\r\n\tIt is a relatively simple process and a standard tool in any industry. Because of the versatility of the titration techniques, nearly all aspects of society depend on various forms of titration to analyze key chemical compounds.
\r\n\tThe aims of this book is to provide the reader with an up-to-date coverage of experimental and theoretical aspects related to titration techniques used in environmental, pharmaceutical, biomedical and food sciences.
Occupational medicine emerged in England in the first half of the nineteenth century during the Industrial Revolution. With the frequent number of illnesses and deaths in the workplace, occupational medicine emerges as a form of intervention and minimizing the damage caused by occupational diseases. A classic case is that of Robert Dernham, owner of a textile industry, who sought out Doctor Robert Baker to find out how he could minimize cases of illness and death in the workplace. Baker told Dernham to invite a doctor to periodically visit the workplace to find out what could be done preventively to reduce cases of illness and death [1].
\nIt did not take long for occupational medical services to emerge in various industries. The expansion of medical services in industrial rather than solve or minimize the problems of disease and death in the workplace, enabled a level of dependency of workers and their families of medical services. With the inefficiency of public health services, especially in peripheral countries, medical services in industrial companies have become an important factor for the dependence of the worker in relation to the industry [2].
\nThe concern to provide medical services to workers also becomes a concern of the International Labor Organization (ILO). In 1953, the ILO creates a document that generates guidelines on the “protection of workers’ health.” In 1954, the ILO convened a group of experts to create general guidelines on “Occupational Medical Services,” which in 1958 was replaced by “Occupational Health Services”. In the ILO document, the Occupational Health Services must: (a) ensure the protection of workers against all risks that harm their health and that may result from their work and the conditions in which it is carried out; (b) to contribute to the physical and mental adaptation of the worker, in particular by the suitability of the work and its placement in workplaces corresponding to their skills; and (c) contribute to the establishment and maintenance of the highest possible level of physical and mental well-being of workers [3].
\nDuring and after the Second World War, many industries suffered from cases of illness, but mainly from deaths in the workplace. The tension produced by the war significantly increased the number of deaths in industries, where the actions of doctors alone limited the containment of deaths and illnesses. It is in this context that occupational health appears, mainly in large industries, through a multidisciplinary team that comprised doctors, nurses, psychologists, sociologists, engineers and nutritionists. With this, the emphasis on occupational health becomes hygiene and the work environment [4].
\nIt did not take long for the occupational health movement to undergo a series of changes and influences. Despite the multidisciplinary perspective, the participation of workers in the occupational health movement was still peripheral. As a result, in the 1960s, a series of demonstrations took place, mainly in developed countries, for greater participation by workers in actions on health and safety at work [5]. From that time on, legislation on health and safety at work began to emerge, as occurred with Italy in 1970 with the enactment of the Law known as the “Workers’ Statute.” This law required, among many other actions, the participation of workers in the surveillance of health and safety at work actions and also the independent inspection actions of the industry [6]. Many developed countries, such as England, Sweden, France and Norway, for example, had their Labor Laws enacted and in all of them there were rights and guarantees of health and safety at work.
\nOccupational health and safety appear as elements not only of occupational health, but as effective actions to control and maintain work processes. In addition to the legal aspects, health and safety at work become normative. Prescriptive work becomes central to industries, as they aim to reduce the indicators of accidents and diseases in the workplace. Prescriptive work integrates two fundamental components: working conditions (physical environment and socioeconomic conditions) and prescriptions (norms, procedures and rules). But prescriptive work is far from real work. What is prescribed is not what actually happens. For this reason, even with the spread of health and safety standards at work, accidents, illnesses and deaths caused by work are still occurring and increasing in recent years [7].
\nAccording to data from the International Labor Organization (ILO) more than 2.7 million people die from occupational accidents. There are over 370 million people who suffer non-fatal accidents and are on leave for 4 days or more from work. Accidents at work generate an economic cost of about 4% of the Global Gross Domestic Product per year. These data show that advances in health and safety at work policies and actions have not had a positive impact on the work environment [8]. At this point, it is necessary to discuss the political dimension of this process and make evident the inequalities in relation to health and safety at work. As the ILO report itself shows, the countries that suffer most from deaths, accidents and illnesses at work are the poor countries. And it is not only due to an unfavorable economic condition, as many of these countries have rapidly industrialized, receiving many international industries, which seek low social and environmental regulations [9]. But it is the question of the value of human life [10].
\nWho deserves to live and who can die. Where regulations must be met and where those regulations must not be met. In view of these inequalities in relation to actions on health and safety at work, subsequent theoretical discussions take place. And an important aspect in this path will be the discussions about biopolitics and biopower carried out by Michel Foucault and Giorgio Agamben, which show this political process and power over life, generating different values about human lives. Thus, the general objective of this chapter is to reflect on health and safety at work from biopolitics and biopower, showing that there is an evident contribution to the discussions on International Health Security. Therefore, initially it will be important to present some methodological explanations. Then, the theoretical discussions on health and safety at work. Soon after, to present the ideas of biopolitics and biopower in Michel Foucault and Giorgio Agamben, highlighting the central aspects of health and safety at work practices. Finally, some final considerations.
\nThis text is characterized by a bibliographic essay [11], written from a bibliographic survey on the topic of Health and Safety at Work. The focus of this text was to understand Health and Safety at Work as an important perspective for International Health Security. As a result, papers were selected that discussed, at the international level, health and safety at work, bringing a history of the development of health and safety within organizations. In this history, actions in health and safety at work were taken into account since the emergence of the industrial system, as well as the nomenclatures on health and safety at work and the linear periods of time in which actions were developed. Although only one paper was cited in each period, the bibliographic survey made it possible to validate the information among the papers cited in the text.
\nSubsequent to this linear path on the evolution of health and safety practices at work in organizations, the second part was developed through a reading of health and safety at work based on the concepts of biopolitics and biopower by Michel Foucault and Giorgio Agamben. In this part, a survey was made on the texts of Foucault and Agamben that deal with the concepts of biopolitics and biopower, relating them to the discussions on Health and Safety at Work. The intention was to show that the rapid development of Health and Safety at Work and that it made an important contribution to International Health Security were linked to changes in the policy of capitalist countries. Biopolitics and biopower are the basis of International Health Security and are reflected in actions on Health and Safety at Work.
\nIn this part, the various actions on health and safety at work, nor the various safety and ergonomic standards created for the work environment will not be explored. The intention will be to conduct a comprehensive discussion on the topic with a view to understanding the intricacies of health and safety at work actions. Thus, some actions on health and safety at work will be presented but with the intention only of understanding its intricacies. The focus will be the description and not the prescription that is established in health and safety at work.
\nOccupational health and safety are terms linked to occupational health and have expanded the way illnesses and accidents are understood in the work environment [12]. Work-related risks are no longer seen only from a physical and chemical perspective and have included biological, ergonomic and psychosocial perspectives [13]. In addition, illnesses are no longer seen only as occupational illnesses that were generated by the work environment and started to include work-related disease and illnesses aggravated by work [14]. These expansions in the way of understanding diseases and accidents accompanied changes in the forms of production and management of industries and organizations [15]. From the industry managed in the Taylorism-Fordist model to flexible production (Toyotas’ model), the risks related to work have changed [16].
\nIt was for this reason that the risks of accidents, deaths and illnesses in the work environment started to be quantified and qualified based on technical and management attributes. The strategies to contain risks involved diagnoses of work and organizational environments (risk assessment) that generated strategies to mitigate and contain these risks [17]. Quantitative methods are used, to a large extent, for hygiene actions at work. And qualitative methods for actions in safety at work. Despite the human benefits existing in the various actions in health and safety at work, the focus is still on technical attributes and not human attributes. This focus generates a gap between prescribed work and real work, precisely because human beings tend to adapt work to their conditions of execution [18].
