Ethics In Research: Principles And Practical Considerations [1 ed.] 3031240596, 9783031240591, 9783031240621, 9783031240607

This book draws a connection between ethics and research across social sciences, philosophy, medical sciences and legal

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Table of contents :
Preface
Contents
Philosophy and Medicine. The Search for Happiness
1 Introduction
2 Medicine as Technics and Art
3 Medicine as Rational Knowledge of Causes
4 Medicine and Philosophy
5 Conclusion
References
Ethics in Legal Research
1 Introduction
2 Law and Research: The Comparative Approach as a Scientific Method
3 Conflict of Interests in Legal Research
3.1 Conflict of Interests in Research: Definition, Content and General Issues
3.2 The Peculiarities of Conflict of Interests in Legal Research
4 Legal Research and Data Protection
4.1 The Use of Personal Data for Scientific Purposes: The European Regulatory Framework
4.2 The Reuse of Personal Data in Legal Research: A Comparative Overview
References
Ethics in Life Sciences and Research
1 Introduction
2 What Makes Clinical Research Ethical?
3 The Role of Research Ethics Committees (RECs) and Institutional Review Boards (IRBs)
4 Ethical Issues in Randomized Clinical Trials (RCTs): Science or Ethics?
5 Conclusions
References
Therapeutic Strategies and Self-Determination: Lessons from the COVID-19 Pandemic
1 Ethical Principles Under Pressure: “Beneficence” and “Autonomy”
2 Apparent Contradictions in the Principle of Justice
3 The “Vexed Question” of the Vaccine
4 Conclusions
Notes
Ethics and Integrity in Academic Publishing
1 Introduction
2 Predatory Publishing: An Overview
3 Ethical Implications and Concerns
4 International Initiatives to Guide Authors
4.1 The Think. Check. Submit Campaign
4.2 The InterAcademy Partnership (IAP) Activities
4.3 The COPE Discussion Document
5 The First Italian Ethical Toolkit on Predatory Publishing
5.1 CNR Research Ethics and Integrity Committee and Its Working Group
5.2 Practical Recommendations for Researchers
6 Preliminary Conclusions and Perspectives
References
Ethical Dilemmas in Urban Studies
1 Ethics and the City
2 Narrating Stories, Interpreting Roles, Telling the Truth
3 To Be, or Not to Be Engaged (in Planning Practices): Technical Expertise Versus Political Vision
4 Conclusions
References
Toward Virtuous Machines: When Ethics Meets Robotics
1 Introduction
2 Proposals in Roboethics
2.1 Top-Down Methods
2.2 Bottom-Up Methods
2.3 LIDA: Integrating Top-Down and Bottom-Up Strategies
3 Artificial Phronesis
4 Cognitive Agents Supporting Artificial Phronesis
5 A BDI Implementation of Artificial Phronesis
6 Conclusions
References
How the Love of Truth Affects the Role of the Researcher: References to the “Third Mission” of Universities and References to the Field of Business Economics Studies
1 On the “Truth”: Conceptual References
2 For “Love”: The Motivational Drive in Search of Truth for the Common Good
3 The Researcher’s Task and Their Working for Good
4 Initial Summary Considerations and References to the “Third Mission” of Universities
5 Ethical References and Specifications in Economic and Business Research: Notes on Entrepreneurial Virtues
6 Conclusions
Notes
The Humanization of Health Care: In-Depth Knowledge Regarding the Ethics of Dental Care in Oncological Patients
1 Introduction
2 The Notion of Care from Hyginus to the Oral Health Care Practitioner (Understood as a Curative Presence)
3 The Human Relationship as an Integral Component of Care
4 Reformulating the Relationship Between Doctor and Frail Patient (With a Need for Oral Care) and Revisiting Settings: How the Ethical Dimension of the Medical Professional is Changing
5 Conclusion
References
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Ethics In Research: Principles And Practical Considerations [1 ed.]
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UNIPA Springer Series

Lorella Congiunti Francesco Lo Piccolo Antonio Russo Mario Serio Editors

Ethics in Research Principles and Practical Considerations

UNIPA Springer Series Editor-in-Chief Eleonora Riva Sanseverino , Department of Engineering, University of Palermo, Palermo, Italy Series Editors Carlo Amenta , Department of Economics, Management and Statistics, University of Palermo, Palermo, Italy Marco Carapezza, Department of Human Sciences, University of Palermo, Palermo, Italy Marcello Chiodi, Department of Economics, Management and Statistics, University of Palermo, Palermo, Italy Andrea Laghi, Department of Surgical and Medical Sciences and Translational Medicine, Sapienza University of Rome, Rome, Italy Bruno Maresca, Department of Pharmaceutical Sciences, University of Salerno, Fisciano, Italy Giorgio Domenico Maria Micale, Department of Industrial and Digital Innovation, University of Palermo, Palermo, Italy Arabella Mocciaro Li Destri, Department of Economics, Management and Statistics, University of Palermo, Palermo, Italy Andreas Öchsner, Esslingen University of Applied Sciences, Southport, QLD, Australia Mariacristina Piva, Department of Economic and Social Sciences, Catholic University of the Sacred Heart, Piacenza, Italy Antonio Russo, Department of Surgical, Oncological and Oral Sciences, University of Palermo, Palermo, Italy Norbert M. Seel, Department of Education, University of Freiburg, Freiburg im Breisgau, Germany

The UNIPA Springer Series publishes single and co-authored thematic collected volumes, monographs, handbooks and advanced textbooks on specific issues of particular relevance in six core scientific areas. The issues may be interdisciplinary or within one specific area of interest. Manuscripts are invited for publication in the following fields of study: 123456-

Clinical Medicine; Biomedical and Life Sciences; Engineering and Physical Sciences; Mathematics, Statistics and Computer Science; Business, Economics and Law; Human, Behavioral and Social Sciences.

Manuscripts submitted to the series are peer reviewed for scientific rigor followed by the usual Springer standards of editing, production, marketing and distribution. The series will allow authors to showcase their research within the context of a dynamic multidisciplinary platform. The series is open to academics from the University of Palermo but also from other universities around the world. Both scientific and teaching contributions are welcome in this series. The editorial products are addressed to researchers and students and will be published in the English language. The volumes of the series are single-blind peer-reviewed. Book proposals can be submitted to the UNIPA Springer Series Technical Secretariat at [email protected] At the following link, you can find some specific information about the submission procedure to the Editorial Board: https://www.unipa.it/strutture/springer/

Lorella Congiunti · Francesco Lo Piccolo · Antonio Russo · Mario Serio Editors

Ethics in Research Principles and Practical Considerations

Editors Lorella Congiunti Pontificia Università Urbaniana Rome, Italy Antonio Russo Dipartimento di Discipline Chirurgiche Oncologiche e Stomatologiche Università degli Studi di Palermo Palermo, Italy

Francesco Lo Piccolo Dipartimento di Architettura Università degli Studi di Palermo Palermo, Italy Mario Serio Dipartimento di Giurisprudenza Università degli Studi di Palermo Palermo, Italy

ISSN 2366-7516 ISSN 2366-7524 (electronic) UNIPA Springer Series ISBN 978-3-031-24059-1 ISBN 978-3-031-24060-7 (eBook) https://doi.org/10.1007/978-3-031-24060-7 © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland

Preface

Ethics and Research operate in two different disciplinary fields and have each one an autonomous theoretic foundation. This volume, however, aims at highlighting the intimate connection established between the two terms just mentioned, under the specific aspect that even research activity, which is usually understood as intended for the maximum expansion of intellectual and cognitive freedom, must observe some ethical rules. Such an adherence by researchers to ethical standards pursues a twofold objective. On the one hand, it aspires to ensure the accuracy and completeness of the information and, thus, to guarantee that no source of knowledge is neglected. Attention to the selection and collection of data is, in fact, an essential requirement for the reliability of any scientific research. On the other hand, the firm and stable reference to ethical rules allows the researcher to report results objectively, without any improper bias and with particular attention to the compliance with those rules, methodologically and ethically, that are commonly accepted by the scientific community. This link between research, as a completely free and purely intellectual activity, and ethics, as a dimension of the human beings striving to identify, on their own, the rules that limit their actions, finds full confirmation in this study. The matter at issue may be approached from a plurality of perspectives, as it transcends the boundaries of a specific topic or field of enquiry, broadening itself on the scope of the intrinsic and extrinsic values of research. It has been deemed fruitful, however, to deal with the topic looking at every specific research field rather than developing it in general terms. Ethical rules should be declined according to a certain discipline, be it part of social sciences or natural sciences, emphasising the specific features of each branch. Although it is possible to trace a common ethical core to every subject under investigation, each field of research—as will emerge from this volume—has its own peculiar rules. In other words, if completeness and accuracy in collecting data and correctness in reporting results are features that are common to all scientific research ensuring its integrity, it is clear that the way of approaching the dialogue between ethics and research depends on the specific character of the methodological framework of each science. v

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It varies from natural sciences, which are susceptible to experimental verification to human or philosophical sciences, that can be evaluated in terms of completeness of the information. The volume, therefore, offers the reader a wide range of insights into the aspects that the topic of ethics and research can present, within a plurality of fields of study, from medicine, dentistry, biotechnology and robotics to philosophy, law and urban studies. In particular, the authors explore ethical issues concerning the relationship between philosophy and medicine and caring for patients during the COVID-19 pandemic. Some ethical concerns for researchers came to light also looking at their role within university institutions and academic publishing. Finally, the ethical dimension of legal research, as observed from a comparative law perspective, urban studies and robotics are deeply analysed. Rome, Italy Palermo, Italy Palermo, Italy Palermo, Italy

Lorella Congiunti Francesco Lo Piccolo Antonio Russo Mario Serio

Contents

Philosophy and Medicine. The Search for Happiness . . . . . . . . . . . . . . . . . . Lorella Congiunti

1

Ethics in Legal Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Serio, Rosalba Potenzano, Giancarlo Geraci, Rosario Petruso, and Nicoletta Patti

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Ethics in Life Sciences and Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Valerio Gristina, Antonio Galvano, Antonina Pirrotta, and Antonio Russo

35

Therapeutic Strategies and Self-Determination: Lessons from the COVID-19 Pandemic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Roberto Garofalo

45

Ethics and Integrity in Academic Publishing . . . . . . . . . . . . . . . . . . . . . . . . . Cinzia Caporale and Roberta Martina Zagarella

53

Ethical Dilemmas in Urban Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Francesco Lo Piccolo and Marco Picone

71

Toward Virtuous Machines: When Ethics Meets Robotics . . . . . . . . . . . . . Antonio Chella, Arianna Pipitone, Francesco Lanza, and Valeria Seidita

81

How the Love of Truth Affects the Role of the Researcher: References to the “Third Mission” of Universities and References to the Field of Business Economics Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . Marcantonio Ruisi

93

The Humanization of Health Care: In-Depth Knowledge Regarding the Ethics of Dental Care in Oncological Patients . . . . . . . . . . . 105 Monica Bazzano, Rodolfo Mauceri, Daniele Montemaggiore, Rita Coniglio, Giuseppe Pizzo, Pietro Tozzo, Olga Di Fede, Vera Panzarella, and Giuseppina Campisi

vii

Philosophy and Medicine. The Search for Happiness Lorella Congiunti

Abstract Philosophy and Medical Sciences have something in common. They search for truth in different ways but they have sometimes the same material object and they ever must have the same goal: human happiness. We can discover this common trait, from the history of both, thanks to some important figures of philosophers and doctors. In this context, a reflection on science and technics in their fundamental epistemological meanings is a matter of interest. We will offer some reflections about this—referring ourselves to two great ancient philosophers, Plato and Aristotle, as well as the great doctor, Galen.

1 Introduction Philosophy and medicine, while being distinct, are strongly related to each other, and in a certain sense, have the same anthropological goal: the happiness of human beings. The relationship between medicine and philosophy is very old; philosophy has always found in medicine a standard of knowledge which unites the characteristics of both science and technics in the classical sense of these terms. Technics, just as medieval arts, or better said, the plurality of technics and arts, used to have a broad meaning which included not only making and producing things but also knowing and acting morally and politically [1]. Therefore, when I refer to medicine as technic and art, I mean it in the classical sense when they were still synonymous, which was extremely meaningful from a theoretical point of view, as the separation between utility and beauty had not yet been produced. In Aristotle’s first book of Metaphysics, we read that technics consists in the capacity of obtaining the universal from the particular experiences of the same type, that it is a science of the “why,” and that it can be taught. The first technics were from the necessity to satisfy our needs, then afterward appeared the technics not L. Congiunti (B) Faculty of Philosophy, Pontifical Urbaniana University, Rome, Italy e-mail: [email protected] © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 L. Congiunti et al. (eds.), Ethics in Research, UNIPA Springer Series, https://doi.org/10.1007/978-3-031-24060-7_1

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strictly aimed at a practical use. In fact, techne1 forms part of the dialectical virtues, or rather perfections of the intellect, and is distinguished from other virtues because it aims at the “how to do” without limiting itself to the production of objects which are external to the subject, but rather has a primary cognitive value pointed towards an ethical and political goal which surpasses it.2 Furthermore, medicine and philosophy have the common goal of human wellbeing, although from different points of view, both of them cannot take care of woman/man without knowing her/him.3 We will offer some reflections about this—referring to two great ancient philosophers, Plato and Aristotle, as well as the great doctor, Galen.

2 Medicine as Technics and Art Interesting to us is what Plato offers in Gorgias, a dialogue dedicated to the analysis of rhetoric, which has as protagonists Plato’s master, Socrates, together with the sophist, Gorgias, as well as both of their respective students, Chaerephon and Polus, with the noble young Callicles, who hosts Gorgias in Athens. Socrates, while searching for a definition of rhetoric which he holds as persuasion without knowledge, institutes some comparisons between the different disciplines, including medicine. In fact, in the dialogue Socrates states: The soul and body being two, have two arts corresponding to them: there is the art of politics attending on the soul; and another art attending on the body, of which I know no single name, but which may be described as having two divisions, one of them gymnastic, and the other medicine. And in politics there is a legislative part, which answers to gymnastic, as justice does to medicine. (Plato, Gorgias 464b–c)

Therefore, Plato judges medicine to be one of the arts that regards the good of the body, together with gymnastics, and medicine is analogous to justice: as medicine cares for the body, justice cares for the soul: and the two parts run into one another, justice having to do with the same subject as legislation, and medicine with the same subject as gymnastic, but with a difference. Now, seeing that there are these four arts, two attending on the body and two on the soul for their highest good. (Plato, Gorgias 464b–c)

The goal of all these disciplines is the greater good; for medicine and gymnastics, it is the good of the body, while for justice and law, it is the good of the soul. It is interesting to see how, from the Greek perspective, “being a human being” and “being 1

Originally, ars used to be the translation of techne. There was a separation between technics and arts until the Modern Age, when gradually the term technics is used more in the field of utility, while art becomes a term used in the field of beauty, which value can be discussed. 2 Virtue—aretè—in the classical sense refers to the perfection of a being, in a way that a virtuous man is he who perfects his own human being, in moral context, acting according to the good, and in the intellectual context, knowing according to the truth. 3 See also: Wulff [3]; Pellegrino [4]; Pagnini [5]; Federspil [6]; Gifford [7]; Campaner [8].

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a citizen” correspond, so that the care of the soul consists in justice and politics, that is, in a political dimension. Unfortunately, these disciplines have to endure attacks of “flattery”, which is a false knowing: Flattery, or rather guessing their natures, has distributed herself into four shams or simulations of them; she puts on the likeness of someone or other of them, and pretends to be that which she simulates, and having no regard for men’s highest interests, is ever making pleasure the bait of the unwary, and deceiving them into the belief that she is of the highest value to them. Cookery simulates the disguise of medicine and pretends to know what food is the best for the body; and if the physician and the cook had to enter into a competition where children were the judges, or men who had no more sense than children as to which of them better understands the goodness or badness of food, the physician would be starved to death. Therefore I deem this flattery activity to be of an ignoble sort, Polus, for to you, I am now addressing myself, because it aims at pleasure without any thought of the best. I do not call it an art, but only an experience, because it is unable to explain or to give a reason of the nature of its own applications. And I do not call any irrational thing an art. (Plato, Gorgias 464c–465b)

The arts that care for the body and soul are counterfeited by false arts, which do not aim at the good but instead at pleasure. Cookery is the counteract of medicine, since it does not have any knowledge about either human nature or food, and it is an irrational activity. Plato continues: “Cookery, then, I maintain to be a flattery which takes the form of medicine; and tiring, in like manner, is a flattery which takes the form of gymnastic, and is knavish, false, ignoble, illiberal, working deceitfully by the help of lines, and colors, and enamels, and garments, and making men affect a spurious beauty to the neglect of the true beauty which is given by gymnastic.” (Plato, Gorgias, 464b–c) Plato compares the false arts to a rhetoric which aims only at emotional persuasion, at consensus, while the true arts, such as medicine, are analogous with philosophy and speak about that which they know, thus aiming at the good and at the truth. And this, I say, is the natural difference between the rhetorician and the sophist, but by reason of their near connection, they are apt to be jumbled up together; neither do they know what to make of themselves, nor do other men know what to make of them. For if the body presided over itself, and were not under the guidance of the soul, and the soul did not discern and discriminate between cookery and medicine, but the body was made the judge of them, and the rule of judgment was the bodily delight which was given by them, then the word of Anaxagoras, that word with which you, friend Polus, are so well acquainted, would prevail far and wide:’Chaos’ would come again, and cookery, health, and medicine would mingle in an indiscriminate mass. (Plato, Gorgias, 465b–e)

Without the cultivation of knowledge, there would be a confusion between true and false arts, and it would not be possible to distinguish true care from merely apparent care. Then consider what truth as well as Hippocrates says about this or about any other nature. Ought we not to consider first whether that which we wish to learn and to teach is a simple or multiform thing, and if simple, then to enquire what power it has of acting or being acted upon in relation to other things, and if multiform, then to number the forms; and see first in the case of one of them, and then in the case of all of them, what is that power of acting or being acted upon which makes each and all of them to be what they are? (Plato, Fedro, 270a–d)

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He proposes yet another parallel between caring for the body and the soul: “Medicine has to define the nature of the body and rhetoric of the soul—if we would proceed, not empirically but scientifically, in the one case to impart health and strength by giving medicine and food, in the other to implant the conviction or virtue which you desire, by the right application of words and training.” (Plato, Fedro, 270b)

3 Medicine as Rational Knowledge of Causes Aristotle concentrates his attention, as already said, on medicine as a type of “art”, or the capacity to know the universal in reference to the particular. In his Metaphysics, he writes: “The animals other than man live by appearances and memories, and have but little of connected experience; but the human race lives also by art and reasonings. Now from memory experience is produced in men; for the several memories of the same thing produce finally the capacity for a single experience. And experience seems pretty much like science and art, but really science and art come to men through experience; for ‘experience made art’, as Polus says, ‘but inexperience luck.’ Now art arises when from many notions gained by experience one universal judgement about a class of objects is produced. For to have a judgement that when Callias was ill of this disease this did him good, and similarly in the case of Socrates and in many individual cases, is a matter of experience; but to judge that it has done good to all persons of a certain constitution, marked off in one class, when they were ill of this disease, e.g. to phlegmatic or bilious people when burning with fevers-this is a matter of art.” (Aristotle, Metaphysics, I 980b 25–981a 12) This work is still more interesting from the point of view of medical history, because it refers to the theory of humors, which as Hippocrates thought, consists in the composition of humors—be it phlegm residing in the head, black bile residing in the milt, yellow bile in the liver, or blood in the heart—as determining the various temperaments (phlegmatic, bilious, choleric, and sanguine), and the balance between them being the cause of the state of health of a person. But what really interests us is the value that is attributed to medicine as a discipline. Indeed, medicine is emblematic of rational knowledge which is superior to simple experience; while through experience, one may verify that a certain remedy has done well to several people, only by science can one understand the why, and can formulate judgments which, even though they only regard individuals, surpass this simple individuality. Far from the mix of magic and superstition in curing illnesses, which have colored the first steps of Greek medicine, it has today qualified as a profession based on a rational knowledge. Aristotle continues: “We think that knowledge and understanding belong to art rather than to experience, and we suppose artists to be wiser than men of experience (which implies that Wisdom depends in all cases rather on knowledge); this is because the former know the cause and the latter do not. For men of experience know that the thing is so, but do not know why, while the others know the ‘why’ and the cause.” (Aristotle, Metaphysics, I 981a 24–30)

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Medicine is therefore a knowledge of causes, as philosophy is, and is born from the search of causes, instituting itself as the science of causes. Thus, the common trait of both medicine and philosophy is the search of the cause. Furthermore, both are teachable subjects. One cannot teach experience; however, the arts, technics, and sciences, can be taught. Under this aspect, medicine and philosophy are very similar: both are historically born in schools, and fundamental to both is the transmission of knowledge from master to disciple, from professor to student. Hippocrates himself was a teacher of medicine and had his own disciples, as did Socrates, Plato, and Aristotle. Aristotle concludes: “And in general it is a sign of the man who knows and of the man who does not know, that the former can teach, and therefore we think art more truly knowledge than experience is; for artists can teach, and men of mere experience cannot.” (Aristotle, Metaphysics, I, 980 a 25–981 b10) Aristotle thus proposes medicine as a privileged example of technics; technics is distinguished from simple experience because it consists in knowledge of causes. Medicine heals not only by simple experience but also by knowledge, and a good doctor knows how to apply his knowledge to singular cases. In this, medicine is the exemplar: true knowledge takes off from individual experiences but is able to understand universal causes and apply this general knowledge to particular cases. Furthermore, medicine, being a true science, can be taught. Mere personal experience and individual practice cannot be taught. True knowledge is verified by the possibility to be communicated and taught. If Plato and Aristotle are examples of philosophers who consider medicine a privileged field of art and science, some centuries later, we will find the figure of the doctor, Galen, who highly esteemed philosophy and considered it indispensable for the formation of doctors.

