Public perceptions of cohort studies and biobanks in Germany.

Cohort studies and biobank projects have led to public discussions in several European countries in the past. In Germany, many medium-sized studies are currently running successfully in terms of respondent rates. However, EU-wide research on general public perceptions of biobanks and cohort studies have shown that Germany is among those countries where people express the highest reluctance for providing body material and other data for research purposes. Because of early efforts of the just-initiated German National Cohort Study, we are able to begin to investigate in greater detail how various groups of people across Germany reflect and discuss the ongoing implementation of cohort studies and biobanking in Germany. Our research is based on 15 focus group discussions in four German regions, as well as on Eurobarometer poll data on biobanking.

From global bioethics to ethical governance of biomedical research collaborations.

One of the features of advanced life sciences research in recent years has been its internationalisation, with countries such as China and South Korea considered 'emerging biotech' locations. As a result, cross-continental collaborations are becoming common generating moves towards ethical and legal standardisation under the rubric of 'global bioethics'. Such a 'global', 'Western' or 'universal' bioethics has in turn been critiqued as an imposition upon resource-poor, non-Western or local medical settings. In this article, we propose that a different tack is necessary if we are to come to grips with the ethical challenges that inter-continental biomedical research collaborations generate. In particular we ask how national systems of ethical governance of life science research might cope with increasingly global research collaborations with a focus on Sino-European collaboration. We propose four 'spheres' - deliberation, regulation, oversight and interaction - as a helpful way to conceptualise national systems of ethical governance. Using a workshop-based mapping methodology (workshops held in Beijing, Shanghai, Changsha, Xian, Shenzen and London) we identified three specific ethical challenges arising from cross-continental research collaborations: (1) ambiguity as to which regulations are applicable; (2) lack of ethical review capacity not only among ethical review board members but also collaborating scientists; (3) already complex, researcher-research subject interaction is further complicated when many nationalities are involved.

Publics and biobanks: Pan-European diversity and the challenge of responsible innovation.

This article examines public perceptions of biobanks in Europe using a multi-method approach combining quantitative and qualitative data. It is shown that public support for biobanks in Europe is variable and dependent on a range of interconnected factors: people's engagement with biobanks; concerns about privacy and data security, and trust in the socio-political system, key actors and institutions involved in biobanks. We argue that the biobank community needs to acknowledge the impact of these factors if they are to successfully develop and integrate biobanks at a pan-European level.

Stem cell treatments in China: rethinking the patient role in the global bio-economy.

The paper looks in detail at patients that were treated at one of the most discussed companies operating in the field of untried stem cell treatments, Beike Biotech of Shenzhen, China. Our data show that patients who had been treated at Beike Biotech view themselves as proactively pursuing treatment choices that are not available in their home countries. These patients typically come from a broad variety of countries: China, the United Kingdom, the United States, South Africa and Australia. Among the patients we interviewed there seemed to be both an awareness of the general risks involved in such experimental treatments and a readiness to accept those risks weighed against the possible benefits. We interpret this evidence as possibly reflecting the emergence of risk-taking patients as 'consumers' of medical options as well as the drive of patients to seek treatment options in the global arena, rather than being hindered by the ethical and regulatory constraints of their home countries. Further, we found that these patients tend to operate in more or less stable networks and groups in which they interact and cooperate closely and develop opinions and assessments of available treatment options for their ailments. These patients also perform a multiple role as patients, research subjects, and research funders because they are required to pay their way into treatment and research activities. This new social dynamics of patienthood has important implications for the ethical governance of stem cell treatments.

Public perceptions of biobanks in China: a focus group study.

During the past decade, biobanks have been the focus of broad attention due to their potential value for scientific research and public health. China has recently made a significant investment in biobank research. Public attitudes towards biobank issues such as consent and privacy are key factors in their development. A number of studies about the public perception of biobanks in Western countries have been conducted, but little is known about the public perception of biobanks in China. This study shows that the public perception of medical research (e.g., with biobanks) is undergoing fundamental transformation in China that is yet to be acknowledged by the public authorities.

Towards biobank privacy regimes in responsible innovation societies: ESBB conference in Granada 2012.

The creation of socially and technically robust biobank privacy regimes presupposes knowledge of and compliance with legal rules, professional standards of the biomedical community, and state-of-the-art data safety and security measures. The strategies in privacy management and data protection presented in this review show a trend that goes beyond searching for compromises or efforts of balancing scientific demands for efficiency and societal demands for effective privacy regimes. They focus on developing synergies that facilitate cooperative use of biomaterials and data and enhance sample search efficiency for researchers on the one hand, and protect rights and interests of donors and citizens on the other hand. Among the issues covered are: a) ethical sensitivities and public perceptions on privacy in biobanking b) tools and procedures that allow maintenance of the rights and dignity of donors, without jeopardizing legitimate information needs of researchers and autonomy of biobanks, and c) a privacy sensitive framework for sharing of data and biomaterials in the research context.