\nThis gap between prescribed work and real work is also reflected in the technical attributes related to the management of health and safety at work. The containment of a risk can generate new risks, as there is a complexity in the working conditions and in the activities developed. For example, the use of personal protective equipment may generate some type of allergy in the worker, precisely because the technical attribute of mitigating a specific risk was thought of, but not in adapting the material to the human organism. In addition, what could be called the minimum acceptable level of risk at work may not trigger a problem in the short term, but be responsible for illnesses, accidents or deaths in the long term. For example, exposure to a certain chemical element may not be harmful in sporadic exposures, but it is a dangerous element precisely because it is accumulated in the human organism. Actions in health and safety at work invalidate the individual aspects of workers, always taking into account aspects related to the majority. The human being continues to be adapted to the work environment and not the other way around. For this reason, health and safety at work actions tend to focus on physical, chemical, biological and ergonomic risks and very little on psychosocial risks. This is because these psychosocial risks are linked to individual attributes, which do not concentrate most cases [19].
\nWith this, it is not only the gap between prescribed work and real work that highlights the problems generated in health and safety at work, but also the problems of unequal treatment of these actions. This does not minimize the importance and existence of actions in health and safety at work but leads to some reflections that are equally important. If accidents, deaths and work-related illnesses continue to happen, then there is something unsaid about the rules and practices aimed at health and safety at work. There is a level of non-compliance with these prescribed actions, which escapes reflections on the number of accidents, deaths and illnesses in the workplace. These inequalities and this level of non-compliance are linked to a broader factor, which is the life of individuals. One might think that the central concern is with life, but there are other factors linked to work in industries and organizations that better explain investments in health and safety at work, as well as inequalities in the actions carried out [20].
\nInvestments in health and safety at work aim to reduce or minimize the costs of accidents, deaths and illnesses generated in the work environment. For this reason, the focus has always been on those risks generated in the work environment, marginalizing work-related disease and illnesses aggravated by work. Like many actions in health and safety at work, they show a minimum level of tolerance to physical, chemical, biological, ergonomic and psychosocial risks, since the total elimination of risk is somewhat illusory [21]. But what is central to this discussion is the value on the lives of these individuals. What hierarchical level are they in the industry or organization, what kind of risks are they exposed to, whether the role in the industry or organization is essential or not, whether the costs generated by accidents, illnesses and deaths are high or not and if following the rules is more advantageous or if working illegally is more favorable (not for the individual but for the industry or organization) [22]. It is this analysis related to inequality in actions on health and safety at work that the next part of this chapter will address. Both Foucault and Agamben reflect on the political level of life, which is a central element in health and safety at work.
\nThe political conception of life is not something that arises in today’s society. At the time of the Principalities, this political conception of life was constituted from death. The sovereign had the right to dispose of the life of his subjects. Of course, it was not an unlimited right, since this right was constituted from the actions of subjects who transgressed the rules or generated dishonor to kings or princes [23]. In these circumstances, the sovereign’s right was to make people die and let them live. This right was derived from the ancient “pátria potesta,” where the Roman father of the family had the right to dispose of the lives of his wife, children and slaves, since he had given them. Despite the strength that the sovereign’s right had in relation to his subjects, the Reigns and Principalities were disappearing during the history of civilizations. This allowed for the emergence of another form of policy on life, much more linked to the promotion and care of life than to its finitude and ability to make people die [24].
\nIn the mid-seventeenth century, wide-ranging discussions on the role of the modern state began to emerge. The focus becomes the various investments that could be made to attract and retain individuals in their territories. The actions at the State level were to promote life, through extensive investments in public health, in improving the quality of life and in improving the economic and social condition. Concerns within the states were focused on basic sanitation, urban cleaning, urban infrastructure and health care. In the midst of the emergence of public health, the use of statistics was of central importance [25].
\nIt was possible to assess, based on statistical data, for example, the number of births, the number of deaths, the most common diseases and the migration of people in regions or states. Statistics were so important that even today they are used to generate a level of normalization on diseases, accidents and deaths, not only in society as a whole, but also in industries and organizations. Statistics made it possible to create strategies and actions to contain problems related to the health and safety of the population. The central role of the modern state will be to make people live and let them die, which is the reverse of the sovereign’s power [26].
\nPolitical actions on the life of the population can demonstrate a level of humanity and care toward individuals. But the exact opposite is starting to happen. Actions at the State level move quickly away from normalization processes on health conditions, birth and mortality rates, infection and contamination flows for body discipline. This discipline of the glass was important to generate the strength of the industrial system, since the entire production system depended on the labor of the workers [27]. The transformation of docile and useful bodies also involved caring for life. In its eagerness to care for, protect and manage the population’s living conditions, the State ends up intensifying the processes of violence. This is because the recognition of what could be called the good life is directly linked to the bad life. It is this inequality that projects the existence of the best living conditions, as the worst living conditions must also be recognized [28].
\nIt is this inequality, this social hierarchy, that will function in government over life. The basis for this inequality will be established, during the nineteenth century, on the theory of biology, particularly on Darwinism. It is from the hierarchy of species, from the struggle for life between species, from the selection that eliminates the least able that a hierarchy over the population is also constituted. That same base that, within the State, was able to institute racism and war [29].
\nHierarchical relations within the population and the justifications for genocide in war are at the basis of social Darwinism. It is this inequality that will produce the “making a living,” the one considered most apt and who are at the top of the social hierarchy, and the “letting die” for the least able and who are at the bottom of the social hierarchy [30]. The concern with those at the bottom of the social hierarchy occurs only when the costs of “letting it die” are higher and have a direct impact on the industrial system [31]. When the profit is diminished by accidents, deaths and illnesses generated in the work environment, then the actions of “letting live” and not “making it live” are exercised.
\nThat is why the normalization process is important in health and safety at work, because despite generating docile bodies and adapted to the production system, they still generate a way of “letting live.” For this reason, too, the prescribed work is distant from real work, as the central concern is not to “make life” for those at the bottom of the social hierarchy, but to establish guidelines that minimize the negative impacts on the industrial system. Accidents, deaths and diseases generate costs for the industrial system and also for the State [32]. Production interruptions, the departure of specialized individuals, sick leave and the hiring of other workers generate large expenses for the industrial system. As well as generating expenses for the State with public health, with disability pensions and with the expansion of hospital systems. All these expenses and costs that burden the capitalist system induce the condition of the prescribed work, in an attempt to establish the discipline of the body, but it remains averse to the human condition [31].
\nIn the midst of this discussion there are differences in life. The Greek term for life as a “naked life” is Zoé, which expresses the condition of being alive. The Greek term for “qualified life” is Bíos, which expresses the political condition of life. Modernity is based on “Zoé” life. It is this politically conceived life that populations are limited [33]. It is on this political conception that it is allowed to kill, maim and fall ill without being guilty of murder, crime or torture. It is this biopolitics that allows us to look at the number of accidents, mutilations or illnesses in the world without blaming the capitalist system or entrepreneurs for this daily genocide. The normalization and standardization processes except the responsibilities for those events considered to be exceptional or pathological [10]. The prescribed work generates a level of non-responsibility and an attempt to adapt human beings to work processes and not the other way around. In other words, work processes and work organization are not altered to better adapt to human factors [34].
\nThe intensification of the processes of biopolitics and biopower, which are exercised over the population, made Zoé and Bíos take a different form from that constituted by the Greeks. Biopolitics appropriated Zoé and introduced it to the political condition. This naked and vital life was consumed by political bodies, which started to manage, organize and normalize it. Modernly, Bíos was marginalized, preventing individuals from having dominion over their own living conditions. As a result, the derivations of Bíos were marginalized in today’s society: bíos theórétikos (contemplative life), bíos apolaustikós (life of pleasure) and bíos politikos (political life) [35].
\nZoé was just a manifestation of the lives of individuals and never entered the political realm. The Greeks had the ability to separate oikos (domestic sphere) and polis (political sphere). Zoé belonged to the domestic sphere and was never within the political condition. Bíos, on the other hand, belonged to the political sphere and led the Greek subject to an active life. Bíos allowed the Greek subject to participate in the actions and decisions of the polís. It made the Greek subject capable of political struggles, the pursuit of pleasures and the choice of a contemplative life. When modernity is understood, it is exactly that active life that has been lost [36].
\nThe modern subject has long lost the ability to control his life (Zoé). Now it is the capitalist system, norms of health and safety at work and management in organizations that determine how it should live and act, how it should be and how it must comply. It is this process of mortification of the human being that has been instituted in modern society [37].
