From omics and etics to policy and ethics: regulating evolution

A commentary on ELSI 2.0 for genomics and society by Kaye,J.,Meslin,E.,Knoppers,B.,Juengst, E., Deschênes,M.,Cambon-Thomsen,A., etal. (2012). Science 336, 673–674. doi: http://dx.doi.org/10.1126/science.121801

Innovation in medicine through degeneration in law? A critical perspective on the Medical Innovation Bill

The current debate surrounding the Medical Innovation Bill purports to be aimed at improving the normative framework to the extent that innovation is more likely. A closer look at the mechanisms of the proposed legislation and a more detailed assessment of the reasons given for initiating the legislative process in this instance reveal that the Bill seem to rest on a significant misunderstanding of the current law of medical negligence. This article analyses the provisions of the Bill, puts them into the wider context of medical negligence and critically reviews the utility of the proposed legislation. © The Author(s) 2014

Research governance in placebo-controlled trials: Is the EMA/ICH position consistent in itself and in accordance with the declaration of helsinki?

The European Medicines Agency and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use are powerful international institutions for the regulation of biomedical research. Although not directly concerned with the ethical aspects of research, both institutions have disseminated position papers on ethical issues relating to the use of placebos in clinical trials. What appears initially to be guidance on the methodology of placebo-controlled trials (with very technical content) clearly has some far-reaching implications for the extent of risk patients can be expected to be subjected to in such trials. On the basis of this guidance, this article questions how much additional harm to patients would be acceptable in placebo-controlled trials in comparison with active-control trials. The article will show that the instruments provided in the guidance are unsuitable, remaining unclear on vital points and thereby leaving patients, researchers and research ethics committees without appropriate direction. In conclusion, placebo-controlled trials urgently need more. © The Author(s) 2014

The Regulation of Biobanking in Germany

Biobanking in Germany is currently not subject to sui generis regulation. Instead, a plethora of norms from differing areas of law form the bundle of regulation that applies to biobanking. The exact shape and extent of the bundle depends on the exact configuration of the biobank. In the context of data protection, the rather fragmented nature of the regulation is to a certain extent alleviated by the direct impact of the EU General Data Protection Regulation (GDPR). In particular, the federalized system of data protection in Germany is simplified by an overarching set of norms that apply equally across the board. Whilst this is a welcome systematization of this part of the regulation of biobanking in Germany, the exact nature of the implementation of the Regulation raises novel issues in its own right. In this paper, I will outline the fragmented nature of biobank regulation in Germany, illustrate the issues on the basis of Germany’s population biobank NaKo and then discuss some of the more significant issues raised by the GDPR in the context of biobanking

Wissenschaftsreflexion und Normativität : Neues Forschungsfeld soll Beitrag zur gesellschaftlichen Diskussion liefern

Wissenschaftler*innen aus den geistes- und gesellschaftlichen Disziplinen sprechen eine andere Sprache als diejenigen aus den naturwissenschaftlichen und technischen Fächern. Prof. Dr. Nils Hoppe und Prof. Dr. Matthew Sample vom Centre for Ethics and Law in the Life Sciences (CELLS) beschäftigen sich mit einem interdisziplinären Konzept der Normativität, das über gemeinsame Arbeitsweisen und gemeinsame Sprache die Kooperationsfähigkeit der Disziplinen verbessern soll

Kooperationswerkzeuge im Kontext virtualisierter Arbeitsprozesse

Aus der Einführung: "Im Bereich der Informations- und Kommunikationstechnologien und im wissensintensiven Sektor finden sich häufig netzwerkartige Organisationsstrukturen, die durch informale Arbeitsorganisation und eine starke Betonung integrierter Kooperation unter Ausbildung unterschiedlicher Spezialisierungen [2] gekennzeichnet sind. Begleitet wird dieses Phänomen der Entgrenzung durch die Virtualisierung von Arbeitsplätzen oder Bürostandorten [15]. Ausgehend von der These, dass sich Organisationsformen von den traditionellen Formen hin zu kooperativen Strukturen fortentwickeln, schlagen wir vor, dass vor allem kreative und wissensintensive Prozesse durch Software unterstützt werden, welche die Besonderheiten dieser Arbeitsprozesse berücksichtigen.

The challenges of German archival document categorization on insufficient labeled data

Document exploration in archives is often challenging due to the lack of organization in topic-based categories. Moreover, archival records only provide short text which is often insufficient for capturing the semantic. This paper proposes and explores a dataless categorization approach that utilizes word embeddings and TF-IDF to categorize archival documents. Additionally, it introduces a visual approach built on top of the word embeddings to enhance the exploration of data. Preliminary results suggest that current vector representations alone do not provide enough external knowledge to solve this task

Learning Design Engines as Remote Control to Learning Support Environments

Commentary on: Chapter5: An Architecture for Learning Design Engines. (Vogten, Koper, Martens and Tattersall, 2005) Abstract: Chapter 5 of the Learning Design book describes the operational model of a learning design engine based on the concept of finite automata with output alphabet. We rely on this event concept to include pre-existing learning tools in flexibe and rich learning designs. We sketch an approach for the integration of complex learning environments in learning designs. Interactive learning support environments, such as argumentation or modelling tools are pre-existent and have a high potential when integrated in learning designs. We propose an approach that aims at a clear separation of the learning design engine, the specification of the learning flow (as LD documents) and learning environments. According to its current state, the engine controls the learning environment with events (such as "start a new phase"), defined as a vocabulary for a set of environments, that are mapped to the environments' existing functionality (such as "create new workspace"). Thus the engine remotely controls the learning tools while the tools can initiate state transitions in the engine on specific events in the tool. Editors: Colin Tattersall and Rob Koper