The unknown nature of tomorrow’s research makes informed consent in biobank research a challenge. Whether the consent given by biobank participants is ‘broad’ or ‘narrow’, the ever present question remains the same: are new activities covered by the original consent? In this article, we focus on the meaning of, and the relation between, broad consent and re-consent in biobank research. We argue that broad consent should be understood as consenting to a framework—a framework which covers aims, core conditions for acceptable (...) use, governance and how these affect participants. Changes that alter the framework in a fundamental way call for re-consent. Three biobank cases of current international interest are used to debate when re-consent is an ethical necessity: whole-genome sequencing, data sharing and commercial utilization. These reflections give us a more nuanced view on what consent is for. We claim that the introduction of broad consents in biobank research has not represented a betrayal of individual participant interests, as some critics have asserted. Broad consents combined with the possible use of re-consent are in certain settings not inferior, but rather ethically superior to narrow consents. In population-based research biobanks, they allow for a reconciliation between individual interest and public matters in society at large. (shrink)

Emotions play an important part in moral life. Within clinical ethics support (CES), one should take into account the crucial role of emotions in moral cases in clinical practice. In this paper, we present an Aristotelian approach to emotions. We argue that CES can help participants deal with emotions by fostering a joint process of investigation of the role of emotions in a case. This investigation goes beyond empathy with and moral judgment of the emotions of the case presenter. In (...) a moral case deliberation, the participants are invited to place themselves in the position of the case presenter and to investigate their own emotions in the situation. It is about critically assessing the facts in the case that cause the emotion and the related (moral) thoughts that accompany the emotion. It is also about finding the right emotion in a given situation and finding the right balance in dealing with that emotion. These steps in the moral inquiry give rise to group learning. It is a process of becoming open towards the perspectives of others, leading to new insights into what is an appropriate emotion in the specific situation. We show how this approach works in moral case deliberation. A physician presents a situation in which he is faced with a pregnant woman who is about to deliver multiple extremely premature infants at the threshold of viability. The moral deliberation of the case and the emotions therein leads to the participants’ conclusion that “compassion” is a more adequate emotion than “sadness”. The emotion “sadness” is pointed towards the tragedy that is happening to the woman. The emotion “compassion” is pointed towards the woman; it combines consideration and professional responsibility. Through the shift towards compassion, participants experienced more creativity and freedom to deal with the sad situation and to support the woman. The paper ends with an analysis and reflection on the deliberation process. In the conclusion we argue for more attention to emotions in clinical ethics support and offer some directions for doing this in the right way. (shrink)

The acceleration of the market globalisation process over the last three decades has internationalised clinical research and influenced both the way in which it is funded and the development and application of research practices. In addition, in recent years international multicentre randomised clinical trials have become the model par excellence for research on new medicines. The neoliberal model of globalisation has induced a decline in state power, both with regard to establishing national research for health priorities and to influencing the (...) development of adequate ethical guidelines to protect human beings that participate in multinational research. In this respect, poor and low-income countries, which lack sustainable control and review systems to deal with the ethical and methodological challenges of complex studies conducted by researchers from affluent countries and funded by large multinational pharmaceutical companies, are particularly vulnerable. The aim of the present paper is to explore critically some of the actual and possible ethical pitfalls of globalisation of clinical research and propose mechanisms for turning transnational clinical research into a more cooperative and fairer enterprise. (shrink)