Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research. Whether or not T1 has these features, translational research beyond approval is unlikely to and, (...) when conducted on the global poor, may support development. Therefore, insofar as T1 is morally problematic, and no independent objections to T2 exist, the ethics of translational research is diverse: while some translational research is problematic, some is not. Funding and oversight should reflect this diversity, and T2 should be encouraged, particularly when conducted among the global poor. (shrink)

The label ‘Translational Research’ (TR) has become ever more popular in the biomedical domain in recent years. It is usually presented as an attempt to bridge a supposed gap between knowledge produced at the lab bench and its use at the clinical bedside. This is claimed to help society harvest the benefits of its investments in scientific research. The rhetorical as well as moral force of the label TR obscure, however, that it is actually used in very different ways. In (...) this paper, we analyse the scientific discourse on TR, with the aim to disentangle and critically evaluate the different meanings of the label. We start with a brief reconstruction of the history of the concept. Subsequently, we unravel how the label is actually used in a sample of scientific publications on TR and examine the presuppositions implied by different views of TR. We argue that it is useful to distinguish different views of TR on the basis of three dimensions, related to (1) the construction of the ‘translational gap’; (2) the model of the translational process; and (3) the cause of the perceived translational gap. We conclude that the motive to make society benefit from its investments in biomedical science may be laudable, but that it is doubtful whether the dominant views of TR will contribute to this end. (shrink)

It is widely accepted that translational research practitioners need to acquire special skills and knowledge that will enable them to anticipate, analyze, and manage a range of ethical issues. While there is a small but growing literature that addresses the ethics of translational research, there is a dearth of scholarship regarding how this might apply to engineers. In this paper we examine engineers as key translators and argue that they are well positioned to ask transformative ethical questions. Asking engineers to (...) both broaden and deepen their consideration of ethics in their work, however, requires a shift in the way ethics is often portrayed and perceived in science and engineering communities. Rather than interpreting ethics as a roadblock to the success of translational research, we suggest that engineers should be encouraged to ask questions about the socio-ethical dimensions of their work. This requires expanding the conceptual framework of engineering beyond its traditional focus on “how” and “what” questions to also include “why” and “who” questions to facilitate the gathering of normative, socially-situated information. Empowering engineers to ask “why” and “who” questions should spur the development of technologies and practices that contribute to improving health outcomes. (shrink)

In their 2007 paper, Swierstra and Rip identify characteristic tropes and patterns of moral argumentation in the debate about the ethics of new and emerging science and technologies (or “NEST-ethics”). Taking their NEST-ethics structure as a starting point, we considered the debate about tissue engineering (TE), and argue what aspects we think ought to be a part of a rich and high-quality debate of TE. The debate surrounding TE seems to be predominantly a debate among experts. When considering the NEST-ethics (...) arguments that deal directly with technology, we can generally conclude that consequentialist arguments are by far the most prominently featured in discussions of TE. In addition, many papers discuss principles, rights and duties relevant to aspects of TE, both in a positive and in a critical sense. Justice arguments are only sporadically made, some “good life” arguments are used, others less so (such as the explicit articulation of perceived limits, or the technology as a technological fix for a social problem). Missing topics in the discussion, at least from the perspective of NEST-ethics, are second “level” arguments—those referring to techno-moral change connected to tissue engineering. Currently, the discussion about tissue engineering mostly focuses on its so-called “hard impacts”—quantifiable risks and benefits of the technology. Its “soft impacts”—effects that cannot easily be quantified, such as changes to experience, habits and perceptions, should receive more attention. (shrink)

In their 2007 paper, Swierstra and Rip identify characteristic tropes and patterns of moral argumentation in the debate about the ethics of new and emerging science and technologies (or “NEST-ethics”). Taking their NEST-ethics structure as a starting point, we considered the debate about tissue engineering (TE), and argue what aspects we think ought to be a part of a rich and high-quality debate of TE. The debate surrounding TE seems to be predominantly a debate among experts. When considering the NEST-ethics (...) arguments that deal directly with technology, we can generally conclude that consequentialist arguments are by far the most prominently featured in discussions of TE. In addition, many papers discuss principles, rights and duties relevant to aspects of TE, both in a positive and in a critical sense. Justice arguments are only sporadically made, some “good life” arguments are used, others less so (such as the explicit articulation of perceived limits, or the technology as a technological fix for a social problem). Missing topics in the discussion, at least from the perspective of NEST-ethics, are second “level” arguments—those referring to techno-moral change connected to tissue engineering. Currently, the discussion about tissue engineering mostly focuses on its so-called “hard impacts”—quantifiable risks and benefits of the technology. Its “soft impacts”—effects that cannot easily be quantified, such as changes to experience, habits and perceptions, should receive more attention. (shrink)

