Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape

Despite the increasing availability of direct-to-consumer (DTC) genetic testing, it is currently unclear how such services are regulated in Europe, due to the lack of EU or national legislation specifically addressing this issue. In this article, we provide an overview of laws that could potentially impact the regulation of DTC genetic testing in 26 European countries, namely Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the Netherlands and the United Kingdom. Emphasis is placed on provisions relating to medical supervision, genetic counselling and informed consent. Our results indicate that currently there is a wide spectrum of laws regarding genetic testing in Europe. There are countries (e.g. France and Germany) which essentially ban DTC genetic testing, while in others (e.g. Luxembourg and Poland) DTC genetic testing may only be restricted by general laws, usually regarding health care services and patients' rights.status: publishe

When Risk Management Systems ‘Fail’: On Criminal Negligence and the Limits of Scientists’ Responsibility

This chapter consists of a brief discussion on some legal aspects concerning scientists’ responsibility in risk prevention processes. After proposing some introductory considerations on scientists’ responsibility as such, the author deals with the L’Aquila earthquake crisis of 2009, when a strong quake destroyed significant parts of L’Aquila (Italy) and surrounding villages, killing more than 300 people. The chapter focuses on the relations between scientific knowledge, normative expectations, decision-making and criminal negligence for ‘failed’ risk assessment and management, paying particular attention to the role of ‘regulatory science’ in constructing the ‘reasonable person’ normative standard of care in the theory of criminal negligence. This allows explaining why the first judgement in the L’Aquila trial (2012) is not convincing, having misunderstood how policy-relevant science should participate in prevention processes and the construction of normative standards. In his conclusions, the author suggests some reasons for the recent tendency to blame experts when natural or technological disasters occur

Identifying Gene-Environment Interactions in Schizophrenia: Contemporary Challenges for Integrated, Large-scale Investigations

Recent years have seen considerable progress in epidemiological and molecular genetic research into environmental and genetic factors in schizophrenia, but methodological uncertainties remain with regard to validating environmental exposures, and the population risk conferred by individual molecular genetic variants is small. There are now also a limited number of studies that have investigated molecular genetic candidate gene-environment interactions (G × E), however, so far, thorough replication of findings is rare and G × E research still faces several conceptual and methodological challenges. In this article, we aim to review these recent developments and illustrate how integrated, large-scale investigations may overcome contemporary challenges in G × E research, drawing on the example of a large, international, multi-center study into the identification and translational application of G × E in schizophrenia. While such investigations are now well underway, new challenges emerge for G × E research from late-breaking evidence that genetic variation and environmental exposures are, to a significant degree, shared across a range of psychiatric disorders, with potential overlap in phenotype

International network of cancer genome projects.

The International Cancer Genome Consortium (ICGC) was launched to coordinate large-scale cancer genome studies in tumours from 50 different cancer types and/or subtypes that are of clinical and societal importance across the globe. Systematic studies of more than 25,000 cancer genomes at the genomic, epigenomic and transcriptomic levels will reveal the repertoire of oncogenic mutations, uncover traces of the mutagenic influences, define clinically relevant subtypes for prognosis and therapeutic management, and enable the development of new cancer therapies.Journal ArticleSCOPUS: re.jinfo:eu-repo/semantics/publishe