4 Medicine and Philosophy Galen (129–200) lived in the second half of the second century A.D. Although born in Pergamos (Asia Minor), he spent a good part of his adult life in Rome, near the imperial court of Marcus Aurelius. An authority in medicine, in the ancient “iatrike” (Greek for “medicine”) technics, which is the art of medicine, he worked in a pagan context in which the value and physiognomy of technics and arts had been conserved and institutionalized and formed part of the education (cfr Lombardi [2]). Galen himself had had a complete education including various types of technics, such as mathematics, astronomy, grammar, and rhetoric; furthermore, he had studied the philosophical branches of logic, ethics, and physics. In accord with his father’s will, he had had different masters of philosophy appertaining to the four philosophical schools: Platonic, peripatetic (also known as Aristotelic), Stoic, and Epicurean. This means he had an interest in philosophy itself, and not only in one of the schools. Fortified by this education, Galen exhorts youth to have a complete education in which philosophy is included, because he considered philosophy as the foundation of every research. Galen goes so far as defining philosophy as a “divine good” (Galen, Adhortatio ad artes addiscenda, I, 17).

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His medical studies started only in the second phase of his life, when his father obeyed the invitation of Asclepius, who had appeared to him in a dream, and decided to make his son Galen be a doctor. For Galen this change of career did not imply abandoning philosophy; he actually continued to consider philosophy indispensable for the good practice of medicine, which he explained in a small work entitled “The Perfect Doctor Should Also Be Philosopher.” He points out and argues this affirmation in a philosophical reflection about the identity of human beings. Galen explains that the logos, which characterizes human beings as rational animals, is both a word, a sentence, a discourse, and a reason (cfr Galen, Adhortatio ad artes addiscenda, I, 1–19). According to Galen, other animals also partly possess the logos, making the real difference between human beings and animals not found in the simple possession of the logos, but in the conscientious and responsible way of living the logos, having the possibility of learning from other men, and aiming in their activities to other’s well-being. The techne constitutes the environment in which humanity can realize itself, in so far as it is the result of a process of abstraction from experience, with the formation of rules and general procedures which, through study and practice, can be applied to singular cases, which are the privileged objects of the specific discipline. Medicine is therefore a scholastic discipline as well as a profession. Therefore, it is proper in the multiplicity of technai, which are learned through practice, that human beings are distinguished from animals. In fact, man discovers and learns many arts and technics, while some animals—though not all of them— practice only one technic, and do so by nature. Some animal arts are copied by men: “Man […] has imitated spiders in weaving, has plasma like bees and is not without exercise in swimming, although it is on earth.” In all his technics, man not only can imitate the technics of animals but also can emulate divine arts, among which medicine is numbered as the medical techne of the God Asclepius: “[Man] does not even miss divine technai, emulating the medical techne of Asclepius, and emulating of Apollo both that same one as all the other arts he possesses […] and still the ones that are proper to every Muse. In fact, he is not a stranger to geometry nor astronomy, but turns his eyes to things both under the earth and above the sky, as says Pindaro, and for love of this work he has procured himself the most important of the divine goods; philosophy. For these reasons, even though other animals take part on the logos, only man is, by excellence, called rational, logicos.” (Galen, Adhortatio ad artes addiscenda, I, 11–19) Medicine is “logos united to experience”; “When I base myself on the opinion of the most expert and wise doctors and the best philosophers of the past, I affirm this: the medical techne is in the first place invented or discovered by the logos united to experience.” (Galen, De experientia medica, I, 1) Thus, medicine is a technic of the gods, and philosophy is a gift from the gods. Both these disciplines share a superior statute, being able to explain experiences with reasoning, and this superior statute, in classical terms, is considered as belonging to the gods. The superiority of the medical science and art explains the complexity of the formation path Galen demands of, as well as the difficulty of entering in the medical

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career: “if, in fact, as the most noble Tessalus has proclaimed, future doctors would not need geometry nor astronomy, nor dialectics, nor music, nor any other beautiful techne, and if there was no need of great experience and familiarity with the works of techne, entering in the career would be possible for anyone who desires to be a doctor in an easy way.” (Galen, De methodo medendi, V, 1.2–9) Galen critics the short formation paths proposed by some doctors: “the promise that it would be possible to lance a medical career after only six months of formation, as the methodical school in Rome proclaimed through one of its most famous representatives, Tessalus,” cited by Galen, “was certainly seducing: the promise of a maximal advantage—a social status, which opened the doors of the rich and powerful, with a minimal force, attracted also the young generations of that age.” (Lombardi [2], p. 133) Galen proposes a complex education for a doctor, and as well demands a human formation, a formation in the virtues of justice, temperance, courage, and good sense, as his father had advised him: “These things all men praise, and all philosophers agree on judging as desirable; we should exercise them from now on and for all our lives. I exhort you to learn them, fortifying yourself, and to aspire to justice, temperance, courage and good sense. In effect, everyone praises such virtues, even though they realize they do not possess any of them. In the eyes of the others, they try to appear courageous, moderate, sensible and just; but in reality they try to hide from pain, also if it does not seem so to the others. That is why you should exercise yourself in this thing before all the others, the thing that is by all men taken most serious of all virtues.” (Galen, Aff. Dig., VIII, 42.11–43). The doctor should therefore study philosophy so that one who takes care of bodies may also take care of his own soul. The doctor then not only appears as an example of knowledge, science, and art but also becomes an example of the human virtues of patience, courage, and justice. Galen continues: It is clear that the true doctor should be a friend of temperance as well as truth. Furthermore, it is necessary to exercise the logical method so as to know how many are the illnesses according to their species and genres, and how to find for every one of them the indications of remedies. […] What is there left to say, then, to favor that a doctor should not be a philosopher, to be a doctor who practices techne in a way worth of Hippocrates? In fact, if to discover the nature of the body and the various illnesses and the indications of remedies one needs to be exercised in the theory of logics, if, to persist in the exercise of these studies with love of the difficulty, it is necessary to contempt richness and cultivate temperance, he will already have all parts of philosophy, the logics, the physics and the ethics. (Galen, Quod optimum medicus, 59.10–60.1; 60.8–61.1)

Therefore, philosophy and medicine find their most strict relation in the love for the truth, in the exercise of virtue, and in the completeness of the very humanity, in which the end human happiness exists. Both medicine and philosophy aim at true happiness, neither at flattery nor at pleasure, they aim at a food that not only pleases—like in the example of cookery— but also does us well. Applying the Platonic scheme, one can say that medicine, along with gymnastics, is concerned about the happiness of the body, and philosophy about the happiness

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of the soul; however, I believe that this dualism is excessive and not at all realistic. Aristotle well accentuates the unity of body and soul in the one substance that constitutes the person. As for the rest, the large field of psychosomatic illnesses and the stories of healing processes confirm in an experimental way that there does not exist a well-being of the body separated from that of the soul, and that the body and soul belong together. In order to attain the health of a person, to cure the body and the soul, one needs to know who the human being really is and offer him the food and remedies that he needs.

5 Conclusion I have chosen only classical examples in both medicine, such as Hippocrates and Galen, and philosophy, like Plato and Aristotle; however, reflections on the relationship between medicine and philosophy are noteworthy in the modern and contemporary spheres, often being stimulated by the interdisciplinary field of bioethics, even though the technicalization and specialization of them both—though necessary and useful in themselves—have at times caused separations, reductionisms, or incommunicability. Understanding philosophy and medicine in their classical context and moment of wellspring can contribute to renovating the general goal and the enthusiasm with which they were born, making evident their common relationships and their common convergence in human happiness. In contemporaneity, we could renew the usefulness of philosophy in reflecting on medicine as an example of complex knowing, both theoretical and practical, and propose to value the possibility of courses of philosophical reflection for doctors as well; like Galen advised, this would not imply studying the thoughts of one or more authors, but of philosophy itself in the sense of theoretical reflections on important themes and the search for truth and good. An integration of philosophy and medicine could correspond better to the globalism of human being, in which in fact does not exist, one happiness of the body and another of the soul, but exists the human happiness of the person who integrates and exceeds both, like the whole always exceeds the parts.

References 1. Lombardi G (2015) Platone e Aristotele su technê e cultura: imparare a discernere. In: Lombardi G, Mantovani M (eds) Pensieri nascoste nelle cose. Arte, Cultura e Tecnica. LAS—Angelicum University Press, Rome, pp 74–95 2. Lombardi G (2012) Logos e Techne. Claudio Galeno e Clemente Alessandrino. In: Carderi F, Mantovani M, Perillo G (eds) Momenti del Logos. Edizioni Nuova Cultura, Rome, pp 123–158 3. Wulff HR, Pedersen SA, Rosenberg R (1996) Filosofia della medicina. Raffaello Cortina, Milan 4. Pellegrino ED (2008) Philosophy of medicine reborn. University of Notre Dame, Notre Dame IN 5. Pagnini A (ed) (2010) Filosofia della medicina, Epistemologia, ontologia, etica, diritto. Carocci, Rome

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6. Federspil G, Giaretta P, Moricci S (eds) (2008) Filosofia della medicina. Raffaello Cortina, Milan 7. Gifford F (ed) (2011) Philosophy of medicine. North Holland, Oxford, Amsterdam, Burlington MA 8. Campaner R (2012) Philosophy of medicine. Casuality, evidence and explanation. Archetipo Libri, Bologna

Ethics in Legal Research Mario Serio, Rosalba Potenzano, Giancarlo Geraci, Rosario Petruso, and Nicoletta Patti

Abstract The essay grapples with one of the most controversial issues about legal research, namely its complex ethical and methodological dimension—here argued to be comparative—assessing the high scientific value of studying law. After clarifying what differentiates such a field of research from other natural and social studies, the authors address the presence of secondary interests and the need to use personal data for scientific purposes, as relevant situations which could undermine the reliability of any legal research or allow its thoroughness at the risk of interfering with human rights. The adherence to a rigorous and effective method in investigating national and foreign law, and the compliance with some ethical canons and principles defined by the scientific community or statutorily imposed, make any legal researcher able to overcome these challenges reaching valuable results.

1 Introduction Scientific research in general obeys a number of rules that are partly common to almost any field in which it is articulated. Mario Serio wrote Sect. 1 of this chapter, Rosalba Potenzano wrote Sects. 2 and 4.1, Giancarlo Geraci wrote Sect. 3.1, Rosario Petruso wrote Sect. 3.2, Nicoletta Patti wrote Sect. 4.2. M. Serio (B) Full Professor of Comparative Law, University of Palermo, Palermo, Italy e-mail: [email protected] R. Potenzano Research Fellow in Comparative Law, University of Palermo, Palermo, Italy G. Geraci · N. Patti PhD in Systems Dynamics - Social Science Path, University of Palermo, Palermo, Italy R. Petruso Assistant Professor in Comparative Law, University of Palermo, Palermo, Italy N. Patti PhD Student in Systems Dynamics - Social Science Path, University of Palermo, Palermo, Italy © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 L. Congiunti et al. (eds.), Ethics in Research, UNIPA Springer Series, https://doi.org/10.1007/978-3-031-24060-7_2

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Mostly, they are aimed at making sure that the research itself is worth being appreciated by scholars belonging to a certain community due to the reliability of its data, thoroughness, correct citations and quotations, completeness of sources, absence of factors negatively affecting its integrity, such as economic interests or links on the part of those who lead the research. Very strict rules are generally applied in order to grant a genuine recognition of the true merits of independent research, the breach of which may well result in discrediting its authors and the outcome of their work. It may well be said that the factors alluded to are supposed to be deemed as prerequisites that every study must possess to be given the green light in every scientific context. This said in broad terms, it has to be observed that peculiar rules govern specific fields of research, according to the goals to be obtained and the particular conditions in which every individual or group research actually operates. As it happens, different catalogs of characteristics are to be found in the various areas where scientific efforts are deployed so as to give them dignity and make them earn acknowledgments and credit. They tend to reflect the specific circumstances surrounding each research and the way of thinking that is typical of the field in question. Legal science is commonly depicted as being founded on the evocative force of words used in laws, judgments, statutory instruments, etc. So, one worldwide bias accompanying legal researches is that they overlook the need to be rigorous and persuading in the development and demonstration of their theses in favor of rhetoric, self-complacency, and assertiveness. One cannot hide the fact that this widely spread criticism can from time to time be encouraged by the attitude shown by legal scholars in their essays, often engaged in confuting other jurists’ theories for the very desire to prove them wrong or in the quest for judicial success in civil litigation or in a criminal trial. But not only is this not always so, but a high degree of profoundness of thought and credible research is more often than not reached in legal studies. To be more precise, a very strong standard of precision, depth, and scientific approach is extensively fulfilled once a series of conditions are adequately met. They have to do with several, different factors, touching upon integrity, width of information, and respect for the position of all those potentially interested in the research. If these objectives are effectively realized, then it follows that research in the legal field may equate itself as far as its genuine value and method are concerned to those in natural sciences. With this perspective in mind, and the desire to rescue legal research from longcultivated prejudices the group of young scholars whom I have been co-ordinating has committed themselves to the task of describing what peculiar rules have to be applied in this cultural environment and what traps have to be avoided with a view to attaining a truly scientifically valuable result. There follow three sections dedicated to central issues regarding legal research, respectively, dealing with the comparative method, the exigency not to unduly mix research and financial interests, and with the protection of sensitive data (and the relevant holders) which may be acquired in the very process of researching.

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As these contributions look at different, national experiences circulating in various legal systems, the final methodological conclusion is that one particular branch of legal science, that is comparative law, can turn out to be of great help owing to its natural inclination to investigate juridical phenomenons taking place elsewhere, i.e., in a country which is not that of the researcher. Putting together the results of a comparison conducted in such a way obviously helps to gain a more ample vision of the legal world in all its manifold, geographical manifestations. And that is in itself a useful manner to let the scientific level of legal research significantly grow.

2 Law and Research: The Comparative Approach as a Scientific Method As social scientists, legal scholars have to investigate and produce new knowledge about human relationships and experiences using a systematic method. Their task is to shed light on the legal phenomena achieving innovative theoretical and practical findings and reflecting society’s expectations. However, one of the main critics against legal research is the failure of such an accomplishment [1] (pp. 187, 189) [2]. Legal scholars’ reasoning often appears too abstract and detached from reality or so biased and rhetorical that it even validates opposite interpretations of the same rule. Before analyzing the specificities of the legal research process, it seems appropriate to take a step back and underline those aspects that every research activity must show to be scientific. Any research “aims to generate (new) information, knowledge, understanding, or some other relevant cognitive good, and does so by means of a systematic investigation” [3] (p. 14). Taking this working definition into account, we can try to identify the hardcore of any science-based enquiry, regardless of the social or natural phenomena into which the research projects itself. These fundamental characteristics are the following: (a) an initial gap in a knowledge field which the research aims to fill; (b) the uncertainty about the result which the research will lead to; (c) the use of a systematic method of investigation which gives scientific dignity to the outcome of the inquiry; and last but not least (d) the adherence to some ethical canons and principles, defined by the scientific community, which are now common heritage for every researcher (see infra paragraph 3.1). The achievement of the expected result is not essential to consider an investigation process as scientific, even though it is possible to clearly recognize an extrinsic value in research that reaches new knowledge and comprehension which are considered beneficial for the whole community. However, any investigation that leads or not to practical outcomes, positively or negatively impacting human life, has an intrinsic value, even only for the scholar who carries the research out. Through the investigation process, the researcher has the chance to acquire new knowledge that

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personally enriches him as a member of the global society and as a scientist. In other words, despite the fact that research is extrinsically valuable when it leads to general progress, “there is something valuable about understanding ourselves and the world around us, even if there is no practical application of that knowledge” [3] (p. 15). Within this conceptual framework, legal research always assumes an intrinsic value that materializes in letting us better understand each other and the environment surrounding us by tracing the object and the thematic area proper to this field of study, that is Law, back into a coherent order. Accordingly, the job of the legal scholar may purely be an ideological task aiming to make society rely on meaningful rules and institutions, through the highlighting of their merits or the denouncing of their evident lacks and defects [4] (p. 12). However, even in this case, legal research would turn out in nothing more than a conceptual abstraction without any extrinsic value since its proper function is the identification of those regulatory solutions which are worth as they are capable of responding to the human needs in a specific historical and social context. The object of legal science, therefore, is not the mere explanation of the rules issued by the legislator, as they exist at a given time within a given legal system nor the building of abstract definition through analytical and value-free reasoning on the enacted statutes [5, 6] (p. 26). Such a formalist and dogmatic conception is derived from the legal positivism doctrine, which assumes that Law coincides with written rules, enacted by institutional bodies and is always fair and just regardless of their contents. This idea is inadequate if compared to the complex structure of modern legal systems whose sources of law are influenced by the rapid and constant evolution of society, undermining the monopoly of legal sources held by the State. Legal researchers should not limit the spectrum of their investigation to the ius conditum, since they are no longer just passive receivers, but active and even critical collaborators when necessary: they are engaged with the process that shapes Law within a legal system, integrating and innovating it [7]. Legal scholarship constitutes one of the ‘formants of the law’ [5, 6], as it cooperates with the legislator and the judge in the construction of the current legal system. Law is a circular process founded on an array of moving or dynamic elements not always enacted nor explicitly formulated by the statutes or the case law [5, 6] (p. 27). As many legal works have distinctively shown [8] (p. 7) [9], one of the first scholars who grasped it was Emerico Amari [10], whose intuition was later developed by Gino Gorla [11] and Rodolfo Sacco [5, 6], becoming a leitmotiv in comparative studies. This latest consideration brings out the first peculiar feature of legal science, which differentiates it from other natural and social sciences. Indeed, any scientific research does not usually change the investigated object: what research focuses on is observed by the researcher without interfering with the existence or the development of the phenomenon under consideration. Conversely, in legal science, the scholar interacts with that object—i.e., Law, as such a complex and dynamic element made up of legislative rules, case law and doctrinal papers—influencing and renovating it. As Professor Rescigno noted, the jurist is also, “simultaneously and necessarily, a co-legislator” [12] (p. 848): the activity of the jurist is neither a mere description nor

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a pure prescription, but it consists of these latter two intertwining elements mediated by an evaluation activity. Legal scholars do not prescribe any rule and their opinion does not have any coercion. On the contrary, the only constraint generated by the outcome of their work can derive from the persuasive force of their speech, if there is a persuasive force. The outcome of legal research very often—within civil law systems and in common law ones lately [13] (p. 42)—prepares the judicial decisions, stimulates the work of the legislator, and may have a leading role in the training of future jurists. This dialectical relationship between the researcher and the object of the research typically characterizes legal science. Finally, there is a second aspect that distinguishes legal research from other social sciences both as to its object and method. Indeed, investigating Law presents necessary a transnational dimension that should always preclude legal researchers from overlooking foreign systems in studying a specific topic. A pure legal domestic investigation would not only reduce the worthiness of the project, but it would even jeopardize the integrity of the scientific activity itself, as it is looked at its ethical side also, which is fundamental in any research. The researchers, indeed, should see their national law as a mere starting point; legal scholars, in other words, should look outside their juridical systems to know Law in depth. Indeed, to fully accomplish the very aim of Legal science in its intrinsic and extrinsic values, researchers should start with the analysis of the facts and the actual needs of people seeking some legal protection. This empirical approach is fundamental for understanding Law and it does not have national boundaries. Gathering all the statutory rules and case law pertinent to the chosen topic, as well as the most relevant opinions from other scholars who have already dealt with that subject is not sufficient to deeply understand a legal phenomenon if all these data refer to a singular legal system. Legal researchers are required to observe how Law responds to certain social expectations that are shared by human beings themselves—as citizens, workers, or parts of other social, family, or economic relationships—over time, within and outside the system of belonging. As Professor Sacco said, “only through comparison do we become aware of certain features of whatever we are studying” [5, 6] (p. 5). Under this point of view, the legal phenomenon is precisely as universal as a human being is. Accordingly, legal research should tailor its own features and methodology to this last evidence, enshrining common categories throughout the scientific community [14].