Extensive conflicts of interest at both individual and institutional levels are identifiable in scientific research and healthcare in China, as in many other parts of the world. A prominent new case from China is He Jiankui’s experiment that produced the world’s first gene-edited babies and that raises numerous ethical, political, socio-cultural, and transnational questions. Serious financial and other COI were involved in He’s genetic adventure. Using He’s infamous experiment as a case study, this paper explores the wider issue of financial (...) and other COI in scientific research and healthcare in China, especially institutional conflict of interest and policy-related COI. Taking a socio-ethical perspective, it examines China’s state policies and its massive efforts to transform and commercialize scientific research, the lack of policies and oversight mechanisms for regulating COI, as well as major ethical issues arising from COI including the undermining of public trust. Some practical suggestions are offered for institutional reform and institutional development so that COI, particularly ICOI, can be avoided or more effectively managed in scientific research in China. (shrink)

The label ‘Translational Research’ (TR) has become ever more popular in the biomedical domain in recent years. It is usually presented as an attempt to bridge a supposed gap between knowledge produced at the lab bench and its use at the clinical bedside. This is claimed to help society harvest the benefits of its investments in scientific research. The rhetorical as well as moral force of the label TR obscure, however, that it is actually used in very different ways. In (...) this paper, we analyse the scientific discourse on TR, with the aim to disentangle and critically evaluate the different meanings of the label. We start with a brief reconstruction of the history of the concept. Subsequently, we unravel how the label is actually used in a sample of scientific publications on TR and examine the presuppositions implied by different views of TR. We argue that it is useful to distinguish different views of TR on the basis of three dimensions, related to (1) the construction of the ‘translational gap’; (2) the model of the translational process; and (3) the cause of the perceived translational gap. We conclude that the motive to make society benefit from its investments in biomedical science may be laudable, but that it is doubtful whether the dominant views of TR will contribute to this end. (shrink)

Advances at the interface between the biological sciences and engineering are giving rise to emerging research fields such as synthetic biology. Harnessing the potential of synthetic biology requires timely and adequate translation into clinical practice. However, the translational research enterprise is currently facing fundamental obstacles that slow down the transition of scientific discoveries from the laboratory to the patient bedside. These obstacles including scarce financial resources and deficiency of organizational and logistic settings are widely discussed as primary impediments to translational (...) research. In addition, a number of socio-ethical considerations inherent in translational research need to be addressed. As the translational capacity of synthetic biology is tightly linked to its social acceptance and ethical approval, ethical limitations may—together with financial and organizational problems—be co-determinants of suboptimal translation. Therefore, an early assessment of such limitations will contribute to proactively favor successful translation and prevent the promising potential of synthetic biology from remaining under-expressed. Through the discussion of two case-specific inventions in synthetic biology and their associated ethical implications, we illustrate the socio-ethical challenges ahead in the process of implementing synthetic biology into clinical practice. Since reducing the translational lag is essential for delivering the benefits of basic biomedical research to society at large and promoting global health, we advocate a moral obligation to accelerating translational research: the “translational imperative.”. (shrink)

Translational research in medicine requires researchers to identify the steps to transfer basic scientific discoveries from laboratory benches to bedside decision-making, and eventually into clinical practice. On a parallel track, philosophical work in ethics has not been obliged to identify the steps to translate theoretical conclusions into adequate practice. The medical ethicist A. Cribb suggested some years ago that it is now time to debate ‘the business of translational’ in medical ethics. Despite the very interesting and useful perspective on the (...) field of medical ethics launched by Cribb, the debate is still missing. In this paper, I take up Cribb’s invitation and discuss further analytic distinctions needed to base an ethics aiming to translate between theory and practice. (shrink)

This dissertation explores the influence of time constraints on different research practices. The first two parts present case studies, which serve as a basis for discussing the epistemological and ethical implications of temporal limitations in scientific research. Part I is a case study on gravitational wave research, conducted by the LIGO Scientific Collaboration. This exemplifies fundamental research – without immediate societal applications, open-ended in terms of timeline and in terms of research goals. It is based, in part, on qualitative interviews (...) conducted with gravitational wave physicists. I show that considerations about time and speed play a role in every stage of research: goal setting, method design, and the evaluation and communication of results. Part II provides a case study on translational medicine, an approach explicitly dedicated to accelerating research in order to develop and implement new therapies. This epitomizes applied research with high social stakes, motivated by non-epistemic goals. Here, epistemic trade-offs between speed and reliability intersect with ethical trade-offs between different types of harms. In Part III, the insights from both of these case studies are used as the basis for a more general discussion concerning the pragmatic aspects of epistemic practices, especially in relation to current debates centered on the role of values in science. A particular focus is on the value of speed and the ability to generate reliable results, either via choice of methods, or via decisions about which goals to set, as well as decisions about when to stop further testing. The primary thesis of the dissertation is that pragmatic considerations stemming from limitations of resources are a necessary feature of the pursuit of epistemic aims, and that the epistemic is thus inherently pragmatic. (shrink)