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Abstract Background Spread worldwide through droplets, the Virus Sars-Cov-19 has caused a global health emergency alarm. In order to limit its spread, the use of masks has become part of the daily life of the entire population, however, little is known about its constant use and the changes generated in the oral cavity. This work aims to investigate correlations between the continuous use of masks covering the nose and mouth for 3 h and changes in the ecological factors of the oral cavity. Methods 34 volunteers were divided into 2 groups: wear only the filtering facepiece code 2 (FFP2) mask (Group A) and wear the FFP2 mask covered by a surgical mask (Group B). Measurement of Volatile Organic Compounds (VOCs), saliva rehydration and consistency test, collection of basal saliva and saliva stimulated with paraffin gum and mucosal swab were collected and analyzed at two times: before using the mask(s) (T0) and 3 h after continuous use of the mask(s) (T1). Results The results indicated a significant difference between the groups, in which the basal saliva volume and pH and the peaks of VOCs increased for group B between T0 and T1. The rehydration time decreased and the volume and pH of the stimulated saliva increased, but with no significant difference between the groups. Furthermore, group B showed a significant decrease in Candida albicans Colony Forming Units (CFUs) and Total Bacterial Count (TBC) between T0 and T1. Conclusion It is concluded that the prolonged use of the FFP2 mask covered by a surgical mask can generate oral alterations in the user.

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Decentralized clinical trials (DCTs) are studies in which the need for patients to physically access hospital-based trial sites is reduced or eliminated. The CoViD-19 pandemic has caused a significant increase in DCT: a survey shows that 76% of pharmaceutical companies, device manufacturers, and Contract Research Organizations adopted decentralized techniques during the early phase of the pandemic. The implementation of DCTs relies on the use of digital tools such as e-consent, apps, wearable devices, Electronic Patient-Reported Outcomes (ePRO), telemedicine, as well as on moving trial activities to the patient's home (e.g., drug delivery) or to local healthcare settings (i.e., community-based diagnosis and care facilities). DCTs adapt to patients' routines, allow patients to participate regardless of where they live by removing logistical barriers, offer better access to the study and the investigational product, and permit the inclusion of more diverse and more representative populations. The feasibility and quality of DCTs depends on several requirements including dedicated infrastructures and staff, an adequate regulatory framework, and partnerships between research sites, patients and sponsors. The evaluation of Ethics Committees (ECs) is crucial to the process of innovating and digitalizing clinical trials: adequate assessment tools and a suitable regulatory framework are needed for evaluation by ECs. DCTs also raise issues, many of which are of considerable ethical significance. These include the implications for the relationship between patients and healthcare staff, for the social dimension of the patient, for data integrity (at the source, during transmission, in the analysis phase), for personal data protection, and for the possible risks to health and safety. Despite their considerable growth, DCTs have only received little attention from bioethicists. This paper offers a review on some ethical implications and requirements of DCTs in order to encourage further ethical reflection on this rapidly emerging field.

ABSTRACT Vulnerability during the coronavirus disease 2019 (COVID-19) pandemic is an emotional state that affects all of us globally. The Italian experience shows that our general practitioners (GPs) seem to have a higher rate of death due to COVID-19 infection than other physicians. This article discusses clinical ethics questions related to the vulnerability of GPs and the community during the pandemic in Italy: the total lack of, or the inadequate protection of personal protective equipment, the increased use of virtual medicine, and the value of a solid synergy between hospitals and territorial systems. We provide a few examples of experiences in other affected countries and populations (Indigenous communities in Brazil, Australia and Germany). In conclusion, we offer some reflections on the crucial role of communication in dealing with vulnerability issues during this COVID-19 pandemic period.