3 Conflict of Interests in Legal Research 3.1 Conflict of Interests in Research: Definition, Content and General Issues One of the common elements of each type of research is the adherence to some ethical canons and principles, defined by the scientific community, which are now

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common heritage for every researcher. The compliance with ethical canons by the entire scientific community, in fact, allows to achieve a scientific product that is intact, pure, and transparent and ensures that the product itself will be more valuable for the whole community [15] (p. 2). As it has been observed [16], ethics pertains to doing good and avoiding harm. Harm can be prevented or reduced through the application of appropriate ethical principles. The researcher, including the legal one, must pursue the integrity of research, i.e., the set of ethical principles and values, ethical duties, and professional standards on which a responsible and correct conduct should be based by those who carry out, fund or even evaluate scientific research, as well as by the institutions that promote and execute it [17]. According to this definition, it can be said that the integrity of an investigation is precisely the final result that can be achieved by the researcher, when he/she respects ethical standards developed by the scientific community. Among the ethical rules to be followed by scholars, there is that of avoiding conflicts of interest in conducting a study affecting the integrity and the accuracy of the findings. Conflict of interest is generally defined as the circumstance which creates a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest [18] (p. 297). If we apply the above definition to the field of sciences, it follows that a conflict of interest arises whenever the main interest of the researcher, i.e., to lead his/her peculiar activity to achieve the best possible result, is improperly influenced by other factors, essentially related to the role played by the researcher inside or outside the academic community. In this way, in substance, such an undue influence will adversely affect the results of the research. As an example, we might consider the case, statistically recurrent, of the researcher who is studying the effects of a certain drug, not yet on the market, produced by a pharmaceutical company that owns corporate shares of the university where he/she carries out the investigation. In such a situation, it is clear that the primary interest of the researcher, that is to study with objectivity and transparency the beneficial effects or, on the opposite, the side effects of that particular drug, may be at odds with other interests, such as that of the pharmaceutical company and, consequently, also of the university to which he/she belongs not to see its product discredited. The researcher, therefore, will find himself forced to decide whether to pursue the main interest inherent in his scientific activity (i.e., to provide better information and knowledge about this drug) or whether to give preference to these secondary interests and to produce an academic paper that is untrue, non-transparent or simply not complete. As can be guessed, the pursuing of a systematic investigation in the presence of a conflict of interest badly affects both the extrinsic purpose of the scientific study and its intrinsic purpose as well (see above paragraph 2). In that order, it unduly affects the extrinsic purpose of the research because the resulting scientific product will not be true or, in any case, objective as it should be and, therefore, will cause harm to the community. In the same way, it will also prevent the achievement of its intrinsic purpose, since the research itself will not be a source of enrichment for the researcher but, on the contrary, a source of compromise of his/her integrity and,

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therefore, will ultimately be a source of harm to himself/herself. For these reasons, where a conflict of interest arises and where that situation negatively affects the outcome, we speak of misconduct of science. This term, as defined by US Public Health Service, “means falsification, fabrication, plagiarism, or other practises that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.” On the basis of the above, it is clear why conflicts of interest should be avoided. In fact, the more the researcher is made free from situations that could negatively influence the investigation, the more the transparency and integrity of the scientific product itself are guaranteed and, conclusively, the freedom to carry out research is also preserved. As has been affirmed by some Italian legal scholars [19, 20], freedom of research is an inviolable right of the individual, that usually is protected under the head of the more general right of freedom of speech [21] as it is safeguarded by Article 9 of the European Convention of Human Rights and by Article 10 of the Charter of Fundamental Rights of the European Union and as such must be guarded against any unjustifiable external influence. At the same time, as pointed out above (see paragraph 2), freedom of research also has an external relevance. In this way, in substance, it is possible to distinguish this right from that of freedom of thought. The research activity, in fact, leads to a scientific product that has lots of implications on the scientific community as a whole and, therefore, is closely tied to a responsible activity of the researcher [22]. Thus, in addressing this point, we could say that the more the researcher is guaranteed an environment free of conflicts of interest, the more his/her freedom of research is protected, and, accordingly, the extrinsic utility of the scientific product itself is safeguarded. If the researcher, on the other hand, carries out an investigation negatively influenced by the existence of a conflict of interest and, therefore, elaborates an untrue scientific product, then he/she would violate the aforementioned principle of accountability and would face negative consequences within his/her own scientific community. Conflicts of interest might arise in various situations. Statistically, the most frequent cases in which a conflict of interest occurs are those in which there are economic interests of the committer of the research in relation to the final scientific product (the so-called financial conflicts of interest). These cases of conflict of interest emerge mainly in the field of medical research, as any type of research dealing with products related to human health. This definition also includes, in particular, cases of conflicts of interest involving the tobacco industry or research, financed by these industries, which tends to sponsor tobacco products while putting aside the main scientific interest, i.e., the integrity and truthfulness of the research [23]. There are at least two reasons. Medical investigation requires the investment of significant economic resources that the public universities are often unable to finance on their own and therefore calls for the intervention of private capital, this kind of research also gives rise to products, such as drugs or

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therapeutic techniques, which can have a significant economic return for the research sponsor [24]. Another critical type of case where conflicts of interest arise are those where the researcher has an interest in not clearly communicating the possible dangers stemming from the investigation to those who voluntarily submit to it. It may happen, in particular, that the researcher (for whatever reasons and in response to a wide variety of factors, e.g., in order to further his/her career) must accomplish the task quickly and, to this end, omits to inform those who voluntarily submit to it of the likely risks that this could cause to their health, inflicting them even very serious damages. Proof of this is the most celebrated and sadly known case Gelsinger case of 1999. Jesse Gelsinger, a volunteer in a clinical study conducted at the University of Pennsylvania, died as a consequence of a gene therapy trial. Both the lead investigator and the University of Pennsylvania owned equity in a company involved in the study. After an investigation, the FDA concluded that Jesse’s liver was not functioning at the minimum level in order to participate in the study. In addition, the researchers failed to report severe side effects experienced by other subjects, which would have resulted in halting the study. The literature on this subject suggests that the potential financial gain by both the lead investigator and the University of Pennsylvania if the trial was successful may have clouded the judgment of those conducting the study [25]. As can be seen, therefore, also, in this case, there is a conflict between the primary interest of the researcher, which should be to conduct scientific research that brings benefits to the community and does not harm it, and a secondary interest that, in the circumstances described, consists of publishing the results as quickly as possible. From our angle of view, another field in which the negative effects of conflict of interest might arise is the evaluation process of an academic research. This topic will be discussed further below. Because of the universal nature of science, the phenomenon of conflict of interest affects the entire scientific community, without territorial limitations. Therefore, one wonders what remedies may be used to eradicate it or, at least, how to limit at the maximum extent this concern. It is necessary to analyze with care what exactly is at issue: the relevant matter is not the conflict of interest itself, but its possible morally reprehensible outcome. In other words, the conflict of interest is not a behavior but simply a condition [26]. The conflict of interest, precisely because it constitutes a condition and not a behavior, becomes morally reprehensible only when it gives rise to reprehensible behavior and, in particular, causes harm (or could likely cause harm) to the scientific community. For this reason, it cannot be banned completely, but must be taken under careful scrutiny through the enforcement of soft law rules [27]. Under this trajectory, each university has developed codes of conduct or ethical charters to which researchers must adhere and through which moral sanctions are imposed on those conducts which are influenced by conflicts of interest. As an example, see the Research Ethics: A Handbook of Principles and Procedures of the University of Gloucester, in which is expressly said that, one of the principles governing research, is the “fidelity— honesty, integrity, trust.” See also art. 26 of the Code of ethics and conduct of the

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University of Palermo. It is worth mentioning that arranging a code of conduct is a precise duty of each Italian University as provided by article 2, paragraph 4 of the Law no. 240 of 30 December 2010, containing “Rules governing the organization of the university, academic staff and recruitment, as well as delegation to the Government for promoting quality and efficiency within the university system.” Among Universities, it is usually also established the formation of advisory ethics committees, the so-called COI Committees (Conflict of Interest Committees), to ensure that these rules are fully accomplished [28]. If, therefore, the conflict of interest is not necessarily a problem in itself, but a situation or a circumstance, and if the main purpose of the conflict of interest discipline is to ensure the transparency of the study and the maximum reliability of the researcher, then one understands how the fundamental remedy consists of imposing prior disclosure obligations on who is carrying out the investigation. These are obligations of transparency that impose on the researcher some specific duties, such as a duty to communicate previously whether there is a conflict of interest with the research client and a duty to communicate the results of the research in full, i.e., without omitting certain results that may be unfavorable to who commissioned and funded the relevant study. To put it in other words, those who are executing a scientific investigation must not allow themselves to be influenced by private interests because, as previously stated, science and research belong to everyone and they cannot be bent to mere private interests. In fact, there is a duty of solidarity among scholars: they must behave in such a way that science and research are useful to all and not only for some and harmful to others. Another remedy that has been developed in some universities, such as at the University of Ulm, to prevent the negative results that a conflict of interest can lead to is to set up training courses focused on identifying the principles of ethics in research and, in particular, aimed at teaching the researcher how to recognize a conflict of interest and how to behave correctly in these situations [29].

3.2 The Peculiarities of Conflict of Interests in Legal Research So far, the problems posed by conflicts of interest have been examined with reference to all types of scientific research. From this point on, we will focus on the peculiarities of conflicts of interest that may occur in legal research. As above highlighted, conflicts of interest occur whenever the researcher is in a situation that leads him/her to pursue a secondary interest, different and at odds with the primary interest that the scientific research should instead aim at. In this vein, in the field of legal research, it can very often happen that the researcher is, at the same time, a lawyer. Generally speaking, there would be nothing

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wrong with this, but a conflict of interest might occur when the research area of the researcher/lawyer is the same as that of a case he/she is advocating. As it is well known, in fact, Law is not an exact science, as it is conducted in the field of human sciences. On the contrary, it is essentially a matter of interpretation. For this reason, it may happen that the researcher/lawyer might try to indirectly influence the opinion of the judge through the publication of articles, formally scientific, but which actually only promote the thesis sponsored in the client’s interest. In other words, in advocating a certain thesis, the author could be only interested in it as a means for circumventing other alternative theses in order to achieve a mere professional goal, in the way considered appropriate in the best interest of the client. In so doing, it is apparent that the researcher betrays the main purpose of science, that is to develop research that fully reflects his or her own thinking without bias and is in no way influenced by secondary ends, such as prevailing in a judgment. It goes without saying that here the way of solving the problem cannot be those examined previously. In fact, against this background, there can be no disclosure obligations on the researcher that can suffice, as it is the same decision to publish a paper or an article on that particular topic that is aborigine influenced by the willingness of the researcher/lawyer to unduly influence the judge’s thinking. Thus, in the light of the foregoing discussion, the present case can be addressed relatively briefly: in the particular circumstances described, the most straightforward answer, consonant with justice and good sense and intended to promote science, should be to refrain from sponsoring that particular case or, on the opposite, not to publish anything on that subject. Such a clash between who acts at once both as a researcher and as a lawyer could also occur in those cases where he/she decides, once the judgment has been handed down (and especially once it has become final), to publish comments relating to that decision, supporting the thesis most favorable to his/her professional interests. Also, in this case, we face the concern signaled above, that is the fact that the scientific product should not be considered as such (at least properly, as if it is true, transparent, accurate, trustworthy in the scientific community) because it is the by-product of the personal experience of the same person who has sponsored, for professional aims, a certain thesis. In fact, it is clear that between the position of the researcher and that of the lawyer there is an inherent incompatibility when the corresponding plans intersect with each other. As it has been said many times, in fact, the researcher must be transparent, inspire confidence and trust from the outside. The lawyer, on the other hand, is by definition partial, because he/she must pursue a specific thesis from the beginning, protecting the interests of the client even if it is not a position shared from a theoretical point of view. The Code of Conduct for European Lawyers emphasizes the importance of the relationship between the lawyer and his/her client. In its preamble, it states that “A lawyer must serve the interests of justice as well as those whose rights and liberties he or she is trusted to assert and defend and it is the lawyer’s duty not only to plead the client’s cause but to be the client’s adviser.” Even more evidently in this sense, in the part relating to general principles, the Code refers to the client interest, providing that “Subject to due observance of all rules of law and

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professional conduct, a lawyer must always act in the best interests of the client and must put those interests before the lawyer’s own interests or those of fellow members of the legal profession.” Although, what differentiates this last hypothesis (that from our angle of view is worthy of mentioning because of its less serious consequences if compared to the previous scenario) is that the researcher/lawyer deals with precisely that field of academic investigation and, therefore, the choice to publish has no ulterior motive other than to enrich the extent of the scientific knowledge in that particular area of law. To sum up, here, there is no secondary end, such as prevailing in a judgment. Nevertheless, in this latter scenario, in order to safeguard the credibility and the trustability of the research, it seems necessary for him/her to communicate to the reader the existence of the (maybe only apparent) conflict of interest that could affect the objectivity of his/her thought and judgment. In this sense, the American Speech– Language–Hearing Association’s (ASHA) Code of Ethics states that “Individuals shall not participate in professional activities that constitute a conflict of interest.” The rationale in such cases is that previously mentioned, regarding research in general: the existence of a conflict of interest could lead to biased findings. That conclusion is far from being an inevitable consequence: however, that does not mean that the potential concern here addressed does not arise in terms of trustworthiness and integrity. From our angle of view, this point should not be underestimated. Even without the complications arising in the case in which the author has the precise willingness to influence the judge, the researcher must bear in mind how to recognize a conflict of interest and how to manage it in order to promote a science that appears as such: that is because the mere appearance of bias is sufficient to overturn the reliability of a scientific work. Citing and applying to the present hypothesis a famous English aphorism on how Courts must adjudicate, we could say that it is not merely of some importance but is of fundamental importance that science should not only be pursued but should manifestly and undoubtedly be seen to be pursued. The original aphorism is as follows: “It is not merely of some importance but is of fundamental importance that justice should not only be done but should manifestly and undoubtedly be seen to be done.” This dictum was laid down by Lord Hewart in Rex v. Sussex Justices, [1924] 1 KB 256. It is worth mentioning that this landmark ruling has been the basis of several decisions where even the appearance of something improper has been a ground to set aside an order of a court, tribunal, or quasi-judicial authority. Accordingly, the most suitable approach that should be adopted to face these events lies in the aforementioned duties of disclosure. It is worth emphasizing that here there is no valid reason why the author should not express his/her point of view on this topic. Quite on the contrary, the fact that the researcher has acquired professional skills in that particular area of the law makes him/her the most appropriate person in dealing with it. What we are now saying is just that the existence of such an overlap of interests (professional on the one hand and merely theoretical, on the other) would add another dimension to the difficulties.

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The potential concern that here arises is that of avoiding that the supported thesis appears not to be biased. With this in mind, it would be necessary that the author takes account of all possible interpretations, paying close attention to the different points of view that have been expressed on the matter or that might be sustained. Most importantly, it would also be necessary to consider the question of the various interests at stake, other than those supported by the author, and how they should be addressed both procedurally and substantively. In short, the researcher is asked for a deeper investigation and he/she must proceed tentatively. Putting matters broadly, in those circumstances it is reasonable to expect from the author a more rigorous approach (in terms of accuracy and completeness) and a more scrupulous duty of disclosure as well, both intended as means of avoiding even the mere suspicion of being thought to have been biased in conducting the investigation. On that basis, a paradigmatic example and a valuable lesson as well come, once again, from the English legal system. Lord Andrew Burrows, both a distinguished professor and a lawyer (and also a judge of the UK Supreme Court since June 2020), in one of his last writings on unjust enrichment (one of his main professional and academic interests as well) [30], quotes a judgment of an English Court, taking care, however, to make it unambiguously clear to the reader that he had been one of the counsels acting on behalf of the claimant in the proceeding before the Court. At note 76 on page 538, he says: “I should make clear that I was one of the counsels acting on behalf of […].” It is evident that this passage gives emphasis to the kind of duty of disclosure we were referring to before, that (in addition to a more scrupulous scientific investigation focused on pinpointing all the strengths and weaknesses of the other possible interpretations) is aimed at safeguarding the trustability of both the researcher and the scientific investigation and its outcome as well. Turning to the hypotheses where a conflict of interest may occur, another fundamental area in which we are interested (mainly from the perspective of ensuring the accuracy and the completeness of the academic investigation) is the assessment process of the findings, particularly in the field of legal research. As highlighted before, legal research differs from hard science because interpretation plays a predominant role in it. Legal research and legal reasoning are matters of interpretation [31–33], since each regulatory provision may be subject to various constructions: therefore, what really counts are the reasons given for a specific interpretation. In this sense, then, the evaluator of the essay plays a fundamental role, since his/her role is to verify and assess whether or not the researcher has followed a legal reasoning based on solid interpretative bases. It is well known that the publication of the results of one’s research in authoritative journals is vital for who is carrying out a scientific investigation, not only for the personal satisfaction of the author and for the dissemination of the findings but also in order to enrich one’s academic curriculum. Proof of this is the common phrase “to publish or to perish,” which describes the pressure in academia to rapidly and continually publish academic works to sustain or further one’s career.

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In order to assess the quality of a scientific research, the evaluation system known as peer review has become widespread. In that regard, peer review is fundamental to the scientific publication process and to the dissemination of sound science. Peer reviewers are experts chosen by editors to provide a written assessment of the strengths and weaknesses of every single piece of research, with the goals of improving the quality of the research and of identifying the most appropriate and finest material to be published in the scientific journals [34]. It is, therefore, clear that peer reviewers must be professional, objective in their valuations, and transparent. Accordingly, their own assessments must be accurate and constructive. The higher the evaluation standards are, the more relevant will be the scientific and popularity of that particular journal. However, and here lies the problem from our point of view, in legal scientific journals, evaluators (as well as those evaluated: for this reason, this system is called double-blind peer review) are protected by anonymity. This feature of the evaluation system may have negative implications in terms of whether or not the evaluated essay/article/note is worthy of publication. In fact, should the quality level of the scientific product not be what one would expect or, worse, should the scientific product contain errors, the only responsible party identifiable from outside would be the author, whose name is published at the bottom of the article. However, the question arises as to whether it should not also be appropriate to publish the name of the person or persons who have evaluated that particular work and considered it worthy of publication. An ethical system of evaluation (that favors accuracy and completeness), in fact, should make it possible to identify externally the accountability not only of the author but also of those who, during the evaluation process, did not realize the error and, therefore, are co-responsible because they negligently carried out their own evaluation work. In line with the foregoing, we can conclude these few observations by saying that the conflict of interest in the field of scientific research and, in particular, in legal research, is a condition that exists and must be interfaced with. To sum up, the best paths to face these kinds of problems are those consisting in disclosing the existence of such a conflict, as well as in refraining from the outset in undertaking a certain scientific activity that can be said to be flawed from the beginning. In that order, the fundamental objective of the various ethical charters and codes of conduct in science is, therefore, not to eliminate any conflict of interest at the root, but to ensure the transparency, reliability, and objectivity of the research itself, so as to protect at the same time its integrity.

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4 Legal Research and Data Protection 4.1 The Use of Personal Data for Scientific Purposes: The European Regulatory Framework Legal research, being carried out in the social sciences field, investigates human experiences. The indissoluble link that binds legal science to people and their behaviors leads the researchers to deal with information that is functional to the inquiry and attributable, directly or indirectly, to an identified or identifiable natural person. Scholars collecting personal data or extracting it from other sources, such as judgments or papers relevant to a specific topic, make this flow into original research that could be deposited in online databases freely and instantly accessible and published in open-access journals. Researchers are, indeed, encouraged to share their knowledge and data, deepening transparency, interdisciplinarity, accessibility, and equality in science and elevating scholars’ and citizens’ learning [35]. To this end, the European Commission has promoted, among other initiatives, a multidisciplinary platform allowing researchers, professionals, and citizens to access services, data, and other resources, using and re-using data for innovation and educational purposes. The implementation of the so-called European Open Science Cloud (EOSC) has the ambition of developing open science practices in Europe [36], to the end of fully achieving a “European research area in which researchers, scientific knowledge and technology circulate freely” (Article 179(1) of the Treaty on the Functioning of the European Union). Nevertheless, to manage information related to a natural person, albeit necessary to conduct research and increase knowledge and awareness, requires the researcher to be careful and consider other priorities than mere pursuing his scientific goals. As the Cambridge Analytical scandal taught, preserving privacy should be one of the main concerns for scholars who use personal data for scientific purposes [35]. Several international documents, such as Article 12 of the Universal Declaration of Human Rights or Article 17 of the International Covenant on Civil and Political Rights and some national and European Charters, protect the above fundamental right. Any researcher, therefore, has to not interfere with the privacy of those involved in their studies and, as far as legal science is concerned, mentioned in the judgments and articles examined by scholars. From the overall European regulatory architecture concerning data protection and the free circulation of personal data, however, scientific research appears to enjoy a very flexible status regarding the processing of those data essential for the development and acquisition of knowledge [37]. Indeed, the European Regulation 2016/679 (known by the acronym GDPR) repealing Directive 95/46/EC suggests that the idea that information that identifies (or allows for the recognition of) a natural person belongs to the exclusive sphere of the subject has been overcome. Recital 4 of the GDPR states that “The right to the protection of personal data is not an absolute right, it must be considered in relation to its function in society and be balanced against other fundamental rights.” Likewise, Article 8 of the Charter of Fundamental

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Rights of the European Union, after plainly having declaimed the right of everyone to the protection of personal data concerning him, subordinates the related processing to the consent of the interested party or another legitimate basis provided for by law. Upon a closer inspection, then, consent is not essential to proceed with the use of personal data, i.e., “any information relating to an identified or identifiable natural person (‘data subject’) (…) who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person” (GDPR, Art. 4(1)). In confirmation of this, Article 6 of the GDPR provides that the data controller can lawfully process personal data with a “legal basis” other than consent, to the extent that, like other alternative conditions, “processing is necessary for the performance of a task carried out in the public interest.” This element, i.e., the public relevance of the task, is precisely the foundation on which tracing the normative status of scientific research. The regulation offers the legal basis to balance a fundamental right like privacy, as it is protected by Article 8(1) of the Charter of Fundamental Rights of the European Union, with a public interest like the legitimate expectations of society for an increase of knowledge. That does not mean that the fundamental character of privacy can be easily disregarded, but only that the processing of personal data, which are an expression of the individual’s personality, cannot be placed in a perspective of total informative self-determination of the subject, having to consider the public interest underlying the circulation of such data [38]. Information is the basis of science which, in turn, produces theories, knowledge, and further data, consequently, it is in the social interest to let scientists have ample access to personal data. Within this framework, the GDPR, at Article 89(2), allows some derogations relating to processing data for scientific research purposes, limiting the right of the data subjects to access personal data and to obtain some information, such as those regarding the aim of the processing itself (Article 15 GDPR). Moreover, the scientific researcher acting as a data controller can refuse the person’s request for the rectification (Article 16 GDPR) or restriction (Article 18) of personal data and process it despite the data subjects’ objection (Article 21). Likewise, under Article 17, par. 3, letter d) GDPR, the right to obtain from the controller the erasure of personal data concerning him or her without undue delay (the so-called right to be forgotten) can be limited for research purposes in so far as “is likely to render impossible or seriously impair the achievement of the objectives of that processing.” The favorable nature of the regulatory discipline relating to the inquiry activity conducted in the scientific field transpires even more clearly if we look at the reuse of personal data collected for other purposes. Indeed, in this regard, the GDPR establishes a presumption of compatibility between the ends of any scientific research and those pursued through the original data gathering (Article 5, paragraph 1, letter b). Moreover, Article 49 states that a transfer or a set of transfers of personal data to a third country or an international organization shall take place in the absence of an adequacy decision under Article 45(3), or of appropriate safeguards under Article 46, if “necessary for important reasons of public interest” (letter d). In combination with

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Article 89 GDPR, these provisions imply that the information collected can be reused or transferred for further and different needs related to cultural and technological development without ensuring to the natural person the entire exercise of its rights, such as the powers of access, rectification, cancellation as well as limitation and opposition to the use of data. The system resulting from the GDPR seems to admit the above-mentioned relevant exceptions to the rights of the data subject exclusively on the assumption that the data controller disposes of some technical and organizational measures, in compliance with the so-called principle of “minimization” of data, as a reflection of the accountability of the data controller [39] (p. 135). This principle refers to the data controller’s duty to act in adherence to the GDPR at the time of the determination of the means for processing and at the time of the processing itself or—in other words—to protect privacy by design and by default (Article 25, GDPR), exclusively using those data that are placed in a relationship of adequacy and relevance for the purposes pursued, following the principles of necessity and proportionality (Articles 5 (1), letter c) and 89, paragraph 1, GDPR). These measures, however, are not strictly predetermined by the European legislator with the result that the line that traces the midpoint of the fair balance between the “two souls” of privacy, one private and the other public, is vague and open to be declined according to the different cultures coexisting in Europe. It follows that this delicate task is up to the sensitivity of each national legislator and, more generally, to the researchers themselves. On the one hand, national legislators must mitigate any potential privacy breach in scientific research based on a preliminary assessment of the risks of the processing, preparing suitable measures in the research planning phase (“privacy by design”) or, later, by default. On the other hand, beyond any legislative obligation, self-control by researchers is needed foremost as a conscious fruit of their firm education, not only about legal issues but also ethical ones: the amount of information obtainable from people must necessarily be parameterized to the expected results and the adopted methodologies [38] (p. 199). If the identification data is filtered upstream, considering the requirements of confidentiality and respect for private life, the danger of infringing on individuals’ rights and freedoms is avoidable [40] (p. 56). Here, the procedural elements stand out: attention must be paid to the conduct of operations carried out with personal data, thus reaching protection from the earliest stages of the activity, when the danger can still be “minimized” if managed correctly, guaranteeing both the access to personal data functional to scientific research and the protection of the right to privacy. To this goal, different approaches can be adopted, among which those suggested by the European Regulation to process data for scientific purposes, such as collecting them anonymously or proceeding with their anonymization or pseudonymization immediately afterward. The anonymization, however, seems to fully solve any juridical and ethical concern about the use of personal data, namely if data are anonymously gathered right from the beginning. In this case, the risk of re-identification is null [41]. In particular, the term ‘anonymisation’ refers to a method of processing personal data aimed at totally and irreversibly preventing the identification of a natural

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or legal person. This technique makes it impossible to connect this specific information to the person to whom it refers, therefore—since the data protection principles apply to all information relating to an identified or identifiable person—the GDPR does not apply to anonymized data. The processing of personal data so that they cannot be attributed to a particular subject without the use of additional information, instead, is called ‘pseudonymisation’ and it consists in storing data using techniques such as coding or hashing that substitute personal information (such as an individual’s name) with another unreal identity-related identifier [41]. In this case, researchers aim to protect data subjects’ rights keeping the possibility to go back to the personal data (GDPR, Article 4(5)).

