Information and Communication Technologies, Genes, and Peer-Production of Knowledge to Empower Citizens' Health.

The different and seemingly unrelated practices of Information and Communication Technologies (ICT) used to collect and share personal and scientific data within networked communities, and the organized storage of human genetic samples and information-namely biobanking-have merged with another recent epistemic and social phenomenon, namely scientists and citizens collaborating as "peers" in creating knowledge (or peer-production of knowledge). These different dimensions can be found in joint initiatives where scientists-and-citizens use genetic information and ICT as powerful ways to gain more control over their health and the environment. While this kind of initiative usually takes place only after rights have been infringed (or are put at risk)-as the two cases presented in the paper show-collaborative scientists-and-citizens' knowledge should be institutionally allowed to complement and corroborate official knowledge-supporting policies.

Emerging ICT for Citizens' Veillance: Theoretical and Practical Insights.

In ubiquitous surveillance societies, individuals are subjected to observation and control by authorities, institutions, and corporations. Sometimes, citizens contribute their own knowledge and other resources to their own surveillance. In addition, some of "the watched" observe "the watchers" "through" sous-veillant activities, and various forms of self-surveillance for different purposes. However, information and communication technologies are also increasingly used for social initiatives with a bottom up structure where citizens themselves define the goals, shape the outcomes and profit from the benefits of watching activities. This model, which we define as citizens' veillance and explore in this special issue, may present opportunities for individuals and collectives to be more prepared to meet the challenges they face in various domains including environment, health, planning and emergency response.

Ethical Design in the Internet of Things.

Even though public awareness about privacy risks in the Internet is increasing, in the evolution of the Internet to the Internet of Things (IoT) these risks are likely to become more relevant due to the large amount of data collected and processed by the "Things". The business drivers for exploring ways to monetize such data are one of the challenges identified in this paper for the protection of Privacy in the IoT. Beyond the protection of privacy, this paper highlights the need for new approaches, which grant a more active role to the users of the IoT and which address other potential issues such as the Digital Divide or safety risks. A key facet in ethical design is the transparency of the technology and services in how that technology handles data, as well as providing choice for the user. This paper presents a new approach for users' interaction with the IoT, which is based on the concept of Ethical Design implemented through a policy-based framework. In the proposed framework, users are provided with wider controls over personal data or the IoT services by selecting specific sets of policies, which can be tailored according to users' capabilities and to the contexts where they operate. The potential deployment of the framework in a typical IoT context is described with the identification of the main stakeholders and the processes that should be put in place.

Nudging or education to responsible choices? The example of breast screening. / Nudging o educazione a scelte civiche responsabili? L'esempio dello screening della mammella.

"Nudge, or nudging, refers to a policy approach inspired by behavioral sciences: it promotes the conducts identified as desirable by regulators without applying prohibition and coercion. This approach has gained a lot of momentum in the domain of health policies. Policy strategies based on behavioral insights appear ideal as to implementing healthier life styles and public health programs while minimizing compliance costs: from organ donation to food choices, from fighting obesity and chronic diseases to screening policies. Nudging, however, is not exempt from problems, especially in the sector of health, where individual free and informed consent constitutes a founding principle. Cancer screening programs, and especially breast cancer population tests, represent an interesting example for nudging strategies which have been widely applied but have also raised serious criticisms. Despite having been widely adopted by health systems, from the United States to the European Union, breast cancer screening programs keep raising debates about their actual impact on reducing mortality, risks of overdiagnosing and unnecessary or harmful treatments. In challenging the validity of screening programs, these controversies also affect their efficacy. Nudging has therefore been seen as a potentially useful tool in increasing participation, even though the extent of its actual impact remains ambiguous and problematic. For nudging to represent a relevant, powerful policy instrument its legitimacy requirements need to be identified. These concern the "right place" of behavioral-based measures within the traditional regulatory framework. The "right place" of nudging in science-based policies is part of a broader rethinking of what is democracy in "knowledge-based societies", namely through which procedures democratic institutions validate and legitimize their normative choices depending on uncertain and controversial knowledge."

Long-term IgG response to porcine Neu5Gc antigens without transmission of PERV in burn patients treated with porcine skin xenografts.

