Bjørn K. Myskja

Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem?

In the endeavour of biobank research there is dispute concerning what type of consent and which form of donor–biobank relationship meet high ethical standards. Up until now, a ‘broad consent’ model has been used in many present-day biobank projects. However it has been, by some scholars, deemed as a pragmatic, and not an acceptable ethical solution. Calls for change have been made on the basis of avoidance of paternalism, intentions to fulfil the principle of autonomy, wish for increased user participation, a questioning of the role of experts and ideas advocating reduction of top–down governance. Recently, an approach termed ‘dynamic consent’ has been proposed to meet such challenges. Dynamic consent uses modern communication strategies to inform, involve, offer choices and last but not the least obtain consent for every research projects based on biobank resources. At first glance dynamic consent seems appealing, and we have identified six claims of superiority of this model; claims pertaining to autonomy, information, increased engagement, control, social robustness and reciprocity. However, after closer examination, there seems to be several weaknesses with a dynamic consent approach; among others the risk of inviting people into the therapeutic misconception as well as individualizing the ethical review of research projects. When comparing the two models, broad consent still holds and can be deemed a good ethical solution for longitudinal biobank research. Nevertheless, there is potential for improvement in the broad model, and criticism can be met by adapting some of the modern communication strategies proposed in the dynamic consent approach.

The categorical imperative and the ethics of trust

Trust can be understood as a precondition for a well-functioning society or as a way to handle complexities of living in a risk society, but also as a fundamental aspect of human morality. Interactions on the Internet pose some new challenges to issues of trust, especially connected to disembodiedness. Mistrust may be an important obstacle to Internet use, which is problematic as the Internet becomes a significant arena for political, social and commercial activities necessary for full participation in a liberal democracy. The Categorical Imperative lifts up trust as a fundamental component of human ethical virtues – first of all, because deception and coercion, the antitheses of trust, cannot be universalized. Mistrust is, according to Kant, a natural component of human nature, as we are social beings dependent on recognition by others but also prone to deceiving others. Only in true friendships can this tendency be overcome and give room for unconditional trust. Still we can argue that Kant must hold that trustworthy behaviour as well as trust in others is obligatory, as expressions of respect for humanity. The Kantian approach integrates political and ethical aspects of trust, showing that protecting the external activities of citizens is required in order to act morally. This means that security measures, combined with specific regulations are important preconditions for building online trust, providing an environment enabling people to act morally and for trust-based relationships.

Precaution or Integrated Responsibility Approach to Nanovaccines in Fish Farming? A Critical Appraisal of the UNESCO Precautionary Principle

Nanoparticles have multifaceted advantages in drug administration as vaccine delivery and hence hold promises for improving protection of farmed fish against diseases caused by pathogens. However, there are concerns that the benefits associated with distribution of nanoparticles may also be accompanied with risks to the environment and health. The complexity of the natural and social systems involved implies that the information acquired in quantified risk assessments may be inadequate for evidence-based decisions. One controversial strategy for dealing with this kind of uncertainty is the precautionary principle. A few years ago, an UNESCO expert group suggested a new approach for implementation of the principle. Here we compare the UNESCO principle with earlier versions and explore the advantages and disadvantages by employing the UNESCO version to the use of PLGA nanoparticles for delivery of vaccines in aquaculture. Finally, we discuss whether a combined scientific and ethical analysis that involves the concept of responsibility will enable approaches that can provide a supplement to the precautionary principle as basis for decision-making in areas of scientific uncertainty, such as the application of nanoparticles in the vaccination of farmed fish.

We have never been ELSI researchers - there is no need for a post-ELSI shift.