\nBut the question that remains is: would an adaptation of work processes to human conditions not have a positive impact on the capitalist system, generating greater profits and lower social costs? Maybe the answer would be “yes,” but as the good living condition is only verified on the bad living condition, then the best strategy is to maintain this inequality, no longer as a “make you die” condition, as it generates costs to the system, but with conditions to “let live.”
\nIt is visible that the discussions on occupational health and also on health and safety at work have advanced a lot in recent years. Everything that has been done to minimize the negative impacts of the industrial system on society is commendable. Much remains to be done, as the rates of accidents, deaths and illnesses related to work remain high. Here, the contradiction between investments in occupational health and the number of accidents, deaths and illnesses at work is already evident, which makes it evident that something is not correct.
\nAgain, it is necessary to repeat that this chapter is not against actions of health and safety at work, but the reflections instituted here aim to shed light on the problem, with the hope that all human life is treated as Bíos (qualified life) and as Zoé (naked life), so that you have respect and responsibility for all lives. The reflections developed here aim to make it clear that in addition to being naked, it is hierarchical and generates uneven living conditions. Only by shedding light on these findings can we fight the processes that maintain these conditions of hierarchy and inequality.
\nLife starts to be managed, controlled, and normalized, but not for the sole and exclusive good of the subject, but for the good of the capitalist system. Perhaps if accidents, deaths, and illnesses at work did not generate costs for the capitalist system, the right to health and safety at work would follow social inequalities. As these accidents, deaths and illnesses cause costs for the capitalist system and for the States, then investment becomes necessary. Here the standardization processes come in to safeguard the lives of workers, but what results is the negligence of the system in cases of accident and death.
\nThere is a risk of killing and maiming, without legal and social penalties for these deaths and mutilations. The work environments also follow this logic, as the level of unhealthy and dangerous on the factory floor is much higher than in the office. Control over ergonomic, chemical, physical, and biological aspects is much greater in the office than on the factory floor. Although the actions in health and safety at work are, for the most part, focused on the factory floor, perhaps due to the greatest risks, they are still exercised from top to bottom, without the knowledge of the real work performed. This creates a gap between the norm and real work, which sets the precedent for accidents, deaths, and illnesses to continue happening and existing.
\nFor this reason, reflect on biopolitics or this qualified life or the processes of social inequality that one can have health and safety at work actions really concerned with human lives. This will generate more effective contributions to International Health Security. Life needs to stop being politically appropriate. Life needs to return to being just a condition of the subject’s existence. It is necessary to have respect and responsibility toward individuals in a society. Only in this way can one think about how to adapt work processes and work organization to the human conditions of the worker. As long as these inequalities and hierarchies are not recognized, the prescribed work will have a central role, since it excepts responsibilities, leaving real work at the mercy of its conditions of production and the fate of destiny.
\nBiomedical ethics has made giant strides over the past decades and has come to be recognised as integral to medical education. This has encouraged the growing inclusion of the teaching of medical ethics, together with that of the human sciences, in the syllabi of medical and nursing schools. In the 1980s, increased awareness of ethical issues shone a light on some excesses of medical research and medical paternalism which conflicted with ethical principles. The 1990s saw the establishment of the first medical ethics committees in hospitals, overseeing both research and clinical practice. Since the 2000s, the various bodies regulating the doctors’ right to practice have issued regulations, guidelines and recommendations laying down formal ethical rules for medical practice, together with a system of penalties for infringement of these rules.
Many social and cultural factors have contributed to the increase in ethical concerns. The increase in individual civil liberties, codified in various Charters of Citizens’ Rights, has fuelled a growing drive to claim new rights in previously unexplored areas. The development of biomedical technologies has created new frontiers, such as the attempt to shape one’s own medical fate, as in the case of the actress Angelina Jolie, who chose to undergo preventive double mastectomy and subsequent ovariectomy because she carried a gene that greatly increased (over 80%) her risk of developing an aggressive and often fatal type of breast cancer, or the decision of a British manager to have his prostate removed for the same reason. In the meantime, the constant budget cuts have increased the need to make very complex choices.
Recently, the Covid-19 pandemic has confronted us with specific ethical dilemmas, in particular the choice about who to treat or not to treat in a health emergency with scarce resources.
The growing ethical concerns have highlighted the fact that doctors only receive very basic training in medical ethics during their studies and practical training. Some studies even show that the awareness of ethical issues of students and trainees decreases as they advance in their studies [1, 2].
Most doctors trust their ethical judgement and believe that their decisions are morally sound. Yet most doctors lack adequate training and theoretical knowledge of ethical issues to support their beliefs and choices in a manner that stands up to scrutiny. The ethical judgement of most doctors is based on their professional life experience, personal opinions, beliefs and values, but few know the theoretical foundations of biomedical ethics and moral decision-making.
The first part of this paper outlines the key theoretical concepts framing ethical decision-making by physicians. Next, the principles governing the ethical decision-making process are presented. This is important because ethics is not only about the medical decision, but also about the process for reaching that decision. Certain issues in the application of ethical principles and the challenges brought by current events to medical ethics are also discussed.
The birth of bioethics as understood today is closely linked to the giant strides made by the biomedical sciences and technologies (most notably molecular biology and genetic engineering) around the 1970s.
The gradual unlocking of the mechanisms of life, coupled with the possibility of manipulating and modifying living beings, enabled a number of procedures that gave rise to widespread ethical concerns: medically assisted reproduction, tissue and organ transplantation, genetic intervention, the possibility of artificial life independent of ‘natural’ life, euthanasia, cloning, etc.
The word Bio-Ethik was coined by German Protestant pastor and ethicist Fritz Jahr, who used the term to propose a new bioethical imperative that extended to all living beings Kant’s categorical imperative of respect for all persons [3, 4].
However, the current meaning of bioethics can be ascribed to American oncologist Van Rensselaer Potter, who used this term in a paper entitled Bioethics: the science of survival [5] and later in his best-known work Bioethics: a bridge to the future [6].
According to Potter, building an ethic based on scientific knowledge is necessary to ensure the very survival of Homo sapiens, which could be threatened if research were allowed to proceed unchecked and unfettered. Potter rejected merely speculative knowledge and stressed the need to connect ethical values, traditionally confined to the realm of the humanities, with biological facts and thus build a ‘bridge to the future’.
Potter himself defined bioethics as the ‘knowledge of how to use knowledge’, to highlight the distinctive nature of this discipline as a dialogical meeting point between the natural sciences, the social sciences and philosophy.
In his subsequent book, entitled Global Bioethics, Potter made the by now well-established subdivision of bioethics into three branches: medical ethics, environmental ethics and animal ethics [7].
It is interesting to note that originally, the scope of bioethics was not restricted to medical practice, even though in subsequent years this came to be considered its main, if not exclusive, area of concern. Indeed, differently from Potter’s definition of bioethics (later followed by Jonas in his work The Responsibility Principle [8]) the term has mostly been applied in the narrower sense given to it by Dutch obstetrician Andre E. Hellegers, co-founder of the Kennedy Institute, who considered bioethics as ethics applied to the biomedical sciences [9]. This narrowing of the scope of bioethics from its original reflection on the ethical problems relating to life, ‘bios’ in all its complexity, is partly due to the fact that the two centres where bioethics research and teaching were first developed (the Kennedy Institute in Washington and the Hastings Center in New York) focused on medical issues, specifically, on medically assisted reproduction. This meant that issues such as the treatment of animals or environmental risks were not considered to fall within the scope of bioethics proper.
The close links between the different facets of bioethics and the high complexity of the problems addressed require constant cross-disciplinary dialogue among scientists and scholars from a range of disciplines such as philosophy, law, economics, sociology, ethology, psychology and anthropology [10].
The interdisciplinary nature of bioethics is also in evidence in the current definition of this discipline, contained in the 2nd edition of the Encyclopedia of bioethics: ‘Bioethics is the systematic study of the moral dimensions - including moral vision, decisions, conduct, and policies - of the life sciences and health care, employing a variety of ethical methodologies in an interdisciplinary setting’ [11].
The relationship between ethics and science is certainly at the heart of philosophical reflection and may be summed up in one question: should we do everything we can do?
