Antonio Spagnolo

El presente articuLo pretende encuadrar y definir las implicaciones éticas reLativas a La aplicación biomédica de las nanotecnologías, a través de La vaLoración deL estado del arte.Las nanotecnologías, expresiÓn de La habilidad humana de manipuLar la materia a escala atómico/molecular se presentan como un instrumento capaz de modificar la investigaciÓn científica y la medicina de manera radicaL.Debates a todo nivel han subrayado las dificultades de darles una definición clara y unívoca, a causa de la convergencia de diversos ámbitos del saber comprendidos en ellas.No obstante que Las nanotecnoLogías estén ya presentes en las ciencias computacionaLes y en La eLectrÓnica, es en eL ámbito médico-sanitario que se proyectan Las aplicaciones más entusiastas: instrumentos de diagnóstico y suministración de fármacos menos invasivos y más eficaces. Estas tecnoLogías se presentan al mismo tiempo como terapias pero también como instrumentos de prevención únicos, Las mismas características que hacen peculiar eL empLeo de las nano tecnologías en medicina, sugieren también precauciones: por una parte la dimensión mínima de las nanopartículasfacilita su ingreso en el organismo humano, traspasando las defensas naturales del organismo, agilizando una distribuciÓn de los fármacos altamente precisa. Por otra parte, estas mismas características pueden revelarse dañinas para el organismo humano .Dado que se trata de tecnología en rápida progresiÓn cuyos adelantos no son fáciles de predecir. los riesgos, aunque sÓlo aquellos potenciales, deben ser cuidadosamente valorados ya sea para las aplicaciones presentes como para aquellas futuras.Por tanto, encuadrar las implicaciones bioéticas de las nanotecnologías significa comprender y valorar su impacto sobre la salud humana

Conscientious objection in the health care field—that is, refusal on the part of a medical professional to perform or cooperate in a procedure when it violates his or her conscience—is a growing concern for international legislators and a source of contentious debates among ethicists and the general public. Recognizing a general right to conscientious objection based on individual liberty, and thus a subjective right, could have negative consequences. Conscientious objection in health care settings should be fully protected, however, when the objection is based on principles that are fundamental to the medical profession and the legal system. Examples from Italy and other nations show how protections there safeguard conscientious objection when a health professional objects to taking a human life. National Catholic Bioethics Quarterly 12.4 (Winter 2012): 611–620.

The authors report the first Italian experience of a research ethics committee (REC) audit focused on the evaluation of the REC’s compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009–February 2011) divided into quarters to better value the influence of the new insurance coverage regulation that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC’s opinions and research studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of the research ethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place

ABSTRACT Nanotechnologies are an expression of the human ability to control and manipulate matter on a very small scale. Their use will enable an even and constant monitoring of human organisms, in a new and perhaps less invasive way. Debates at all levels – national, European and international – have pointed out the common difficulty of giving a complete, clear definition of nanotechnologies. This is primarily due to the variety of their components, to the fact that there is not just one technology but several. The most significant medical applications of nanotechnologies are in the diagnostic and the therapeutic fields, eg biosensors and molecular imaging, providing diagnosis and drug delivery with no invasive methods involved. Like any other emerging field, such technologies imply new possibilities for improving health but, on the other hand, they are still at an experimental stage and therefore should be implemented under rigorous safety testing before going on general release. For this purpose, the ethical, legal and social implications (ELSI) of nanotechnologies have been elaborated by study groups, in order to develop solutions before the results of the tests are diffused into medical practice. The aim of this paper is to define some of the ethical issues concerning biomedical applications and to evaluate whether there is a need for new or additional guidelines and regulations.

A Second level Master in “Clinical Bioethics Consultation” has been organized in Italy to offer an opportunity to offer an adequate training to carry out an ethics consultation in different health fields. The master has been promoted and realized by different institutions: Catholic University of Sacred Hearth in Rome, Insubria University in Varese, “Federico II” University in Naples, Lanza Foundation in Padua and the Local Health and Social Care Unit n.7 in Veneto Region. The aim of the master is train ethics consultants to offer help regarding a correct decision, which will take by others. The choice must be as much as possible shared between patient, family and health care team. Ethics consultation can be primarily request by the physicians, nurses and health care staff such as support about a choice that wants to be the most appropriate and to clarify a dilemma between different options. Secondly an ethics consultation can be demand by the patient and the family members to find a clarification about their dilemmas and future choices. Also the administrative staff could ask the consultation, when it need to better explain ad example about a specific clinical case or a question concerned the health policy.

