After three proceedings in which neuroscience was a relevant factor for the final verdict in Italian courts, for the first time a recent case puts in question the legal relevance of neuroscientific evidence. This decision deserves international attention in its underlining that the uncertainty still affecting neuroscientific knowledge can have a significant impact on the law. It urges the consideration of such uncertainty and the development of a shared management of it.

Goldberg notes that the relationship is a component of Conflicts of Interests. Networks of relationships and the simultaneous presence of several interests are not negative per se but become so when they generate a conflict that undermines impartiality. The solution to the problem of COIs, therefore, cannot be to abolish relationships and the interests that they necessarily express but rather to verify whether those relationships are such as to unduly affect an individual’s judgement. The evolution of an Italian legislation about (...) COIs is eloquent in this regard. (shrink)

Public health emergencies such as pandemics can put health systems in a position where they need to ration medical equipment and interventions because the resources available are not sufficient to meet demand. In public health management, the fair allocation of resources is a permanent and cross-sector issue since resources, and especially economic resources, are not infinite. During the COVID-19 pandemic resources need to be allocated under conditions of extreme urgency and uncertainty. One very problematic aspect has concerned intensive care medicine (...) and age discrimination has been among the most hotly discussed issues, as age has been touted as a probable criterion for selection. In this paper we analyse some documents originating from scientific societies and medical associations, mainly related to EU sphere and available in English, French, Spanish and Italian, concerning the criteria for admission to the intensive care units. We highlights how, in most of these documents, it is explicitly stated that “age itself” is not a criterion for patient selection. Our conclusion is that these criteria should be defined in advance of a crisis situation and be grounded in clinical indicators. Establishing “cut-off” policies with regard to criteria such as age or chronic disability is definitely an unjustifiable form of discrimination even in the context of a public health emergency. (shrink)

Alzheimer’s disease is a very common, progressive and still incurable disease. Future possibilities for its cure lie in the promotion of research that will increase our knowledge of the disorder’s causes and lead to the discovery of effective remedies. Such research will necessarily involve individuals suffering from Alzheimer’s disease. This raises the controversial issue of whether patients with Alzheimer’s disease are competent to give their consent for research participation.

PurposeThe aim of this paper is to assess the complex issue of responsibility in clinical practice. The paper focuses mainly on the relationship between personal- and medical-professional responsibility of practitioners and clinical guidelines.MethodsAfter a theoretical review of the different definitions of responsibility in selected bioethical and biojuridical literature, two recent juridical proceedings concerning medical responsibility from Italian Courts are discussed. Subsequently, a theoretical analysis of the definition of clinical practice guidelines is proposed in order to show their feasibility to assess (...) personal- and medical-professional responsibility.ResultsThe definitions of responsibility and the two Italian cases show the theoretical and practical difficulties of shared assessments of both personal-professional and medical-professional responsibility in clinical practice. Clinical practice guidelines cannot be assumed as an objective code of action stating exactly a rule of conduct in all situations, but as a tool suggesting how to decide what to do in different conditions.ConclusionsResponsibility in clinical practice is such a complex issue to deserve a special ethical assessment. The clinician’s personal-professional responsibility cannot be replaced or reduced by clinical practice guidelines, because medicine is as such a relationship focused on the expertize of practitioners. Nonetheless, a shared approach to different clinical conditions is needed in order to avoid a relativist outcome and protect patients’ and even clinicians’ rights. Formal guidelines (that describe not exactly what to do but how to decide what to do) are proposed as potential useful tool to achieve this aim. (shrink)

Notwithstanding fundamental methodological advancements, scientific information about disorders of consciousness (DOCs)—e.g. Vegetative State/Unresponsive Wakefulness Syndrome (VS/UWS) and Minimally Conscious State (MCS)—is incomplete. The possibility to discriminate between different levels of consciousness in DOC states entails treatment strategies and ethical concerns. Here we attempted to investigate Italian clinicians’ and basic scientists’ opinions regarding some issues emerging from the care and the research on patients with DOCs. From our survey emerged that Italian physicians working with patients with DOCs give a central role (...) to ethics. Current Italian regulation regarding basic research conducted in patients with DOCs apparently risks to be inadequate to support scientific advancement, and would deserve a different assessment compared to ordinary treatments. We think the results of our survey deserve attention from an international audience because they exemplify the difficulty to define a shared approach to the issues related to patients with DOCs and the necessity to better assess both the ordinary and experimental treatment of patients with DOCs at the ethical and legal level. (shrink)