4.2 The Reuse of Personal Data in Legal Research: A Comparative Overview The theme of the reuse of personal data for scientific research purposes—which we will focus on from now on—introduces a more specific scenario, both essential and critical, for the legal investigation, which is often based on the collection and study of a large number of information acquired for other purposes (e.g., by the judge to solve a litigation). These personal data, indeed, are frequently reused to be then published in academical reviews, amplifying so their spread without the consent of the interested people. The information (concerning, for example, the sexual orientation, the reasons for a divorce, the state of health, or the desire of a terminal patient to die) may refer to very personal events faced within the decisions which are often retrieved and discussed by reference to the name of the parties involved in the proceedings: this is a common practice in national systems, regardless of the judicial tradition such systems belong. To refer to the name of the parties to identify the judgments, indeed, it is frequent not only in common law countries—where it is functional to create a univocal correspondence to recognize any binding precedent (i.e., the Donoghue v. Stevenson)—but also in civil law ones (think, for example, the Englaro case or the Meroni case). The same applies to the rulings of the Court of Justice of the European Union in Luxembourg (e.g., Google Spain SL and Google Inc. v Agencia Española de Protección de Datos (AEPD) and Mario Costeja González) or the European Court of Human Rights in Strasbourg (e.g., Pretty v. UK case). In this way, in substance, it is possible to know the individuals to whom the private details of life that emerge from the judgment itself pertain [42] (p. 693) and, at the same time, to figure out how the two above highlighted privacy aspects—that of publicist relevance and that of the individual one—could clash. On the one hand, the interest in increasing the spread of the content of the judgments to provide better information and knowledge about the evolution of the law to citizens, as well as to check judicial power to better trust in it, is higher and higher among contemporary democracies (infra). The decisions of the judges, after all, participate in the creation of the national legal systems as a formal or informal source of law (see above paragraph 2), therefore, their knowledge must

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be necessary as the knowledge of the other official rules. On the other hand, the need to maintain confidentiality on delicate events revealed by the parties during a trial it is equally considered a priority and, generally speaking, legal research disregards the clarification of the parties involved. However, it is not always possible to omit any reference to the parties: consider, for example, the cases in which subjects of public notoriety are involved in the procedural affair or disputes relating to the confusion of distinctive signs (where often the contested sign coincides with the name or with the denomination—if it is a legal person—of one of the parties). States are thus required to face such a conflicting situation as that above described and provide, case by case, a fair balance. A brief comparative overview shows how— both at national and European levels—to fulfill this delicate aim, it is more and more frequent the use to the techniques of anonymization and/or pseudonymization of the subjects involved in a judicial proceeding (as suggested by the GDPR) voluntarily or, more rarely, on a legislative impulse [43]. As we will see, such techniques can take on different connotations: from the obscuring of the identity of the parties since the introductory phase of the trial and in all subsequent procedural acts, up to the affixing (at the bottom of the ruling) of a ban on disclosure of names. Nevertheless, in some cases, due to the close link between the matter of the dispute and the name of the parties, the anonymization procedure does not appear abstractly admissible [42] (p. 718). In the Italian legal system, for example, the limits and methods of anonymization of personal data of the proceeding’s parties have their normative discipline in Articles 51 and 52 of the Code on the protection of personal data, issued by Legislative Decree 196/2003 (cd. Privacy Code), as amended by Article 3, para. 2 (c), of Legislative Decree 101/2018. The aforementioned GDPR adjustment decree did not incisively change the previous regulatory situation, having deleted from art. 52 only the words “for legal information purposes in legal journals, electronic media or through electronic communications networks.” Namely, on some conditions—at the request of a party or even ex officio—the Privacy Code allows the judge to order the deletion of the names of the parties before the publication of the judgment. The main goal of the legislative discipline is coordinating the protection of confidentiality with promotion and openness of justice: the abovementioned Articles, indeed, tend “to facilitate the development of legal information technology in compliance with the principles regarding the protection of personal data” (as explained by the Report annexed to the Privacy Code). In the same way, the Guidelines on the processing of personal data in the reproduction of judicial measures for legal information purposes—dictated by the Privacy Guarantor with its own document dated 2 December 2010—promote “the spread of legal judgments” such as “a precious source for the study and growth of legal culture and an indispensable tool for citizens to control the exercise of judicial power” [49]. However, the same Guidelines warn about the “risk of on-line publications, susceptible to indexing, decontextualized reproduction, alteration, even manipulation and therefore in no way comparable to paper publications,” recommending thus the protection of personal data included in the contents intended for publication [49].

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It should be noted that the precautions to be observed in the spread of decisions do not concern all the data (for example, the particular event relating to the subject’s state of health or sexual orientation) but only the identification data; moreover, they do not concern all the decisions, but only those in which, by law or according to the assessment of the judge, there is an actual need to conceal the same data. In general, therefore, as stated in articles 51 and 52, paragraph 7, of the Privacy Code, the judgments and the other judicial measures can be disseminated in their full text, including the details of the parties and of the subjects involved in the judicial matter (articles 51 and 52, paragraph 7, of the Privacy Code) [44]. Article 52 of the Privacy Code, besides, does not affect the provisions concerning the drafting and content of the sentences, so that the pronouncement, at the moment in which it is drawn up and filed with the registry, must contain an indication of the names of the judge, as well as of the parties and their lawyers (cf. art. 133 cod. proc. civ. and art. 536 and 545 cod. proc. pen.), it intervenes only to regulate the moment of disclosure of the sentence or of the judicial measure for purposes of legal information. In particular, according to the first paragraph of the aforementioned rule, the person involved in the dispute may request the anonymization of the decision for “legitimate reasons” and “before the relative level of judgment is defined.” The anonymization takes place, under paragraph 4, by affixing a specific annotation on the original of the judge’s ruling that requires the anonymization of the personal details and other identification data of the person concerned, in case of dissemination of the judicial measures. The adoption of this precaution is the responsibility of the judicial authority, which will have to evaluate concretely the legitimate reasons given by the person concerned balancing, on the one hand, the principle of general knowledge of judicial measures and the complete content of the judgments as an instrument of democracy and, on the other hand, the legal information and the protection of the person [42] (p. 715). Anonymization is thus a possible solution, but not automatic, since it is subject to the presence of particular circumstances and duly justified reasons whose assessment is to the discretion of the judge. The same authority, indeed, may order ex officio anonymization to protect the rights or dignity of the data subjects (Art. 52, paragraph 2, D.Lgs. 30 June 2003, n. 196). In other cases, however, the anonymization of the identification data takes place necessarily, because it is imposed by a legislative provision. As paragraph 5 of Article 52 of the Privacy Code underlines, the prohibition of disclosure of the personal details of persons offended by acts of sexual violence without their consent is illegal under Article 734-bis of the criminal code. Moreover, in the event of spread of judicial decisions, it is always necessary to omit—even in the absence of the aforementioned annotation—“the personal details, identification data or other data also relating to third parties, from which can be even indirectly inferred the identity of minors or of those parties involved in proceedings concerning family relations and the status of individuals” (Art. 52, paragraph 5, D.Lgs. 30 June 2003, n. 196). If Italian law deals in depth with this delicate issue, however, the practice of the nominative disclosure of judgments certainly finds its most complete and significant expression in the common law model; therefore, after analyzing the discipline

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adopted by a country of civil law, it is appropriate to make a comparison with the solutions adopted in the United Kingdom. Looking at the sources governing the issue, a premise is necessary: the process of withdrawal of the United Kingdom from the European Union (so-called Brexit) is now complete. UK organizations processing personal data during the transition period (until 31 December 2020) have remained bound by two laws: the EU GDPR and the UK DPA (Data Protection Act) 2018. Currently and starting from January 2021 the EU GDPR no longer applies directly in the UK. However, British organizations have yet to meet its requirements. The name of the parties—plaintiff and defendant—plays a crucial role in the context of the application, repertory, and study of English law: their spreading, indeed, is felt as a fundamental part of the Open Justice principle, which constitutes the foundation of the English judicial system and, probably, of democracy itself. Open Justice is one of the most important principles for the administration of justice in common law systems, describing legal processes characterized by openness and transparency [45]. Although it is functional to the observance of the first principle, the concept of Open Data is different. The latter term, indeed, refers to making structured databases available for public download [40] (p. 47). As Jeremy Bentham said, “Publicity is the very soul of justice. It is the keenest spur to exertion and the surest of all guards against improbity” (Scott v Scott [1913] AC 417, p. 477; R (Guardian News and Media Ltd) v City of Westminster Magistrates Court). Therefore, open Justice is a jealously guarded constitutional principle, but it is not absolute and it can be excepted, although on highly restrictive conditions (R v Bedfordshire Coroner, ex p Local Sunday Newspapers Ltd [1999] 164 JP 283, in [2]; In Re S (A Child) (Identification: Restriction on Publication) [2005] 1 AC 593, in [18]). The courts, indeed, have recently recognized some exceptions to that principle considering two main hypotheses [46] (p. 723): the first concerns the proceedings precisely initiated to protect privacy (e.g., dispute concerning trade secrets or alleged violation of some of the provisions of the Data Protection Act, 2018). In these cases, the need for anonymization is in re ipsa, because the publication of private information or the plaintiff’s identity would compromise the administration of justice, revealing the same information that the party who sued sought to be reserved. The second exception concerns those cases in which the violation of the right to privacy is not the subject of the dispute, but some private information is however disclosed during the proceedings. In these latter situations, the Court may guarantee anonymity in order to prevent a violation of Articles 2, 3 or 8 of the European Convention of Human Rights (ECHR), as it was implemented in the UK by the Human Rights Act 1998. On the one hand, the absolute nature of the rights proclaimed by Articles 2 and 3 implies that the principle of publicity of judgments must necessarily withdraw if in the event of disclosure there is a “real and immediate” danger to life or the concrete risk of suffering serious physical damage (Re Officer L [2007] 1 WLR 2135; R (M) v Parole Board [2013] EWHC 1360 (Admin), [50]). On the other hand, in the event of conflict with Article 8 of the ECHR, the court is called upon to carry out an assessment of proportionality, balancing the right to privacy with the principle of Open Justice.

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The request for anonymization of the identification data must be presented by the party in the introductory phase of the process or, in any case, before the hearing on the merits, supported by the evidence which the applicant intends to rely on (R (M) against Parole Board [2013] EWHC 1360 (Admin), (69)). The judge, according to the circumstances of the case, may order not only that the parties’ identification data be obscured from the judicial ruling, but he may also adopt suitable measures to prevent the name of the persons involved in the judicial procedure from being disclosed during the course of the public hearing. Moreover, as the Supreme Court stated in R (C) v Secretary of State for Justice, 2016, “there is a dating practice according to which certain types of people, mainly children and mentally ill, should not be appointed in the proceedings that concern them.” In these cases, the judge, even ex officio, must exercise a careful balancing of opposing interests in order to determine whether the anonymization of data is necessary in the interest of the vulnerable abovementioned subjects [45] (p. 217). In any case, all anonymization orders pronounced by the judge are mandatory, so their violation could carry to a criminal sanction (i.e., contempt of court). The need to respect privacy in judicial activity and legal research, as already anticipated, is strongly felt at the level of the European Union. In light of the new general regulation on the protection of personal data (GDPR), the European Court of Justice has decided that starting from 1 July 2018, in all documents relating to each preliminary ruling case before the same court, the identification data of the parties will be deleted before being published [50]. To allow identification and citation of cases, the Court will assign to each case a name corresponding to two initials (different from those of any person involved in the proceedings) and an additional distinctive element which may consist of the name of the legal person possibly involved in the case or in indicating the object of the dispute. The CJEU may derogate the new guidelines where the party or the circumstances of the case require to do so. This general anonymization system of judicial measures adopted by the Court follows the clear intention of ensuring the protection of data of the natural persons involved in preliminary ruling cases and, at the same time, of informing citizens and publicizing justice. In line with the trend European of enhancing the techniques of anonymization of personal data contained within the judgments, also Article 47 (4) of the Rules of the European Court of Human Rights allows the applicants to maintain anonymity in all acts of the trial, pursuant to Article 40, c. 2 of the Strasbourg Convention: “Applicants who do not wish to have their identity disclosed to the public must indicate this and submit a statement of the reasons justifying this deviation from the normal rule of public access to information in proceedings before the Court. The President of the Chamber can authorize anonymity in exceptional and duly justified cases.” For a long time, the decisions of the ECHR were made anonymous only in extraordinary cases; however, in 2008, the aforementioned paragraph of Article 47 was changed and the last sentence now reads: “The Court can authorize anonymity or grant it ex officio” [47]. It is evident, then, that there is a growing bias in favor of anonymization, with the aim of achieving, through this technique, a balance between the interests of the individual and that of the community.

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Both at the European and national levels, the analyzed rules show the possibility of inhibiting disclosure of the identification data of the parties involved in a judicial proceeding. In this way, the preventive intervention of the judge relieves from the beginning the researcher to preserve parties’ privacy. On the contrary case, the appeal can only be addressed, once again, only to the sensitivity and professional ethics of the individual researcher, who must limit the use of data to those necessary for his investigation, adopting measures that allow, in any case, to protect the person. Indeed, any scientific inquiry uses a set of personal data which are nothing less than the expression of the personality of the individual, constituting his “electronic body” [48]. In line with this latter consideration, human dignity—although this principle is not expressly mentioned by the GDPR—has a very central importance, because it represents the ultimate limit to the compressibility of human rights, whatever the interest pursued is, even public or scientifical one. The encounter between personal data and research cannot go so far as to make the person an empty simulacrum, conversely, scientific research should see the protection of personal data not as an obstacle, but as “the way through which scientific and technological innovations can legitimately enter our societies and our lives” [48].

References 1. Watson A (1977) Society and legal change. Scottish Academic Press, Edinburgh 2. Hunt A (1986) The theory of critical legal studies. Oxf J Leg Stud 6(1):1–45 3. Hunter D (2010) Locating ethics in research. In Hughes J (ed) EU Commission European textbook on ethics in research. European Union, Belgium, pp 11–32 4. Monateri PG (2012) Methods in comparative law: an intellectual overview. In: Monateri PG (ed) Methods of comparative law. Edward Elgar, Cheltenham, Northampton, pp 7–24 5. Sacco R (1991a) Legal formants: a dynamic approach to comparative law (installment I of II). Am J Comp Law 39:1–34 6. Sacco R (1991b) Legal formants: a dynamic approach to comparative law (installment II of II). Am J Comp Law 39:343–401 7. Bobbio N (2007) Dalla struttura alla funzione: Nuovi studi di teoria del diritto. Laterza, Bari 8. Portale GB (2001) Lezioni di diritto privato comparato. Giappichelli, Torino 9. Serio M (2012) Gli albori della comparazione giuridica nella “Critica di una scienza delle legislazioni comparate” 10. Amari E (1857) Annuario di Diritto Comparato e degli Studi Comparatistici, pp 413–452 11. Gorla G (1964) Lo studio interno e comparativo della giurisprudenza e i suoi presupposti: le raccolte e le tecniche per la interpretazione delle sentenze. Foro It 87(7):73–87 12. Rescigno GU (2003) Il giurista come scienziato. Dirit Pubblico 3:833–864 13. Criscuoli G, Serio M (2016) Nuova introduzione allo studio del diritto inglese. Giuffrè, Milano 14. Serio M (2010) Il ricorso alle legal categories nell’esperienza del diritto privato inglese. Europa e Dir Priv 2:511–539 15. Resnik DB (2015) What is ethics in research & why is it important? National Institute of Environmental Health. https://www.niehs.nih.gov/research/resources/bioethics/whatis 16. Orb A, Eisenhauer L, Wynaden D (2000) Ethics in qualitative research. J Nurs Scholarsh 33:93–96 17. All European Academy ALLEA (2018) The European code of conduct for research integrity. ALLEA, Berlin 18. Sax JK (2012) Financial conflict of interest in science. Ann Health Law 21(2):291–328

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19. Esposito C (1958) La libertà di manifestazione del pensiero nell’Ordinamento italiano. Giuffrè, Milano 20. Orsi Battaglini A (1990) Libertà scientifica, libertà accademica e valori costituzionali. In Onida V et al (eds) Nuove dimensioni nei diritti di libertà, Scritti in onore di P. Barile. CEDAM, Padoa, pp 89–108 21. Bilancia F (2016) La libertà della scienza e della ricerca: attualità della riflessione di Andrea Orsi Battaglini. Dir Pubbl 3:177–192 22. Jonas H (1984) The imperative of responsibility: in search of an ethics for the technological age. University of Chicago Press, Chicago 23. Bero LA (2005) Tobacco industry manipulation of research. In: Public health chronicles, vol 120, pp 200–208 24. Blumenthal D (2002) Conflict of interest in biomedical research. Health Matrix—J Law Med 12(2):377–392 25. Wilson RF (2010) The death of Jesse Gelsinger: new evidence of the influence of money and prestige in human research. Am J Law Med 36:295–325 26. Inst. of Med. of the Nat’l Academies (2009) Conflict of interest in medical research, education and practice, vol 1, no 6, Washington 27. Bin R (2009) Soft law, no law. In Somma A (eds) Soft law e hard law nelle società postmoderne. Giappichelli, Turin, pp 31–39 28. Henderson JA, Smith JJ (2003) Financial conflict of interest in medical research: overview and analysis of institutional controls. Food Drug Law J 58(2):251–268 29. Sponholz G (2000) Teaching scientific integrity and research ethics. Forensic Sci Int 113:511– 514 30. Burrows A (2019) In defence of unjust enrichment. Camb Law J 78(3):521–544 31. Dickson J (2016) Interpretation and coherence in legal reasoning. In: Zalta EN (ed) The Stanford encyclopedia of philosophy, Winter 2016 edn. https://plato.stanford.edu/archives/win2016/ent ries/legal-reas-interpret/ 32. Levi EH (1948) An introduction to legal reasoning. Univ Chic Law Rev 15(3):501–574 33. Viola F, Zaccaria G (1999) Diritto e interpretazione. Lineamenti di teoria ermeneutica del diritto. Laterza, Bari 34. Callaham ML (2003) Journal policy on ethics in scientific publication. Ann Emerg Med 41:82– 89 35. Dennis S, Garrett P, Yim H et al (2019) Privacy versus open science. Behav Res 51:1839–1848 36. EC, Directorate-General for Research and Innovation (2021) European research area policy agenda—overview of actions for the period 2022–2024, Luxembourg 37. European Data Protection Supervisor (EDPS) (2020) A preliminary opinion on data protection and scientific research. https://edps.europa.eu/sites/edp/files/publication/20-01-06_opinion_r esearch_en.pdf 38. Bernes A (2020) La protezione dei dati personali nell’attività di ricerca scientifica. In: Le nuove leggi civili commentate, vol 1, pp 175–205 39. Guarda P (2021) Il regime giuridico dei dati della ricerca scientifica. Editoriale Scientifica, Naples 40. CEPEJ, European Commission for the Efficiency of Justice (2018) European ethical Charter on the use of Artificial Intelligence in judicial systems and their environment, Strasbourg. https:// rm.coe.int/ethical-charter-en-for-publication-4-december-2018/16808f699c 41. EC, European Commission (2021) Ethics and data protection. https://ec.europa.eu/info/ funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ethics-and-data-protec tion_he_en.pdf 42. Resta G (2005) Privacy e processo civile: il problema della litigation anonima. Diritto dell’Informazione e dell’Informatica, Fasc 4–5:681-725S 43. Opijnen, M, Peruginelli G, Kefali E, Palmirani M (2017) On-line publication of court decisions in the EU: report of the policy group of the project ‘Building on the European Case Law Identifier’. https://ssrn.com/abstract=3088495

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44. Corte Suprema di Cassazione, Ufficio del Massimario (2005) Corte di cassazione e tutela della privacy: “l’oscuramento” dei dati identificativi nelle sentenze, Rome. https://www.cortedica ssazione.it/cassazione-resources/resources/cms/documents/Relazioni_privacy_05.pdf 45. Nicholls J (2018) Open justice and developments in the law on anonymity, access to material on the court file and reporting restrictions. Judic Rev 23(3):200–224 46. Bailin A, Craven E (2020) Publicity: the UK perspective. In: The practitioner’s guide to global investigations, vol 4, pp 718–731 47. European Court of Human Rights (2022) Rules of court. European Union, Strasbourg. https:// www.echr.coe.int/Documents/Rules_Court_ENG.pdf 48. Rodotà S (2004) Privacy, freedom and dignity, conclusive remarks at 26th international conference on privacy and personal data protection. https://www.garanteprivacy.it/home/docweb/-/ docweb-display/docweb/1049293 49. Italian Data Protection Authority (Garante per la protezione dei dati personali), Linee guida in materia di trattamento di dati personali nella riproduzione di provvedimenti giurisdizionali per finalità di informazione giuridica, 2 dicembre 2010 (Gazzetta Ufficiale n. 2 del 4 gennaio 2011) 50. Court of Justice of the European Union, Luxembourg, 29 June 2018, available at https://curia. europa.eu/jcms/upload/docs/application/pdf/2018-06/cp180096en.pdf

Ethics in Life Sciences and Research Valerio Gristina, Antonio Galvano, Antonina Pirrotta, and Antonio Russo

Abstract Ethics of clinical research deals with norms and values defining what ought and ought not to be done in the context of clinical trials to protect the rights, safety, and well-being of the study participants. As a result of past unethical approaches, protection for human subjects has been strictly regulated, introducing three fundamental ethical principles: respect for person, beneficence and non-maleficence, and justice. Many believe that informed consent is the sufficient and necessary step point to make clinical research ethical. However, to be ethical a clinical research must satisfy seven specific requirements underpinning the three general principles (social or scientific value, scientific validity, fair subject selection, favorable risk/benefit ratio, independent review, informed consent, and respect for enrolled participants). In this regard, RECs/IRBs have been established to protect patients’ dignity and well-being while promoting the potential benefit of ethical research, even if presenting with large variation in practice across different countries. In the clinical research setting, the primary ethical dilemma is that only those individuals enrolled in a clinical trial are asked to face burden or risk as research subjects to benefit others and society with a range of unique ethical problems featuring the design and conduction of RCTs. Dealing with individuals who serve as human subjects, the chance of exploitation must be minimized, and the respect must be pursued in accordance with ethical principles and the rigorous methodology of clinical research. This chapter aims to highlight ethical principles, concerns, and considerations surrounding the clinical research setting while discussing the legislative and organizational role of research committees.