In the United States, the debate on ethical issues had already started long before the breakthroughs in genetics: it was prompted by news of gross abuses committed in several clinical trials, namely at the Jewish Chronic Disease Hospital in Brooklyn, the Willowbrook State Hospital in New York and in the famous ‘Tuskegee Study of Untreated Syphilis in the Negro Male’ which began in 1932 and continued until 1972 [12].
However, the historical roots of bioethics and, in particular, of medical ethics, can be traced further back in time by a deeper examination of the relationship between science and ethics.
The atrocities committed in the experiments on concentration camp prisoners in Nazi Germany dramatically revealed, well before the later events that prompted the appearance of the term ‘bioethics’ in the literature, the need to investigate the relationship between ethics and science.
The Nuremberg Code was the first document to enshrine in specific rules the ethical principles that govern research on human subject. The Code, which although it never attained legal value has a universal moral value, established for the first time the following standards for human experiments:
The voluntary consent of the human subject is absolutely essential: this means that the person involved must be given detailed prior information about the nature, purpose, duration, means and risks of the experiment;
the experiment must be justified in terms of necessity, anticipated results and avoidance of injury;
the risks of the experiment must be carefully weighed against the expected benefits;
the personnel conducting the experiment must be appropriately trained and qualified;
appropriate equipment and facilities must be used;
it must be possible to bring the experiment to an end at any time on the initiative of either the human subject or the scientist.
Thus, the Nuremberg Code is a landmark document in the development of medical ethics, paving the way for a gradual and profound revision of the doctor-patient relationship in order to shed the traditional paternalistic approach in favour of the principles of consent, shared decision-making and therapeutic alliance.
Following the Nuremberg trial and the consequent drafting of the Nuremberg Code (1946), several international instruments on human rights were drafted, starting from the Universal Declaration of Human Rights (1948), which laid down the first legal principles of bioethics. The Declaration contains strong statements on the right to life and physical integrity, together with other fundamental civil and political freedoms. In so doing, it opened up a new legal and regulatory path for bioethics and inspired and influenced the subsequent development of international legislation.
The global and regional documents, charters, declarations and conventions that followed explicitly refer to the Universal Declaration of Human Rights as the foundation of their statutes and precepts, including the WMA Declaration of Geneva and the International Code of Medical Ethics of 1948 and the WMA Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects of 1964 (with its several subsequent amendments.
However, with regard to the aims of bioethics, it would be reductive and historically incorrect to limit its statutory, founding aims to the need to fix the ethical boundaries for the technical progress of science. As Mori [13] pointed out, what the Nuremberg trial itself so dramatically exposed is the need to set limits not to the technological advances of science but to the abuse of those advances. Thus, Mori reminds us that the core problem of bioethics is not to trace the boundaries of technological advancement, pitting science against ethics, but to identify the reasons that justify a specific moral judgement. Thus, as remarked by Schiavone [14], a crucial premise for any ethical approach to be legitimate and justified is that any critical reflection on scientific areas and disciplines should originate and develop within science itself and the scientific and technical advances achieved by it, instead of referring to a source of regulation outside science.
Far from being a system distinct from science and which attempts to stem its progress, bioethics aims to pursue critical and coherent reflection on human dignity, as an instrument of moral control (in the secular sense) over science in terms of its impact on human beings and the environment.
The subject matter of bioethics (which concerns itself with the sphere of ‘bios’, i.e. living beings) is associated with the theme of the destiny of human beings, and thus is an emotionally charged topic, inevitably subject to strong pressures. Bioethics is constantly at risk of sliding from the role of neutral and unbiased observatory – to the extent that such a role can effectively be achieved and maintained – onto the dangerous terrain of ideology and its associated dogmatic views.
Returning to the question of the origins of bioethics, it should be noted that ethical reflection in medicine dates back to long before Potter’s text. The Hippocratic oath is significant evidence of this. The oath, which evidently reflects the philosophy and culture of a time when the medical profession had a hieratic character, contains the seed bioethics in its principles of non nocere (i.e. ‘do no harm’ to the patient) and ‘beneficence’ as cornerstones of the doctor’s activity.
The Western world has adopted this approach and has formulated codes of medical ethics and laws inspired by ethical principles to regulate the exercise of the medical profession. These sets of rules are regularly updated in response to cultural and ethical developments and to the growing demand for professional standards to safeguard not only the interests of medical professionals, but also, and most importantly, those of their patients.
In this regard, medical ethics and standards of professional conduct play a major role in the physician-patient relationship. This is the setting where protecting the patient’s fundamental rights is crucial and where the risk that medical practice may infringe the individual’s rights protected by the Constitution is highest. Indeed, since ancient times, the power imbalance inherent in the patient-provider relationship has required a framework of principles and rules specifying the physician’s duties, in order to protect the patient (Figure 1).
Main documents on medical ethics.
Ethical theories can be grouped for simplicity into two main currents.
One is teleological ethics. Teleological theories focus on the purpose of the decisions taken and on their positive and negative impacts, and assess the consequences of the action [15]. These theories are deductive and pragmatic. Among the best known are John Stuart Mill’s utilitarianism [16] and American principlism [17]. The latter is undoubtedly one of the most widespread currents in medical ethics, at least in the United States, and will be discussed below. These theories focus on doing good for each individual, but also for the community.
The second current is deontological ethics; this differs fundamentally from the teleological approach in that its focus is not on achieving a good outcome but on doing what is morally right. The deontological approach is based on a series of ‘prima facie’ principles; it is an inductive principle focused on processes rather than on the final decision and it refers to the theories of Kant and Habermas [18]. Deontological ethics recognises absolute prohibitions, which admit no exceptions for any reason, override other duties, are fixed ‘a priori’ and are unchangeable. However, since conflict may arise between different duties, priorities must be identified in the hierarchy. Thus, a shift occurs from a hierarchy with absolute ‘a priori’ duties to an ethics with ‘prima facie’ duties, which also requires examination of the circumstances.
Teleological ethics and deontological ethics are two alternative ethical theories that determine the moral good or evil of an action.
The key difference between the two theories is that teleological ethics weighs the good or evil of an action according to its consequences. By contrast, deontological ethics determines the good or evil of an action on the basis of an examination of the action itself. Its vision is based on rules that determine the action.
Application of these two theories to end-of-life care can help to clarify the difference between them. Under the teleological framework, doctors who practice assisted dying focus on the purpose of decisions. They respect the patient’s choice to end her suffering when there is no hope of improvement. By contrast, under the deontological approach, doctors may refuse to provide assisted dying care on the basis of the a priori principle that doctors are trained to treat and not to take life. These are two diametrically opposed positions, which require different ethical frameworks.
General principles that state universal values of common morality also contribute to the basic reasoning on medical ethics . Beauchamp and Childress [17] have identified a model consisting of four moral principles that constitute the most common framework for achieving what is ‘good’ and what is ‘right’ in healthcare. ‘Principlism’ is a basic framework because it identifies four fundamental principles that come into play in most medical decisions, across the different medical specialities, countries and continents. These principles do not constitute a moral system or theory, but offer a framework for reflection on the moral problems encountered, and provide a starting point for making a moral judgement and assessing the procedure to be followed. The main principles are:
respect for autonomy/the individual
beneficence
non maleficence
justice.
The principle of autonomy refers to liberal thought, which has always emphasised individual rights and freedom of choice as an expression of the individual’s free will. The patient is recognised as possessing critical thinking and decision-making skills that must be respected. The model that emphasises the autonomy principle aims to oppose and overcome the paternalistic approach that has long dominated the doctor-patient relationship. The paternalistic model was based on an asymmetric relationship between the doctor (acting as a good parent) and the patient, who was treated as a ‘child’, unable to make decisions because of his lack of scientific and, especially, medical knowledge. This model has been discarded by reversing the patient’s role, from a passive one, to that of an autonomous person, capable of self-determination according to the principle of individual autonomy. The principle of autonomy ensures that the patient is involved in the medical decision-making process and protects his right to choose, accept, refuse or stop treatment. This is an absolute right of the individual, even where the refusal or interruption of treatment might cause adverse health consequences or even death. Autonomy implies respect for an individual’s physical and mental integrity. A person cannot be forced to receive treatment against her will. The patient cannot be subjected to any physical or mental coercion. The principle of autonomy also underpins the patient’s right to accurate and exhaustive information on the proposed treatment. Recognition of this right has led to development of the informed consent procedure. However, for certain specifically identified medical conditions that pose a public health threat, the government has the coercive power to impose treatment; this can occur, for instance, in the case of acute psychiatric patients or highly infectious diseases. However, even in these cases, the dignity of the person must always be respected. To apply these rules, doctors must know the legislation in force in the country in which they work; in any case, they must take all proper actions to minimise the need for coercion and maximise the patient’s consent.