Roberta Monzani,1 Giovanna Barbera,2 Umberto Restelli,3,4 Carlotta Galeone,5 Flavia Petrini6 1Day Hospital Chirurgico, IRCCS Humanitas Research Hospital Rozzano, Rozzano, Italy; 2Independent researcher, Milan, Italy; 3Centre for Health Economics, Social and Health Care Management Carlo Cattaneo University, Castellanza, Italy; 4School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 5Bicocca Applied Statistics Center (B-ASC), Università degli Studi di Milano-Bicocca, Milan, Italy; 6Anestesia, Rianimazione e Terapia Intensiva, Università Gabriele d’Annunzio — ASL 2 Abruzzo, Chieti, ItalyCorrespondence: Carlotta GaleoneBicocca Applied Statistics Center (B-ASC), Università degli Studi di Milano-Bicocca, 8 Via Bicocca Degli Arcimboldi, Milan 20126, ItalyTel +39 02 6448 5823Email carlotta.galeone@gmail.comIntroduction: Hypothermia is a well-known risk of the perioperative period and considered a preventable effect of anesthesia care. Nevertheless, it is not fully controlled, causing a number of adverse outcomes following surgical operations and thus increasing length of stay in hospital and treatment costs. The aim of this study was to assess the budget impact (BI) of the implementation of proactive strategies to prevent inadvertent perioperative hypothermia (IPH) in surgical patients in Italy, as recommended by international guidelines and by a good clinical practice (GCP) guideline of the Italian Society of Anesthesia, Analgesia, Reanimation, and Intensive Care.Methods: BI was calculated over a 3-year period from the perspective of the Italian National Health Service (NHS). Model inputs were extracted from national literature when available and otherwise from international sources. The reference analytic model was based on the cost-effectiveness analysis of the National Institute for Health and Care Excellence clinical guidance 65. Estimates were based on assessments made about current malpractice in Italy and on a hypothesis of how future practice might change by implementing the GCP. Model output included overall BI results, variations in the number of warmed patients, medical-device average costs and use of mix.Results: The base-case estimate quantified a decrease of 35% in extra days of hospital stay due to IPH and a net BI of –€ 60.92 million.Conclusion: Increasing protocol adoption for preventing IPH would lead to both clinical advantages and significant savings for the NHS. Its large diffusion in Italian hospitals is thus desirable.Keywords: budget-impact analysis, active-warming systems, inadvertent perioperative hypothermia, Italy, perioperative warming

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.

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.

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.

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.

Numerous documents (declarations, codes, recommendations, guidelines) issued by eminent institutions recommend that the donation of blood should be voluntary and unremunerated. This does not preclude the possibility: 1) that donors receive some form of reimbursement; 2) that subsequent procedures, which inevitably incur costs, may involve considerable financial activity; 3) that legislation in some nations may allow trade in certain types of human biological material; 4) that voluntarily donated human blood be used to derive products that are subsequently marketed. The present article highlights some of the contradictions generated by these considerations and affirms that they do not undermine the primary duty to uphold the voluntary nature of donation.

This article examines some of the ethical issues associated with the use of physical restraint in psychiatry and neurology. It offers no specific answers to individual operational problems, but a methodological matrix is proposed as an aid to experts in the various settings in which decisions are taken. The subject is addressed mainly by considering two sources: reference documents published by eminent organisations, and the theoretical framework of ethical values (or principles). A number of analytical criteria arising from these sources are then identified and proposed. The proposed criteria can be applied in cases for which the legitimate use of restraint may be an option, bearing in mind that restraint is an extremely serious affront to human dignity and is widely held to be of no therapeutic value. Its abuse is illegitimate in both ethical and legal terms.

Surgical techniques are not introduced into clinical practice as the result of randomised clinical trials (RCT), but usually through the gradual evolution of existing techniques or, more rarely, through audacious departures from the norm that are decided by a surgical team on the basis of experience. Sham surgery is held by some to be not only an ethically acceptable procedure but also a perfectly fit and proper one, as it could endow surgical experiments with the strict methodological and statistical precision typically associated with RCTs. This article first briefly examines some of the methodological aspects of both RCTs and surgical experiments and then offers a few considerations regarding the ethical issues raised by sham surgery.

The "public health" perspective is different from the "patient-centred" clinical perspective for various reasons. Tensions between collective and individual interests are unavoidable in public health. Intersections between public health ethics and clinical bioethics can be traced to a set of duties which derive from respect of the person. Human rights and solidarity are "personcentred" cornerstones of both clinical and public health ethics.