V. Gristina · A. Galvano · A. Russo Department of Surgical, Oncological and Oral Sciences, University of Palermo, Palermo, Italy A. Pirrotta (B) Engineering Department, University of Palermo, Palermo, Italy e-mail: [email protected] © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 L. Congiunti et al. (eds.), Ethics in Research, UNIPA Springer Series, https://doi.org/10.1007/978-3-031-24060-7_3

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1 Introduction The purpose of research is to develop generalizable knowledge to improve health, striving to be valuable to society. Despite being a lengthy and cost-intensive process, good quality research is essential for establishing the clinical and cost-effectiveness of healthcare systems. Namely, ethics of clinical research more deeply deals with norms and values defining what ought and ought not to be done in the context of clinical trials to protect the rights, safety, and well-being of the study participants [1]. The scientific progress is the result of inductive reasoning arising from the experience and enabling the scientists gather observations to draw inferences based on the available data. In the very beginning, research was carried out sporadically with the distinction between experimentation and therapy being so difficult given the rare systematic evidence of the effectiveness of medical interventions. Hence, even if administered by well-intentioned and trusted medical practitioners, such treatments resulted to be uneffective and toxic with fraud and abuse being minimized in absence of ethics-specific codes or governing regulations. Sadly, research involving human subjects stems from an unglorious legacy, since unethical demeanor was fairly carried out by many early-stage researchers during the twentieth century. Indeed, the term “human experimentation” still recalls the terrifying experience of the infamous experiments conducted during World War II, followed by some notable unethical episodes of human exploitation in the postwar period (such as the inadequate disclosure of information to determine the natural history of untreated latent syphilis in the Tuskegee syphilis study) [2]. Experimentations reflect the progress of medicine that could not condone trespassing the wellness of any individual patients while ensuring the protection of participating patients according to ethical principles inspired by the Hippocratic Oath primum non nocere (first, do no harm) [3]. In this vein, the respect for safety, dignity, and autonomy of human subjects represents the cornerstone to ethically secure and spread valuable knowledge for the scientific community while being socially responsible. This chapter aims to highlight ethical principles, concerns, and considerations surrounding the clinical research setting while discussing the legislative and organizational role of research committees.

2 What Makes Clinical Research Ethical? As a result of past unethical approaches, protection for human subjects was thus strictly regulated worldwide. The Nüremberg Code first introduced the voluntary informed consent of individuals as a critical element to enter a clinical trial ethically involving human subjects [4]. Afterward, the Declaration of Helsinki and the

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Belmont Report integrated and refined the spirit of the Nüremberg Code [5], introducing three fundamental and widely accepted ethical principles on which research on human subjects must be carried out to avoid unnecessary physical and mental exploitation while providing evidence that the experiment is scientifically intended to yield profitable social results: • Respect for person, based on the ethical convictions that individuals must be treated according to a shared and voluntary informed consent to participation, and persons with diminished autonomy must be protected. • Beneficence and non-maleficence, whereby human rights and safety should prevail over scientific and social benefit. • Justice, according to whom all patients must be treated fairly and not exploited while procedures should be properly performed and managed. The sufficient recruitment of human subjects in clinical trials is the key for a good quality research confidently testing hypotheses while minimizing the bias. In this vein, Good Clinical Practice (GCP) guidelines and International Conference on Harmonization (ICH) recommendations have been optimized and are now crucial for guiding the informed consent [6]. However, many health professionals do believe that informed consent is the sufficient and necessary step point to make clinical research ethical. Although being in any circumstances necessary and still considered as the key indicator of the ethics of a research protocol, obtaining the informed consent should be never seen as sufficient for ethical clinical research [7]. Actually, further ethical issues surrounding the clinical research approach should be taken into account: unnecessary risks for the patients, duplication of unjustified research, use of inappropriate control favoring the experimental interventions, use of placebo, phase 1 research, protection for communities, involvement of developing countries and/or children. In this scenario, a systematic framework of seven complementary principles applying sequentially to all clinical research has been suggested [8], introducing the idea that the research ethics should exceed the mere logic of scientific protocols methodology. Even if universal, the proper implementation of such framework should be adapted and tailored to specific cultures, health conditions, and economic settings. According to this comprehensive framework, to be ethical a clinical research must satisfy seven specific requirements underpinning the 3 general principles (Table 1): • Scientific or Social value: the research idea should pose a scientifically and/or socially valuable question contributing to generalizable knowledge about health while being responsive to social use of finite resources and avoidance of exploitation. • Scientific Validity: the study design should feature a rigorous methodology with appropriate and feasible endpoints to ensure valid and reproducible data without exposing subjects to undue risks. • Fair subject selection: research subjects should be not selected according to biased or inaccurate outcomes; inclusion and exclusion criteria should ensure that vulnerable or socially powerful individuals would not be unfairly targeted for risky or potentially beneficial research, respectively.

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Table 1 Ethical framework for clinical research [8] Requirements

Description

Social or scientific value

Evaluation of a diagnostic or Beneficence therapeutic intervention leading to health improvement while increasing knowledge

Underlying principles

Scientific validity

The study should present with a scientifically sound design, ensuring research outcomes with accurate and reproducible endpoints

Fair subject selection

Research subjects should be Justice selected through fair inclusion and exclusion criteria

Favorable risk/benefit ratio

Risks to participants should be minimized while benefits should be maximized

Independent review

Evaluation of adherence to ethical Avoidance of potential conflict of standards by a full committee of interests unaffiliated individuals with expertise

Informed consent

Subjects must be accurately informed of benefits, harms, and alternatives to the proposed research

Respect for person

Respect for enrolled participants

Individuals must be respectfully treated throughout the study

Respect for person

Beneficence, respect for person

Beneficence, non-maleficence

• Favorable risk/benefit ratio: study risks should be balanced by potential benefits and value of the knowledge. Individual and social benefits should be proportionated to or outweigh potential risks. • Independent review: adherence to ethical guidelines should be Independently evaluated within the design, conduct, and analysis of research by ethics committees. • Informed consent: clear and adequate information should be provided to promote the voluntary enrollment of subjects in line with their interests, values, and preferences. • Respect for enrolled participants: the rights of participants should be respected throughout all the research study, even after their participation ends. Investigators must protect confidentiality and privacy, provide opportunity to withdraw, monitor patients’ welfare, inform subjects of new information and study results, and compensate for attributable research injury. All information should be properly recorded, handled, and stored.

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3 The Role of Research Ethics Committees (RECs) and Institutional Review Boards (IRBs) Research Ethics Committees (RECs), otherwise called Institutional Review Boards (IRBs) in the United States, are internationally recognized tools underscored by key ethical guidelines, such as the Declaration of Helsinki [9]. Such boards, consisting of professionals with different backgrounds and know-how, have been established to protect patients’ dignity and well-being by ensuring ethics review and informed participation. Likewise, RECs/IRBs aim to promote the potential benefit of ethical research to science and society by critically evaluating the methodological relevance of clinical and epidemiological research. Until the early 1980s, the presence of ethics committees was very limited in the health sector. Subsequently, even if distinct factors contributed to the development of ethics committees [10], the management of some cases of extreme political and social importance in the USA highlighted an evident difficulty on the part of the courts regarding ethical issues which promoted the diffusion of ethics committees as an alternative to medico-legal disputes [11]. In this way, it was possible not only to resolve relevant issues concerning daily clinical practice but also to produce and expand the scientific literature that analyzes ethical issues. Today, ethics committees are almost always permanent bodies of health structures characterized by a representation made up of health and non-health workers (lawyers, citizen representative, bioinformatician, expert in medical devices, and representatives of the health administration). RECs/IRBs are supposed to critically appraise study protocols while answering to researchers’ appeals and fully justifying the judgment when challenged, mostly considering that standard operating procedures and target time scales have been firmly stipulated. Notwithstanding, clinical investigators complain about inconsistencies and delays in such a review process, often resulting in minor modifications that could jeopardize the scientific integrity of the studies [12]. Overwhelmingly, there is still confusion and large variation in practice across different countries often without a clear justification, denoting that the identification of any aberrations and distortions that could arbitrarily affect judgments is eagerly warranted and should be promptly pursued. In this setting, the standardization and harmonization of procedures among different international and national RECs/IRBs should be favored to finalize similarities and differences between the scope and the matter of a more comprehensive ethics review in terms of both theoretical and practical significance. In this vein, clarifying expectations and centralizing data among differing RECs/IRBs would be crucial steps to test metrics for measuring quality and effectiveness of the ethical reviewing process.

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4 Ethical Issues in Randomized Clinical Trials (RCTs): Science or Ethics? Clinical research aims to generate reproducible scientific knowledge that would influence clinical routine practice for future patients and for society, thus being vital to clinical care. The primary ethical dilemma in clinical research is that only those individuals enrolled in a clinical trial are asked to face burden or risk as research subjects to benefit others and society. While in clinical care diagnostic and therapeutic procedures are supposed to be tailored following an individualized care, research subjects receive a pre-specified intervention based on the scientific design of a research protocol. Ethically speaking, in the routine clinic, the potential benefits of standardized care must outweigh the risk posed to patients, whereas study protocol procedures in the research setting may not be the most optimal care that a patient should receive posing risks without providing any individual benefits. These separate features seem to suggest distinct roles for the clinician and clinical researcher, with the former striving to do everything possible to benefit current patients whereas the latter being obligated to forward medical science to benefit future patients. In this scenario, ethical concerns could arise because of the potential for exploitation and/or abuse of human research subjects. According to the ICH-GCP guidelines, a well-organized and -documented scientific protocol with a favorable benefit/risk ratio and in compliance with the mentioned ethical standards should always guide the conduction and the analysis of a clinical trial; furthermore, the trial staff should be adequately trained with scientific data being accurately accessible along with investigational products in accordance with Good Manufacturing Practice (GMP) guidelines [13]. In this complex scenario, the randomized controlled trial (RCT) remains the gold standard for proving efficacy and safety of new interventions, comparing the action of an experimental approach versus a benchmark procedure. Such a comparison takes place under several tight characteristics to extrapolate a generalizable conclusion for the scientific community. However, a range of unique ethical problems feature the design and conduction of RCTs (Table 2). The ethical rationale to start an RCT usually refers to the paradigm of clinical equipoise, based on the idea that patients should not receive an already known inferior intervention while not being denied the effective available approach according to the scientific literature [14]. Such a principle aims to provide convincing evidence about the single value of each intervention. However, there remains confusion and ethical tension about the meaning and substantiation of equipoise in the research field. Accordingly, it is argued that a credible evidence should not be considered only according to the common statistical significance at the p-value level, potentially underestimating clinically significant observations that do not eventually reach the statistical threshold. In this vein, even if ruling out the most obvious bias due to the interference of investigators and/or patients, the randomization process raises two sorts of ethical

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Table 2 Ethical issues in Randomized Controlled Trails (RCTs) Features of RCTs

Description

Caveats

Clinical equipoise

No existing evidence that one intervention is better than another

Underestimation of clinically valid observations not reaching the statistical significance

Randomization

Random assignment of subjects to decrease bias and control for confounding variables

Random assignment is not always compatible with patients’ interests or autonomy

Blinding

Single or double blinding is often used to decrease bias

Investigators and/or participants are not informed. Blindfolding could be suspended due to pending medical conditions

Choice of control

Accurate choice of a proper control raises the scientific validity

Use of placebo without ethical justification

Sharing preliminary data

Preliminary results could help distribute the equipoise

Independent safety and data monitors decide to stop the study and/or to share information

concerns involving the blindfolding of participants: patients could receive an experimental treatment that eventually turns out to be inferior to the standard approach while not enjoying a tailored and personalized medical intervention that could be the best standard of care available. To enhance the study validity, the subject together or not with the investigator is often not informed about the intervention arm (single- or double-blinded RCTs) to further decrease bias while controlling for varying factors; notwithstanding this, blindfolding could be interrupted to treat some medical emergencies. Withal, the appropriate choice of the historical gold standard as a control arm is mandatory to raise scientific validity and generalizability of RCT. In this regard, the use of placebo must be carefully evaluated and justified according to the study design, when no standard treatment for a certain condition is available, or when a standard treatment does not provide a therapeutic advantage according to new evidence [15]. Nonetheless, the placebo should not be even considered when patients would experience death or serious comorbidity in absence of an otherwise available treatment [16, 17]. Finally, as growing evidence concerning harms and benefits of intervention and control arms accumulate, RCT preliminary results should be shared with the scientific community to spread knowledge and, mostly in the oncology field, help the clinical routine care.

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5 Conclusions Considering the progressing research era and the increasing clinical questions, ethics of clinical trials has become crucially complex and sophisticated. Dealing with individuals who serve as human subjects, in the research setting the chance of exploitation must be minimized and the respect must be pursued in accordance with ethical principles and the rigorous methodology of clinical research. Even if still in the need of additional and unanimous requirements that must be tailored to specific clinical conditions, a systematic ethical framework should guide investigators and RECs/IRBs for ensuring that clinical research is ethical while providing an adequate reference guidance for medical research. Ethical considerations surrounding the unique features of RCTs must be considered. Besides adherence to principles and regulations, an increasing level of interplay must be implemented with particular emphasis to the integrity and thoughtfulness of all actors involved in the research context.

References 1. Nardini C (2014) The ethics of clinical trials. Ecancer 8:387. https://doi.org/10.3332/ecancer. 2014.387 2. Sierra X (2011) Ethics in medical research in humans: a historical perspective. Actas DermoSifiliográficas 102(6):395–401 3. Bernard C (1859) Introduction à l’étude de la médecine experimental. Collège de France, Paris 4. Merz JF (2018) The Nuremberg code and informed consent for research. JAMA 319(1):85–86. https://doi.org/10.1001/jama.2017.17704 5. Rice TW (2008) The historical, ethical, and legal background of human-subjects research. Respir Care 53(10):1325–1329 6. Dixon JR (1998) The international conference on harmonization good clinical practice guideline. Qual Assur 6(2):65–74. https://doi.org/10.1080/105294199277860 7. Truog RD, Robinson W, Randolph A, Morris A (1999) Is informed consent always necessary for randomized, controlled trials? N Engl J Med 340:804–807 8. Emanuel EJ, Wendler D, Grady C (2000) What makes clinical research ethical? JAMA 283(20) 9. Ross A, Athanassoulis N (2014) The role of research ethics committees in making decisions about risk. HEC Forum 26(3):203–224. https://doi.org/10.1007/s10730-014-9244-6 10. Aulisio MP (2016) Why did hospital ethics committees emerge in the US? PhD AMA J Ethics 18(5):546–553 11. Hajibabaee F, Joolaee S, Cheraghi MA, Salari P, Rodney P (2016) Hospital/clinical ethics committees’ notion: an overview. J Med Ethics Hist Med 9(17) 12. Whitney SN, Alcser K, Schneider CE, McCullough LB, McGuire AL, Volk RJ (2008) Principal investigator views of the IRB system. Int J Med Sci 5(2):68–72 13. Vijayananthan A, Nawawi O (2008) The importance of good clinical practice guidelines and its role in clinical trials. Biomed Imaging Interv J 4:e5 14. Levine R (1986) Ethics and regulation of clinical research, 2nd edn. Urban & Schwarzenberg, Baltimore

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15. Freedman B (1990) Placebo controlled trials and the logic of clinical purpose. IRB: Rev Hum Subj Res 12(6):1e5 16. Miller F, Brody H (2002) What makes placebo-controlled trials unethical? Am J Bioeth 2(2):3e9 17. Howick JH (2011) The philosophy of evidence-based medicine. Wiley-Blackwell, London. https://doi.org/10.1002/9781444342673

Therapeutic Strategies and Self-Determination: Lessons from the COVID-19 Pandemic Roberto Garofalo

Abstract The theme of the good, though it may be adapted to the field of health, is valued by constituting itself in principle, traceable to both the objective conduct of the caregiver and the subjectivity of the patient. It seems appropriate, in the era of the COVID-19 pandemic, to analyze recent events related to the arrival of the Sars-CoV2 pandemic in light of these principles, highlighting in what terms their applicability can still be confirmed, if and how they could be changed in their articulation and in the drafting of a priority scale between them and, finally, whether valid correction strategies can be created in the case that one or more of them have been infringed. The operation seems quite appropriate; undoubtedly, the pandemic’s unique virulence has brought certain critical issues to the fore and created extreme distress on several fronts, increasing the risk of errors and failures.

Moral action in medicine has its roots in a genuine disposition toward the psychophysical well-being of the person. In this context, the theme of the good, though it may be adapted to the field of health, is valued by constituting itself in principle, traceable to both the objective conduct of the caregiver and the subjectivity of the patient. The development of a “principlist bioethics” many years ago by Beauchamp and Childress was based on this very dichotomy.1 As it is well known, from its first enunciation, the principles of beneficence, non-maleficence, autonomy, and justice have provided the framework for ethical issues for the entire sector of the life sciences. In the biomedical field, in particular, the analysis of bioethical questions according to these principles has been widely applied, and still today it is considered a valid and reliable reference for the formulation of doubts and the identification of possible answers. It seems appropriate, then, to analyze recent events related to the arrival of the Sars-CoV-2 pandemic in light of these principles, highlighting in what terms their R. Garofalo (B) Head of Ethical Committee at Mediterranean Institute of Transplantation, ISMETT—ASP Palermo U.O.C. Integrazione Sociosanitaria Unità Operativa di Cure Palliative, Palermo, Italy e-mail: [email protected] © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 L. Congiunti et al. (eds.), Ethics in Research, UNIPA Springer Series, https://doi.org/10.1007/978-3-031-24060-7_4

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applicability can still be confirmed, if and how they could be changed in their articulation and in the drafting of a priority scale between them and, finally, whether valid correction strategies can be created in the case that one or more of them have been infringed. The operation seems quite appropriate; undoubtedly, the pandemic’s unique virulence has brought certain critical issues to the fore and created extreme distress on several fronts, increasing the risk of errors and failures. The innovative clinical treatment of this disease initially suffered from the uncertainty of contradictory treatment strategies which had to continuously adapt to emerging research findings. The obvious disorientation on the side of clinical practice, in the face of conditions as dramatic as they were unprecedented, also extended to moral choices, generating equal bewilderment and making, at the same time, the adoption of solutions both urgent and risky.