This article addresses some critical aspects of the relationship between aesthetic medicine (AM) and ethics and proposes a possible deontological ethical line to pursue based on current practices. The role of AM has always been controversial and suffers from unclear practical and moral boundaries, even within academic settings, since it aims to improve the appearance of individuals, not to cure a disease. Today, it is essential and pertinent to discuss these issues, as AM specialists are dealing with a growing and increasingly demanding patient population that has undergone profound evolution in recent years. Current challenges within the field of AM include a lack of global uniformity concerning the education of AM specialists, an increasing number of physicians practicing AM with diverse training backgrounds, the spread of AM being practiced outside of medical practice or hospital settings, and the influence of social media where the success is modelled and dictated by the identification of a youthful appearance). By the field of action enriched by technologies that aim not only at enhancement per se but also at the preservation and regeneration of tissues, it is necessary to establish an active multidisciplinary discussion on the definition of shared ethical limits. This discussion would allow AM to fully reclaim its identity as a specialty that aims to improve patient well-being whilst maintaining respect for patient aesthetic harmony, the expertise of specialists who practice AM, the essential role of safety, and awareness of the importance of a confidential doctor−patient relationship.

El tema del fin de la vida está entre aquellos afrontados por la revista Medicina e Morale con mayor amplitud y profundización. Desde la fundación de la Revista hasta hoy se cuentan más de 70 publicaciones en la materia entre contribuciones científicas, editoriales y artículos colocados en la rúbrica El debate en Bioética. Las temáticas tratadas pueden ser de este modo clasificadas: muerte en general; eutanasia; muerte cerebral ; ensañamiento terapéutico; cuidados paliativos y asistencia al moribundo; rechazo actual de los tratamientos; estados vegetativos; declaraciones anticipadas de tratamiento ; testamento biológico. Diversas son las perspectivas de reflexión y la integración entre los diversos conocimientos que se descubren en la lectura de las numerosas contribuciones presentes en la revista. Las cuestiones del "fin de la vida" han sido afrontadas desde un punto de vista ético, pero también clínico y médico-legal, biojurídico, deontológico, antropológico-filosófico, con una mirada siempre atenta a las controversias que han suscitado el debate público en el curso de los años.The theme about the end of life is discussed fullness and with deep analysis by the review Medicina e Morale. Over 70 articles, editorial and paper about end of life are published form the review foundation. The themes discussed may be classified like that: death, euthanasia, brain death, aggressive therapy, palliative cares, treatment refusal, post coma unresponsiveness, advanced directives, living will. Reading several articles published on this review is possible to find various useful remarks and integration between different branch of learning. The issues about end of life are discussed ethical, clinical, legal, juridical, deontological, philosophical point of view, paying attention to public events

El artículo analiza cómo la revista Medicina e Morale ha afrontado en su historia el tema de la ética en la experimentación clínica, que representa una parte muy amplia y compleja de la bioética y también de la deontología médica. Los aspectos que esta temática comprende son ya numerosos y la literatura producida ingentísima. La ética de la experimentación ha recibido particular impulso y atención a continuación de diversas experimentaciones no éticas que han turbado profundamente la opinión pública y hecho necesario una fuerte reconsideración en el ámbito de la investigación clínica. En general, de los años 60's a los años 80's del siglo XX, ha prevalecido en la literatura un intenso empeño e interés en la elaboración de los principios de referencia y en la reflexión teórica relativa a varias cuestiones . De los años 90 en adelante se ha en cambio intensificado -probablemente por las exigencias nacidas en seno de los Comités de ética que precisamente en aquel período han iniciado a difundirse masivamentela elaboración de códigos, reglamentos, líneas-guía que han orientado el desarrollo de la disciplina más en sentido de procedimiento y con un acercamiento ético-deontológico. En particular, Medicina e Morale, ha estado siempre en estas temáticas, desde los inicios de su historia, constituyendo una voz original en el debate, además que un instrumento de difusión de documentos nacionales y sobre todo internacionales. La Revista ha representado, sobre todo en los últimos treinta años, un verdadero punto de referencia a nivel nacional y en algunos casos también internacional, proponiendo a veces orientaciones originales, que han sido luego acogidas en el ámbito de líneas-guía y de normativas.The article deals with how the journal Medicina e Morale has faced ethics in clinical trials, which represents a very large and complex bioethical issue, but also deontological one. This area comprises many questions and the literature is huge. It has risen after unethical clinical trials that have shocked the public and have produced a big rethinking about it. In general, from the '60s to the '80s of the XXth century, an intense commitment and interest have prevailed on the elaboration of the reference principies and on theoretical reflection on various issues, such as informed consent, the ethical significance of clinical research, the protection of vulnerable people, the risk acceptability). Since the '90s onwards the development of codes, regulations, guidelines -that have guided the development of the discipline in a procedural and also deontological sense- has increased, probably due to the large diffusion of ethics committees. Particularly, the journal "Medicina e Morale" has always been present on these issues, since the beginning of its history, creating an original voice in the debate, as well as a dissemination tool of national and especially international documentabon. The journal has been, especially in the last thirty years, a real national, and sometimes international, be nchmark, offering original suggestions which are then accepted in guidelines and regulations