Biobank governance: heterogeneous modes of ordering and democratization.

The great interest in biobanks, the related, substantial investments, and the expectations connected with them raises the question of how to explain the relative successes and failures of contemporary biobank projects. In this article we will present and discuss areas that need ongoing attention by many stakeholders in order stabilize and utilize biobanks and biobank networks in the future. Our aim is to present and utilize an analytical model for comparing structures of biobank governance. The governance model we deduce from empirical case studies is not a well-ordered, almost bureaucratic type of government. The patchwork character and the interrelatedness of heterogeneous activities that constitute biobank governance in its multiple dimensions will be highlighted. Biobank governance should therefore be understood as strategy for patterning a network of interaction that unfolds within and across a number of different fields including a variety of activities that go beyond regulatory activities: the scientific/technological field, the medical/health field, the industrial-economic field, the legal-ethical, and the sociopolitical field. Our account emphasizes that biobanks are not technical visions that operate vis-à-vis an external society. The article discusses attempts to develop participatory governance structures. It concludes that facilitating and managing the integration of a network of more or less interrelated actors, in many nonhierarchic ways, should not be equated with democratization per se, but can nevertheless be regarded as an important step towards a more pluralistic and inclusive style of policy making.

Biobanks and the phantom public.

This paper surveys the current state of knowledge about the relationship between different national publics and biobanks, how different publics perceive biobanks, and which issues are identified as important by various stakeholders. We discuss existing studies and emerging governance strategies dealing with the biobank-publics interface and argue that the search for phantom (biobank) public(s) is on, but still much needs to be done. We argue that the existing data originate in a relatively few regions, among them Northern Europe, the United Kingdom, and in certain U.S. states and are often based on survey research with small samples and short questionnaires. Combined usage of qualitative and quantitative methodology in studies is still rare though of great importance in order to investigate distributions of public opinion and also to be able to explain these patterns. Many important questions in the relationship between publics and biobanks are unexplored, or the existing data are inconsistent.

The endless hESC controversy in the United States: history, context, and prospects.

Human embryonic stem cell research has faced a long, tough political battle in the United States. The article explores the history of this controversy and the motives behind it, leading up to the August 23, 2010 district court injunction temporarily stopping all U.S. federal funding for research with human ESCs.

"The choice for death" and neurology.

In the last decade, "end-of-life" issues have gained prominence in political and social debates in many countries. The deliberate ending of the life of a patient upon his/her own request has become a hotly contested topic. This paper discusses the implications of this debate and of corresponding policy and legal developments for neurology. We discuss the nomenclature of the "choices for death", euthanasia, doctor-assisted suicide and palliative care as well as the social dynamics underlying these developments. We suggest that we need a more nuanced and empirically based understanding of the process of the "choice for death and its implications for medical practice."

Biobank governance in the post-genomic age.

Biobank governance is about the regulation of the relationship between individual citizens, society and biobanks. Its key agenda is to link society, citizens and biobanks with respect to issues of consent, privacy, ownership, access and benefit sharing. With the transformation of biobank research from local/national activities towards transnational projects and the emergence of post-genomic medical research, biobanks need to establish novel governance structures. We consider governance solutions that focus on 'bioethical-theoretical' arguments to be of only limited value in this context. By contrast, we think the key lies in developing participatory arrangements that are responsive to the views of patients and 'lay people', and also operate on a transnational level. The social-political and communicative competence of biobank infrastructures must be improved, thereby assuring the long-term legitimacy and commitment to these often highly expensive projects from a large variety of different stakeholders over the decades.

Emotion in political discourse: contrasting approaches to stem cell governance in the USA, UK, Israel and Germany.

In August 2004, Stojkovic and Murdoch from the University of Newcastle upon Tyne, UK, were granted the UK's first license to create human embryonic stem cells (hESCs) using cell nuclear replacement. While this news made headlines around the globe, a spokesman for the German Ministry of Research warned scientists in his country of the illegality of advising their English colleagues on hESC research. Meanwhile, US Members of Congress had asked President Bush to revoke his decision to limit federal funding to research on a limited number of hESC lines created before 9 August, 2001 (a decision that he confirmed in July 2006, while nonfederally funded research on hESC continues to be unrestricted). In Israel, where hESC research is legal and has never been a contested political issue, a bioethicist argued that, in light of the potential to alleviate human suffering, "banning research is against human dignity". How can such striking differences in the regulation of hESC research be explained?

Regulating genomics in the 21st century: from logos to pathos?

There is currently an important change in the governance of genomics. In the past, much of the regulatory discussion about genomics has focused on issues of risk. Today, a new discussion is evolving that emphasizes the uncertainties involved in the development and diffusion of genomics into society. The increasing importance of emotional language and the focus on trust in the discussion about genomics reflects the attempt to substitute for the shortcomings of logos with ethos and pathos.