1 Ethical Principles Under Pressure: “Beneficence” and “Autonomy” It is hardly necessary to mention how, due to overcrowding caused by the rapid spread of the virus, intensive care units were the scene, not only of unexpected healings but also of distressing ways of dying. We learned to recognize the symptoms arising in the final stages of the disease, including dyspnea leading to suffocation, anxiety of death, agitation, and delirium. But, evidently, in those terrible moments the sense of excitement and urgency present in the intensive care wards, the tumultuous arrival of new patients, the rapid worsening of many of them, and the spasmodic search for effective therapies against an almost unknown disease, conspired to direct care workers’ maximum attention to such emergencies in a way that led to a certain degree of neglect towards terminal cases. Indeed, as is easy to imagine, a firm resolve to pursue healing at all costs prevailed among those attending to these patients in such dramatic circumstances. Understandably, when almost all of the energy and resources available are directed towards saving as many lives as possible, it is almost impossible to draw the already difficult line between the expectation of survival and the need to terminate treatment and therefore modify treatment strategies. Even today, excellent resuscitation expertise is rarely accompanied by valid palliative competence; consequently, recognizing that a patient’s care needs could, at any given moment, shift from more strictly resuscitative ones to palliative ones, an operation already traditionally burdened by various degrees of difficulty,2 has been greatly complicated by the addition of the urgent conditions brought by the pandemic. The consequence, in many cases, has been that of a “bad death”, not sufficiently supported by the standard and well-tested remedies offered by palliative care. To translate this into bioethical terms: the spirit that constitutionally animates a doctor’s actions, traditionally based on the “principle of beneficence”, has suffered distress due to a need to quickly shift the objectives to be pursued from patient survival to palliative care, an operation that is not always successful and which thus

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can result in a consequent increase in suffering in the absence of gain in terms of survival. But something even more critical has happened with regard to the “principle of autonomy”. As we know, this is inspired by the priority given to respect for patient choices if they are expressed in conditions of full freedom of action and decision-making. In Italy, Law no. 219 of 22 December 20173 recognizes the right of sick people to participate in “shared care planning” as well as through appropriate “advance healthcare directives”. The conceptual transition generated by the “renewing spirit” of the provision was that, through the application of these tools, a person’s right to decide their own destiny and authorize any future treatments is recognized and made viable in clinical practice, even in the event that their cognitive and/or communicative faculties fail. The epochal significance of this provision lies in the inversion of the order of priority which, since the enactment of the law, puts the patient’s will above the doctor’s therapeutic indications. The therapeutic options are, in other words, subjected first to the will of the patient, and the final decisions are then determined from that basis. Contrary to how this may seem, the bioethical articulation of this situation does not insist that the principle of autonomy must override that of beneficence, but that the two principles should harmonize and coexist in agreement, guaranteeing a more balanced space for the two actors at stake: the patient and the doctor. Now, according to what has been reported in the literature,4 the will expressed by hospital patients suffering from critical-stage COVID has only rarely been correctly and adequately taken into consideration when making the most demanding therapeutic decisions, especially invasive ones, such as assisted breathing, cardiological assistance, and artificial nutrition practices. That is to say, the principle of autonomy has been applied with difficulty in some cases, and completely ignored in others. It follows that patients’ legitimate participation in decisions concerning their lives and their care, together with the required consent, suitably preceded by the information necessary to give their consent,5 has been largely omitted.

2 Apparent Contradictions in the Principle of Justice The scenario being described was complicated by a further critical element from the moment hospital wards were suddenly flooded by urgent requests for care for a progressively and unpredictably increasing number of cases. The offer of care, in terms of beds and, more generally, material and human resources, was in fact found to be progressively insufficient. In other words, a close resemblance to the better-known “disaster medicine6 ” scenarios gradually emerged. Like in disaster circumstances, as the pandemic rapidly progressed, a critical situation emerged in which the available resources had to be marshaled on the simple principle of treating those with the best chance of survival first.7 To adequately cope with the emergency, we witnessed the expansion of hospital spaces, procurement of additional equipment for intensive care units, reconversion of available personnel, and extraordinary recruitment

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of other personnel from various sources in a spirit of solidarity. But, as might be expected, faced with the inescapable need to save as many lives as possible, we have unfortunately witnessed, in numbers that are difficult to quantify, the sacrifice of human lives due to their difficulty or impossibility of recovery. In the meantime, there have been a number of contributions to the relevant literature that attempt to define specific guidelines for the benefit of medical personnel operating “in the trenches”. The prevailing content is in line with what has already been mentioned with regard to “disaster medicine”; almost all of these works point out the already-outlined principle of making treatment decisions based on the degree of severity of the patient’s condition and recommend appropriate behavior in the ward.8 In these situations, the application of the principle of justice seems merciless, yet equally flawless. It may be comforting, perhaps, to know that the actual situations in which it was necessary to act in this way were probably few in number; but the inestimable value of every single human life causes enormous regret and makes us hope that we will never have to bear witness to such a dramatic situation ever again. But there is an additional element of dangerous continuity with the foregoing. It was, perhaps, a sudden extensive interpretation of the same principle of justice that, at the beginning of the pandemic, led to inappropriate pronouncements by politicians9 aimed at avoiding taking measures, deemed excessive and disproportionate, to limit the spread of the contagion, neglecting the devastating trend affecting the most fragile. According to what was publicly stated by government agencies, the people most at risk—because of chronic health problems, advanced age, and objective conditions of fragility—were considered to be inevitable victims of the pandemic, while it was necessary to develop adequate measures to fight and contain the spread of the virus in favor of those who were deemed more valid or more useful; that is, those who could offer greater guarantees for the maintenance and economic development of society. Obviously, in the content of these provisions, the application of the “principle of justice” has undergone a clear distortion. In our opinion, a reading of the dramatic reality we have been describing would rather oblige us to develop attitudes of openness, human solidarity, and giving precedence to the most fragile; certainly not to the potential “eugenic” drifts deriving from these pronouncements, which were subsequently corrected under the pressure of a media wave of public dissent. But what has been said speaks volumes about the difference in the cultural reference models that animate the moral choices of those called to choose, decide, and guide; there is a pragmatic/utilitarian vision of people that is opposed to a very different vision, which is respectful of the natural essence of humanity, precious in the individuality of its components, that disregards people’s abilities and values the universe enclosed within each of its members. Humanity is made up of individuals whose lives must be respected as an end in themselves, never as a means.

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3 The “Vexed Question” of the Vaccine Continuing in the light of the principles we have been following here, there is a final question to be analyzed that gravitates around the complex story of the pandemic. With a historic effort in terms of its unprecedented speed and the unparalleled quantity and quality of resources used, the scientific world has dedicated itself to the creation, production, and distribution of vaccines against Sars-CoV-2. The success of this undertaking is changing the course of the entire pandemic event, on all fronts. A few months after the outbreak of the pandemic, a document called “Covid-19 vaccine for all […] Lettera dei 101”,10 whose first signatory was Muhammad Yunus, Nobel Peace Prize winner in 2006, attained a very high moral status worldwide, affirming the need for the universal distribution of the vaccines which were then being developed, advocating that the production should not generate profit for anyone. The key to the success, in a human sense, of the vaccination campaign, destined to start if and when the vaccine had been tested and demonstrated efficacy and safety, would be its universality. Undoubtedly, it was a sound application of the principle of justice that animated this document. It is always under the aegis of this same principle that vaccine administration follows a priority scale: according to “justice”, in fact, the “helping professions” are privileged in the first instance as they are destined, by definition, to provide care to others afterward. Compatible with the quantitative availability of vaccine doses, priority was therefore given to health care personnel, followed by the category of at-risk subjects, and then, gradually, to other categories of people. However, the detailed definition of this “scale” was critical, and it was difficult to classify nonhomogeneous categories against the background of the new urgency given by the problematic supply of vaccine doses. The slavish application of the “principle of justice”, while not losing the veneer of its undeniable value, obviously finds some difficulty in dealing with unprecedented situations, albeit of global scope. But another aspect linked to vaccination practice has forcefully returned to the limelight, after having occupied public debate in many areas of civil society not so long ago. It is time to talk about the “vexed question” of compulsory vaccination. Undoubtedly, the success in eradicating ancient and devastating diseases such as smallpox and polio, just to mention the most recent epidemics, built its foundations on the practice of legally mandatory vaccination, though with various articulations in different countries according to their geographical location and economic development. On the other hand, the aforementioned “renewing spirit” of the “principle of autonomy” has, in the clinical setting, inadvertently allowed the possibility of considering vaccination as optional, that is, linked to free acceptance like a simple medical treatment. Without dwelling on the various conceptual positions which, on the basis of this, also inspire positions of refusal—unexpectedly, even by a certain part of the caregivers of the “helping professions”—some clarifications must be made. It seems obvious that vaccination practice cannot, in any way, be assimilated into a therapeutic procedure. The act of caring for others, in fact, is not only limited to the individuals who directly receive it but also spreads to the subjects with whom

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they come into contact and, in broader terms, to the entire society to which they belong. Consequently, the responsible choice of vaccine acceptance or refusal, while respecting the freedom of the individual, finds an insurmountable limit in the need to protect others.11 Recent positions taken by various jurists12 have focused on the possible need to resume, in a detailed manner and specifically for some categories, obligatory vaccination. In fact, it is stated that: The protection of the right to health in a pandemic scenario should […] be inspired by a principle of solidarity which, in the balance between individual freedom and collective interest, makes the legislator lean towards the latter in every case. Hence, there is the need to impose obligatory vaccination at least for the population groups most at risk—healthcare personnel, the elderly, students, teachers, public transport staff—and for those who intend to travel abroad, as indeed is already provided for by some international conventions.13

4 Conclusions Finally, the game of principles is intensified with the intuitive need to harmonize “justice”, “autonomy”, and “beneficence” into an effective convergence. Clearly, it is not a question of re-inventing or re-booting these principles; rather, it seems more appropriate, once again, to return to our fundamental ethical values in the critical and unpredictable moment of an emergency such as that of the pandemic. The instances of conscience, far from resting on an invisible background, rather emerge in a clear and forceful way. Therefore, it is up to the individual to respect his own conscience, but always within the general context of the “collective conscience”. Fyodor Dostoevsky wrote: “Suffering and pain are always obligatory for a broad consciousness and a deep heart”.14 In conclusion, we believe that, in this dramatic collective circumstance, in the face of the dramatic statistics, we are witnessing and the unpredictability of an event as unexpected as it is painful, once again this thought can find its right place and time.

Notes 1. 2. 3.

4. 5.

6.

Beauchamp TL, Childress JF (1978) Principles of biomedical ethics. SIAARTI (2013) Grandi insufficienze d’organo ‘end stage’: cure intensive o cure palliative? ‘Documento condiviso’ per una pianificazione delle scelte di cura. Law no. 219 of 22 December 2017 (2018) Norme in materia di consenso informato e di disposizioni anticipate di trattamento. Gazzetta Ufficiale, Serie Generale no. 12 of 16 January 2018. Spinsanti S (2020) L’etica al tempo della pandemia. Saluteinternazionale.info. Law no. 24 of 8 March 2017 (2017) Disposizioni in materia di sicurezza delle cure e della persona assistita, nonché in materia di responsabilità professionale degli esercenti le professioni sanitarie (also known as the “Gelli-Bianco Law”). Department of Civil Protection, Ministerial Decree no. 116 of 13 February 2001 (2006) Criteri massima per l’organizzazione dei soccorsi sanitari nelle catastrofi. Italian Ministry of Health,

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7. 8.

9. 10. 11.

12. 13. 14.

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Guidelines: “Attività di assistenza tecnica per il miglioramento delle attività ospedaliere ed il mantenimento delle funzioni strategiche in situazioni di emergenza”, Rome. Dyer C (2020) Covid-19: guidance is urgently needed on who should be treated in event of shortages, say lawyers. BMJ https://doi.org/10.1136/bmj.m1503. SIAARTI (2020, March 6) Raccomandazioni di etica clinica per l’ammissione a trattamenti intensivi e per la loro sospensione, in condizioni eccezionali di squilibrio tra necessità e risorse disponibili. ‘Abituatevi a perdere i vostri cari’: Boris Johnson ‘gela’ il Regno Unito. Huffpost.it, 13 March 2020. ‘Vaccino Covid-19 per tutti: Dichiarare ora il vaccino COVID-19 bene comune universale!’— Lettera dei 101 per un vaccino anti Covid bene universale. Repubblica.it, 28 June 2020. It is no coincidence that the definition of the “principle of autonomy”, according to the personalist reading of Christian bioethics, is transformed into the “principle of freedom/responsibility”. See Sgreccia E (2012) Manuale di bioetica. Fondamenti ed etica biomedica, vol 1. Milan, Vita e Pensiero. See, for example: Villani A (2021, February 4), Scelta di non vaccinarsi—La non obbligatorietà del vaccino anti-Covid: un’occasione mancata o una scelta coerente? Diritto.it. Ibidem (Author’s translation). Pevear R, Volokhonsky L (trans) (1992) Crime and punishment. Vintage Classics, New York, p 264.

Ethics and Integrity in Academic Publishing Cinzia Caporale and Roberta Martina Zagarella

Abstract Predatory journals, publishing and conferences are becoming an increasingly widespread worldwide phenomenon. Reaching an agreed definition and finding criteria for the complex identification of a predatory journal, publisher or conference, are two of the main problems encountered in the analysis of this phenomenon. In recent times, a consensus definition was proposed at an international stakeholders meeting. Ethical concerns have been raised about the potential effects of this phenomenon on scientific competition between researchers and research projects; on academic careers; on the allocation of funds for research; more generally, on the advancement of scientific knowledge and with regard to the risk that erroneous, fabricated, falsified or plagiarized data may be published, thus compromising scientific literature and contributing to the dissemination of fake news. The international scientific community recognize that predatory publishing activities represent a crucial issue to be addressed in science and in the research integrity field; as a consequence, action is needed to mitigate and manage their implications as well as to guide authors, especially younger ones, in the process of academic publishing. International campaigns have been undertaken over the last few years with the aim of establishing a set of measures both to identify predatory journals or dubious editors and to discourage researchers from publishing in such journals. In this chapter, we present a series of practical recommendations aimed at preventing and controlling the risks to be prey of predatory journals and conferences. These recommendations are presented in the first Italian ethical toolkit on the issue, which have been published in 2019 by the Research Ethics and Integrity Committee of the National Research Council (CNR). A standard-setting process and the development of best practices can contribute to foster a culture of research integrity and to preserve the quality of scientific publishing.

C. Caporale · R. M. Zagarella (B) National Research Council (CNR), Interdepartmental Center for Research Ethics and Integrity, Rome, Italy e-mail: [email protected] © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 L. Congiunti et al. (eds.), Ethics in Research, UNIPA Springer Series, https://doi.org/10.1007/978-3-031-24060-7_5

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1 Introduction Research ethics reflects on the principles, ethical norms and practices that should guide the conduct of researchers from a moral and ethical standpoint. The overall objective of such reflection is to protect the interests, rights and fundamental freedoms of research participants, researchers, investigators and society as a whole.1 Research Integrity, on the other hand, focuses on the principles, ethical values, ethical responsibilities and professional standards that are the foundation of responsible and proper conduct by those who conduct, fund or evaluate scientific research, as well as by the institutions that promote and carry it out. The promotion of ethics and integrity in research has two main purposes: (i) to propose good practices, which protect the quality of research and its fundamental values (rigour, correctness, clarity of argument, transparency, accountability, etc.); (ii) to make researchers more aware of the ethical value of science as such and especially of the ethical values that are inherent in its method. The concepts of ethics and integrity in the field of scientific publication refer to responsible practices and principles that guide authors, reviewers and scientific publishers, including honesty, accountability, impartiality, accuracy and transparency. Scientific publications are one of the pillars of modern science, always subjected—through the peer-review process—to a system of internal evaluation and self-correction. Over the past 20 years, the scientific publishing industry has grown immensely.2 On one hand, scientific publications have increasingly become a key tool to disseminate research and ensure that it has an impact on society by inspiring laws, authorizing drugs and treatments, influencing political decisions and so on. On the other hand, for researchers, the pressure to publish has become increasingly strong to attract funding and especially to obtain career advancement, according to the well-known ‘publish or perish’ mechanism. In this context of enormous demand for scientific publication opportunities, the market of predatory journals and predatory conferences is flourishing. This chapter aims to provide an overview of the phenomenon of predatory publishing (PP), to highlight the potential ethical risks and the negative impact on scientific research, to illustrate the measures proposed at the international level to curb the phenomenon and, finally, to present the first Italian ethical toolkit on the subject developed by the CNR Research Ethics and Integrity Committee.

2 Predatory Publishing: An Overview The term ‘predatory publishing’ first appeared a decade ago [4]. Since then, several efforts have been made in an attempt to analyse the phenomenon of predatory journals and conferences, which is becoming more extensive and alarming [5]. In general, the 1 2

Cf. CNR Research Ethics and Integrity Committee [1]. Cf. COMETS [2, 3].

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expression ‘predatory publishing’ refers to journals and publishers who, for a fee, publish almost all the contributions submitted to them, making an insufficient assessment of scientific content and squandering the model of Open Access (OA) for profit. The titles of these journals, and their websites, often revisit those of high-quality journals in the same subject area, and often internationally renowned researchers are included among the board members of predatory journals without their knowledge. It is therefore often quite difficult to recognize a predatory journal, which in itself poses a significant risk to all researchers and the quality of their publications. This is a complex phenomenon, which encompasses several systemic aspects related to the world of research (career evaluation, Open Access, oligopoly of scientific publishing, etc.) and around which a very broad debate has developed, including the ethical one. The international scientific community agrees on the need to act now in order to prevent and mitigate the phenomenon; in this struggle, the first preliminary barrier to overcome has been the lack of an agreed definition and the determination of criteria for the complex identification of a predatory journal, publisher or conference. In order to reflect on the definition of predatory publishing and to reach a consensus definition, which could serve as a reference point for the analysis of the possible impact of the phenomenon and for the design of targeted interventions, an international stakeholders meeting was organized in 2019 in Ottawa, involving representatives of academic institutions, publishing societies, research funders, researchers, policymakers, etc., for a total of 43 participants from 10 countries. The consensus definition reached was published a few months later by Nature: Predatory journals and publishers are entities that prioritize self-interest at the expense of scholarship and are characterized by false or misleading information, deviation from best editorial and publication practices, a lack of transparency, and/or the use of aggressive and indiscriminate solicitation practices [6] (p. 211).

The process that led to the achievement of this consensus definition required several steps and conceptual choices: “Participants in our summit completed a threeround modified Delphi survey (a structured technique to elicit input, offer feedback and build consensus) that included 18 questions and 28 sub-questions. There were also 12 h of discussion, followed by 2 further rounds of feedback and revision” (ibidem). Even the use of the adjective ‘predatory’ has been questioned, whose connotation has the flaw—according to some—of excessively overshadowing the responsibility of those researchers who consciously choose to publish in predatory journals to obtain an improvement of their CV.3 Among the alternative adjectives evaluated were ‘dark’, ‘deceptive’, ‘illegitimate’ and ‘acting in bad faith’. However, it was generally agreed that customary practice and—in other words—the already widespread use of the term ‘predatory’ in the scientific community, with its limitations, should prevail in the choice of nomenclature. 3

In fact, the term ‘predatory’ (from Latin ‘praedatorius’, ‘praedari’) refers to the attitude of those who obtain something through an act of violence. The etymology of the term refers to the idea of a helpless ‘prey’, ‘victim’ of the predator animal, which is not attributed any responsibility for what happened.

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The consensus definition has attempted to highlight a set of distinctive traits that unite ‘by family resemblance’—in the words of Wittgenstein—predatory activities in scientific publishing. In particular, these distinctive traits are: • the mere pursuit of private financial interest at the expense of contributing to the advancement of knowledge; • manipulation of the information provided to readers and researchers, for example through the websites of these journals and the emails sent out that often contain unverifiable claims, fake impact factors or ambiguous descriptions of peer-review processes; • deviation from the relevant ethical standards, as described by leading international organizations or committees, such as the COPE (Committee on Publication Ethics) and the DOAJ (Directory of Open Access Journals); • a lack of transparency regarding operational procedures, contact information or article processing charges (APCs); • the use of aggressive and indiscriminate practices for article solicitation, such as the email bombing most researchers receive even on a daily basis, recognizable by an overly flattering style and reference to past publications of the author receiving the message, generally not pertinent to the topic of the solicited article. As reported by the authors themselves, some criteria and characteristics were deliberately left out of the consensus definition, including in particular journal quality and intent to deceive. The most problematic aspect consists in not having included among the defining criteria the quality of peer review, as it is considered too subjective: Most controversially, we omitted quality of peer review, even though negligent peer review is often a prominent feature of predatory journals. We are not saying that peer review is unimportant, only that it is currently impossible to assess. Unfortunately, many legitimate journals fail to make their peer-review processes sufficiently transparent, for instance by sharing peer reviewers’ comments and other data. At the moment, journal quality, adequacy of peer review and deceit are too subjective to include [6] (p. 212).

Although difficult to assess, this is nevertheless a crucial and distinctive aspect of predatory journals, which pretend to use internationally recognized standards for peer review, but in reality, do not carry out an accurate assessment of the articles they publish. These five elements (in our view, possibly along with the quality of peer review) characterize predatory publishing and yet do not always help researchers and institutions to identify them and distinguish with certainty a predatory journal or conference from a legitimate journal or conference. With regard to identification criteria, it is interesting to note how the system of ‘lists’ of predatory publishers was generated and evolved. In 2008–2010, Jeffrey Beall of the University of Colorado Denver coined the expression ‘predatory publishing’ and created a list of ‘potential, possible, or probable’ predatory journals, which later became known as ‘Beall’s list’. The judgement was based on an assessment of contents, practices and websites conducted against a set of criteria inspired by

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the ethical standards of leading international publisher organizations. The success of the list prompted some publishers on the list to take legal action against Beall, who in 2017 was forced to disable the blog where the list was published. Since then, similar blacklists have been generated; the most well-known one is curated by Cabell’s International, a company that offers a range of paid academic services including a ‘searchable database of deceptive and predatory academic journals.’ At the same time, conversely, many institutions and review agencies have begun to adopt a system of whitelists of legitimate journals, such as Scopus and DOAJ. While blacklists aim to alert authors to presumed fraudulent journals, whitelists take the inverse approach of providing an index of vetted, presumably legitimate outlets [7] (p. 2).

Two traits are common to all of these lists, both blacklists and whitelists. The first is the search for inclusion criteria: a recent qualitative analysis, conducted by Strinzel and colleagues, included a total of 198 criteria underlying only 4 lists. The second trait is the partial fallibility of such criteria and the consequent presence of ‘infiltrated’ journals in both types of lists: whitelists include predatory journals and, on the opposite side, legitimate journals appear in blacklists [5, 8, 9]. While, then, lists and criteria provide an important aid in establishing the quality of a scholarly journal, it is risky to use these criteria as the sole assessment tool: Such criteria provide a starting point for a discussion on predatory aspects of academic publishing. Nevertheless […] our duty is to refrain from offering up these lists as the final word on predatory journals. Rather, it is our responsibility to (1) use such lists and criteria as tools for teaching faculty to be proactive about evaluating what journals to publish in and (2) to ensure that newer journals, which are often OA, are not disqualified unfairly from consideration as part of quality scholarly output [8] (pp. 62–63).

Therefore, in order to avoid predatory journals, the first weapon available to researchers is to learn about the phenomenon and be aware of the potential risks involved.