This article criticizes recent suggestions that the current ELSI research field should accommodate a new direction towards a ‘post-ELSI’ agenda. Post-ELSI research seeks to avoid the modernist division of responsibility for technical and social issues said to characterize ELSI research. Collaboration and integration are consequently the key terms of post-ELSI strategies that are to distinguish it from ELSI strategies. We argue that this call for a new direction relies on an inadequate generalized analysis of ELSI research as modern that will affect the construal of post-ELSI strategies. We are concerned that the call for post-ELSI shift will exclude imaginative proposals and intellectual freedom by narrowing down the scope and methodologies of ELSI and thereby missing opportunities to play a critical and constructive normative role. Instead of framing current trends in ELSI research as a radical and progressive shift from ELSI to post-ELSI, we suggest an alternative story of expansion and diversification described in terms of a drift from ELSA 1 to ELSA 2, pertaining to acronyms in use in Europe. ELSI research has never been modern. It has been experimenting from the very start on ways to mesh the works of humanist, social and natural scientist in order to bridge and build alignments of emerging scientific and societal goals and matters of concern. The development from ELSA 1 to ELSA 2 expands in our account the range of intellectual and methodological capacities of analysis and engagement of complex and dynamic science-society relationships. We present three areas of ELSA expertise to illustrate that the expertise within the field builds on scholarly achievements within the humanities, social sciences as well as the natural sciences. The plurality of disciplinary background of ELSA researchers represents a valuable diversity that enables mutual criticism and formulations of complementary approaches that together constitute a viable ELSA field.

The Sublime in Kant and Beckett: Aesthetic Judgement, Ethics and Literature

Becketts novel Molloy and the question how this work evokes a particular kind of feeling associated with its exhibition of meaninglessness, namely the feeling of the sublime, is the point of departure for this study. Kants theory of the sublime is interpreted within the framework of his aesthetic and moral theories, suggesting a way to understand the claim to universal validity for aesthetic judgements. Kant claims that the judgement of the sublime serves morality but he fails to provide this link, so a theory of how this aesthetic judgement can contribute to the cultivation of moral character is developed. It is argued that Kant held that art, including narrative art like the novel, can be sublime. Kants theory of the sublime is shown to be relevant for modern works of art, and the application of this Kantian framework throws new light on the discussion of the moral aspects of Becketts literary work. According to this account, Molloy is a sublime work of art, and despite its amoral content can serve the readers moral cultivation.

Rationality and religion in the public debate on embryo stem cell research and prenatal diagnostics

Jürgen Habermas has argued that religious views form a legitimate background for contributions to an open public debate, and that religion plays a particular role in formulating moral intuitions. Translating religious arguments into “generally accessible language” (Habermas, Eur J Philos 14(1):1–25, 2006) to enable them to play a role in political decisions is a common task for religious and non-religious citizens. The article discusses Habermas’ view, questioning the particular role of religion, but accepting the significance of including such counter-voices to the predominant views. Furthermore it is pointed out that not only religious but also numerous secular views stand in need of translation to be able to bear on policy matters. Accepting Habermas’ general framework, I raise the question whether experts (such as clinicians working in relevant specialised areas of care) participating in political debates on biomedical issues have a duty to state their religious worldview, and to what extent the American government decision to restrict embryo stem cell research is an illegitimate transgression of the State-Church divide.

Conscientious objection to intentional killing: an argument for toleration

BackgroundIn the debate on conscientious objection in healthcare, proponents of conscience rights often point to the imperative to protect the health professional’s moral integrity. Their opponents hold that the moral integrity argument alone can at most justify accommodation of conscientious objectors as a “moral courtesy”, as the argument is insufficient to establish a general moral right to accommodation, let alone a legal right.Main textThis text draws on political philosophy in order to argue for a legal right to accommodation. The moral integrity arguments should be supplemented by the requirement to protect minority rights in liberal democracies. Citizens have a right to live in accordance with their fundamental moral convictions, and a right to equal access to employment. However, this right should not be unconditional, as that would unduly infringe on the rights of other citizens. The right must be limited to cases where the moral basis is more fundamental in a sense that all reasonable citizens in a liberal democracy should accept, such as the constitutive role of the inviolability of human life in liberal democracies.ConclusionThere should be a legal, yet circumscribed, right to accommodation for conscientious objectors refusing to provide healthcare services that they reasonably consider to involve the intentional killing of a human being.

