Research with human–animal chimera raises a number of ethical concerns, especially when neural stem cells are transplanted into the brains of non-human primates . Besides animal welfare concerns and ethical issues associated with the use of embryonic stem cells, the research is also regarded as controversial from the standpoint of NHPs developing cognitive or behavioural capabilities that are regarded as “unique” to humans. However, scientists are urging to test new therapeutic approaches for neurological diseases in primate models as they better (...) mimic human physiology than all current animal models. As a response, various countries have issued reports on the topic. Our paper summarizes the ethical issues raised by research with human–animal brain chimeras and compares the relevant regulatory instruments and different recommendations issued in national reports from three important European research nations: Germany, Switzerland and the United Kingdom. We assess and discuss the focus and priorities set by the different reports, review various reasons for and perspectives on the importance of the brain in chimera research, and identify critical points in the reports that warrant further specification and debate. (shrink)

Recent progress in synthetic biology has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including ‘risk’ minimization. These concerns are associated with any FIH trial, however, due to the (...) novelty of the approach, they become more pronounced for medical applications of emerging technologies like SynBio. To minimize potential harm for trial participants, scholars, guidelines, regulations and policy makers alike suggest using ‘risk assessment’ as evaluation tool for such trials. Conversely, in the context of emTech FIH trials, we believe it to be at least questionable to contextualize uncertainty of potential adverse events as ‘risk’ and apply traditional risk assessment methods. Hence, this issue needs to be discussed to enable alterations of the evaluation process before the translational phase of SynBio applications begins. In this paper, we will take the opportunity to start the debate and highlight how a misunderstanding of the concept of risk, and the possibilities and limitations of risk assessment, respectively, might impair decision-making by the relevant regulatory authorities and research ethics committees, and discuss possible solutions to tackle the issue. (shrink)

To be made aware of bioethical issues related to their disciplines, undergraduate students in biology and pharmaceutical sciences at the University of Basel are required to enroll in the bioethics course called “Introduction to Bioethics”. This article describes the chances and challenges faced when teaching a large number of undergraduate biology and pharmaceutical sciences students. Attention is drawn to the relevance and specific ethical issues that biology and pharmaceutical sciences students may be confronted with and to how these could be (...) integrated into ethics curricula. Results from a survey addressing the knowledge and opinion of students taking the course in spring semester 2012, 2013, and 2014 are presented and discussed. Finally, we describe the lessons learned and how we have improved the course based on students’ feedback throughout the following years. (shrink)