3 Ethical Implications and Concerns As underlined by the most important international charters and made explicit also in the ‘Guidelines for Research Integrity’ produced by the CNR Research Ethics and Integrity Committee (Italy) [1], in the publication of research results it is ethically fundamental to: Safeguard the quality of publications: researchers publish their results regularly and promptly. Publishing quickly or aspiring to a high number of publications in one’s curriculum should not come at the expense of the originality, accuracy, soundness and relevance of research results. When choosing where to publish, researchers evaluate the reputation of the journal and make every effort possible to identify and avoid predatory publishing [1] (p. 5).

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Specifically, it is considered a questionable and/or irresponsible practice: “deliberately publishing in journals known to practice predatory publishing, in order to avoid adequate peer review” [1] (p. 13). Although, as we will see in the next section, there is still little data on how many researchers in the world publish in predatory journals, Beall’s list included 1,294 journals and 1,155 publishers in 2017 (before closure) [5] and the Cabells’ Predatory Reports database recently surpassed 15,000 individual predatory journal entries.4 Hence, there are many predatory journals and the phenomenon is expanding worldwide. In this regard, the widespread idea that the phenomenon is restricted mainly to the developing countries seems to be a prejudice refuted by extensive research on the subject: We spent 12 months rigorously characterizing nearly 2,000 biomedical articles from more than 200 journals thought likely to be predatory. More than half of the corresponding authors hailed from high- and upper-middle-income countries as defined by the World Bank. Of the 17% of sampled articles that reported a funding source, the most frequently named funder was the US National Institutes of Health (NIH). The United States produced more articles in our sample than all other countries save India. Harvard University (with 9 articles) in Cambridge, Massachusetts, and the University of Texas (with 11 articles across all campuses) were among the eight institutions with the most articles. It is easy to imagine other, similar institutions coming up in a different sample. The point is, the problem of predatory journals is more urgent than many realize [10] (pp. 23–24).

In other words: predatory publishing is affecting us, and affecting us closely. The quantity of predatory journals, the existence of ‘infiltrated’ journals in the databases of high-quality journals, the inclusion of internationally renowned experts on the scientific or editorial boards of predatory journals and conferences without their knowledge, and the fraudulent communication and website creation practices of such journals all contribute to the possibility that researchers—especially inexperienced ones—disseminate their research through these channels. It should also be considered that, especially in the case of younger researchers, there is the risk that the invitation to participate in conferences, to publish or even to become members of editorial boards of predatory journals, may be seen as an opportunity, as a fast lane to acquire titles considered useful in the advancement of one’s career. These activities and roles are, in fact, important academic titles; however, if these activities are carried out and these roles filled in the context of predatory conferences and journals they represent, on the contrary, irresponsible practices from the point of view of research ethics and integrity that therefore, contribute to harm researchers instead of facilitating them. Furthermore, from the point of view of funding, especially if provided by public institutions, predatory publishing is an ethical problem as it causes a waste of economic and intellectual resources. From the research integrity perspective, concerns have been also raised about the potential effects of predatory publishing on the advancement of scientific knowledge 4

https://www.stm-publishing.com/cabells-predatory-reports-passes-15000-predatory-journals-lis ted/.

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and with regard to the risk that erroneous, fabricated, falsified or plagiarized data may be published, thus compromising scientific literature and contributing to the dissemination of fake news. So, in general, whether it happens unconsciously through inexperience or consciously for irresponsible scopes, predatory publishing constitutes an unethical practice and represents a crucial issue in research integrity, as it introduces significant distortive effects on fair academic competitions, research careers, funds allocation and scientific progress. The inherent risk is to make the system unequal and to ultimately disrupt trust within the scientific community as well as between the scientific community and the population at large. This represents a problem in itself and not only for the practical effects it generates in the publication of research results. Another aspect to be taken into account is that predatory publishing has found in the Open Access movement a fertile ground that has accidentally allowed it to proliferate. On the one hand, the two phenomena (PP and OA) have been associated and analysed together since the first studies by Jeffrey Beall [4], who first spoke of ‘predatory open-access publishers’. On the other hand, it should be specified that there is no biunivocal relation between the two phenomena and that, according to the new European policies to promote OA, using the adjective ‘predatory’ always in connection with ‘open access journals and publishers’ complicates the understanding of both phenomena instead of facilitating it. From an ethical perspective, confusing newly published, less prestigious or amateur Open Access journals with predatory publishing can easily lead to misjudgements and lead one to not “clearly delineate Open Access as a legitimate publishing entity that should not uniquely be characterized as harboring predatory journals” [11]. In this regard, it has been acknowledged that “in order to ensure better future for scholarly publishing and sustain the value of open access, it is essential to educate researchers and librarians alike about good versus bad” [12]. A further ethical issue relates to newly published journals. These are often journals that intercept new fields of knowledge. Confusing such journals with predatory journals can significantly affect or even hinder the development of new areas of thought, and thus partially compromise society’s ability to benefit from the results of such research. Mutatis mutandis, the same can be argued for small multidisciplinary journals. Therefore, generally speaking, the international scientific community recognize that predatory publishing activities represent a crucial issue to be addressed in science and in the research integrity field and that, as a consequence, action is needed to mitigate and manage their implication as well as to guide authors in the process of academic publishing. Measures have been proposed at the international level to assess the reputation of journals and publishers, including the first Italian ethical toolkit elaborated by the CNR Research Ethics and Integrity Committee. These interventions will be described in the following two sections.

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4 International Initiatives to Guide Authors The scientific community is taking action to prevent and mitigate predatory publishing and to foster a better culture of responsible publishing. International campaigns have been undertaken over the last few years with the aim of establishing a set of measures both to identify predatory journals or dubious editors and to discourage researchers from publishing in such journals. The measures proposed at the international level can be divided into two macrocategories: the creation of (white or black) lists of journals and publishers; and information-educational measures that include the development of information campaigns, the implementation of research projects and the development of guidance documents to help researchers recognize predatory journals and conferences and avoid them. Focusing on the second category, in this section, we will describe three prominent international initiatives over the past few years.

4.1 The Think. Check. Submit Campaign The first major initiative on the issue of predatory publishing is the campaign ‘Think. Check. Submit,’ which was launched in 2015 to help researchers, especially the most ‘vulnerable’ including early careers, carefully choose which journals to publish in [13]. As reported on the official website,5 the campaign was conceived and promoted by several organizations including Committee on Publication Ethics (COPE), Directory of Open Access Journals (DOAJ); INASP; ISSN International Centre; Ligue des Bibliothèques Européennes de Recherche—Association of European Research Libraries (LIBER); Open Access Publishing in European Networks (OAPEN); Open Access Scholarly Publishers Association (OASPA); International Association of STM Publishers (STM); UKSG. The campaign has the merit of taking a positive approach rather than a sanctioning or punishing one: in fact, it proposes tools to help researchers make decisions based on a critical and conscious evaluation of scientific publishing. On a practical level, the campaign recognizes the importance of researchers sharing research results as well as the difficulty in trusting the right journal and it proposes a checklist to follow before submitting a paper to a journal. The checklist is organized into three sections (from which the campaign takes its name): think, check and submit. The ‘Think’ section includes the following questions and observations: “Are you submitting your research to a trusted journal? Is it the right journal for your work? 5

https://thinkchecksubmit.org/about/.

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More research is being published worldwide. New journals are launched each week. Stories of publisher malpractice and deception are also on the rise. It can be challenging to find up-to-date guidance when choosing where to publish.

How can you be sure the journal you are considering is the right journal for your research?”.6 In the second section, entitled ‘Check’, you will find a more extensive list of indications “for your chosen journal to check if it is trusted”, including: Do you or your colleagues know the journal? Can you easily identify and contact the publisher? Is the journal clear about the type of peer review it uses? Are articles indexed in services that you use? Is it clear what fees will be charged? Do you recognize the editorial board? Is the publisher a member of a recognized industry initiative? If the journal is open access, is it listed in the Directory of Open Access Journals (DOAJ) and does the publisher belong to the Open Access Scholarly Publishers’ Association (OASPA)?7 The third section suggests submitting the article to those who answered affirmatively to most or all of the questions in the previous sections, making explicitly and schematically clear what reputational and scientific benefits derive for researchers from the suggested best practices. Specifically, it is recommended: “Complete the check list and submit your article only if you are happy you can answer ‘yes’ to most or all of the questions. • You need to be confident your chosen journal will have a suitable profile among your peers to enhance your reputation and your chance of gaining citations. • Publishing in the right journal for your research will raise your professional profile, and help you progress in your career. • Your paper should be indexed or archived and be easily discoverable. • You should expect a professional publishing experience where your work is reviewed and edited. • Only then should you submit your article”.8 The guide ‘Think. Check. Submit’ is not the only campaign designed with the purpose of raising consciousness and creating awareness about the ethics of scientific publication. A similar initiative is ‘Think. Check. Attend’9 promoted, in the Arab countries, by the ‘Knowledge E’10 with the intent “to guide and assist researchers and scholars to judge the legitimacy and academic credentials of conferences in order to help them decide whether to or not attend the same” and to provide “guidelines that help researchers to differentiate between an authentic conference and the one they

6

https://thinkchecksubmit.org/sample-page/think/. https://thinkchecksubmit.org/sample-page/check/. 8 https://thinkchecksubmit.org/sample-page/submit/. 9 https://thinkcheckattend.org/. 10 https://knowledgee.com/about-us/. 7

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should avoid”. With the same objective in mind the AuthorAID11 network provides support, mentoring, resources and training for researchers in low- and middle-income countries.

4.2 The InterAcademy Partnership (IAP) Activities A second major international initiative is the InterAcademy Partnership’s (IAP) project ‘Combatting Predatory Academic Journals and Conferences’ (2020), which involved an independent working group of international experts nominated by academies around the world. Starting once again from the recognition that “predatory journals, publishers and conferences are on the rise and becoming increasingly sophisticated”, the project aims to concretely measure the spread and impact of the phenomenon: Indeed, predatory journals and conferences threaten to cause long-term, widespread damage to research and researchers. Although several studies suggest the problem is widespread and increasing, the true extent and impact globally are not known, which makes addressing these practices all the more difficult.12

A central part of the project was the dissemination, between November and December 2020, of a survey on predatory academic practices, involving 1872 participants in 112 countries, the results of which will be used to develop guidelines and recommendations on the topic. The first results, published through an infographic,13 confirm that more than 90% of participants “think that predatory practices should be combatted to preserve the integrity of, and public trust in, research; to ensure that research informing policy is rigorous”. Furthermore, over 80% of the participants “perceive that predatory practices are a serious problem or on the rise in their country of work”. The data collected also reveal that at least 25% of respondents have either published in a predatory journal, participated in a predatory conference, or don’t know if they have, with the following primary reasons: (1) they were not aware at the time; (2) they needed to advance their career; (3) it was a faster, easier or cheaper option; (4) they were encouraged by their peers. The survey also shows that, according to participants, the more revealing signs of predatory journals and conferences are the following: (1) the invitation to submit a paper is in a subject matter outside my expertise; (2) the conference/journal has an unusual combination of words in the name; (3) they keep sending me invitations over and over again; (4) the invitation is not very focused and the language is odd; and (5) the invitation is very flattering. The IAP activities are also aimed at building a network of stakeholders from all the fields involved (research, publishing, libraries, databases, universities, etc.) 11

https://www.authoraid.info/en/about/. https://www.interacademies.org/project/predatorypublishing. 13 https://www.interacademies.org/sites/default/files/2021-06/Results%20from%20a%20Survey% 20on%20Combatting%20Predatory%20Academic%20Journals%20and%20Conferences.pdf. 12

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to promote an increasingly coordinated approach to the phenomenon, for example, through the creation of an interesting series of webinars.

4.3 The COPE Discussion Document In the field of ethical guidance documents, one of the landmarks on the subject is the ‘Discussion Document: Predatory Publishing’ published on November 1, 2019, by the Committee on Publication Ethics [14] and addressed to all stakeholders involved in the phenomenon (authors, research institutions, funding agencies, publishers, reviewers, etc.). The document addresses the issues of definition, nomenclature and identification of predatory publishing and discusses its impact on the various stakeholders involved. In the first part, it identifies commonly co-occurring features that may sufficiently characterize predatory publications, which include in particular: hidden or unclear author fees, the lack of quality peer review of articles by experts in the field; the guarantee of acceptance and/or the promise of very fast publication times, e.g. within 1 week or 48 h. The first part of the document also outlines that some of the key warning signs of predatory journals “represent the opposite of the Principles of transparency and best practice in scholarly publishing of COPE, the Directory of Open Access Journals (DOAJ), the Open Access Scholarly Publishers Association (OASPA), and the World Association of Medical Editors (WAME)” [14] (p. 6), and suggests to adopt the 16 Principles of transparency “as a framework of warning signs that may indicate the presence of a fake journal, especially if multiple signs occur together”. In the second part, a particularly interesting aspect concerns the description of the two main approaches used to deal with the phenomenon of predatory publishing: There are two main approaches to addressing the problem of fake or predatory publishers. One is to examine, expose, analyse, and educate through scholarly research on the topic; raise wider awareness through journalistic articles on the players and scope of the problem; and provide guides and other forms of education to prospective authors. The other approach is to criminalise the behaviour and utilise the court system in an attempt to penalise the owners and producers and exert the force of the law in terms of heavy fines. Both of these approaches are complementary and often characteristic to similar approaches to other violations of business ethics [14] (p. 10).

While some, in fact, believe that caveat emptor is the best approach to achieve an adequate degree of awareness, others, instead, prefer a criminalization approach through legal complaints and responses. COPE, as well as CNR in Italy as we will see in the next section, has chosen the first kind of approach, suggesting “actions for selected stakeholders to take so as to tackle, avoid, and raise awareness of the problem of predatory journals” [14] (p. 11). The first recommendations are addressed to authors, professional societies and institutions. In particular: (1) educate researchers, supervisors, librarians and administrators in publishing literacy and about fake journals; (2) identify trustworthy journals through the ‘Think. Check. Submit.’ campaign; (3) create and continually update

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community- and discipline-specific journal whitelists/safelists using clear criteria; (4) verify spam invitations to submit manuscripts or attend conferences; (5) check journal names, ISSN codes, and URLs are real ones; verify any claimed metrics, indexed status and organizational membership. Check that researcher profiles on institutional websites or LinkedIn mention claimed editorship of journals; (6) read a sample of archived articles from potential target journals to check quality. Avoid citing predatory journal articles and beware when performing systematic and meta-analyses; (7) beware of paying author fees, especially those that are suddenly demanded as a condition of acceptance, without checking what they are for, and assigning copyright to a predatory journal. This is followed by other general recommendations (‘General advice and approach going forward’): some aimed at funders and institutions, some at journals and publishers and, lastly, some at reviewers and editors. Of the same kind, but with a specific focus on researchers, are the recommendations contained in the first Italian document on the subject.

5 The First Italian Ethical Toolkit on Predatory Publishing In this paragraph, we present the first Italian ethical toolkit on predatory publishing, elaborated by the Research Ethics and Integrity Committee of the National Research Council [15], which includes a series of practical recommendations for researchers aimed at preventing and controlling the risks to be prey of predatory journals and conferences. This ethical toolkit is freely available online14 and it has been presented as a poster presentation at the ENRIO 2021 Congress on Research Integrity Practice, 27–29 September 2021 [16].

5.1 CNR Research Ethics and Integrity Committee and Its Working Group The Research Ethics and Integrity Committee of the Italian National Research Council (CNR) is an independent body with an advisory role on matters of research ethics and integrity, and of biolaw. The CNR is the largest research institution in Italy, counting over 8,000 scholars working in all disciplines and across all knowledge domains [19, 20]. In 2018, the CNR Committee, having been solicited by researchers, established a working group with the task of drafting an internal ethical toolkit on predatory publishing [21]. This working group conducted a literature review and drafted an ethical toolkit with the twofold objective of (i) introducing the issue of predatory publishing to all CNR researchers; (ii) advancing practical recommendations 14

https://www.cnr.it/en/doc-ethics.

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to recognize, prevent and amend possible research misconducts and irresponsible practices related to predatory publishing. The resulting document entitled ‘Increasing Risks of Predatory Publishing: Recommendations for Researchers’ (Rapporteur: Vincenzo Di Nuoscio), was finally approved on 13 June 2019 (a few months before the COPE document was published) [22, 23]. This document represents the first step in a process of deeper analysis and informed discussion on these issues, to which the CNR Committee as well as the CNR Interdepartmental Center for Research Ethics and Integrity aim to contribute to. A systematic review and integration of the document will be carried out by the CNR Committee every two 2, also on the basis of comments and suggestions received from the scientific community and from representatives of public institutions and industry [24–26].

5.2 Practical Recommendations for Researchers The CNR ethical toolkit on predatory publishing is articulated in 12 practical recommendations, divided ino two groups. As we will illustrate, these are not rigid instructions, but rather ethical advice, still provisional, with exceptions, which nonetheless aims above all to assume a symbolic and cultural value for researchers: to make them more aware, more vigilant and more accurate in their choice of journals for publication and in the selection of conferences and seminars to attend [27, 28]. The first group is the one dedicated to provide researchers with more information about predatory publishing and also with practical guidelines on how to spot, identify and possibly avoid predatory journals and conferences [29]. When researchers are planning to submit a paper to a scientific journal, it is recommended to: 1. 2.

3.

Verify that the journal is indexed in the main databases (e.g. Web of Science, Scopus). Examine the journal’s impact indicators and verify their stability over time (e.g. Impact Factor, SCImago). Indicators and other standard criteria are useful parameters to ascertain the reliability of a scientific journal. However, attention must be paid to bogus or misleading impact factors, with names similar to the classic Impact Factor, which predatory journals often show in order to mislead the judgement. Furthermore, it needs to be considered that new non-predatory journals may require several years to be indexed in reputable databases and to have an official Impact Factor, so they may not meet these requirements without, however, being predatory journals. A third criterion for identifying predatory journals is to: check the rejection rate, which is the percentage of rejections of papers submitted to scientific journals.

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This rate is considered effective in assessing the rigor of the peer-review process and, as a consequence, of the publications accepted by a journal. In fact, the most prestigious journals have rejection percentages above 90–95%, while in predatory journals these percentages are close to 10%. Nevertheless, this rate is often not disclosed, even by prestigious journals. Furthermore, when deciding whether to disseminate your research through a journal it is recommended to: 4. verify if the journal is a member of the COPE (Committee on Publication Ethics),15 which defines ethical practices for scientific publication, and supports editors and publishers in reaching the highest standards in publication ethics; 5. review the scientific cv of the Editor-in-Chief and the Editorial Board members. Particularly, pay attention to Editorial Boards which include researchers linked to a single country (unless the journal is a national circulation one) and keep in mind that a predatory journal often includes in its scientific committee excellent researchers without their knowledge or consent, a conduct similar to identity theft. Therefore, internationally renowned scientists may appear as members of the Editorial Board, misleading those who are consulting this list; 6. consider the name of a new journal since predatory journals often choose titles that are reminiscent of those of the best journals in the sector, and create fraudulent websites to look like a legitimate academic journal16 ; 7. assess the thematic coherence of the papers published by the journal. In predatory journals, the contents can be too heterogeneous and far from the aims stated by the publisher; 8. check if the journal is an official journal of a qualified scientific society. This is an important parameter for evaluating the trustworthiness of a scientific journal. Very often the most accredited journals are organs of relevant scientific societies, which exercise rigorous quality control in their official journals. The second group of practical recommendations is meant to provide aid and guidelines for researchers who find themselves, either consciously or unconsciously, involved in predatory publishing or other forms of predatory scientific production. In these situations, a researcher is invited to: 9. withdraw her/his name from the predatory publication and urge any co-authors to do the same; 10. withdraw her/his name from any predatory conference programme and do not participate; 11. if included in an Editorial Board, request the deletion of his/her name; 12. if a colleague is involved in predatory publishing, both intentionally or unintentionally, address the topic with her/him and refer back to the CNR’s ethical toolkit for more context about the negative impact of predatory publishing.

15

https://publicationethics.org/. A list of journals that appear to have been hijacked is available at: https://predatoryjournals.com/ hijacked/. 16

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6 Preliminary Conclusions and Perspectives As we have been discussing, predatory publishing is a complex and nuanced phenomenon that needs to be addressed from different perspectives. From the ethical point of view, the choice of the CNR Research Ethics and Integrity Committee has been to avoid dealing with it from a disciplinary standpoint, but rather through the promotion of a culture of ethics and integrity in research that can preserve the quality of scientific publishing [30, 31]. However, this path is only at the beginning: there are many theoretical issues to be investigated and questions to be answered with the aim of mitigating the phenomenon of predatory publishing, not only on a global level but also through targeted local interventions based on the specific national context [32]. Among these unsolved themes to be investigated, and regarding which data should be collected at the national level, there are at least the following: what are the sociodemographic characteristics of those who publish in predatory journals?; what role do those who publish in predatory journals play within their own institution? are there more single cases or repeated cases?; is extended temporary employment a risk factor, in countries like Italy where short-term contracts represent a systemic problem?; are there disciplinary sectors in which the phenomenon is more widespread, and with what consequences?; what is the relationship between articles published in predatory journals and scientific fraud?; how much public funds are wasted to publish in predatory journals?; are expert evaluators in Italy adequately trained on the subject?; how does the national agency for the evaluation of the university and research system (ANVUR) behave in this regard? The challenge for the near future is to involve the various players in the system of research and scientific publishing for a joint and coordinated debate and action on ethics and integrity in scientific publication [33]. Responsibility, accountability, honesty, impartiality, accuracy and transparency, in fact, are of great importance for high-quality research [34].