The principle of beneficence states that the patient’s well-being is the ultimate goal of care. This principle lies at the heart of medicine, whose mission is precisely to prevent, diagnose and treat illness in order to promote the patient’s health. It is a question of proposing a treatment that is proportionate to the patient’s needs and whose benefits for the patient outweigh its possible harms. This principle means that doctors may act in the patient’s best interest also by refraining from acting and/or by acting prudently, always from the viewpoint of the benefit for the patient. Traditionally, this principle has been focused on ‘objective’ good, i.e. the outcome considered to be good by the doctor. However, cultural and ethical developments have gradually led to add to this principle that of autonomy, supporting a more subjective interpretation of the patient’s ‘best interest’.
The principle of non-maleficence has been well known to doctors since the time of the Hippocratic precept of primum non nocere. Non-maleficence encompasses two key concepts. The first is that of not causing harm to patients, even before doing them good. The second is the need to properly assess the risks and the benefit/risk balance of a treatment, and hence to refrain from prescribing a treatment that, although effective, could be harmful to the patient.
The non-maleficence principle is reflected in a number of legal provisions regarding wilful medical malpractice, where the patient was intentionally injured, or negligent malpractice, where the harm was caused by negligence, inexperience, recklessness or failure to comply with laws, regulations, orders or standards.
The principle of justice requires that all people be treated fairly. It is difficult to provide a single definition of justice, as various theories have produced different versions. Egalitarian theories stress the importance of universal access to basic necessities [19]. Libertarian theories affirm the right to social and economic freedom [19]. Utilitarian doctrines require the balancing of the two principles in order to maximise public and private utility [17]. Moreover, the principle of justice includes the concept of distributive justice, which states that resources should be allocated so as to ensure that access to care is not affected by socio-economic, ethnic or other factors which could favour certain sectors of the population to the detriment of others. The problem of resource allocation arises at different levels. For example, a national government decides which share of funding to allocate to finance social and healthcare relative to other sectors such as education, labour, transport. Moreover, the healthcare budget is in turn distributed differently among the different specialties. Thus, in practice, implementing the distributive principle raises complex issues; for instance, to what extent can expensive experimental treatments be justified in patients who have not responded to conventional approaches? Some of these treatments can cost more than €100,000 per year and clearly erode the sums available to treat other patients.
These four principles are not independent of each other. Rather, they interact in all medical situations of varying complexity, engaging in a dialectical relationship which requires their careful balancing. The clinician’s art is to fully understand how to best weigh these factors on a case-by-case basis, to reach the most appropriate decision for the individual patient.
In modern biomedical ethics, the process by which a decision is reached is as important as the decision itself. This is why it is necessary to have a clear approach that takes into account the problems to be addressed and all the persons concerned.
Figure 2 shows a decision making process according to Jonsen’s four box model for decision making which evaluates four fundamental variables: medical indications, patient and family preferences, quality of life and contextual features [20].
Jonsen’s four box for medical decision-making.
The approach proposed here is one example, among the many available, of a framework to guide the decision-making process. The approach is based on a series of questions, which are set out and explained below.
What are the facts, the circumstances? This question prompts a description of the clinical problem, concurring factors and psychosocial and environmental aspects. The starting point is awareness that the interaction is not with an illness, but with a sick person with a life history, family, affections, job and deep personal, existential and ideological values. Each participant will, in their own way, experience the impact of the decision. Clearly, at the centre of the decision is the patient, being the person that will ultimately make the decision and bear the consequences. The available options should be assessed from a clinical standpoint, considering the likelihood of success of the option chosen. For example, what are the chances that a patient with aggressive cancer will survive mutilating surgery which may have major adverse effects? Besides the purely clinical assessment, the human and emotional costs involved must also be considered.
What is the ‘spontaneous’ option? What do the patient, their family members, the treating physician, the nursing staff and the medical team want? What is the impact of pressure from fellow doctors or hospital managers, for instance in the event of a shortage of inpatient beds. What is the possible impact of pressure from the media?
What are the values at stake for each of the parties concerned? To answer this question it is necessary to draw up a personalised list of the hierarchy of values at stake, in the specific clinical situation, for the main parties concerned, mainly the patient, but also her family members (clearly where they have a say) and the medical team. For example, in the case of surgery entailing the risk of serious adverse effects and disability, the patient might refuse the surgery if she feels that the degree of beneficence, as perceived by her, is not adequate; the patient might instead wish to retain her current physical status, refusing a procedure that she considers to be invasive and destructive; this because the patient fears that after surgery, she might not recognise herself as the person she was before. On her part, the doctor may feel that the surgery will enable the patient to survive with what the doctor considers an acceptable quality of life (beneficence/maleficence). In other cases, the reverse may happen: the patient and his family members may want the surgery to be performed no matter what, even if its positive impact may be minimal or zero (patient autonomy vs. doctor autonomy vs. fair allocation of resources).
What is the moral dilemma? The matter here is not to choose the best course of action, but to identify clearly the moral dilemma faced by the doctor and the whole team, spelling it out in the most explicit and detailed way. What must be decided is not whether to operate on a patient who demands a treatment that will yield little or no benefits, but whether to prioritise the patient’s autonomy, and what he considers to be beneficial, or to prioritise the professional autonomy of the doctor, expressed through his clinical judgement on a procedure that he considers to be maleficent (a useless operation that will cause suffering to the patient) and to entail an unfair allocation of resources.
What are the alternatives? All too often, emotionally charged situations lead to a polarisation of views between just two possibilities. In the example in point 3, the only two options considered are surgery versus non-surgery. Instead, all options should be considered and presented to both the patient and his family members: chemotherapy, palliative care, home care, etc.
Which was the initial spontaneous choice? It is always advisable to return to the first spontaneous choice and assess whether the position of the main parties has evolved, and whether they have moved closer or farther apart from each other or have otherwise changed their views. If a change of position did happen, it should be considered whether this could help to reduce the conflict.
Making the decision. The decision must be made after consultation with the main parties involved, first and foremost the patient, but also his family members (where their involvement is authorised by the patient), the medical team, etc. It is important to have an open attitude and to truly listen. The patient must be seen not only from a medical point of view, but as an all-round individual with a life story, beliefs and concerns. As J. F. Malherbe [21] said, the patient remains the protagonist of his illness and not just the object of treatment. One should not hesitate to consult a colleague to get a second opinion, or even the hospital’s ethics committee. After exhausting all these steps, a decision must be made. The decision must be justified by taking into account the medical evidence for each situation, but also the ethical issues specific to the situation. It is essential to specify which elements justify the principles that were given priority in the decision-making process.
In theory, the description of ethical principles seems to give a clear overview of medical ethics and the procedures to be followed when making treatment decisions.
However, in clinical practice, the application of ethical principles is increasingly complex and is often affected by issues that complicate the decision-making process and come into conflict with ethical principles. Some issues arise when different principles clash with each other; others are linked to patient-specific situations, while yet others are linked to the organisation of services.
With regard to the conflict between principles, a common opposition may arise between the principles of autonomy and beneficence, for example in terminal cancer patients. According to the principle of autonomy, the patient should be told that her condition is now terminal, to allow her to freely choose among treatment options and decide what to do with the time she still has to live. However, under the principle of beneficence, one might argue that providing such accurate information might cause deep pain, and hence be harmful to the patient, affecting negatively her will to live and her quality of life in the time left to her. Moreover, the conflict between the two principles is not an abstract one; on the contrary, it is experienced by the parties to the decision-making process, with real consequences. The principle of autonomy can be interpreted in very different ways by doctors. For example, some doctors might resort to the legacy of medical paternalism and feel authorised to deliver all the bad news to the patient; other doctors could rely on the principle of autonomy to avoid making difficult decisions by shifting the responsibility onto the patient and/or her family members, placing a heavy emotional burden on the patient; still other doctors may not provide the full set of options to their patient to prevent her from making decisions that the doctor does not consider beneficial to her, resorting to a sort of ‘palliative paternalism’ [22] and thereby arbitrarily reducing the patient’s free choice.