Las biotecnologías son ciencias destinadas a incidir en manera profunda en la sociedad. El alcance de los cambios que a través de ellas será posible realizar es notable, pero sobre todo se aleja de las ciencias de ingeniería, de las alimentarias, de las médicas. La bioética está decididamente llamada a acoger el reto representado por las biotecnologías. La presente contribución parte precisamente de aquí: captar los aspectos característicos y peculiares de algunas de las posibles aplicaciones biotecnológicas para encuadrar la singularidad de las problemáticas bioéticas que de estas aplicaciones pueden derivar con el fin de leer tales contribuciones a la luz del valor al cual se refieren y por el cual están pensadas: la persona En lo específico, los autores se detienen en tres específicas aplicaciones biotecnológicas que representan sectores cuyas potencialidades preanuncian grandes promesas y, en ciertos aspectos, algunos retos verdaderamente cautivadores; en particular: los OGM, las nanotecnologías y la farmacogenética, temas en diversos modos considerados en la revista en el curso de los años.Biotechnologies, the use of living organisms or their products to modify human environment, are flourishing very rapidly. They cover many fields: from engineering science, to food, to medicine. Bioethics is therefore called to face the challenge given by biotechnologies. The present contribution takes advantage from this: it catches all the scientific peculiarities showed by these technologies and their application to outline the peculiarities of their ethical issues and to read them in the light of their end: the human persono In fact, thanks to them, it will be possible to realize many transformations within the society. In particular, the authors evaluate three main aspects of biotechnologies OGM, Nanotechnologies and pharmacogenetics, topics covered in the journal on several occasions over the years

El artículo pone en evidencia la dimensión ético-antropológica de la historia de la medicina. En el pasado podemos encontrar aquellos elementos de relevancia ética que están en estrecha continuidad con el presente. Desde los orígenes el médico ha experimentado el conflicto entre el mundo del deseo y el mundo del límite. El cuidado de los enfermos comienza desde ahí, de la consciencia de compartir el mismo deseo, el mismo límite, el mismo destino. El artículo mira la historia de la medicina como historia de la humanidad; dentro está toda la vida humana, según la definición del historiador Fielding Garrison . En esta perspectiva la dimensión ético-antropológica emerge sobre todo en las múltiples figuras de médicos ejemplares caracterizados por valores como el valor, la dedicación, la empatía, pero sobre todo por un gran sentido de humanidad y de solidaridad por sus enfermos. En fin, una lectura ético-social puede emerger del arte y de la literatura. Ellas son no sólo testimonio de una época sino también un sismógrafo de las dimensiones éticas de la medicina.This article highlights the ethical-anthropological level of the history of medicine. It explores the close connection between past and present regarding those elements of ethical relevance in medicine. Since the beginning, the physician experienced the conflict between hopes and limits. Medical care springs exactly from the awareness of sharing the same desire, the same limit, and the same destiny. This article regards the history of medicine as history of mankind; according to the historian Fielding Garrison, the history of medicine embodies the entire human life . In this perspective, the ethical-anthropological dimension emerges particularly in many exemplary figures of physicians, distinguished for courage, commitment, empathy, humanity and solidarity towards their patients. Finally, arts and literature can be regarded as instruments to get a cultural perspective, as well as guidelines for social and ethical key of interpretation. They are not only historical documents, but also a seismograph, registering the fundamental historical dimension of medicine