This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

It can be very difficult to communicate with people with dementia. Each case requires its own unique handling. Not every scenario is covered, as many times your own judgment is what will work, best according to the circumstances. These can change from dawn to evening and from day to day. Never assume things will be the way they were the last time you communicated. Be on your guard. Be adaptable. The article will help get you started to think of your own ways to communicate.

Videorecording of patients requires the utmost respect for the privacy and confidentiality of the patients. Consent should be requested from patients for all videorecording. When a mental disability or mental or physical illness prevents patients from giving their permission, agreement to recording from a legal representative or from a close relative or carer are necessary. Three documents on this subject issued in the United Kingdom, the United State of America and Italy are briefly summarized and discussed. The problem of consent for videorecording is addressed particularly in reference to persons incapable of making decisions on their own, such as persons in vegetative state. The general ethical framework is outlined and a few practical proposals are given.

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.

The problem of experimentation involving subjects whose mental condition prevents them from understanding information and providing proper informed consent has been addressed in various codes, declarations, conventions, treaties and regulations adopted by national, international and supranational institutions and authorities. This article summarizes the basic ethical criteria these documents provide and stresses the historical development from the nearly total exclusion of incapacitated subjects, established in the mid-twentieth century, to their contemporary inclusion in clinical trials on certain ethical conditions. The problem of proxy consent by legal representatives for participation in clinical trials is addressed particularly in reference to current Italian regulations. Exceptions to human experimentation requirements in emergency situations are also briefly discussed.

In public health ethics, as in bioethics, utilitarian approaches usually prevail, followed by Kantian and communitarian foundations. If one considers the nature and core functions of public health, which are focused on a population perspective, utilitarianism seems still more applicable to public health ethics. Nevertheless, faulting additional protections towards the human person, utilitarianism doesn't offer appropriate solutions when conflicts among values do arise. Further criteria must be applied to protect the fundamental principles of respect for human life. Personalism offers similar advantages to utilitarianism but warrants more protection to the human person. We suggest a possible adaptation of personalism in the specific field of public health by means of four principles: absolute respect for life or principle of inviolability; subsidiarity and the "minimum" mandatory principle; solidarity; justice and non discrimination.

First we give an overview of the historical development of public health. Then we present some public-health deontology codes and some ethical principles. We highlight difficulties in defining ethics for public health, with specific reference to three of them that concern: (i) the adaptability to public health of the classical principles of bioethics; (ii) the duty to respect and safeguard the individual while acting within the community perspective that is typical of public health; and (iii) the application-oriented nature of public health and the general lack of attention towards the ethical implications of collective interventions (compared with research). We then mention some proposals drafted from North American bioethics "principles" and utilitarian, liberal and communitarian views. Drawing from other approaches, personalism is outlined as being the theory that offers a consistent set of values and alternative principles that are relevant for public health.