Conflict may also occur between the principles of beneficence and non-maleficence. An example is found in pain management for terminal patients, where the use of opioids relieves pain and meets the beneficence principle, but may shorten life, thereby violating the non-maleficence principle. Both principles are not absolute and are often combined, as in the above example, giving rise to the ‘double effect’ phenomenon, a term that in bioethics refers to an action that can have more than one result and contrasts two principles [17].
Other issues in the application of ethical principles arise when healthcare systems have to contend with limited resources. In these cases, the first ethical problem is patient selection for access to and discharge from care, which clashes with the principles of beneficence, non-maleficence and justice [23, 24]. The American Medical Association [25] has provided guidance on the ethical implications of the allocation of organs for transplant, which may be helpful in the task of determining priority of access to scarce and costly medical resources. The AMA paper has identified five criteria related to the patient’s Medical Needs, which should be considered when making resource allocation decisions: likelihood of benefit
the improvement in quality of life
the duration of the benefit to the patient
the urgency of the patient’s condition
only in some cases, the amount of resources required for successful treatment
These criteria help to maximise three primary goals of medical treatment: number of lives saved, number of years saved and improvement in quality of life. A hierarchy of objectives prioritises the goal of saving the greatest number of lives. [25] While the AMA document makes an important contribution to ethical decision-making, many questions about distributive justice and discrimination against older people remain open.
Furthermore, major social changes have affected the organisation of health systems and have further complicated the application of ethical principles. The globalisation of modern society, with its marked contradictions, inequalities and injustices has also inevitably affected healthcare systems. The undoubtedly successful McDonaldization phenomenon, [26], characterised by efficiency, productivity, cost reduction, procedural standardisation and control, has also influenced the organisation of healthcare services. The double pressure to cut costs and make a profit has impoverished the healthcare system, hitting hardest the most vulnerable and deprived citizens and generating major inequalities in the access to healthcare services: this has deeply affected the ethical principle of justice and beneficence and has altered the doctor-patient relationship [27].
In 2020, the whole world was struck by the Covid-19 pandemic. The pandemic disrupted life for every person with an unexpected, novel situation and caused an unprecedented humanitarian emergency. Its sudden outbreak has put the health systems under massive strain, causing a number of ethical problems for healthcare staff and managers, and giving rise to real challenges to basic ethical principles.
Compounding the existing problems in applying ethical principles, the pandemic has brought about new complex scenarios and issues, which have not always been addressed appropriately and in line with ethical principles.
The first moral dilemma posed by the pandemic relates to the strain on healthcare quality caused by the surge in demand. The pandemic has spread quickly, catching the health structures unprepared to handle the rapid increase in workload. At the height of the crisis, the number of patients rose dramatically and the hospitals soon ran out of beds. The number of healthcare workers (doctors and nurses) was also insufficient to deal with the surge in cases. Many health workers faced the additional workload with great dedication and sense of responsibility, aware that their patients’ lives also depended on their willingness to put in the extra hours. They prioritised the beneficence for their patients over their personal well-being. Many healthcare workers fell ill and many died [28]. At the peak of the pandemic, medical and nursing staff worked 12–14 hours a day wearing uncomfortable face masks, visors and coveralls. It is fair to assume that fatigue and stress at work may have affected the quality of care, hence the actual beneficence for patients. It can also be presumed that the quality of the care provided at the start of a work shift was higher than that provided by the same worker after 12 hours of gruelling work. Thus, the actual working conditions undermined both the principle of beneficence and the principle of justice, according to which all patients must be treated equally.
Moreover, the spike in patient numbers was so high that it produced an imbalance between the healthcare needs of the population and the availability of intensive care resources. The situation that came about was and still is an exceptional one, to the extent that it has been classified as ‘disaster medicine’ [29]. With regard to intensive care, in addition to the criteria for access to and termination of care, traditionally based on the appropriateness and proportionality of care, the criteria of distributive justice and appropriate allocation of limited health resources had to be applied. The ‘first-come, first-served’ criterion for access could not be applied. Healthcare workers were forced to carry out an unusual triage, in which they often had to apply the criterion of ‘greater life expectancy’. In Italy, SIAARTI (the Italian Society of Anaesthesiology, Analgesia, Resuscitation and Intensive Care) issued ‘Clinical ethics recommendations for the allocation of intensive care treatments, in exceptional, resource-limited circumstances’ [29]. The recommendations are solidly grounded in ethical principles, to relieve clinicians from the burden of making subjective decisions, and establish explicit resource allocation criteria [29]. (SIAARTI). Robert et al. highlighted the ethical issues in patient management in intensive care units during the pandemic in France [30]. Despite the guidance provided, the dramatic pressure of the situation often forced physicians to grapple alone with the final decision about who should get life-saving care. While admittedly it was necessary to make a selection among the patients, we must also note that a dramatic discrimination occurred by age group, comorbidity and patient type. Elderly patients, patients with comorbidities and frail patients were often denied access to the ICU.
The pandemic emergency also gave rise to other issues. Many patients could not even reach the hospital and died at home while waiting for an ambulance that never arrived. In those cases, the decision was not guided by any particular and specific recommendations, but was simply left to chance: the lottery of life decided for them.
For the patients’ protection, during their stay in hospital, the patient-family and healthcare worker-caregiver connection was severed, counter to more than 20 years of research and care practice aimed at improving those relationships for the patient’s benefit [30]. Many patients were left to face death alone, without the comfort of family members, without any spiritual or religious care. As hospitals were overwhelmed, much was attempted to provide the benefit to the body but little was done to provide psychological and emotional care; healthcare moved back from caring for the whole person to focusing on the illness alone.
Yet other decisions have impacted ethical principles and good clinical practice in the management of chronic patients. For a long time now, the healthcare system has placed emphasis on prevention and early diagnosis programmes, educating the public about the importance of health screening and monitoring. The emergency has deeply disrupted this approach. Many cancer patients have been unable to attend their routine checks, and the same has happened to patients with heart conditions or diabetes. The principles of beneficence and non-maleficence have been severely compromised. An increase in deaths due to cardiovascular diseases has already been recorded, and the number of deaths secondary to cancer is also expected to rise [31].
The above overview confirms that the practical application of ethical principles in medicine is fraught with difficulties that may complicate the decision-making process. The current pandemic is confronting us with novel organisational, social and ethical challenges.
As a rule, major changes in healthcare occur at a much slower pace, giving us enough time to process them, adapt and make decisions. Today’s explosive crisis calls instead for urgent emergency measures. The assessment tools we have used so far have been made obsolete by the extraordinary pace of the crisis. In the health sector, clinical guidelines have traditionally been the gold standard for good clinical practice, in addition to providing some protection from medical liability. However, many guidelines have lost their relevance in the pandemic, which has created an unprecedented health situation for which no specific guidance could be prepared. The dramatic developments have put ethical principles under strain in various circumstances and cases. Moral dilemmas have severely affected the emotional resilience of clinical staff; in the near future we will have to deal with the moral distress they experienced.
Ethics, once a discipline of interest to scholars, has nowadays taken on a prominent role in the social debate. However, moral questions must be addressed and analysed critically, in order to define not only what is right, but also why it is right. [32]
Hopefully, we can draw some lessons from this tragedy.
The rationalisation of healthcare resources – through major budget cuts, the push for standardised care processes according to the McDonaldization model, the emphasis on hi-tech and highly specialised care – has not withstood the test of the pandemic. While of course it is hard to say which model would withstood the Covid crisis, it remains a fact that the current one failed, and this requires some reflection.
