La ética clínica se refiere a un campo emergente en la medicina clínica que se centra en el proceso de toma de decisiones éticas en un entorno clínico. Se ha desarrollado como resultado de una creciente conciencia de que la medicina moderna -caracterizada por el progreso tecnológico, la diversidad cultural y los problemas sociales- está planteando una serie de nuevos "dilemas éticos" que la ciencia médica por sí sola no puede resolver. Por esta razón, la ética clínica suele estar relacionada con la "consulta ética", que consiste en los servicios prestados por un especialista en ética, un equipo ético o un comité de ética para abordar las cuestiones éticas implicadas en un caso clínico específico. Si bien la ética clínica se desarrolló al principio esencialmente como un análisis metodológico para llegar a una justificación de las decisiones éticas clínicas, rápidamente se hizo evidente que la dificultad en la toma de decisiones clínicas es solo un aspecto de los problemas éticos más amplios relacionados con la relación médico-paciente en su totalidad y, muy probablemente, con el valor fundamental de la profesión médica. El método de principios generalmente se presenta como el enfoque metodológico más extendido para el análisis de casos clínicos. Sin embargo, una fuerte crítica de este modelo se ha manifestado, y se hace referencia a otros enfoques alternativos, como el modelo de la casuística. Recientemente, se han producido importantes contribuciones de la medicina narrativa y la ética de la virtud. De acuerdo con estas metodologías, una sana antropología y una buena relación con el enfermo son elementos clave requeridos de cualquier persona que trabaje en la práctica médica que pretende ser auténticamente apropiada desde una perspectiva ética.

Clinical ethics refers to an emerging field in clinical medicine that focuses on the process of ethical decision-making in a clinical setting. It has developed as a result of a growing awareness that modern medicine - characterized by technological progress, cultural diversity and social challenges - is posing a range of new "ethical dilemmas" that medical science alone cannot solve. For this reason, clinical ethics is often linked to "ethics consultation," which consists of services provided by an individual ethicist, ethics team or committee to address the ethical issues involved in a specific clinical case. Although clinical ethics developed in the beginning mainly as a methodological analysis to arrive at a justification for clinical ethical decisions, it quickly has become clear that the difficulty in clinical decision-making is only one aspect of wider ethical problems pertaining to the doctor-patient relationship as a whole and, most likely, to the core value of the medical profession. The principles method is usually presented as the most popular methodological approach to an analysis of clinical cases. However, strong criticism of this model has been voiced, and other alternative approaches are referred to, such as the casuistry model. Recently, significant contributions have been made by narrative medicine and virtue ethics. According to these methodologies, sound anthropology and a good relationship with the sick person are key elements required of any person engaged in medical practice who aims to be genuinely appropriate from an ethical perspective.

A ética clínica se refere a um campo emergente na medicina clínica que se concentra no processo de tomada de decisões éticas num contexto clínico. Tem se desenvolvido como resultado de uma crescente consciência de que a medicina moderna -caracterizada pelo progresso tecnológico, pela diversidade cultural e pelos problemas sociais- está propondo uma série de novos "dilemas éticos" que a ciência médica por si só não pode resolver. Por essa razão, a ética clínica costuma estar relacionada com a "consulta ética", que consiste nos serviços prestados por um especialista em ética, por uma equipe ética ou por um comitê de ética para abordar as questões éticas implicadas num caso clínico específico. Embora a ética clínica tenha se desenvolvido a princípio essencialmente como uma análise metodológica para chegar a uma justificativa das decisões éticas clínicas, rapidamente se tornou evidente que a dificuldade na tomada de decisões clínicas é só um aspecto dos problemas éticos mais amplos relacionados com a relação médico-paciente em sua totalidade e, bem provável, com o valor fundamental da profissão médica. O método de princípios geralmente se apresenta como o enfoque metodológico mais difundido para a análise de casos clínicos. Contudo, uma forte crítica desse modelo vem se manifestando e fazendo referência a outros enfoques alternativos, como o modelo da casuística. Recentemente, têm sido produzidas relevantes contribuições da medicina narrativa e da ética da virtude. De acordo com essas metodologias, uma antropologia saudável e uma boa relação com o paciente são elementos-chave exigidos de qualquer pessoa que trabalhe na prática médica que pretenda agir de forma apropriada segundo uma perspectiva ética.

In an article in The Boston Globe, Steven Pinker holds that the primary moral good of bioethics should be to "get out of the way". The accusation that bioethics is an obstacle to research because it calls attention to basic principles such as personal dignity and justice is clearly contradicted by the facts. There are, nonetheless, other ways in which bioethics can stand in the way of science, two of which, bureaucratisation and the loss of cultural vivacity, are worth addressing. Ethics committees provide a framework for evaluating problems and determining an appropriate course of action.

The issues raised by public health surveillance are typical of those involved in public health ethics. Surveillance calls, in particular, for the balancing of individual rights and collective interests, which are often in conflict. One of the issues most closely linked with public health surveillance is the collection and use of personal data for purposes of public concern. Numerous frameworks (proposed by institutions, working groups or single individuals) are available for use in assessing the ethical correctness of public health interventions in general or, more specifically, of public health surveillance. While heterogeneous in nature, these frameworks are nonetheless built on a foundation of common values that are similar to those typically encountered in a clinical setting and to which bioethics has traditionally devoted considerable attention. However, it is necessary to apply these values to the specific context of public health, where the focus is more on the interests of the public at large than on those of the individual.

