Judit Sándor

The case of biobank with the law: between a legal and scientific fiction

According to estimates more than 400 biobanks currently operate across Europe. The term ‘biobank’ indicates a specific field of genetic study that has quietly developed without any significant critical reflection across European societies. Although scientists now routinely use this phrase, the wider public is still confused when the word ‘bank’ is being connected with the collection of their biological samples. There is a striking lack of knowledge of this field. In the recent Eurobarometer survey it was demonstrated that even in 2010 two-thirds of the respondents had never even heard about biobanks. The term gives the impression that a systematic collection of biological samples can constitute a ‘bank’ of considerable financial worth, where the biological samples, which are insignificant in isolation but are valuable as a collection, can be preserved, analysed and put to ‘profitable use’. By studying the practices of the numerous already existing biobanks, the authors address the following questions: to what extent does the term ‘biobank’ reflect the normative concept of using biological samples for the purposes of biomedical research? Furthermore, is it in harmony with the so far agreed legal–ethical consensus in Europe or does it deliberately pull science to the territory of a new, ambiguous commercial field? In other words, do biobanks constitute a medico-legal fiction or are they substantively different from other biomedical research protocols on human tissues?

Managing Access to Biobanks: How Can We Reconcile Individual Privacy and Public Interests in Genetic Research?

This article is concerned with the ultimate objectives of genetic biobanks set up to promote the public interest—being the sharing of samples and data for medical research—and the consequences for personal privacy of realising them. Our aim is to chart the values, interests and principles in play, to consider the challenges of realizing biobanking objectives on a global scale, and to propose viable ways forward that ensure, as far as possible, that access provisions remain fit for purpose throughout the entire life of a biobank, while adequately protecting the privacy interests at stake. It is argued that key features in any robust access model must include mechanisms to (a) maintain participant trust in management of the resource and to measure and respond to participants’ expectations, (b) facilitate and promote the sharing of benefits, and (c) respond timeously and effectively to new challenges.

Public views on gene editing and its uses

This paper reports on an online contrastive vignette study investigating the publics views of gene editing for therapy and enhancement in adult and prenatal contexts. The study, comprising quota samples of 1000 respondents per country, involved 10 European countries and the United States. Vignettes featuring gene editing for therapy compared to enhancement are seen as more morally acceptable and gain more support. Adult therapy attracts majority support, while prenatal enhancement elicits almost complete rejection. The assessment of adult enhancement and prenatal therapy are more ambivalent. These results and the respondents’ accounts of the reasons behind the decision point to a focus on the uses of gene editing, rather than the technology itself. The study is a contribution to understanding the practical dimensions of the ethical question: how can gene editing contribute to human flourishing?

Protection of Human Beings Trafficked for the Purpose of Organ Removal : Recommendations

Abstract This report presents a comprehensive set of recommendations for protection of human beings who are trafficked for the purpose of organ removal or are targeted for such trafficking. Developed by an interdisciplinary group of international experts under the auspices of the project Trafficking in Human Beings for the Purpose of Organ Removal (also known as the HOTT project), these recommendations are grounded in the view that an individual who parts with an organ for money within an illegal scheme is ipso facto a victim and that the crime of trafficking in human beings for the purpose of organ removal (THBOR) intersects with the crime of trafficking in organs. Consequently, the protection of victims should be a priority for all actors involved in antitrafficking activities: those combating organ-related crimes, such as health organizations and survivor support services, and those combating trafficking in human beings, such as the criminal justice sectors. Taking into account the special characteristics of THBOR, the authors identify 5 key stakeholders in the protection of human beings trafficked for organ removal or targeted for such trafficking: states, law enforcement agencies and judiciary, nongovernmental organizations working in the areas of human rights and antitrafficking, transplant centers and health professionals involved in transplant medicine, and oversight bodies. For each stakeholder, the authors identify key areas of concern and concrete measures to identify and protect the victims of THBOR. The aim of the recommendations is to contribute to the development of a nonlegislative response to THBOR, to promote the exchange of knowledge and best practices in the area of victim protection, and to facilitate the development of a policy-driven action plan for the protection of THBOR victims in the European Union and worldwide.

Anonymity and Privacy in Biobanking

The present book chapter intends to provide a conceptual framework on the use and misuse of anonymity in biobank projects. The major point of departure is the comparative analysis of various functions of anonymity in the biomedical field. By applying this method, the authors also highlight differences between traditional and contemporary notions anonymity. The other aim of the chapter is to distinguish between the overlapping terms of confidentiality, anonymity, data protection, and privacy. While medical guidelines focus on the notion and technicalities of anonymisation, legal provisions are based on the pillars of data protection norms, such as the possibility of identification, and the attachment to the original goal of data processing. The difference between these approaches resulted in various forms of ambiguities in the practice of biobanks. In addition to offering a theoretical framework, the authors analyze numerous models for regulation, with examples mainly from the Central and Eastern European region. The overview of the functions of anonymity reveals also to what extent anonymity can be regarded as an efficient solution for the regulatory challenges. The authors sketch out the most influential regulatory positions and analyze them critically, using a multidisciplinary approach.