First, we should strengthen the human dimension of the physician-patient relationship. The focus on performance and profit has reduced the time available for listening to patients and their family members; as medical professionals, we have contributed to the achievement of the productivity targets set by the health authorities, but we have not always respected the ethical principles of an authentic doctor-patient relationship based on caring for the individual as opposed to simply treating a medical condition. Health professionals should take the brave step of fostering the relationship with their patients and prioritising quality over quantity, eschewing the industrial assembly line model: people are not machines and do not function like machines.
Social systems as a whole should revisit their resource allocation models. For a long time now, policy makers from all sides have made major cuts to health care; the pandemic has shown that ‘sick countries’ with difficulties in the delivery of healthcare are also countries with persistent economic problems. The share of public spending allocated to healthcare should be fairer, instead of treating the health service as the poor relation.
During the pandemic, we helped the patients with the greatest chance of survival, but we were unable to help the frailest ones. We went back to the model of Sparta, the ancient Greek city where frail male infants were tossed off a cliff, to train the others to become strong and valiant warriors. However, the Spartan model was not the one that prevailed in ancient Greece, nor the one that produced the greatest protagonists of classical culture. Healthcare systems, with the contribution of medical ethics, should develop care models that protect the frailest and shelter them from ‘competition’ for survival in which they would be doomed from the start.
We should also send the message that medical ethics is not just a matter for the individual health professional but is the responsibility of the whole community. The pandemic is teaching us that the responsible behaviour of each of us plays a key role in preventing the spread of the infection. The principles of medical ethics, beneficence and non-maleficence should be better known, understood and applied not only by health workers but by all persons.
Last but not least, the expectations placed on doctors today are very high, if not excessive, as concerns both clinical skills and patient relations. Although ethical issues are now on the front line, there is still very little training in biomedical ethics for health professionals. The development of science and technology require that physicians be knowledgeable of ethical issues pertinent to end-of-life care [33, 34]. It is crucial to invest more in this of training, to ensure that the new generations of doctors and other health professionals, within their respective roles, are better equipped to face the new challenges for medical ethics.
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\\n\\n6.3 IntechOpen is granted the authority to enforce the rights from this Publication Agreement, on behalf of the Corresponding Author and any Co-Author, against third parties (for example in cases of plagiarism or copyright infringements). In respect of any such infringement or suspected infringement of the copyright in the Chapter, IntechOpen shall have absolute discretion in addressing any such infringement which is likely to affect IntechOpen's rights under this Publication Agreement, including issuing and conducting proceedings against the suspected infringer.
\\n\\n7. MISCELLANEOUS
\\n\\n7.1 Further Assurance: The Corresponding Author shall and will ensure that any relevant third party (including any Co-Author) shall, execute and deliver whatever further documents or deeds and perform such acts as IntechOpen reasonably requires from time to time for the purpose of giving IntechOpen the full benefit of the provisions of this Publication Agreement.
\\n\\n7.2 Third Party Rights: A person who is not a party to this Publication Agreement may not enforce any of its provisions under the Contracts (Rights of Third Parties) Act 1999.
\\n\\n7.3 Entire Agreement: This Publication Agreement constitutes the entire agreement between the parties in relation to its subject matter. It replaces and extinguishes all prior agreements, draft agreements, arrangements, collateral warranties, collateral contracts, statements, assurances, representations and undertakings of any nature made by or on behalf of the parties, whether oral or written, in relation to that subject matter. Each party acknowledges that in entering into this Publication Agreement it has not relied upon any oral or written statements, collateral or other warranties, assurances, representations or undertakings which were made by or on behalf of the other party in relation to the subject matter of this Publication Agreement at any time before its signature (together "Pre-Contractual Statements"), other than those which are set out in this Publication Agreement. Each party hereby waives all rights and remedies which might otherwise be available to it in relation to such Pre-Contractual Statements. Nothing in this clause shall exclude or restrict the liability of either party arising out of its pre-contract fraudulent misrepresentation or fraudulent concealment.
\\n\\n7.4 Waiver: No failure or delay by a party to exercise any right or remedy provided under this Publication Agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall preclude or restrict the further exercise of that or any other right or remedy.
\\n\\n7.5 Variation: No variation of this Publication Agreement shall be effective unless it is in writing and signed by the parties (or their duly authorized representatives).
\\n\\n7.6 Severance: If any provision or part-provision of this Publication Agreement is or becomes invalid, illegal or unenforceable, it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible, the relevant provision or part-provision shall be deemed deleted.
\\n\\nAny modification to or deletion of a provision or part-provision under this clause shall not affect the validity and enforceability of the rest of this Publication Agreement.
\\n\\n7.7 No partnership: Nothing in this Publication Agreement is intended to, or shall be deemed to, establish or create any partnership or joint venture or the relationship of principal and agent or employer and employee between IntechOpen and the Corresponding Author or any Co-Author, nor authorize any party to make or enter into any commitments for or on behalf of any other party.
\\n\\n7.8 Governing law: This Publication Agreement and any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with it or its subject matter or formation shall be governed by and construed in accordance with the law of England and Wales. The parties submit to the exclusive jurisdiction of the English courts to settle any dispute or claim arising out of or in connection with this Publication Agreement (including any non-contractual disputes or claims).
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The Corresponding Author (acting on behalf of all Authors) and INTECHOPEN LIMITED, incorporated and registered in England and Wales with company number 11086078 and a registered office at 5 Princes Gate Court, London, United Kingdom, SW7 2QJ conclude the following Agreement regarding the publication of a Book Chapter:
\n\n1. DEFINITIONS
\n\nCorresponding Author: The Author of the Chapter who serves as a Signatory to this Agreement. The Corresponding Author acts on behalf of any other Co-Author.
\n\nCo-Author: All other Authors of the Chapter besides the Corresponding Author.
\n\nIntechOpen: IntechOpen Ltd., the Publisher of the Book.
\n\nBook: The publication as a collection of chapters compiled by IntechOpen including the Chapter. Chapter: The original literary work created by Corresponding Author and any Co-Author that is the subject of this Agreement.
\n\n2. CORRESPONDING AUTHOR'S GRANT OF RIGHTS
\n\n2.1 Subject to the following Article, the Corresponding Author grants and shall ensure that each Co-Author grants, to IntechOpen, during the full term of copyright and any extensions or renewals of that term the following:
\n\nThe aforementioned licenses shall survive the expiry or termination of this Agreement for any reason.
\n\n2.2 The Corresponding Author (on their own behalf and on behalf of any Co-Author) reserves the following rights to the Chapter but agrees not to exercise them in such a way as to adversely affect IntechOpen's ability to utilize the full benefit of this Publication Agreement: (i) reprographic rights worldwide, other than those which subsist in the typographical arrangement of the Chapter as published by IntechOpen; and (ii) public lending rights arising under the Public Lending Right Act 1979, as amended from time to time, and any similar rights arising in any part of the world.
\n\nThe Corresponding Author confirms that they (and any Co-Author) are and will remain a member of any applicable licensing and collecting society and any successor to that body responsible for administering royalties for the reprographic reproduction of copyright works.
\n\nSubject to the license granted above, copyright in the Chapter and all versions of it created during IntechOpen's editing process (including the published version) is retained by the Corresponding Author and any Co-Author.
\n\nSubject to the license granted above, the Corresponding Author and any Co-Author retains patent, trademark and other intellectual property rights to the Chapter.
\n\n2.3 All rights granted to IntechOpen in this Article are assignable, sublicensable or otherwise transferrable to third parties without the Corresponding Author's or any Co-Author’s specific approval.
\n\n2.4 The Corresponding Author (on their own behalf and on behalf of each Co-Author) will not assert any rights under the Copyright, Designs and Patents Act 1988 to object to derogatory treatment of the Chapter as a consequence of IntechOpen's changes to the Chapter arising from translation of it, corrections and edits for house style, removal of problematic material and other reasonable edits.
\n\n3. CORRESPONDING AUTHOR'S DUTIES
\n\n3.1 When distributing or re-publishing the Chapter, the Corresponding Author agrees to credit the Book in which the Chapter has been published as the source of first publication, as well as IntechOpen. The Corresponding Author warrants that each Co-Author will also credit the Book in which the Chapter has been published as the source of first publication, as well as IntechOpen, when they are distributing or re-publishing the Chapter.
