Mariachiara Tallacchini

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.

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

Abstract:  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.

Building Trust in the Human?Internet of Things Relationship

Our vision in this paper is that agency, as the individual ability to intervene and tailor the system, is a crucial element in building trust in IoT technologies. Following up on this vision, we will first address the issue of agency, namely the individual capability to adopt free decisions, as a relevant driver in building trusted human-IoT relations, and how agency should be embedded in digital systems. Then we present the main challenges posed by existing approaches to implement this vision. We show then our proposal for a model-based approach that realizes the agency concept, including a prototype implementation.

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.

Defining an appropriate ethical, social and regulatory framework for clinical xenotransplantation

Purpose of reviewThe complex and global health issues surrounding xenotransplantation require all regulatory aspects to be thought of within a coherent framework. This article reviews recent literature on normative issues of xenotransplantation, giving particular attention to contributions focusing on the relationships among ethical, legal and social factors within the context of global changes and challenges. Recent findingsAlthough the main regulatory issues (i.e. informed consent, criteria for patient enrollment in clinical trials, the rights and obligations of third parties, the ethical management of safety measures, and use of animals) remain central to the xenotransplantation literature, new ways of addressing these topics and relatively new regulatory issues are emerging. SummaryInadequacies or weaknesses in national and international regulation of xenotransplantation interact and affect each other in terms of both ethics and safety. Confronted with the worldwide scale of research, the main focus of regulatory issues in xenotransplantation is shifting toward the multifaceted issues of locality and globality.

Community and public participation in the risk assessment of experimental clinical trials

investigator [4]. Further, one should be careful about conducting research on adolescents that will affect them throughout their lives in the absence of very convincing evidence of benefit and strong justification for performing the research intervention prior to the subject reaching the age of adulthood. Insulin treats diabetes and while far from ideal, it is an effective treatment that enables children to reach their adult years. Therefore, the transplantation of pig islet cells was not necessary to treat the condition from which the adolescents were suffering. Finally, humans who will be subjected to xenotransplantation procedures are supposed to promise that they will not undertake certain behaviors for the rest of their lives, such as blood donations or sex without a condom, to avoid the possibility of spreading viruses through the population. These promises are entirely unenforceable by the researcher or anyone else. As a result, such research should be limited to those who are most likely to comply with such recommendations. It is unlikely that teenagers will be able to make and keep promises regarding their conduct, especially their sexual conduct in the future. While xenotransplantation research offers the promise of future medical advances it is important that researchers not forget their current obligations to their subjects.

Human Tissues in the ‘Public Space’: Beyond the Property/Privacy Dichotomy

During the past 20 years, human biological materials (HBMs) have become increasingly important for research as well as for therapeutic uses and related commercial exploitation. The scientific and regulatory conditions for their procurement, testing, processing, preservation, storage, and distribution have been reflected upon widely and developed in both the civil law and the common law domains.

A participatory space beyond the "autonomy versus property" dichotomy

In response to the various questions that have arisen around the biobanking of human biological materials (HBMs) and information, two strategies have been adopted in the US and in Europe; these are distinguished by their respective focus on two main legal concepts: individual property rights and individual autonomy—or the right to privacy.

Governance of ICT Security: A Perspective from the JRC

Information and communication technologies (ICT) are enabling unforeseen capabilities in all aspect of our lives. They are reframing how we think, learn, work, play, and interact at personal, social, and political level. While these technologies are essential for society and for todays information economy, several aspects of their applications remain un-reflected and open to surprises. For the first time in Opinion 26 (2012) the EGE has extended its analysis to ICT, identifying and addressing some key- problems in ICT ethics, as well as looking at the ethical implications of different ICT applications, new fields of research, and future developments. Opinion 28 will specifically deal with security and surveillance technologies, a domain where the ICT normative issues are even more problematic, due to the ethical, legal, and political ambiguities affecting these concepts and their histories. The reflections proposed here below touch on some general normative issues concerning ICT implications, and discuss a few key elements in the construction of a framework for their governance, especially in the fields of security and surveillance.

A legal framework from ecology

This paper proposes some legal principles for environmental protection as outlined from ecology. Such an environmental legal framework consists essentially of three criteria which deal (1) with ecological limits, (2) Gestalt, and (3) uncertainty. These guidelines for an ecologically-oriented law are defined as normative because they show that there is a link between ecological descriptions and legal prescriptions.