Nils Hoppe

Direct-to-consumer genetic testing for predicting sports performance and talent identification: Consensus statement.

The general consensus among sport and exercise genetics researchers is that genetic tests have no role to play in talent identification or the individualised prescription of training to maximise performance. Despite the lack of evidence, recent years have witnessed the rise of an emerging market of direct-to-consumer marketing (DTC) tests that claim to be able to identify childrens athletic talents. Targeted consumers include mainly coaches and parents. There is concern among the scientific community that the current level of knowledge is being misrepresented for commercial purposes. There remains a lack of universally accepted guidelines and legislation for DTC testing in relation to all forms of genetic testing and not just for talent identification. There is concern over the lack of clarity of information over which specific genes or variants are being tested and the almost universal lack of appropriate genetic counselling for the interpretation of the genetic data to consumers. Furthermore independent studies have identified issues relating to quality control by DTC laboratories with different results being reported from samples from the same individual. Consequently, in the current state of knowledge, no child or young athlete should be exposed to DTC genetic testing to define or alter training or for talent identification aimed at selecting gifted children or adolescents. Large scale collaborative projects, may help to develop a stronger scientific foundation on these issues in the future.

ELSI 2.0 for Genomics and Society

We need an international infrastructure for the ethical, legal, and social implications of genomic research. Anticipating and addressing the ethical, legal, and social implications (ELSI) of scientific developments has been a key feature of the genomic research agenda (1–4). Research in genomics is advancing by developing common infrastructures and research platforms, open-access and sharing policies, and new forms of international collaborations (5–12). In this paper, we outline a proposal to establish a “collaboratory” (13) for ELSI research to enable it to become more coordinated, responsive to societal needs, and better able to apply the research knowledge it generates at the global level. Current ELSI research is generally nationally focused, with investigator-initiated approaches that are not always aligned with the developments in international genomics research. This makes it difficult to efficiently leverage findings that impact global practice and policy. Moreover, as translational genomic research design challenges become more pressing (14), ELSI research will need to develop greater capacity to respond rapidly to new developments. The ELSI 2.0 Initiative is designed to catalyze international collaboration in ELSI genomics and to enable those in the field to better assess the impact and dynamics of global genome research.

A comparative analysis of the requirements for the use of data in biobanks based in Finland, Germany, the Netherlands, Norway and the United Kingdom

To understand the causes of disease and improve diagnosis and treatment regimes, biomedical researchers need access to large numbers of well-characterized data and samples. Over the past decade, biobanks have been established across Europe to collect and manage access to data and samples. The challenge that we face is how to develop the tools and collaborations to enable researchers to access samples and data from a network of biobanks, rather than applying to individual biobanks. One of the perceived stumbling blocks to achieving this is represented by the different legal requirements in each country. The aim of the BioSHaRE-European Union (EU) project is to address these challenges by developing tools and methods for researchers to access and use pooled data from different cohort and biobank studies. The purpose of this article is to identify and compare the key legal requirements regarding research use of data across biobanks based in Finland, Germany, the Netherlands, Norway and the UK. Our investigation starts with the analysis of the key differences for the use of data between these countries. As a result, we identified three key areas where legal requirements differ across the five BioSHaRE-EU jurisdictions, namely, in the definition of personal data, the requirements regarding pseudonymization and processing for medical research purposes. This article provides an overview of these differences and describes them in the light of the proposed EU regulation on data protection.

Medical Law and Medical Ethics

1. Introduction 2. Confidentiality and access to information 3. Errors and fault 4. Consent and autonomy 5. Incapable adults and children 6. Resource allocation and prioritisation 7. Assisted reproduction 8. Abortion, neonaticide and infanticide 9. Organ and tissue transplantation 10. Research 11. End of life 12. Concluding thoughts.

An ethical framework for expanded access to cell-based therapies

273 ISSN 1746-0751 10.2217/RME.11.12

Innovation in medicine through degeneration in law? A critical perspective on the Medical Innovation Bill

The current debate surrounding the Medical Innovation Bill purports to be aimed at improving the normative framework to the extent that innovation is more likely. A closer look at the mechanisms of the proposed legislation and a more detailed assessment of the reasons given for initiating the legislative process in this instance reveal that the Bill seem to rest on a significant misunderstanding of the current law of medical negligence. This article analyses the provisions of the Bill, puts them into the wider context of medical negligence and critically reviews the utility of the proposed legislation.

A Sense of Entitlement: Individual vs. Public Interest in Human Tissue

This chapter argues that the balancing exercises undertaken between individual interest and public interest in the context of human material procurement are distorted on the basis of unconvincing arguments. It shows different bases for entitlements and makes a clear distinction between live and post-mortem procurement. The destination of the material is also argued to be of pivotal concern: where the material is used to save a life, where it is used to improve a person’s health and wellbeing and where it is used for (potentially commercial) research – all of these scenarios demand different approaches to procurement governance. The text culminates in the proposal of an initial framework for a three-tiered system. Where the procurement is post-mortem and the material to be procured is necessary to save another’s life, it is argued that there is no justification for withholding the material by means of an inter-vivos arrangement and it should be available without consent. Where the material is taken post-mortem and destined to improve another patient’s health or wellbeing, the current system of free and voluntary donation can remain in place with all its limitations. Finally, where the material is taken from a live source and is required for research purposes, the source should be entitled to stipulate conditions (financial or otherwise) for the excision and further use.

From omics and etics to policy and ethics: regulating evolution

Few technologies have experienced such an explosive development and significant increase in utility as the study, description and manipulation of the genes that spell out many of the functions of human life—it almost seems as if the science of our genes is autopoietic in terms of generating innovation. Genetic information is used to address large-scale problems, for example where whole genome and exome sequencing advances the understanding of rare diseases. It is used to tailor individualised health interventions, such as where the identification of a HER2 mutation may open the therapeutic pathway to a treatment with Herceptin or where evidence of a BRCA mutation may trigger potentionally life-saving surgery. From Sir Alec Jeffreys discovery of DNA similarities, used to identify perpetrators of crime and family relations in immigration cases, to direct-to-consumer genetic testing, used to identify a childs father (or possibly more frequently—establishing the fact that the putative father is not the genetic father) and an individuals genetic disease probability (relative to some nebulous population), genetics and -omics are becoming all-pervasive and, above all, affordable. The cost of whole genome sequencing has decreased dramatically in little more than 10 years—Figure 1 (Wetterstrand, 2013) shows the decreasing cost of sequencing a genome at NHGRI: from just under

The Legal Governance of Animal Biotechnologies

100 m in 2001 to just over

Privacy Laws and Biobanking in Germany

5000 in 2013. 23 and Me, a prominent provider of direct-to-consumer genetic testing for disease probability and ancestry, started in 2007 at a cost of