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

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.Peer reviewe

Revoking consent: a 'blind spot' in data protection law?

The flow of personal data throughout the public and private sectors is central to the functioning of a modern society. The processing of these data is, however, increasingly being viewed as a major concern, particularly in light of many recent high profile data losses. It is generally assumed that individuals have a right to withdraw, or revoke, their consent to the processing of their personal data by others; however this may not be straightforward in practice, or addressed adequately by the law. Examination of the creation of data protection legislation in Europe and the UK, and its relationship with human rights law, suggests that such a general right to withdraw consent was assumed to be inbuilt, despite the lack of express provisions in both the European Data Protection Directive and UK Data Protection Act. In this article we highlight potential shortcomings in the provisions that most closely relate to this right in the UK Act. These raise questions as to the extent of meaningful rights of revocation, and thus rights of informational privacy, afforded to individuals in a democratic society

Identifiability, genomics and UK Data Protection Law

Analyses of individuals' genomes - their entire DNA sequence - have increased knowledge about the links between genetics and disease. Anticipated advances in 'next generation' DNA-sequencing techniques will see the routine research use of whole genomes, rather than distinct parts, within the next few years. The scientific benefits of genomic research are, however, accompanied by legal and ethical concerns. Despite the assumption that genetic research data can and will be rendered anonymous, participants' identities can sometimes be elucidated, which could cause data protection legislation to apply. We undertake a timely reappraisal of these laws - particularly new penalties - and identifiability in genomic research

Legislation on direct-to-consumer genetic testing in seven European countries

An increasing number of private companies are now offering direct-to-consumer (DTC) genetic testing services. Although a lot of attention has been devoted to the regulatory framework of DTC genetic testing services in the USA, only limited information about the regulatory framework in Europe is available. We will report on the situation with regard to the national legislation on DTC genetic testing in seven European countries (Belgium, the Netherlands, Switzerland, Portugal, France, Germany, the United Kingdom). The paper will address whether these countries have legislation that specifically address the issue of DTC genetic testing or have relevant laws that is pertinent to the regulatory control of these services in their countries. The findings show that France, Germany, Portugal and Switzerland have specific legislation that defines that genetic tests can only be carried out by a medical doctor after the provision of sufficient information concerning the nature, meaning and consequences of the genetic test and after the consent of the person concerned. In the Netherlands, some DTC genetic tests could fall under legislation that provides the Minister the right to refuse to provide a license to operate if a test is scientifically unsound, not in accordance with the professional medical practice standards or if the expected benefit is not in balance with the (potential) health risks. Belgium and the United Kingdom allow the provision of DTC genetic tests