Access Governance for Biobanks: The Case of the BioSHaRE-EU Cohorts

Currently, researchers have to apply separately to individual biobanks if they want to carry out studies that use samples and data from multiple biobanks. This article analyzes the access governance arrangements of the original five biobank members of the Biobank Standardisation and Harmonisation for Research Excellence in the European Union (BioSHaRE-EU) project in Finland, Germany, the Netherlands, Norway, and the United Kingdom to identify similarities and differences in policies and procedures, and consider the potential for internal policy "harmonization." Our analysis found differences in the range of researchers and organizations eligible to access biobanks; application processes; requirements for Research Ethics Committee approval; and terms of Material Transfer Agreements relating to ownership and commercialization. However, the main elements of access are the same across biobanks; access will be granted to bona fide researchers conducting research in the public interest, and all biobanks will consider the scientific merit of the proposed use and it's compatibility with the biobank's objectives. These findings suggest potential areas for harmonization across biobanks. This could be achieved through a single centralized application to a number of biobanks or a system of mutual recognition that places a presumption in favor of access to one biobank if already approved by another member of the same consortium. Biobanking and Biomolecular Resources Research Infrastructure-European Research Infrastructure Consortia (BBMRI-ERIC), a European consortium of biobanks and bioresources with its own ethical, legal, and social implications (ELSI) common service, could provide a platform by developing guidelines for harmonized internal processes

Access Governance for Biobanks: The Case of the BioSHaRE-EU Cohorts

Currently, researchers have to apply separately to individual biobanks if they want to carry out studies that use samples and data from multiple biobanks. This article analyzes the access governance arrangements of the original five biobank members of the Biobank Standardisation and Harmonisation for Research Excellence in the European Union (BioSHaRE-EU) project in Finland, Germany, the Netherlands, Norway, and the United Kingdom to identify similarities and differences in policies and procedures, and consider the potential for internal policy "harmonization." Our analysis found differences in the range of researchers and organizations eligible to access biobanks; application processes; requirements for Research Ethics Committee approval; and terms of Material Transfer Agreements relating to ownership and commercialization. However, the main elements of access are the same across biobanks; access will be granted to bona fide researchers conducting research in the public interest, and all biobanks will consider the scientific merit of the proposed use and it's compatibility with the biobank's objectives. These findings suggest potential areas for harmonization across biobanks. This could be achieved through a single centralized application to a number of biobanks or a system of mutual recognition that places a presumption in favor of access to one biobank if already approved by another member of the same consortium. Biobanking and Biomolecular Resources Research Infrastructure-European Research Infrastructure Consortia (BBMRI-ERIC), a European consortium of biobanks and bioresources with its own ethical, legal, and social implications (ELSI) common service, could provide a platform by developing guidelines for harmonized internal processes

Consent for biobanking: The legal frameworks of countries in the BioSHaRE-EU project.

Currently, there is no single, Europe-wide regulation of biomedical research using human samples and data. Instead, the law that applies spans a number of areas of law, such as data protection, clinical trials, and tissue regulation. In the absence of harmonized regulation, there is considerable scope for national legal variation. This article analyzes the legislative frameworks that apply to biobanking activities to identify differences in legal requirements between the BioSHaRE-EU project countries: Finland, France, Germany, the Netherlands, Norway, and the United Kingdom. This article highlights the primary role of consent and accompanying governance mechanisms, such as research ethics committee oversight, which enable consent exemptions in the context of research. Our analysis identifies a complicated legal landscape, whereby broadly similar provisions are contained in varied sources of law in each jurisdiction. The challenge for researchers is locating the applicable legal provisions within each national legal framework

Biobank and Biomedical Research: Responsibilities of Controllers and Processors under the EU General Data Protection Regulation

Biobanks are essential infrastructures in current health and biomedical research. Advanced scientific research increasingly relies on processing and correlating large amounts of genetic, clinical and behavioural data. These data are particularly sensitive in nature and the risk for privacy invasion and misuse is high. The EU General Data Protection Regulation (GDPR) developed and increased harmonization, resulting in a framework defining specific duties and obligations of entities processing personal data – controllers and processors. Biobanks, in the exercise of their functions assume the role of controllers and/or processors and as such need to comply with a number of complex rules. This chapter analyses these rules, in light of Article 89 GDPR, which creates safeguards and derrogations relating to processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. It identifies key compliance challenges faced by biobanks as data controllers and processors, such as determining whether the GDPR is applicable and its intersection with other regulations; when should a biobank be considered controller and processor; what are the main duties of biobanks as data controllers and processors and options for compliance

Minimum resale price maintenance in EU in the aftermath of the US Leegin decision

Leegin decision of the Supreme Court in 2007 affirmed that minimum RPM was to be evaluated under the rule of reason henceforth. Conversely, minimum RPM retains its position as a hard-core restraint in EU's BER 2010 and the De Minimis Notice. The limited amount of case law reveal that in the absence of certain factors, such as significant market power of the parties, minimum RPM is unlikely to result in the detriment of consumers. Consequently, despite the retention of the maintenance of the single market as a significant aim in EU competition policy, minimum RPM practices are entitled to a more lenient approach, if the ultimate aim is to attain consumer welfare as stated by the Commission and through most judgments of the Court of Justice of the European Union