Biobanking in Europe has made major steps towards harmonization and shared standards for the collection and processing of data and samples stored in biobanks. Still, biobanks and researchers face substantial legal difficulties in the field of data protection and sample management. Data protection law was harmonized almost 15 years ago while rights in samples fall under the competence of the Member States of the EU. Despite the Data Protection Directive the field of data protection shows a substantial degree of deviation (...) as public health was excluded from the harmonization. Biobanks seem to have substantially fewer difficulties to cope with in terms of the legal requirements in the field of sample management. This paper discusses the legal framework, experiences of different biobanks in Europe and potential ways forward. It also highlights the need for a health economic analysis of the costs and benefits of privacy protection in Europe. At the moment, policymakers seem to build their decisions on an insufficient evidence base which underestimates the potential value of biobanks for European public health. Within the past few years little progress has been achieved with regards to the development of a unified legal framework in Europe, The diversity in the legal system is also reflected in the different approaches of ethics committees towards biobanking. To secure the responsible and effective use of data and samples, more efforts are needed to come up with pathways for a solution. (shrink)

The production of genetic knowledge -- Scientific and economic strength of genetic reductionism -- Policy implications : discourses of genetic enlightenment as new disciplinary devices -- Genetic conceptualizations of normality and the idea of genetic justice -- Beyond genetic universality and authenticity, the lure of the genetic underclass -- Previews of the future as background -- Economic and actuarial perspective on genetics and insurance -- Practical and normative arguments against genetic exceptionalist legislation -- The changing social role of private insurance (...) : risk as a new representational regime. (shrink)

The phenomenon of the New Genetics raises complex social problems, particularly those of privacy. This book offers ethical and legal perspectives on the questions of a right to know and not to know genetic information from the standpoint of individuals, their relatives, employers, insurers and the state. Graeme Laurie provides a unique definition of privacy, including a concept of property rights in the person, and argues for stronger legal protection of privacy in the shadow of developments in human genetics. He (...) challenges the role and the limits of established principles in medical law and ethics, including respect for patient autonomy and confidentiality. This book will interest lawyers, philosophers and doctors concerned both with genetic information and issues of privacy; it will also interest genetic counsellors, researchers, and policy makers worldwide for its practical stance on dilemmas in modern genetic medicine. (shrink)

Genetic database initiatives have given rise to considerable debate about their potential harms and benefits. The question arises as to whether existing ethical frameworks are sufficient to mediate between the competing interests at stake. One approach is to strengthen mechanisms for obtaining informed consent and for protecting confidentiality. However, there is increasing interest in other ethical frameworks, involving solidarity — participation in research for the common good — and the sharing of the benefits of research.

It is predicted that the rapid acquisition of new genetic knowledge and related applications during the next decade will have significant implications for virtually all members of society. Currently, most people get exposed to information about genes and genetics only through stories publicized in the media. We sought to understand how individuals in the general population used and understood the concepts of ???genetics??? and ???genes.??? During in-depth one-on-one telephone interviews with adults in the United States, we asked questions exploring their (...) basic understanding of these terms, as well as their belief as to the location of genes in the human body. A wide range of responses was received. Despite conversational familiarity with genetic terminology, many noted frustration or were hesitant when trying to answer these questions. In addition, some responses reflected a lack of understanding about basic genetic science that may have significant implications for broader public education measures in genetic literacy, genetic counseling, public health practices, and even routine health care. (shrink)

The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to understanding for members of research ethics committees (RECs), professionals involved with medical research and those with an academic interest in the subject.