Jane Reichel

ERIC: a new governance tool for Biobanking

In 2009, the EU introduced a new governance tool for research, the European Research Infrastructure Consortium, commonly referred to as ERIC. On 22nd November 2013, an ERIC within biobanking research was established, the BBMRI-ERIC, with its seat in Graz, Austria. This article analyses what use the ERIC can be to researchers in biobanking, focusing on legal and ethical perspectives. Our conclusion is that the main advantages with the ERIC are its functions as a platform, creating opportunities for long-term cooperation between the Member States involved and their researchers. Within the platform, research groups can develop functional standards for technical, legal and ethical purposes, set up criteria for biobanks, and so on. The ERIC also creates a platform for the involved researchers to communicate with policymakers in the EU and the Member States. However, when it comes to addressing the diverse regulatory framework for biobanking in the EU, one of the more important hurdles today, the ERIC does not provide for any substantial tools.

BiobankCloud: A Platform for the Secure Storage, Sharing, and Processing of Large Biomedical Data Sets

Biobanks store and catalog human biological material that is increasingly being digitized using next-generation sequencing (NGS). There is, however, a computational bottleneck, as existing software systems are not scalable and secure enough to store and process the incoming wave of genomic data from NGS machines. In the BiobankCloud project, we are building a Hadoop-based platform for the secure storage, sharing, and parallel processing of genomic data. We extended Hadoop to include support for multi-tenant studies, reduced storage requirements with erasure coding, and added support for extensible and consistent metadata. On top of Hadoop, we built a scalable scientific workflow engine featuring a proper workflow definition language focusing on simple integration and chaining of existing tools, adaptive scheduling on Apache Yarn, and support for iterative dataflows. Our platform also supports the secure sharing of data across different, distributed Hadoop clusters. The software is easily installed and comes with a user-friendly web interface for running, managing, and accessing data sets behind a secure 2-factor authentication. Initial tests have shown that the engine scales well to dozens of nodes. The entire system is open-source and includes pre-defined workflows for popular tasks in biomedical data analysis, such as variant identification, differential transcriptome analysis using RNA-Seq, and analysis of miRNA-Seq and ChIP-Seq data.

Privacy Threat Modeling for Emerging BiobankClouds

Abstract There is an increased amount of data produced by next generation sequencing (NGS) machines which demand scalable storage and analysis of genomic data. In order to cope with this huge amount of information, many biobanks are interested in cloud computing capabilities such as on-demand elasticity of computing power and storage capacity. There are several security and privacy requirements mandated by personal data protection legislation which hinder biobanks from migrating big data generated by the NGS machines. This paper describes the privacy requirements of platform-as-service BiobankClouds according to the European Data Protection Directive (DPD). It identifies several key privacy threats which leave BiobankClouds vulnerable to an attack. This study benefits health-care application designers in the requirement elicitation cycle when building privacy-preserving BiobankCloud platforms.

Administrating Data Protection : or the Fort Knox of the European Composite Administration?

Administrating Data Protection : or the Fort Knox of the European Composite Administration?

EU Governance for Research and Ethics in Biobanks

In this paper the new governance tool for research developed within the EU, the European Research Infrastructure Consortium, ERIC, will be studied. One specific research infrastructure is put in focus, the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI.eu), a pan-european research infrastructure financed by the EU, the Member States and associated countries involved.

Judicial Control in a Globalised Legal Order – A One Way Track? An Analysis of the Case C-263/08 Djurgården-Lilla Värtan

This article examines the preliminary ruling given by the Court of Justice in the Djurgarden-Lilla Vartan case. The case involves the Swedish implementation of the Aarhus Convention via an EU Dire ...