Este estudo transversal investigou condições de trabalho e a morbidade dos profissionais de saúde da atenção básica em Pelotas, através de informações sociodemográficas, comportamentais, da atividade e ambiente de trabalho e de morbidade. Foram estudados 329 profissionais em 39 serviços. A grande maioria era do sexo feminino (80%) e a média de idade era de 41 anos (±9,2 anos). Quase 30% dos profissionais pertenciam às classes C e D. O hábito de fumar foi referido por 19% dos indivíduos da amostra e 61% não praticaram nenhuma atividade física regular no mês anterior à entrevista. Cerca de metade dos entrevistados tinha outro emprego (51%) e 25% precisaram faltar ao trabalho no último mês, principalmente por problemas pessoais de saúde (59%) e problemas familiares (22%). Em média, os trabalhadores atendiam cerca de 30 pessoas por dia em uma jornada semanal de 40 horas. Problemas de saúde foram referidos por 40% dos entrevistados, com destaque para problemas do aparelho circulatório (27%) e osteomusculares (18%). Independente de ter problema de saúde, 67% dos entrevistados faziam uso de medicamentos regularmente e 47% referiram este uso nos últimos 15 dias. Um quarto costumava automedicar-se, significativamente em maior proporção entre médicos e outros profissionais de nível superior, entre os trabalhadores de maior nível socioeconômico e entre aqueles com mais de um emprego.This cross-sectional study investigated working conditions and the morbidity of basic healthcare professionals in Pelotas using data on sociodemographics, behavior, activities and working environment, as well as morbidity. 329 professionals from 39 healthcare services were studied. The vast majority of these were women (80%) and the average age was 41 (±9.2 years). Almost 30% of these professionals came from the C and D social strata; 19% were smokers and 61% had not done any regular physical exercise during the one month prior to being interviewed. Almost half of the interviewees had another job (51%) and 25% needed to miss work over the past month mainly due to personal health problems (59%) and to family problems (22%). On average, workers saw nearly 30 people per day in a 40-hour working week. Health problems were reported by 40% of the interviewees, 27% concerning circulation, and 18% concerning osteomuscular difficulties. Apart from having health problems, 67% of the interviewees used medicines on a regular basis and 47% had used medicines in the past 15 days. A quarter were accustomed to self-medicating themselves, with a significantly greater proportion among doctors and other professionals of a higher level, among workers of greater socioeconomic status and among those with more than one job.

Background: Western Connecticut Health Network created the Lyme Disease Registry in response to the community’s request and clinical need for more Lyme disease research. The registry includes acute, recovered, and persistently symptomatic patients to better define the different stages of the disease. The design of the registry was guided by community and clinician input through a community-based participatory research process. Methods: Registry participants are asked questions regarding their diagnosis, symptoms, treatments, recovery, and satisfaction with the Registry. A blood specimen is also collected and stored at the initial appointment. Results: The Lyme Disease Registry has enrolled 256 participants, 24% are acute cases, 45% are persistently symptomatic cases, and 31% are recovered cases. The symptoms experienced by the group of patients with persistent symptoms had unexpectedly strong overlap with those experienced by acutely infected patients. Conclusion: The difference between symptoms in the acutely infected patients and those experiencing persistent symptoms is not as large as initially thought.

Biological samples collected in biobanks are a resource with significant research potential. The Italian Joint Group cNB - cNBBSV (National committee of Bioethics - National committee for Biosecurity, Biotechnologies and Life Sciences) published a document reporting recommendations on storage and use of dried blood spot (DBS) and on the development of a National Network of Regional Newborn Screening Repositories for collection of residual DBS. Several ethical questions (about consent, possible use of genetic information, unanticipated possible usages for research purposes) rise from residual newborn screening specimens collections. Moreover, legal and ethical controversies are accentuated by the conflicts between the interests of sample donors, biobank holders, researchers and the public. To overcome these difficulties the identification of a few criteria for storage and research usage of DBS is crucial.

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 different approaches of two nations to the issues surrounding informed consent by persons with no or limited capacity of understanding are compared. It is important that efforts to ensure formal compliance with consent procedures should not be allowed to distract attention from the risks of harm to individuals.

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.

The Healthy Growth Charter is an educational and health-promoting project aimed at an active involvement of the primary school children in health surveillance and protection. Being duly acquainted of the matter, scholars are asked to fill by their own a questionnaire on height, weight, sport attendance and other items of medical and demographic interest. According to the project, problems suitable of corrective measures, such as amblyopia, are signalled to the families and dealt individually. The project has been previously tested on about 1500 boys and girls from various Italian regions, showing that, despite the limits of self-reported data, it provides information in line with literature. Health inequalities in children remain an important problem also in Italy, and a second test of the Healthy Growth Charter was launched in a group of socially disadvantaged children. As reported in this paper, overweight, reduced physical activity, visual problems and other items markedly differed in this with respect to the previous study. These results provide some indication on the potential role of social disadvantage and poverty on health status of children. To better tackle the problem of health inequalities, the actual surveillance systems should be empowered, preferably with an active educational involvement of children, translating the information into public health intervention policies.