Doris Schroeder

The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT.

The European debate around genetically modified foods was one of the most sustained and ardent public discussions in the late 1990s. Concerns about risks to human health and the environment were voiced alongside claims that healthier foods can be produced more efficiently and in a more environmentally friendly manner using the new technology. The aims of this paper are to test the usefulness of Stephen Toulmin’s argumentation model for the analysis of public debates almost 50 years after it was first introduced, and to establish whether any of the parties in the genetically modified food debate used seriously flawed argumentation. The paper argues that Stephen Toulmin’s argumentation model can be useful in three ways when analysing public debates. Firstly, incomplete or flawed claims can be defeated by exposing missing or mismatching argumentation elements; all examined arguments in the GM debate were well formulated. Secondly, weaknesses in argumentation can be identified by making explicit warrants and backing; in the GM case, this allowed the identification of points of attack for counter-argumentation. Thirdly, analysing the type of backing used, allows inferences about the persuasion approach taken. The industrialists employed ethical principles as their backing much more than the scientists and environmentalists, a surprising result.

“Globalisation is the Yeti of … newspapers. Everybody knows it, but nobody has ever seen it. What does it look like? Tall, monkeyish, hairy? Or rather weasel-like? With glasses? Like a ferret or a marten?” Globalization means different things to different people, a laudable development uniting humankind or an epidemic crushing the vulnerable peoples of the earth. Whether it is something we can control remains to be seen, but it is certainly upon us. The move to “go global” is such a strong force that hardly any human activity is exempt. We have global treaties, global media, global celebrities, global bookstores, and even a global antiglobalization movement! a

Global bioethics is a bold project. In its moderate form, it aims to find solutions to the dilemmas posed by modern medicine and the biological sciences through intercultural understanding of human obligations and opportunities. In its more ambitious form, it endeavors to cover all possible ethical problems arising with regard to life and living things on earth. Given the ambitiousness of even the moderate aim, it is unsurprising that disputes are frequent and agreements are scarce. One of the most contentious issues is whether human rights should play an important role in global bioethics or not. a

Imagine you are walking down a city street. It is windy and raining. Amidst the bustle you see a young woman. She sits under a railway bridge, hardly protected from the rain and holds a woolen hat containing a small number of coins. You can see that she trembles from the cold. Or imagine seeing an old woman walking in the street at dusk, clutching her bag with one hand and a walking stick with the other. A group of male youths walk behind her without overtaking, drunk and in the mood for mischief. It doesn't need an academic to say what vulnerability is. We can all see it, much more often than we care to

Benefit sharing has been a recurrent theme in international debates for the past two decades. However, despite its prominence in law, medical ethics and political philosophy, the concept has never been satisfactorily defined. In this conceptual paper, a definition that combines current legal guidelines with input from ethics debates is developed. Philosophers like boxes; protective casings into which they can put concisely-defined concepts. Autonomy is the human capacity for self-determination; beneficence denotes the virtue of good deeds, coercion is the intentional threat of harm and so on. What about benefit sharing? Does the concept have a box and are the contents clearly defined? The answer to this question has to be no. The concept of benefit sharing is almost unique in that various disciplines use it regularly without precise definitions. In this article, a definition for benefit sharing is provided, to eliminate unnecessary ambiguity

On September 28, 2002, 11-year-old Jakob von Metzler, a banker's son, was abducted on the way to his parents' house in Frankfurt. A sum of one million Euro was demanded for his release. Three days after Jakob's disappearance, Magnus Gäfgen, a 32-year-old law student, collected the ransom from the arranged tram stop in Frankfurt during the night. While under observation by the police, he ordered a new Mercedes and booked a holiday abroad. Seventy-six hours after Jakob's disappearance, the police arrested Gäfgen and his 16-year-old girlfriend while simultaneously searching his flat. There they found the missing ransom, but no sign of Jakob. a b

Liberal theories of social justicefocus predominantly on the national, ratherthan international, level, and where they doaddress international concerns they insist thatprinciples of justice at the national levelhave priority over principles at theinternational level. We question the coherenceof this arrangement, given liberal theory'scommitment to moral equality of persons as suchrather than to that of particular sets of persons. What isat issue is whether liberal theory can providea coherent basis for international justice atall. If it is to do so, we suggest that it mustbe prepared to theorise beyond the nationstate, and to take a historical perspectivewhich takes into account the ways in whichcolonial power and exploitation have given riseto the problems of international justice weface today.

Achieving equity in international research is one of the pressing concerns of the twenty-first century. In this era of progressive globalization, there are many opportunities for the deliberate or accidental export of unethical research practices from high-income regions to low- and middle-income countries and emerging economies. The export of unethical practices, termed “ethics dumping,” may occur through all forms of research and can affect individuals, communities, countries, animals, and the environment. Ethics dumping may be the result of purposeful exploitation but often arises from lack of awareness of good ethical and governance practice. This chapter describes the work of the TRUST project toward counteracting the practice of ethics dumping through the development of tools for the improvement of research governance structures. Multi-stakeholder consultation informs all of TRUST’s developments. Most importantly, this gives voice to marginalized vulnerable groups and indigenous people, who have been equal and active partners throughout the project. At the heart of the TRUST project is an ambitious aim to develop a Global Code of Conduct for Research in Resource-Poor Settings. Uniquely, the Code provides guidance across all research disciplines in clear, short statements, focusing on research collaborations that entail considerable imbalances of power, resources and knowledge and using a new framework based on the values of fairness, respect, care, and honesty. The code was recently adopted by the European Commission as a reference document for Horizon 2020 and Horizon Europe.