Oversight of EU medical data transfers – an administrative law perspective on cross-border biomedical research administration

The notion of privacy has long had a central role in human rights law, not least in connection to health and medicine. International, regional and national bodies have enacted a number of binding and non-binding document for physicians and researchers to adhere to, in order to protect the autonomy, dignity and privacy of patients and research subjects. With the development of new technologies, the right to privacy has gained a new perspective; the right to protection of personal data within information and communication technologies. The right to data protection has been attributed an increasing importance within EU law. Accordingly, the use of health data in medical research in general and in biobank-related medical research in particular, has made data protection law highly relevant. In medical research involving biobanks, transferring human biological samples and/or individual health data is taking place on a daily basis. These transfers involve several oversight bodies, institutional review boards (IRBs), research ethics committees, or even data protection authorities. This article investigates the role of these national oversight bodies in the transfer of health data in cross-border research, from an EU law point of view. A special focus is laid on transfer of health data for research purposes from the EU to the US, in the light of the recently enacted EU-US Privacy Shield. The main question posed is how American oversight bodies for medical research can be expected to handle the increasingly strict EU requirements for the processing of health data in medical research review.

The New General Data Protection Regulation—Where Are We Are and Where Might We Be Heading?

The current EU Directive on Data Protection, has been described as the most far reaching Data Protection regime in the world. Still, the ongoing work within the EU to enact a new General Data Protection Regulation seems to be heading towards an even stricter regime. Medical researchers in biobanking and epidemiology have had quite a fright on behalf of the proposal, especially the amendments suggested by rapporteur Albrecht of the European Parliament’s LIBE Committee in December 2012, that to a large extent were accepted by the Committee in a October 2013 and the European Parliament in its first reading of the proposal in March 2014. In this short overview, the status of the legislative procedures will be addressed, a comment on the consequences of changing the legal form from a directive to a regulation, as well as a brief description of the content of the General Data Protection Regulation relevant to research on health data.

Legal & ethical compliance when sharing biospecimen

Abstract When obtaining samples from biobanks, resolving ethical and legal concerns is a time-consuming task where researchers need to balance the needs of privacy, trust and scientific progress. The Biobanking and Biomolecular Resources Research Infrastructure-Large Prospective Cohorts project has resolved numerous such issues through intense communication between involved researchers and experts in its mission to unite large prospective study sets in Europe. To facilitate efficient communication, it is useful for nonexperts to have an at least basic understanding of the regulatory system for managing biological samples. Laws regulating research oversight are based on national law and normally share core principles founded on international charters. In interview studies among donors, chief concerns are privacy, efficient sample utilization and access to information generated from their samples. Despite a lack of clear evidence regarding which concern takes precedence, scientific as well as public discourse has largely focused on privacy concerns and the right of donors to control the usage of their samples. It is therefore important to proactively deal with ethical and legal issues to avoid complications that delay or prevent samples from being accessed. To help biobank professionals avoid making unnecessary mistakes, we have developed this basic primer covering the relationship between ethics and law, the concept of informed consent and considerations for returning findings to donors.

Supporting the development of biobanks in low and medium income countries

Biobanks are an organized collection of biological material and associated data. They are a fundamental resource for life science research and contribute to the development of pharmaceutical drugs, diagnostic markers and to a deeper understanding of the genetics that regulate the development of all life on earth. Biobanks are well established in High Income Countries (HIC) and are rapidly emerging in Low and Middle Income Countries (LMIC). Surveys among biobanks operating in a LMIC setting indicate that limited resources and short term funding tied to specific projects threaten the sustainability of the biobanks. Fit-for-purpose biobanks targeting major societal challenges such as HIV and Malaria provide an excellent basis for integrating biobanks with the available research communities in LMIC regions. But to become sustainable for the future it is important that biobanks become an integrated part of local research communities. To achieve this, the cost of operating biobanks must be lowered, templates must be developed to support local ethics committees and researchers must be given the opportunity to build experience in successfully operating biobank based research projects. The B3Africa consortium is based on these conclusions and set up to support biobank based research by creating a cost efficient Laboratory Information Management System (LIMS) for developing biobanks and also contribute to the training and capacity building in the local research community. The technical platform called the eB3Kit is open source and consists of a LIMS and a bioinformatics module based on the eBiokit that allow researchers to take control over the analysis of their own data. Along with the technical platform the consortium will also contribute training and support for the associated infrastructures necessary to regulate the ethical and legal implications of biobank based research.