Let us talk about eggs! Professional resistance to elective egg vitrification and gendered medical paternalism

In this paper, by applying a feminist bioethical perspective, we identify a new form of medical paternalism that still shapes contemporary legal policies on human egg cryopreservation performed without medical reasons. The fear of negligent, careless women who opt to delay their pregnancy for mere convenience is a widely known gender biased stereotype. Nevertheless, the opinions and judgments of medical professionals on this issue have not yet been sufficiently explored by in-depth research. In this essay, therefore, first we look at the broader bioethical, legal, and social aspects of human egg cryopreservation. In the second part of the paper we discuss a unique qualitative study conducted with professionals working at Hungarian IVF clinics. We argue, based on a bioethical analysis of the collected data, that when new reproduction technologies provide opportunities for women to widen their range of reproductive choices, the traditional forms of medical paternalism can be reinforced by gendered paternalism, as well. We identify several elements of gendered paternalism that characterized the attitudes of the IVF staff and discuss the professionals’ resistance to elective egg freezing and vitrification of eggs for the future. We conclude by suggesting directions for future policy. Although we focus on the Hungarian case in this paper, we are aware that similar attitudes can be observed in some other countries where this technology has become available and requested by women, but where they also face difficulties in their access to it.

The Legal Regulation of Biobanks: National Report: Greece

This paper is an overview and analysis of the relevant Greek laws on data protection, and on genetic research.

Genetic testing, genetic screening and privacy

For moral philosophers and lawyers one of the most embarrassing characteristics of genetics is that it touches intergenerational problems. It follows from the intergenerational nature of genetics that it is difficult to draw the line between medical and non-medical information produced by genetic testing or screening. Since the concept of medical confidentiality, and parallel to this privacy protection, has grown out of the elementary human wish to maintain control over the individual’s own personal information, including medical data, it became a challenging task for philosophers and lawyers to define how far genetic data can be classified as personal information and how far it can be classified as information which affects spouses, children, the fetus or the planned child. David Heyd (1992) elaborates this scepticism when he claims that prior to any moral and legal discourse it is necessary to decide whether questions provoked by genetics are parts of ethics, or whether they belong to a non-moral sphere of deliberation and evaluation. It is not my purpose to challenge this position but it may be evident from my enterprise that genetic screening, testing and moreover fundamental problems of genetics are moral problems and those who choose to undergo these examinations are subjects of the general legal protection of persons. In contrast to ordinary medical diagnosis both genetic screening and genetic testing touch upon the questions of future generations and as a consequence they go beyond the sphere of moral and personal rights of one single individual concerned (e.g. counsellee).

Transnational Surrogacy: An Overview of Legal and Ethical Issues

Surrogacy can be of various types and the difference in arrangement may imply very different ethical and legal questions. Surrogacy may be prohibited, ignored, tolerated, restricted or permitted in different parts of the world. But this diversity of the ethical and legal norms around surrogacy becomes problematic during transnational practices when the domestic laws or understanding of families often fail to accommodate the children born out of transnational surrogacy. This chapter discusses the controversies arising out of a legal fallout during transnational surrogacy and based on the lessons drawn from legal cases argues for the need for international norms. It examines the possibility of an adequate international legal framework that would better respond to the challenges of transnational surrogacy agreements.

Bottom up ethics - neuroenhancement in education and employment

Neuroenhancement involves the use of neurotechnologies to improve cognitive, affective or behavioural functioning, where these are not judged to be clinically impaired. Questions about enhancement have become one of the key topics of neuroethics over the past decade. The current study draws on in-depth public engagement activities in ten European countries giving a bottom-up perspective on the ethics and desirability of enhancement. This informed the design of an online contrastive vignette experiment that was administered to representative samples of 1000 respondents in the ten countries and the United States. The experiment investigated how the gender of the protagonist, his or her level of performance, the efficacy of the enhancer and the mode of enhancement affected support for neuroenhancement in both educational and employment contexts. Of these, higher efficacy and lower performance were found to increase willingness to support enhancement. A series of commonly articulated claims about the individual and societal dimensions of neuroenhancement were derived from the public engagement activities. Underlying these claims, multivariate analysis identified two social values. The Societal/Protective highlights counter normative consequences and opposes the use enhancers. The Individual/Proactionary highlights opportunities and supports use. For most respondents these values are not mutually exclusive. This suggests that for many neuroenhancement is viewed simultaneously as a source of both promise and concern.