Genetic tests frequently produce more information than is initially expected. Several documents have addressed this issue and offer suggestions regarding how this information should be managed and, in particular, concerning the expedience of revealing (or not revealing) it to the persons concerned. While the approaches to the management of these incidental findings (IFs) vary, it is usually recommended that the information be disclosed if there is confirmed clinical utility and the possibility of treatment or prevention. However, this leaves unsolved some fundamental issues such as the different ways of interpreting "clinical utility", countless sources of uncertainty and varying ways of defining the notion of "incidental". Guidelines and other reference documents can offer indications to those responsible for managing IFs but should not be allowed to relieve researchers and healthcare professionals of their responsibilities.

For the 28 member states of the European Union, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, which repeals Directive 2001/20/EC, represents a substantial innovation in the procedures for authorising clinical trials and for handling all the subsequent stages. It introduces a single authorisation that will be valid for all EU member states, as well as a single portal through which all data concerning all clinical trials performed throughout the EU will pass. The present article offers an overview of the general aspects of the new procedures. It does not address the specific issues involved, each of which merits separate examination.

Difficulties of behavioral assessment of consciousness. An astonishingly high rate of misdiagnosis between vegetative state/unresponsive wakefulness syndrome and minimally conscious state has been detected. This raises the issue of the adequacy of the consciousness' assessment in patients with disorders of consciousness. The behavioral assessment of consciousness could be not able to detect covert awareness, which is increasingly identified by the instrumental assessment. Ancillary methods. Neurotechnology, particularly neuroimaging, provides relevant data concerning the neurological underlying condition of patients with DOCs, but the instrumental approach has still to assess some technical issues. Ethical considerations. A correct diagnosis of a DOC is not only an instrumental issue, but also an ethically relevant demand to the scientific community. Finally, an integration between behavioral and instrumental assessments seems to be the most adequate strategy in order to decrease the rate of misdiagnosis.

The directive 2001/20/UE and the research involving patients with docs. Research involving patients with disorders of consciousness (DOCs) deserves special ethical and legal attention because of its Janus-faced nature. On the one hand, it raises concerns about the risk to expose the involved subjects to disproportionate risks not respecting their individual dignity, particularly their right to be cared for; on the other hand, research is an essential tool in order to improve the clinical condition of patients with DOCs. The present paper concerns the ethical and legal dimensions of biomedical research involving patients with disorders of consciousness. In particular, it focuses on informed consent to experimental treatments, which is a challenging issue both from an ethical and legal point of view. The first part reads the Directive 2001/20/EU in the light of the experimentation of patients with DOCs, and suggests a revision in order to better assess the issue of informed consent. The particular case of informed consent for observational studies of non-communicative patients. The second part presents an informed consent form for studies through video-recording of patients unable to communicate their own consent. This form has been elaborated by the bioethics unit of the project "Review of the nosography of vegetative states: application of methods of behavioral analysis to individuals in coma or vegetative state" developed at the Italian National Institute of Health. Relevance of the suggested form. The paper describes the conceptual framework of the form for informed consent to studies through video-recoding, which is a relevant example of what issues should be included in an informed consent for any type of studies through video-recording of patients unable to express their own consent. The article has been sent on November the 7th 2013, before the adoption of the Regulation (EU) no. 536/2014 (and consequent abrogation of the Directive 2001/20/EU) and the release of the new edition of the Italian Code of Medical Ethics.

Italy has recently introduced regulations that profoundly change the arrangement of ethics committees. Specifically, their numbers have been reduced from more than 200 to a few dozen.The decree defining the criteria for their composition and functioning includes regulations intended to improve efficiency and efficacy. The present article provides a brief overview of the new provisions and identifies some critical aspects.

The present commentary is based on the following considerations: 1) for the purposes of authorisation, a distinction is drawn between "research" and "intervention". The procedures for authorising the former are more complex, the relevant controls are stricter and approval has to be granted by a Research Ethics Committee (REC); 2) although the debate is still open, it is barely credible to claim that public health surveillance is not a form of research. It should, therefore, be subject to rigorous ethical assessment; 3) when addressing specifically the issue of surveillance, it would be appropriate to shift the focus of attention from the type of procedure (research/intervention) to the risk implied in that procedure; 4) much emphasis has hitherto been placed on the risks that public health surveillance may imply for the protection of personal data; 5) the emphasis on the protection of personal data is frequently excessive and the risks should be examined in a broader context.

INTRODUCTION: The medical aim of translational research is to smooth the transition of discoveries made through basic research from the laboratory bench to their diagnostic or therapeutic applications for patients. These applications may be extended to current clinical practice and to health policies. AIM: The converse is also important: health policies should provide a point of departure when identifying research priorities. Translational research poses the same ethical problems as trials with human subjects - albeit in different ways. One of the more significant problems is the risk for participants in trials: it is thus necessary to ensure that the risks to which these subjects are exposed are not out of proportion to the expected benefits. DISCUSSION: Translational research does not require new ethical principles, but existing biomedical principles need to be adjusted to the specific context. The well-being of participants should always be the primary objective; these persons should never be considered as means for the advancement of knowledge or for the improvement of applications.

Public health programmes pose some very important ethical problems. One of the most pressing is the possible conflict between individual interests (and rights) and collective interests, which becomes particularly important in the public health surveillance setting. The present article first looks at the definitions of "public health surveillance" in a historical context and then identifies the key ethical problems that are raised. These reveal the differences - and sometimes deviations - between the bioethical issues typically encountered in a clinical setting and those that prevail in a public health context. Human rights are suggested as a possible common ground between the two. The article then draws on the specialised literature to indicate tools and checklists to help evaluate the ethical acceptability of public health surveillance programmes. It concludes with a description of the key criteria underlying these tools and checklists.