Open consent, biobanking and data protection law: can open consent be ‘informed’ under the forthcoming data protection regulation?
This article focuses on whether a certain form of consent used by biobanks – open consent – is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions ...
Source: Life Sciences, Society and Policy - January 24, 2015 Category: Medical Ethics Source Type: research
Precaution, governance and the failure of medical implants: the ASR (TM) hip in the UK
Abstract
Hip implants have provided life-changing treatment, reducing pain and improving the mobility and independence of patients. Success has encouraged manufacturers to innovate and amend designs, engendering patient hopes in these devices. However, failures of medical implants do occur. The failure rate of the Articular Surface Replacement metal-on-metal hip system, implanted almost 100,000 times world-wide, has re-opened debate about appropriate and timely implant governance. As commercial interests, patient hopes, and devices’ governance converge in a socio-technical crisis, we analyse the respo...
Source: Life Sciences, Society and Policy - November 26, 2014 Category: Medical Ethics Source Type: research
The past and future of RRI
Abstract
Within the space of a few years, the idea of Responsible Research and Innovation, and its acronym RRI, catapulted from an obscure phrase to the topic of conferences and attempts to specify and realize it. How did this come about, and against which backdrop? What are the dynamics at present, and what do these imply for the future of RRI as a discourse, and as a patchwork of practices? It is a social innovation which creates opening in existing (and evolving) divisions of moral labour, a notion that is explained with the help of the history of responsibility language. It is filled in for the pres...
Source: Life Sciences, Society and Policy - November 6, 2014 Category: Medical Ethics Source Type: research
The evolution of withdrawal: negotiating research relationships in biobanking
Abstract
The right to withdraw from research, along with the necessity of adequately informed consent, is at the heart of the post-Nuremburg code of ethical safeguards in biomedical research on human participants. As biomedical research moves away from direct interventional studies towards research using networks of linked human tissue samples and data, however, questions arise about what withdrawal can and should mean in these new contexts. Some of the more expansive traditional understandings, such as the right to withdraw from a study ‘at any time’ are limited in practice by the nature of biobank...
Source: Life Sciences, Society and Policy - October 5, 2014 Category: Medical Ethics Source Type: research
Health research access to personal confidential data in England and Wales: assessing any gap in public attitude between preferable and acceptable models of consent
This study sought to investigate a relatively unexplored difference between the consent model that people prefer and that which they are willing to accept. It also sought to explore any reasons for such acceptance.
A mixed methods approach was used to gather data, incorporating a structured questionnaire and in-depth focus group discussions led by an external facilitator. The sampling strategy was designed to recruit people with different involvement in the NHS but typically with experience of NHS services. Three separate focus groups were carried out over three consecutive days.
The...
Source: Life Sciences, Society and Policy - July 30, 2014 Category: Medical Ethics Source Type: research
The use of agrobiodiversity for plant improvement and the intellectual property paradigm: institutional fit and legal tools for mass selection, conventional and molecular plant breeding
Abstract
Focused on the impact of stringent intellectual property mechanisms over the uses of plant agricultural biodiversity in crop improvement, the article delves into a systematic analysis of the relationship between institutional paradigms and their technological contexts of application, identified as mass selection, controlled hybridisation, molecular breeding tools and transgenics. While the strong property paradigm has proven effective in the context of major leaps forward in genetic engineering, it faces a systematic breakdown when extended to mass selection, where innovation often displays a c...
Source: Life Sciences, Society and Policy - June 27, 2014 Category: Medical Ethics Source Type: research
Nature is (a) mine: conceptions of nature in the Dutch ecogenomics community
Abstract
Every field of science, but especially biology, contains particular conceptions of nature. These conceptions are not merely epistemological or ontological, but also have normative dimensions; they provide an ethos, a framework for moral orientation. These normative dimensions, whilst often remaining ‘hidden’ and inarticulate, influence the way in which biologists practice their profession. In this paper, I explore what happens when different versions of these implicit normative frameworks collide. To do so, I will focus on a case study from the field of ecological genomics as it has evolved...
Source: Life Sciences, Society and Policy - May 17, 2014 Category: Medical Ethics Source Type: research
Early detection of criminality concerns and the social link
Abstract
In modern societies, rhetoric focused on body and health is common as biomedical sciences have taken a big place in people’s lives. They must enhance the society, health and living conditions of citizens. Solving criminality problems remains a major challenge and the early detection of antisocial children - future offenders - promises to offer a solution to criminality thanks to science and medical advances. But in a democratic society that values solidarism and pluralism and tends to preserve the social link, it is necessary to question the ethical relevance of this method of managing ...