Increases in international travel and migratory flows have enabled infectious diseases to emerge and spread more rapidly than ever before. Hence, it is increasingly easy for local infectious diseases to become global infectious diseases (GIDs). National governments must be able to react quickly and effectively to GIDs, whether naturally occurring or intentionally instigated by bioterrorism. According to the World Health Organisation, global partnerships are necessary to gather the most up-to-date information and to mobilize resources to tackle GIDs when necessary. Communicable (...) disease control also depends upon national public health laws and policies. The containment of an infectious disease typically involves detection, notification, quarantine and isolation of actual or suspected cases; the protection and monitoring of those not infected; and possibly even treatment. Some measures are clearly contentious and raise conflicts between individual and societal interests. In Europe national policies against infectious diseases are very heterogeneous. Some countries have a more communitarian approach to public health ethics, in which the interests of individual and society are more closely intertwined and interdependent, while others take a more liberal approach and give priority to individual freedoms in communicable disease control. This paper provides an overview of the different policies around communicable disease control that exist across a select number of countries across Europe. It then proposes ethical arguments to be considered in the making of public health laws, mostly concerning their effectiveness for public health protection. (shrink)

The American Journal of Bioethics, Volume 12, Issue 1, Page 37-38, January 2012.

According to Howick (2009a), the three main reasons for believing that placebo-controlled trials (PCTs) are methodologically superior to active-controlled trials (ACTs)—sensitivity, absolute effect...

Translational research is a main focus of current health policy (Albani and Prakken 2009; PLoS Medicine 2008). Translation of biomedical research knowledge to effective clinical treatment is essential to the public good (Lavis et al. 2003). Only 5% of basic science studies showing significant therapeutic promise are successfully translated into clinical application (Contopoulos-Ioannidis, Ntzani, and Ionannidis 2003; FDA 2004). As Hall (2001) observes, this is a problem: "When too many important discoveries lie dormant, the public good suffers" (p. G1127). Recent (...) health policy initiatives intended to foster the translation of basic science into clinical advances must consider the unique bioethical issues raised by .. (shrink)

Clinical ethics refers to an emerging field in clinical medicine that focuses on the process of ethical decision-making in a clinicalsetting. It has developed as a result of a growing awareness that modern medicine – characterized by technological progress, culturaldiversity and social challenges – is posing a range of new “ethical dilemmas” that medical science alone cannot solve. For thisreason, clinical ethics is often linked to “ethics consultation,” which consists of services provided by an individual ethicist, ethicsteam or committee to (...) address the ethical issues involved in a specific clinical case. Although clinical ethics developed in the beginningmainly as a methodological analysis to arrive at a justification for clinical ethical decisions, it quickly has become clear thatthe difficulty in clinical decision-making is only one aspect of wider ethical problems pertaining to the doctor-patient relationshipas a whole and, most likely, to the core value of the medical profession. The principles method is usually presented as the mostpopular methodological approach to an analysis of clinical cases. However, strong criticism of this model has been voiced, and otheralternative approaches are referred to, such as the casuistry model. Recently, significant contributions have been made by narrativemedicine and virtue ethics. According to these methodologies, sound anthropology and a good relationship with the sick person arekey elements required of any person engaged in medical practice who aims to be genuinely appropriate from an ethical perspective. DOI: 10.5294/pebi.2016.20.1.3. (shrink)

The use of human biological materials involves a number of issues from both an ethical and a legal point of view. In recent decades, the purposes for which this material has been used have i...

Background On December 2017 the Italian Parliament approved law n. 219/2017 “Provisions for informed consent and advance directives” regarding challenging legal and bioethical issues related to healthcare decisions and end-of-life choices. The law does not contain an explicit reference to Ethics Committees (ECs), but they could still play a role in implementing the law. Methods A questionnaire-based survey was performed among the ECs of the Italian Institute for Research and Care belonging to the Network of neuroscience and neurorehabilitation, with the (...) aim of (1) knowing whether the ECs participated and, if so, how in the process of implementation of law n. 219/2017 in the referring institutes; (2) investigating the point of view of the ECs regarding their possible involvement in the process; (3) exploring the contribution ECs can provide to give effective implementation to the law principles and provisions. Results Seventeen ECs out of thirty took part in the survey; the characteristics of the responding and non-responding committees are similar, so the responding ECs can be regarded as representative of all ECs in the Network. Nine ECs did not discuss the law in anyway: the main reason for this is that the referring institutions (6) and the health care professionals (3) did not ask for an EC intervention. Nevertheless, the large majority of the ECs believe that their involvement in the implementation of the law as a whole is appropriate (8) or absolutely appropriate (6), while 3 of them are neutral. No EC believes that the involvement is inappropriate. The aspect of the law on which the 14 ECs converge in considering the EC involvement appropriate/absolutely appropriate is the one related to the health facilities obligation to guarantee the full and proper implementation of the principles of the law. Conclusions Our survey confirms that ECs believe they can play a role in the implementation of law n. 219/2017, although this does not entirely correspond to what the committees have actually done in reality. This role could be better exercised by ECs specifically established for clinical practice, which would have a composition, functioning and a mandate better suited to the purpose. This supports the call for a national regulation of ECs for clinical practice. (shrink)