\n\n3.2 When submitting the Chapter, the Corresponding Author agrees to:
\n\nThe Corresponding Author will be held responsible for the payment of the Open Access Publishing Fees.
\n\nAll payments shall be due 30 days from the date of the issued invoice. The Corresponding Author or the payer on the Corresponding Author's and Co-Authors' behalf will bear all banking and similar charges incurred.
\n\n3.3 The Corresponding Author shall obtain in writing all consents necessary for the reproduction of any material in which a third-party right exists, including quotations, photographs and illustrations, in all editions of the Chapter worldwide for the full term of the above licenses, and shall provide to IntechOpen upon request the original copies of such consents for inspection (at IntechOpen's option) or photocopies of such consents.
\n\nThe Corresponding Author shall obtain written informed consent for publication from people who might recognize themselves or be identified by others (e.g. from case reports or photographs).
\n\n3.4 The Corresponding Author and any Co-Author shall respect confidentiality rights during and after the termination of this Agreement. The information contained in all correspondence and documents as part of the publishing activity between IntechOpen and the Corresponding Author and any Co-Author are confidential and are intended only for the recipient. The contents may not be disclosed publicly and are not intended for unauthorized use or distribution. Any use, disclosure, copying, or distribution is prohibited and may be unlawful.
\n\n4. CORRESPONDING AUTHOR'S WARRANTY
\n\n4.1 The Corresponding Author represents and warrants that the Chapter does not and will not breach any applicable law or the rights of any third party and, specifically, that the Chapter contains no matter that is defamatory or that infringes any literary or proprietary rights, intellectual property rights, or any rights of privacy. The Corresponding Author warrants and represents that: (i) the Chapter is the original work of themselves and any Co-Author and is not copied wholly or substantially from any other work or material or any other source; (ii) the Chapter has not been formally published in any other peer-reviewed journal or in a book or edited collection, and is not under consideration for any such publication; (iii) they themselves and any Co-Author are qualifying persons under section 154 of the Copyright, Designs and Patents Act 1988; (iv) they themselves and any Co-Author have not assigned and will not during the term of this Publication Agreement purport to assign any of the rights granted to IntechOpen under this Publication Agreement; and (v) the rights granted by this Publication Agreement are free from any security interest, option, mortgage, charge or lien.
\n\nThe Corresponding Author also warrants and represents that: (i) they have the full power to enter into this Publication Agreement on their own behalf and on behalf of each Co-Author; and (ii) they have the necessary rights and/or title in and to the Chapter to grant IntechOpen, on behalf of themselves and any Co-Author, the rights and licenses expressed to be granted in this Publication Agreement. If the Chapter was prepared jointly by the Corresponding Author and any Co-Author, the Corresponding Author warrants and represents that: (i) each Co-Author agrees to the submission, license and publication of the Chapter on the terms of this Publication Agreement; and (ii) they have the authority to enter into this Publication Agreement on behalf of and bind each Co-Author. The Corresponding Author shall: (i) ensure each Co-Author complies with all relevant provisions of this Publication Agreement, including those relating to confidentiality, performance and standards, as if a party to this Publication Agreement; and (ii) remain primarily liable for all acts and/or omissions of each such Co-Author.
\n\nThe Corresponding Author agrees to indemnify and hold IntechOpen harmless against all liabilities, costs, expenses, damages and losses and all reasonable legal costs and expenses suffered or incurred by IntechOpen arising out of or in connection with any breach of the aforementioned representations and warranties. This indemnity shall not cover IntechOpen to the extent that a claim under it results from IntechOpen's negligence or willful misconduct.
\n\n4.2 Nothing in this Publication Agreement shall have the effect of excluding or limiting any liability for death or personal injury caused by negligence or any other liability that cannot be excluded or limited by applicable law.
\n\n5. TERMINATION
\n\n5.1 IntechOpen has a right to terminate this Publication Agreement for quality, program, technical or other reasons with immediate effect, including without limitation (i) if the Corresponding Author or any Co-Author commits a material breach of this Publication Agreement; (ii) if the Corresponding Author or any Co-Author (being an individual) is the subject of a bankruptcy petition, application or order; or (iii) if the Corresponding Author or any Co-Author (being a company) commences negotiations with all or any class of its creditors with a view to rescheduling any of its debts, or makes a proposal for or enters into any compromise or arrangement with any of its creditors.
\n\nIn case of termination, IntechOpen will notify the Corresponding Author, in writing, of the decision.
\n\n6. INTECHOPEN’S DUTIES AND RIGHTS
\n\n6.1 Unless prevented from doing so by events outside its reasonable control, IntechOpen, in its discretion, agrees to publish the Chapter attributing it to the Corresponding Author and any Co-Author.
\n\n6.2 IntechOpen has the right to use the Corresponding Author’s and any Co-Author’s names and likeness in connection with scientific dissemination, retrieval, archiving, web hosting and promotion and marketing of the Chapter and has the right to contact the Corresponding Author and any Co-Author until the Chapter is publicly available on any platform owned and/or operated by IntechOpen.
\n\n6.3 IntechOpen is granted the authority to enforce the rights from this Publication Agreement, on behalf of the Corresponding Author and any Co-Author, against third parties (for example in cases of plagiarism or copyright infringements). In respect of any such infringement or suspected infringement of the copyright in the Chapter, IntechOpen shall have absolute discretion in addressing any such infringement which is likely to affect IntechOpen's rights under this Publication Agreement, including issuing and conducting proceedings against the suspected infringer.
\n\n7. MISCELLANEOUS
\n\n7.1 Further Assurance: The Corresponding Author shall and will ensure that any relevant third party (including any Co-Author) shall, execute and deliver whatever further documents or deeds and perform such acts as IntechOpen reasonably requires from time to time for the purpose of giving IntechOpen the full benefit of the provisions of this Publication Agreement.
\n\n7.2 Third Party Rights: A person who is not a party to this Publication Agreement may not enforce any of its provisions under the Contracts (Rights of Third Parties) Act 1999.
\n\n7.3 Entire Agreement: This Publication Agreement constitutes the entire agreement between the parties in relation to its subject matter. It replaces and extinguishes all prior agreements, draft agreements, arrangements, collateral warranties, collateral contracts, statements, assurances, representations and undertakings of any nature made by or on behalf of the parties, whether oral or written, in relation to that subject matter. Each party acknowledges that in entering into this Publication Agreement it has not relied upon any oral or written statements, collateral or other warranties, assurances, representations or undertakings which were made by or on behalf of the other party in relation to the subject matter of this Publication Agreement at any time before its signature (together "Pre-Contractual Statements"), other than those which are set out in this Publication Agreement. Each party hereby waives all rights and remedies which might otherwise be available to it in relation to such Pre-Contractual Statements. Nothing in this clause shall exclude or restrict the liability of either party arising out of its pre-contract fraudulent misrepresentation or fraudulent concealment.
\n\n7.4 Waiver: No failure or delay by a party to exercise any right or remedy provided under this Publication Agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall preclude or restrict the further exercise of that or any other right or remedy.
\n\n7.5 Variation: No variation of this Publication Agreement shall be effective unless it is in writing and signed by the parties (or their duly authorized representatives).
\n\n7.6 Severance: If any provision or part-provision of this Publication Agreement is or becomes invalid, illegal or unenforceable, it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible, the relevant provision or part-provision shall be deemed deleted.
\n\nAny modification to or deletion of a provision or part-provision under this clause shall not affect the validity and enforceability of the rest of this Publication Agreement.
\n\n7.7 No partnership: Nothing in this Publication Agreement is intended to, or shall be deemed to, establish or create any partnership or joint venture or the relationship of principal and agent or employer and employee between IntechOpen and the Corresponding Author or any Co-Author, nor authorize any party to make or enter into any commitments for or on behalf of any other party.
\n\n7.8 Governing law: This Publication Agreement and any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with it or its subject matter or formation shall be governed by and construed in accordance with the law of England and Wales. The parties submit to the exclusive jurisdiction of the English courts to settle any dispute or claim arising out of or in connection with this Publication Agreement (including any non-contractual disputes or claims).
\n\nLast updated: 2020-11-27
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