Acellular materials of xenogenic origin are used worldwide as xenografts, and phase I trials of viable pig pancreatic islets are currently being performed. However, limited information is available on transmission of porcine endogenous retrovirus (PERV) after xenotransplantation and on the long-term immune response of recipients to xenoantigens. We analyzed the blood of burn patients who had received living pig-skin dressings for up to 8 wk for the presence of PERV as well as for the level and nature of their long term (maximum, 34 y) immune response against pig Ags. Although no evidence of PERV genomic material or anti-PERV Ab response was found, we observed a moderate increase in anti-αGal Abs and a high and sustained anti-non-αGal IgG response in those patients. Abs against the nonhuman sialic acid Neu5Gc constituted the anti-non-αGal response with the recognition pattern on a sialoglycan array differing from that of burn patients treated without pig skin. These data suggest that anti-Neu5Gc Abs represent a barrier for long-term acceptance of porcine xenografts. Because anti-Neu5Gc Abs can promote chronic inflammation, the long-term safety of living and acellular pig tissue implants in recipients warrants further evaluation.

[Science and law in courts]. / Scienza e diritto in tribunale.

Science and law can be seen as the main creators of orders and rules in knowledge-based societies. These relations are particularly delicate in domains where scientific uncertainty and probabilistic causality are more frequently involved, such as environment and health. The decision of the Court of Florence (Tuscany Region, Northern Italy) (Second Criminal Division, 3217/2010, 17th May 2010) - here analysed - deals with the uncertain correlations between PM10 and health. The criminal law case involved some public officers in Tuscany, indicted for having failed to adopt the adequate measures to keep PM10 levels within the limits set by European Directive 2008/50/EC on air quality. In arguing that accusations were ill-founded, the Court, while invoking the validity of science, deliberately chose the scientific evidence relevant to drawing specific legal consequences. Meteorological phenomena are considered as the single determinant of high levels of PM10; their uncertainty is framed as absolute unpredictability and ungovernability, and from these flaws non-responsibility. The concept of coproduction is applied as a useful critical tool to open up the complex relationships between science and law by showing how scientific and legal concepts generate and influence each other even when legal regulations claims to be neutrally and objectively science-based.

[Citizens' veillance on environmental health through ICT and Genomics]. / La vigilanza dei cittadini sulla salute ambientale tra tecnologie digitali e genomica.

In the last decade three different phenomena have merged: the widespread use of ICT devices to collect and potentially share personal and scientific data, and to build networked communities; biobanking for genomics, namely the organized storage of human biological samples and information; and the collaboration between scientists and citizens in creating knowledge, namely peer-production of knowledge, for shared social goals. These different forms of knowledge, technical tools, and skills have merged in community based scientific and social, as well as legal, initiatives, where scientists and citizens use genetic information and ICT as powerful ways to gain more control over their health and the environment. These activities can no longer be simply qualified as epidemiological research and surveillance. Instead, they can be framed as new forms of citizens' participatory "veillance:" an attitude of cognitive proactive alertness towards the protection of common goods. This paper illustrates two Italian case-studies where citizens and scientists, by making use of both ICT and biobanking, have joined with the goal of protecting environmental health in highly polluted contexts. The statute of these initiatives still needs to be defined as to both the validity of the underlying citizen science and the lack of adequate legal tools for structuring them. However, as to their scientific quality and use of sophisticated technologies, these activities cannot be compared to previous experiences, such as those inspired by so-called popular epidemiology. Moreover, the deep awareness towards the data to be transparent, reliable, and accessible, as well as towards funding mechanisms to be crowdsourced, allows these experiences to go beyond the mere confrontation with institutional knowledge, and to represent a potential model for knowledge production for institutional implementation.

The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 1: Key ethical requirements and progress toward the definition of an international regulatory framework.

The outstanding results recently obtained in islet xenotransplantation suggest that porcine islet clinical trials may soon be scientifically appropriate. Before the initiation of such clinical studies, however, it is essential that a series of key ethical and regulatory conditions are satisfied. As far as ethics is concerned, the fundamental requirements have been previously reported in a position paper of the Ethics Committee of the International Xenotransplantation Association. These include aspects related to the selection of adequately informed, appropriate recipients; animal breeding and welfare; safety issues and the need for a favorable risk/benefit assessment based on strong efficacy data in relevant xenotransplantation studies in the primate. As most diabetic patients are not at risk of short-term mortality without islet transplantation, only a small subset of patients could currently be considered for any type of islet transplant. However, there are potential advantages to xenotransplantation that could result in a favorable benefit-over-harm determination for islet xenotransplantation in this subpopulation and ultimately in a broader population of diabetic patients. With regard to regulatory aspects, the key concepts underlying the development of the regulatory models in existence in the United States, Europe and New Zealand are discussed. Each of these models provides an example of a well-defined regulatory approach to ensure the initiation of well-regulated and ethically acceptable clinical islet xenotransplantation trials. At this stage, it becomes apparent that only a well-coordinated international effort such as that initiated by the World Health Organization, aimed at harmonizing xenotransplantation procedures according to the highest ethical and regulatory standards on a global scale, will enable the initiation of clinical xenotransplantation trials under the best auspices for its success and minimize any risk of failure.