BackgroundInnovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.MethodsAn interdisciplinary workshop jointly organised by the University of Oxford (...) and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach.ResultsDynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies.ConclusionsDynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures. (shrink)

Personalized medicine aims to tailor disease prevention, diagnosis, and treatment to individuals on the basis of their genes, lifestyle and environments. Patient and interest organizations may potentially play an important role in the realization of PM. This paper investigates the views and perspectives on PM of a variety of PIOs. Semi-structured telephone interviews were conducted among leading representatives of 13 PIOs located in Europe and North-America. The data collected were analysed using a conventional content analysis approach. The PIO representatives supported (...) the realization of PM but feared that many financial, structural and organizational challenges may delay its realization. They encouraged strategies to modernize drug licencing mechanisms, develop research and data sharing infrastructures, and educate patients and health care professionals in PM. Notably, they emphasized the importance of developing PM in an equitable way and taking into consideration the patients’ needs, values and personal situation. Despite varying levels of awareness regarding PM, the PIO representatives expressed willingness to engage in the PM agenda and recommended that PIOs work closely with policy-makers to design PM in a way that truly addresses the needs and concerns of patients. PIOs have the potential to become central drivers of the PM agenda. Collaborations should be further developed between PIOs, researchers, drug developers and health care authorities. (shrink)

Abstract.This article focuses on a critical interpretation of the work of Unger. It is argued that Unger's view is less revolutionary than he depicts it and that American law often develops as Unger describes it, though this is absolutely no revolution. The authors further show what the possibilities and the limits of a transformative vocation at the bar can be.

. Legal theory has so far focused exclusively on judicial activity, not on legislation. This is due to the specific legal framework of reasoning, upon which it is essential to act upon rules, wherever they come from. This form of legalism is criticized and replaced by weak legalism. Weak legalism makes it possible to detect the principles of legislation that underly the activity of the legislator. Legisprudence is the theory of these principles.

.The article deals with the difference between some forms of legal positivism. It is argued that, even in continental legal systems which are typically “rule bound,” there is some space left for principles in the legal system. The author tries to explain how this space can be filled and what methods should be used by a judge to do so.

"Proceedings of the fourth Benelux-Scandinavian Symposium on Legal Theory."--T.p.

The metaphysics of legalism -- The individual in context -- Rationality in context -- Freedom in context -- Strong legalism or the absent theory of legislation -- Legitimacy and legitimation : from strong legalism to legisprudence -- From proxy to trading off : the principles of legisprudence -- Legisprudence and the duties of power : a legisprudential assessment of rational legislation.

In this contribution the author explores some aspects of the relation between sovereignty, democracy and representation. After shortly focusing on the idea of sovereignty, he then questions Rousseau's refusal to take representation into account within a democratic framework, an idea that is however latent in his general approach.