From Protection to Restoration: A Matter of Responsible Precaution

Climate change and human activities are the main reasons for the increasing degradation of ecological systems. Advances within modern biotechnologies, as genetic engineering and synthetic biology, hold promises for saving endangered species and revival of extinct species. The same biotechnologies are followed with concerns for unforeseen environmental harm. This has resulted in a call for regulation, including the application of the precautionary principle. There are, however, significant disagreements on how to apply the precautionary principle and how to handle risk. A key question concerns the meaning of the precautionary demand to avoid ‘morally unacceptable harm’ to the environment (UNESCO COMEST 2005) when applying new technologies. This needs further elaboration and we will draw some lessons from the controversies surrounding the introduction of genetically modified organisms (GMOs). Some similarities are for instance related to how to acknowledge risk and uncertainties, the existence of systemic properties of ecosystems and how to study the effect of changes induced in ecosystems. It has been argued that risk claims and awareness to uncertainties depend on assumptions about which facts and values are to be considered and which are to be left out. This may have implications for what we consider to be environmental harm as well as how we regard the significance of environmental harm that is identified.

Trustworthy Nanotechnology: Risk, Engagement and Responsibility

The papers in this special edition are based on contributions to the symposium “Trustworthy nanotechnology” in Trondheim, Norway in June 2010. This symposium was initiated by the research project NANOTRUST,1 funded by the Research Council of Norway’s Programme for nanotechnology and new materials. The motivation for the project was a realization that the question of trust in nanotechnology has been raised at a stage when the material, conceptual and social body of nanotechnology has been in its infancy. As trust or distrust in social and technological systems generally is based in previous experiences with these systems, nanotechnology raises new conceptual and social challenges. A number of public engagement exercises and research projects on the societal aspects of nanotechnology have, due to the relative novelty of the nano field, been fairly general in their involvement with the technology. One of the potential strengths of this project was its collaboration with a project investigating the use of polymeric micro- or nanoparticles to enhance vaccine formulations for farmed salmon. Thus we raised the question of trust in relation to a concrete case of nanotechnology development, integrating ELSA research with the technology research. Reflecting on trust in collaboration with technologists at this early stage has both advantages and drawbacks. It provides a unique opportunity in creating a forum for ethical reflection, opening the possibility for making a positive impact on technology development. By engaging technology researchers at this stage one can avoid the historical role of ELSA research as an exercise in negative ethics, i.e. ethics as border guard against real and perceived risks and harm to environment and society. On the other hand, being too far upstream may imply that the engagement is reduced to hypothetical discussions or conceptual clarifications. Engaging with nanotechnology at this stage means that attempts to foster public trust would need to focus less on technological products and more on the complex process of science. While a products focus draws attention to the public’s choices, understanding, knowledge and acceptability of the product, a process focus draws attention to the visions and goals as well as organization and governance of nanotechnology. Thus the focus of the project and the symposium shifted from the conditions for public trust in general, to the body of scientific practitioners and practices that is to be trusted. This shift implies a corresponding shift from the concept of trust to the concept of trustworthiness and from what conditions trust to what conditions trustworthiness. With this focus, we aim at addressing to what extent nanotechnology is providing a sound basis for fostering public trust. One important feature of recent approaches to technology studies is that they draw attention to extraordinary cases where there is much at stake, values are disputed and high risks are involved. These cases are often accompanied with high degree of controversy, either scientifically or publically, calling attention to post-normal strategies that widens the circles of engaged stakeholders. Controversies function as a mobilizing factor. The normal case however is not the one of controversies, but more like the case of exploring PLGA particles for delivery of vaccines in aquaculture. Projects like this one, that run under the heading of nanotechnology display low degree of substantial controversy. When the mechanisms of society “talking back” to science [3] are staged through initiatives like the NANOTRUST project there is little visible and unusual scientific or public questioning—neither of individual projects of nanotechnology nor of nanoscience initiatives in general. Nanoscience and -technology differs from genomics in this respect: the “talking back” is staged in ways that may suppress internal scientific conflicts, conflicts on specific products, engage NGOs or media coverage in the ways that we have witnessed in connection with genomics. Therefore the symposium sought to explore how the challenges related to trustworthiness can be raised in projects where there are few or no controversies to spark increased scrutiny and scientific self-reflection. What do such normal cases require from the working scientist in terms of their responsibility to display and be able to normatively account for co-produced societal changes? How can and should nanotechnologists meet the challenge of societal interaction under such presumably low risk circumstances? In this issue, three of the papers are products of the reflections of the NANOTRUST research group on the trustworthiness of a technology application subject to uncertainty and ignorance regarding potential harms to health and environment. In addition, we include papers related to two of the invited presentations that contextualized the issue of trustworthiness based on other nanotechnology governance research projects.