Experimental design is one aspect of a scientific method. A well-designed, properly conducted experiment aims to control variables in order to isolate and manipulate causal effects and thereby maximize internal validity, support causal inferences, and guarantee reliable results. Traditionally employed in the natural sciences, experimental design has become an important part of research in the social and behavioral sciences. Experimental methods are also endorsed as the most reliable guides to policy effectiveness. Through a discussion of some of the central concepts (...) associated with experimental design, including controlled variation and randomization, this chapter will provide a summary of key ethical issues that tend to arise in experimental contexts. In addition, by exploring assumptions about the nature of causation and by analyzing features of causal relationships, systems, and inferences in social contexts, this chapter will summarize the ways in which experimental design can undermine the integrity of not only social and behavioral research but policies implemented on the basis of such research. (shrink)

The role of the Research Ethics Committee (REC) in the design, conduct and dissemination of scientific research is still evolving and many important questions remain unanswered. Hence, the aim of this paper is to address some of the uncertainty that exists around the role and responsibilities of RECs and to discuss some of the controversy that exists over the criteria that RECs should follow when evaluating a research proposal. The discussion is organised around five of the major roles currently performed (...) by RECs when assessing proposals in the biomedical sciences. It will be shown that these five roles need to be critically evaluated and reassessed. The five roles addressed are: assessing the legitimacy and validity of the informed consent process, second, conducting a comprehensive risk/benefit analysis, third, assessing the validity of a research proposal, fourth, ensuring that researchers observe the social norms, values, customs, traditions and laws that prevail in the community or jurisdiction in which the research will be conducted and finally, monitoring the research project as it unfolds and providing an ongoing advisory and consultancy service to both new and experienced researchers. In reassessing the role of the REC, this paper concludes with a set of general recommendations for RECs. These provide some guidance on the minimum criteria that should be followed when RECs evaluate proposals. These guidelines will be beneficial for new and experienced members of REC, and will help to make the process a more objective, efficient and standardised process. The guidelines will also be beneficial for researchers in the biomedical sciences who are preparing proposals for ethical review. (shrink)

This paper argues that specific individual informed consent and other forms of consent predicated on a right to autonomy may not in all circumstances be appropriate for the establishment and use of large data sets of health information. We suggest that there are inherent failings in such an approach, shortcomings that we analyse below. We argue that individuals share an obligation to contribute their data, as doing so is cost-free and benefits accrue to the population as a whole. Large health (...) data sets can be considered public goods – goods that are non-rival in consumption and in some cases non-exclusive in use – and contributing to these goods may be an obligation, the meeting of which allows citizens to invest in knowledge infrastructure. The approach argued for here is a variation of a communitarian ethic in which people have an obligation to contribute their data but have no correlative right to expect or receive an individual benefit. (shrink)

Definition of the problem: The question whether a prohibition of physician-assisted suicide is justifiable plays a prominent role in recent debate about this practice. Many authors argue that assisted suicide is an issue of individual choice, that a prohibition would base on particular conceptions of the good and that such a justification is not acceptable in a liberal society. Arguments: Within the frame of a communitarian approach the article demonstrates that the handling of dying and what physicians are allowed to (...) do is central for society and the professional identity of physicians and that every ethical position within this debate unavoidably rests upon certain conceptions of the good. Conclusion: Therefore it is necessary to deal with these conceptions in a transparent way and it is justifiable to impose a prohibition of physician-assisted suicide based on a conception of the common good that does not consult supposed social consequences. (shrink)

ZusammenfassungEthische Aspekte von Biobanken-basierter Forschung werden zunehmend kontrovers diskutiert. In diesem Artikel wird die Debatte um ethisch angemessene Formen der Einwilligung in Biobanken-basierte Forschung nachgezeichnet. Nach einer Einführung in etablierte Einwilligungsmodelle skizziert der Beitrag kurz die Entwicklung alternativer Ansätze und diskutiert die damit verbundenen ethischen und regulatorischen Herausforderungen. Dabei wird dargestellt, welche ethischen Prinzipien in diesen Diskussionen eine Rolle spielen. Der Beitrag schließt mit einem Ausblick für Deutschland.