly difficult in a data-intensive medical research context

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

European Journal of Human Genetics, no. 7 (2016)

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Abstract

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 revie...More

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Introduction
  • Both medical research and the legal landscape have been changing as a result of the rapid developments in information technology (IT).
  • 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.
Highlights
  • In recent years, both medical research and the legal landscape have been changing as a result of the rapid developments in information technology (IT)
  • What can we learn from the above? In the debate on how to deal with the challenges to the consent or anonymise approach in the context of data-intensive medical research, within the European Union (EU) legal framework on data protection, we suggest that the following considerations should be taken into account
  • We conclude that the search for ways forward within the consent or anonymise paradigm becomes increasingly difficult in a data-intensive medical research context
  • The draft General Data Protection Regulation (GDPR) texts do provide an overlapping EU legal framework on this topic, but leave considerable room for a more detailed regulation on a national level. It seems that it will be largely up to the EU member states to determine the appropriate conditions of research exemptions
  • Initiatives within the medical research community to coordinate the development of harmonised approaches, such as BBMRI-ERIC and the Global Alliance, may remain of vital importance to achieve the goal of international interoperability
  • We notice that there is a lack of consensus on what the conditions of a research exemption from consent should be, while these conditions are of great influence to how relevant rights and interests need to be taken into account in a data-intensive medical research context
Results
  • They indicate that the combination of strict consent requirements and limited research exemptions will severely restrict medical research.[10,11,12,13,14,15,16] To contribute to this evolving debate, this paper reviews how the consent or anonymise approach is challenged in a data-intensive medical research context, and discusses possible ways forward within the EU legal framework on data protection.
  • 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.
  • Some argue that research exemptions should be kept to a minimum by using dynamic consent approaches, taking into account the requirements of necessity and proportionality.[68] Others suggest that consent should serve as ‘a default starting point from which departure is possible’ for a particular data usage, when there is evidence of a strong justification in the public interest.[6] A more radical view is that providing another legal basis than consent should not be considered as an ‘exemption’, but as an acceptable route to achieve protection when data are re-used in large biobanks and data sets.[9] some argue to reduce or eliminate the need for consent by focusing on solidarity arguments and harm mitigation.[69]
  • It is argued though that a strict interpretation of this requirement will possibly render most data useless for epidemiological research.[14] According to Article 83 (2) of the Council’s draft GDPR, technological and/or organisational protection measures, such as pseudonymisation, could ensure that the processing of personal data is minimised, in pursuance of the proportionality and necessity principles.
  • Technological and organisational or governance measures have been proposed in the literature to justify alternative legal bases to consent, such as opt-out registration,[9] authorisation by an ethics committee,[8] limiting data access and use, and engaging in public participation.[32] To overcome some of the challenges related to implementing governance mechanisms on an international scale, an e-governance system is proposed.[70]
Conclusion
  • In the debate on how to deal with the challenges to the consent or anonymise approach in the context of data-intensive medical research, within the EU legal framework on data protection, the authors suggest that the following considerations should be taken into account.
  • Further interdisciplinary research is needed to determine when a shift away from consent as a legal basis is necessary and proportionate in a data-intensive medical research context, and what technological and governance measures should be put in place when such a research exemption from consent is provided.
Study subjects and analysis
participants: 500000
Vital to the collection, re-use and linkage of multiple data sources on a large scale are the research infrastructures and networks in and outside the EU. For example, the UK Biobank provides access to medical researchers from all around the world to a wide variety of health-related data and human samples from more than 500 000 participants.26. In Europe, the Biobanking and BioMolecular resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI-ERIC) aims to facilitate the re-use of human samples and health-related data available in biobanks scattered across different nations.[27]

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