Source: Life Sciences, Society and Policy - May 14, 2014 Category: Medical Ethics Source Type: research
Adapt or perish? Assessing the recent shift in the European research funding arena from ‘ELSA’ to ‘RRI’
Abstract
Two decades ago, in 1994, in the context of the 4th EU Framework Programme, ELSA was introduced as a label for developing and funding research into the ethical, legal and social aspects of emerging sciences and technologies. Currently, particularly in the context of EU funding initiatives such as Horizon2020, a new label has been forged, namely Responsible Research and Innovation (RRI). What is implied in this metonymy, this semantic shift? What is so new about RRI in comparison to ELSA? First of all, for both labels, the signifier (S) was introduced in a top-down manner, well before the concep...
Source: Life Sciences, Society and Policy - May 14, 2014 Category: Medical Ethics Source Type: research
Obituary for Herbert Gottweis, Professor of Political Science, University of Vienna: Born 8 February 1958 in Vienna, died 31 March 2014 in Vienna
(Source: Life Sciences, Society and Policy)
Source: Life Sciences, Society and Policy - April 30, 2014 Category: Medical Ethics Source Type: research
The role of philosophy of science in Responsible Research and Innovation (RRI): the case of nanomedicine
Abstract
Research on ethical, legal and social aspects (ELSA) of life sciences and new technologies has mainly been focused on impacts and consequences, while the emerging framework of Responsible Research and Innovation (RRI) focuses rather on increased involvement and reflexivity in research processes to foster science and technology that better answers the needs of society. I argue that philosophy of science should be a central feature of RRI and demonstrate how the philosophy of science can contribute in this sense. I show how investigating basic assumptions in research, here exemplified by reductiv...
Source: Life Sciences, Society and Policy - April 26, 2014 Category: Medical Ethics Source Type: research
We have never been ELSI researchers – there is no need for a post-ELSI shift
This article criticizes recent suggestions that the current ELSI research field should accommodate a new direction towards a ‘post-ELSI’ agenda. Post-ELSI research seeks to avoid the modernist division of responsibility for technical and social issues said to characterize ELSI research. Collaboration and integration are consequently the key terms of post-ELSI strategies that are to distinguish it from ELSI strategies. We argue that this call for a new direction relies on an inadequate generalized analysis of ELSI research as modern that will affect the construal of post-ELSI strategies. We are concerned that the call f...
Source: Life Sciences, Society and Policy - April 5, 2014 Category: Medical Ethics Source Type: research
Limiting and facilitating access to innovations in medicine and agriculture: a brief exposition of the ethical arguments
This article explores the main ethical theories used to demand a greater share in the benefits from scientific progress for the poor. Since life sciences bring about a number of special concerns, a short list of conflictive issues is also offered. (Source: Life Sciences, Society and Policy)
Source: Life Sciences, Society and Policy - April 5, 2014 Category: Medical Ethics Source Type: research
Ethical considerations of research policy for personal genome analysis: the approach of the Genome Science Project in Japan
Abstract
As evidenced by high-throughput sequencers, genomic technologies have recently undergone radical advances. These technologies enable comprehensive sequencing of personal genomes considerably more efficiently and less expensively than heretofore. These developments present a challenge to the conventional framework of biomedical ethics; under these changing circumstances, each research project has to develop a pragmatic research policy. Based on the experience with a new large-scale project—the Genome Science Project—this article presents a novel approach to conducting a specific policy for p...
Source: Life Sciences, Society and Policy - April 5, 2014 Category: Medical Ethics Source Type: research
Challenges for the European governance of synthetic biology for human health
Abstract
Synthetic biology is a series of scientific and technological practices involved in the application of engineering principles to the design and production of predictable and robust biological systems. While policy discussions abound in this area, emerging technologies like synthetic biology present considerable challenges in the articulation of concrete policy options given that their introduction into society may still be in the distant future. This paper reports on a series of governance workshops that focused on synthetic biology’s ethical, legal, and social implications (ELSI) as they per...
Source: Life Sciences, Society and Policy - March 20, 2014 Category: Medical Ethics Source Type: research