References 1. CNR Research Ethics and Integrity Committee (2015) Guidelines for research integrity, updated 2019. https://www.cnr.it/en/doc-ethics 2. COMETS (2011) Relations entre chercheurs et maisons d’édition scientifique. https://comiteethique.cnrs.fr/wp-content/uploads/2019/10/AVIS-2011-24.pdf 3. COMETS (2012) Le libre accès aux publications scientifiques (“open access”). https://comiteethique.cnrs.fr/wp-content/uploads/2019/10/AVIS-2012-25.pdf 4. Beall J (2012) Predatory publishers are corrupting open access. Nature 489(7415):179–179. https://doi.org/10.1038/489179a 5. Bagues M, Sylos-Labini M, Zinovyeva N (2019) A walk on the wild side: ‘predatory’ journals and information asymmetries in scientific evaluations. Res Policy 48(2):462–477. https://doi. org/10.1016/j.respol.2018.04.013 6. Grudniewicz A, Moher D, Cobey KD, Bryson GL, Cukier S, Allen K, Ardern C, Balcom L, Barros T, Berger M, Ciro JB, Cugusi L, Donaldson MR, Egger M, Graham ID, Hodgkinson M,

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C. Caporale and R. M. Zagarella Khan KM, Mabizela M, Manca A et al (2019) Predatory journals: no definition, no defence. Nature 576(7786):210–212. https://doi.org/10.1038/d41586-019-03759-y Strinzel M, Severin A, Milzow K, Egger M (2019) Blacklists and whitelists to tackle predatory publishing: a cross-sectional comparison and thematic analysis. mBio, 10(3):e00411–e00419. https://doi.org/10.1128/mBio.00411-19 Olivarez J, Bales S, Sare L, vanDuinkerken W (2018) Format aside: applying Beall’s criteria to assess the predatory nature of both OA and non-OA library and information science journals. Coll Res Libr 79(1). https://doi.org/10.5860/crl.79.1.52 Singh Chawla D (2021) Hundreds of ‘predatory’ journals indexed on leading scholarly database. Nature. https://doi.org/10.1038/d41586-021-00239-0 Moher D, Shamseer L, Cobey KD, Lalu MM, Galipeau J, Avey MT, Ahmadzai N, Alabousi M, Barbeau P, Beck A, Daniel R, Frank R, Ghannad M, Hamel C, Hersi M, Hutton B, Isupov I, McGrath TA, McInnes MDF et al (2017) Stop this waste of people, animals and money. Nature 549(7670):23–25. https://doi.org/10.1038/549023a Jimenez DF, Garza DN (2017) Predatory publishing and academic integrity. World Neurosurg 105:990–992. https://doi.org/10.1016/j.wneu.2017.05.157 Pujar SM (2017) Predatory open access journals publishing: what, why and how? In: Proceedings of the national conference on the role of LIS professionals in the changing academic paradigm, Bangalore, Feb. 17–18, pp 117–122 Shen C, Björk B-C (2015) ‘Predatory’ open access: a longitudinal study of article volumes and market characteristics. BMC Med 13(1):230. https://doi.org/10.1186/s12916-015-0469-2 COPE (2019) Discussion document: predatory publishing. https://publicationethics.org/files/ cope_dd_a4_pred_publishing_nov19_screenaw.pdf CNR Research Ethics and Integrity Committee (2019) Increasing risks of predatory publishing: recommendations for researchers. https://www.cnr.it/en/doc-ethics Zagarella RM, Annoni M, Caporale C (2021) Preventing predatory publishing: the CNR’s Italian guidelines for researchers. In: Poster presentation at the ENRIO 2021 congress on research integrity practice, 27–29 Sept 2021. http://www.enrio.eu/wp-content/uploads/2021/ 09/Programme-for-the-website.pdf Amaral OB (2018) All publishers are predatory—some are bigger than others. An Acad Bras Ciênc 90(2):1643–1647. https://doi.org/10.1590/0001-3765201820170959 Bauer P, Krause T, Kropshofer K, Langhans K, Wagner L (2018) Das Scheingeschäft: Angriff Auf Die Wissenschaft. Süddeutsche Zeitung Magazin, pp 11–24 Bohannon J (2013) Who’s afraid of peer review? Science 342(6154):60–65. https://doi.org/10. 1126/science.2013.342.6154.342_60 Brainard J (2019) U.S. judge rules deceptive publisher should pay $50 million in damages. Science. https://doi.org/10.1126/science.aax5720 CNR Research Ethics and Integrity Committee (2019) Increasing risks of predatory publishing: recommendations for researchers. https://www.cnr.it/en/doc-ethics Cobey KD, Lalu MM, Skidmore B, Ahmadzai N, Grudniewicz A, Moher D (2018) What is a predatory journal? A scoping review. F1000Research 7:1001. https://doi.org/10.12688/f1000r esearch.15256.2 Duc N, Hiep D, Thong P, Zunic L, Zildzic M, Donev D, Jankovic S, Hozo I, Masic I (2020) Predatory open access journals are indexed in reputable databases: a revisiting issue or an unsolved problem. Med Arch 74(4):318. https://doi.org/10.5455/medarh.2020.74.318-322 Fanelli D, Larivière V (2016) Researchers’ individual publication rate has not increased in a century. PLoS ONE 11(3):e0149504. https://doi.org/10.1371/journal.pone.0149504 Frandsen TF (2017) Are predatory journals undermining the credibility of science? A bibliometric analysis of citers. Scientometrics 113(3):1513–1528. https://doi.org/10.1007/s11192017-2520-x Laine C, Winker MA (2017a) Identifying predatory or pseudo-journals. Int J Occup Environ Med 8(2):117–124. https://doi.org/10.15171/ijoem.2017.1048 Laine C, Winker MA (2017b) Identifying predatory or pseudo-journals. Int J Occup Environ Med 8(2):117–124. https://doi.org/10.15171/ijoem.2017.1048

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28. Pyne D (2017) The rewards of predatory publications at a small business school. J Sch Publ 48(3):137–160. https://doi.org/10.3138/jsp.48.3.137 29. Rice DB, Skidmore B, Cobey KD (2021) Dealing with predatory journal articles captured in systematic reviews. Syst Rev 10(1):175. https://doi.org/10.1186/s13643-021-01733-2 30. Richtig G, Berger M, Lange-Asschenfeldt B, Aberer W, Richtig E (2018) Problems and challenges of predatory journals. J Eur Acad Dermatol Venereol 32(9):1441–1449. https://doi.org/ 10.1111/jdv.15039 31. Swanberg SM, Thielen J, Bulgarelli N (2020) Faculty knowledge and attitudes regarding predatory open access journals: a needs assessment study. J Med Libr Assoc 108(2). https://doi.org/ 10.5195/jmla.2020.849 32. Teixeira da Silva JA, Dobránszki J, Tsigaris P, Al-Khatib A (2019) Predatory and exploitative behaviour in academic publishing: an assessment. J Acad Libr 45(6):102071. https://doi.org/ 10.1016/j.acalib.2019.102071 33. Teixeira da Silva JA, Kimotho SG (2021) Signs of divisiveness, discrimination and stigmatization caused by Jeffrey Beall’s “predatory” open access publishing blacklists and philosophy. J Acad Libr 102418. https://doi.org/10.1016/j.acalib.2021.102418 34. Wallace FH, Perri TJ (2018) Economists behaving badly: publications in predatory journals. Scientometrics 115(2):749–766. https://doi.org/10.1007/s11192-018-2690-1

Ethical Dilemmas in Urban Studies Francesco Lo Piccolo and Marco Picone

Abstract This chapter discusses research into urban studies, and specifically how we might best frame the ethical issues which arise in, and through, such research. One of its central contentions is that ethical sensitivity is developed by researchers as part of a social practice, i.e. through communal activity of a particular kind. Therefore, important as it is to ensure that researchers are aware of their personal ethical responsibilities, understanding what the moral point of view requires—i.e. being sensitive to ethical issues, especially in new circumstances—is something which researchers acquire through involvement in appropriately conducted social practices. The chapter’s suggestion is that the notion of a social practice, as used by MacIntyre and others, is helpful in framing our thinking about research ethics in planning, because it places the individual’s acquisition and development of a moral perception, and judgements, within a social context. The chapter also explores whether the notion of a social practice can be usefully employed to distinguish between the ethical issues which arise in scholarly research in urban studies as opposed to those which arise in policy-related research in that field.

1 Ethics and the City The debate on ethics in urban studies has entered a new phase over the last 50 years. While ethical matters were always deemed relevant for urban studies [1], a disciplinary field that includes both planning and geography [2], things definitely changed between the late 60s and the early 70s. As George Henderson suggests [3], those decades started a sort of ‘moral turn’ in the geographical literature, due to the influence of radical, feminist, queer and critical human geographies. The ‘social revolutions’ of those years (movements for civil rights, gender equity, debates over war and peace) ignited a thorough discussion on the role of social justice—sometimes referred to as spatial justice, a concept that maintains a few peculiarities of its own but still overlaps the former [4]. F. Lo Piccolo (B) · M. Picone Department of Architecture, University of Palermo, Palermo, Italy e-mail: [email protected] © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 L. Congiunti et al. (eds.), Ethics in Research, UNIPA Springer Series, https://doi.org/10.1007/978-3-031-24060-7_6

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Social justice can be considered the declination of the ethical debate in urban studies and reflects progressive, sometimes even radical scholarly positions [5]. There are four particularly relevant scholars who have contributed to the definition of this field of study. We will briefly mention the role each of them played in this definition and then highlight the most important ethical issues that are still discussed in urban studies today. The theoretical debate on ethics and social justice draws, first and foremost, on the foundational work by John Rawls [6]. His book, A Theory of Justice, attempted to mix the traditional liberal approaches encouraging individual freedom with the idea of ‘social contract’, which is an ‘equality of opportunities’ and a reduction of social and economic disparities. It was Rawls’s work which inspired the notion of ‘distributive justice’, a notion which supports and builds upon Keynesian theories to advocate for a just distribution of both quantifiable goods (resources) and immaterial capabilities (rights and opportunities). Other scholars adopted even more radical stances in their analysis of what justice and ethics are—or should be—in urban studies. Iris Marion Young was particularly influential with her book, Justice and the Politics of Difference. Young contests Rawls’s idea of distribution and stresses the role of oppression and domination. ‘Domination consists in institutional conditions which inhibit or prevent people from participating in determining their actions or the conditions of their actions’ [7], Young writes, thus showing how that political approach raises severe ethical issues. Although Young’s ideas are now often mobilised as the most progressive and radical approach to ethical issues in urban studies, no analysis of ethics and social justice in this domain can ignore David Harvey’s contribution to the debate. In the early 70s, Harvey had already introduced his critique of the capitalist system [8], but it was in the late 80s that he published his most successful contribution on social and environmental justice, The Condition of Postmodernity [9]. Harvey’s approach met with several criticisms from feminist scholars, but it was particularly influential in establishing the perimeter of ethical concerns in urban studies. Another—perhaps even more relevant—milestone in the debate on ethics in urban studies comes from France, with Henri Lefebvre’s seminal book Le droit à la ville (The Right to the City in its English translation) [10]. Lefebvre sparked a debate on what it means for all urban stakeholders (including common residents of any neighborhood) to reclaim an active role in defining urban policies. His radical approach is still exerting a long-lasting influence over contemporary scholars, as proven by the recent revival of his theories [11]. Obviously, each of the four above-mentioned authors (Rawls, Young, Harvey and Lefebvre) expresses a specific idea of what ethics and social justice are. Regardless, scholars have built upon those authors and their works to create a sort of ‘common ground’ for ethical discourses in urban studies. Based on the philosophies of Giorgio Agamben, Gilles Deleuze and Jacques Derrida, amongst others, urban scholars now conceive of ethics not as a collection of universally applicable moral principles, but as the ability to include and take into account all those points of view which are different from our own. In other words, ethics become a way to reflect on ourselves, our (fluid) identities and our relationships with ‘the other’.

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This reflexive approach permeates all critical urban studies today, along with several other domains which are close to urban studies, like geopolitics, spatial analysis and GIScience [12]. Over the next sections, we will focus on one particular field (i.e. planning) and show how the theoretical debate on ethics and social justice is affecting urban planning today. We will adopt a methodological framework that combines urban studies and story-telling through the critical analysis of some famous Shakespearean plays.

2 Narrating Stories, Interpreting Roles, Telling the Truth Throughout this chapter, we use the notion of social practice, as proposed by MacIntyre [13] and others. This notion is helpful in framing our understanding of research ethics in planning, since it places the individual’s acquisition and development of a moral perception, and judgements, within a social context [14]. We also inquire whether the notion of social practice is useful in distinguishing between the ethical issues which arise in scholarly research in urban studies, as opposed to those which arise in policy-related research in that field. In order to develop this issue, the analyses of planning activities and story-telling will be used and critically revised. In our view, and experience, the most challenging and intriguing element of the methodological approach of analysing planning and planners’ experiences is its ethical dimension, both in substantive terms as well as in epistemological ones. To simplify here our basic (and instrumental) distinction between substantive and epistemological, we will use here ‘substantive’ in reference to what planners do and say, and ‘epistemological’ in reference to what planning researchers do and say. We are aware that there is already an epistemological dimension in the substantive one (what planners do and say), that is the ‘epistemological consciousness’ [15], which is necessary in order to cope with the diversity of interactions and multidependent, ethical and contextual issues. However, here, we want to stress and highlight this basic distinction (and mutual relationship) between substantive and epistemological, linking it to planning practices (the first) and to planning research and education (the latter), because they often overlap and influence one another. For what concerns the ethical dimension in substantive terms, John Forester has deeply investigated it, and many other planning theorists developed and discussed the issue of communicative ethics, both considering the inclusive (or exclusionary) process of communicative ethics and discussing the relations between rationality and ethics. In this framework, rationality and ethics rely on accuracy, integrity, accountability and sincerity of what participants say and do in communicatively rational discussions, and on a planner’s duty of responsibly constructing dialogues (and knowledge) accountable to standards of truth and rigour [16]. Consequently, the normative framework of communicative ethics has been applied and ‘adjusted’ to a variety of practices, highlighting the following: the ethical commitment of respecting different arguments, positions and feelings, and a claim for establishing practices of

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intelligent, multi-sided discussions in order to cultivate ‘the intelligence of a polity’ according to the principles developed by Dewey [17], and as deeply discussed in Healey [18]; under the influence of Forester [19], the normative imperative of developing appropriate and just planning skills, being attentive, asking good questions, exploring meanings and implications, helping to correct the self-deception of others, providing respect, treating the other in a relationship seriously; and finally, the planners’ mission of developing skills and sensitivity in order to nurture the capacity of ‘reasoning in public’ as a key element of a rich and critical democratic life, as developed in Habermas [20–22]. Planners, faced with a diversity of groups and individuals in their interactions, confront a range of multi-dependent, ethical and contextual issues, which demand sensitivity to the socio-spatial diversity of people’s daily life experiences [23]. This assumption, and the normative ideal that nurtures it, was and still is both very convincing and challenging, not only in the ‘US and the Anglo-Saxon environment’ but also in the Italian context. In John Forester’s works [24, 25] as well as in some of Patsy Healey’s works [26, 27], there is a normative political and ethical fil rouge. The emphasis—when analysing the processes of planning rather than examining their contents or tools—is on individual agents and their interactions, without underestimating the importance of the structural contexts and the consequent configurations of power and influence within which these interactions occur. The emphasis here is also about planning and planners’ activity conducted as a complex set of inter-relationships or social networks, where planners interact with people in highly varied positions and roles and, at the same time, where planners themselves perform in highly varied positions and roles. Also of interest are the potentials of micro-practices in planning activities and in urban dynamics as well; a recognition and appreciation of the multiple identities and ways of life; the importance of discourse, in formal, but, moreover in informal contexts, through the analysis of normally invisible or unrecorded dialogues with different actors—formal and informal, institutional and not, technical and not, with different levels and nature of knowledge—not to talk about their interests, cultures and values. These concepts and definition reveal what planning is, beyond plan-making, in Italy as well as everywhere: it is not entertainment but, in deeds, a serious play, a drama, a tragedy sometimes, with many actors and roles. Planning is not an individual practice, but a collective, or better, plural ensemble (and interaction) of multiple practices [28]. If planners interact with people in highly varied positions and roles, we would add that planners themselves are forced to act in different roles and positions at the same time, with all the ethical dilemmas arising from playing multiple roles in multiple dramas [29]. Rephrasing the opening of the famous monologue spoken by the melancholy Jacques (William Shakespeare, As You Like It, act 2, scene 7, 139–166), all the planning activities are a stage, and all the planners are players on that stage; they have their exits and their entrances, and all planners in their time play many parts. For this reason, we stress the role of the plurality of practices in influencing the life of individuals (planners as well as researchers), and consequently, the capacity of

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adaptation (and learning) of each of them, playing a variety of roles in their lives and practices. We already used Shakespearean characters, such as Cordelia and Polonius, as metaphors for some theoretical dilemmas in the theory/practice relationship, in order to reflect on planning and democracy in general terms and, specifically, in order to stress the ethical as well as operational implications for planners when they face huge imbalances of power, status and rights in contexts that are largely dominated by false promises [30]. In that regard, King Lear is a planning tragedy, and in our eyes the most outstanding planning tragedy in the entire story of Western literature. Formally, the lands’ assignment (that is, planning decisions) is based on and justified by common principles and shared values, which are argued and expressed in public discourses. Substantially, decisions are established as the consequence of discursive inter-relationships, in formal, and more significantly, informal contexts and unrecorded dialogues. Moreover, most of the public discourses are deceptive and false, as they are oriented to power and to individual interests. Decisions are formally taken according to equity and rigour in (formal) principles and rules, but they are substantially revealed, and considered, as the most unjust and inequitable by all the subjects involved, whether they benefit from or are damaged by them. In short, the tragedy of King Lear reveals that planning is no ‘simple’ activity of plan-making or decision-making, but a multilevel and multi-role set of interactions, also being the result of sincere or insincere speeches and acts of public reasoning. For what concerns planning theory, our instrumental use and analysis of King Lear reveal the dilemma of a theory of truth or of some truth criteria on which planning discursive inter-relationships might ever rely. Consequently, the ethical dilemma posed by the effects of false promises in public reasoning requires further insights; it still remains a highly debated issue. Considering some historical and cultural peculiarities of the Italian context, our open questions remain the following: what are the conditions and, indeed, the preconditions for a fair and substantial public reasoning? How to practice this normative ideal in those contexts or situations in which the ‘reasoning in public’ arena is a mere deceitful pretence, or on some occasions, when there is no ‘reasoning in public’ at all? How to develop this in contexts where false promises are the rule, and where the gap and imbalance in role between the public arena and the closed rooms of power and the most powerful elites are so huge? Epistemologically, the same questions and ethical dilemmas apply to any set of narratives, story-telling, interviews or autobiographies; in short, who tells the truth? Can anyone speak honestly and sincerely? The narration of stories, experiences and autobiographies in planning literature and research provides some answers to these questions and at the same time also opens new questions concerning the ethical dimension of being directly engaged in planning practices.

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3 To Be, or Not to Be Engaged (in Planning Practices): Technical Expertise Versus Political Vision In planning activities, there is a continuous shifting and waving between at least four positions: researcher, planner, activist and academic. Consequently, a number of ethical dilemmas stem from all the experiences described in planning literature, as well as from our personal experiences. We wish to stress here one of these dilemmas, which is the following: an ethic of ‘responsibility’, based on self-reflection, entails removing a priori that being engaged in planning practices is ‘a good thing’. Thomas [31] reminds us there are “good reasons for wanting to ‘stay close’ to practice, but staying close carries with it a danger of ‘going native’”, and we are every time in the position of running that risk. This leads to some conclusions that have already been expressed [32] in reference to the necessary distinction between scholarly and policy/governance-related projects, in order to escape from the ambiguity of playing multiple (and even conflicting) roles in the attempt of ‘squaring the circle’—obeying institutional requests on one side and writing ‘shadow works’ to fulfil the moral obligation of truth and rigour on the other side. Nevertheless, there is a further open question: how could planners ‘carve out room for manoeuvre’ and still maintain intellectual independence and integrity? Thomas fully describes how planning researchers have to face and even negotiate a complex moral landscape, which is subjected to potentially morally compromising possibilities. These compromises are essentially due to: • The subjective status of the researcher which depends on access, cooperation and even (financial) support from powerful (political) institutions; • The unpredictable exploitation or misuse of research findings; • The direct interest and consequent pressures of funding institutions on the research areas. Here, there are both general ethical issues and specifically research ethical issues: a strict and rigid distinction does not entirely apply to planning practices, and, moreover, very similar compromises arise as well in the field of planning practices and not only in the research field. The reading of the above-mentioned compromises raises another question: how are we supposed to consider planners—understood as immersed in the policy process—as moral/political agents, given their political commitments? All the planners and planning academics are publicly engaged, in one way or in another. The question is: how are they engaged? According to what kind of values, interests and political views? What is the role of technical knowledge? If we look at the role, effectiveness and legitimacy of planning knowledge in dealing with a wide range of practices and policies, in many cases we could notice that quite often a pure technical knowledge is weak and frail. Many planning theorists have discussed limits and weaknesses of the technical dimension of planning knowledge. Nevertheless, the neoliberal stream has determined a ‘revival’ of technical knowledge and technocrats, globally and locally; so, it has become again an issue to be debated.

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Especially when ‘closed rooms’ activities are very frequent or the only rule, technical knowledge is very weak and useless, and reasoning in public becomes a mere deceitful pretense, particularly at the local level of governance. This is the role and fate of a planner when speaking truth to power, as in the case of Kent in King Lear: a role model for the democratically committed planner who even when disavowed keeps an allegiance to justice and democracy. But this is also the fate of the institutional bureaucrat in the enforcement of his/her mandated role, as in the case of Polonius in Hamlet: not only are the boundaries of Polonius’s space for action and, hence, potential for influence, more limited than he would wish, but in attempting to increase his influence, Polonius adopts principles that are likely to be acceptable to those he seeks to influence. Consequently, Polonius is the first to die in the long series of murders in Hamlet. This happens—in our view—in contexts where most of the conflicts are latent or hidden, and the first victim is not power itself, but technical expertise. Polonius’s acts and character fit very well with planners’ attitudes to serve the interests of those they are working with, the reference group. At the same time, Polonius’s presumption of neutrality is merely fake and inconsistent. If we consider either the early work of Healey and Underwood [26] in the UK context (as a mere example of a long list of planners’ ‘observational studies’) as well as the Italian experiences, we have to recognize that planners are neither neutral nor consistent in the interests they are likely to promote, and this observation contrasts with the assumption of technical neutrality. In our experience, planners cannot act as Polonius; otherwise, they will die first, or they will be ‘blinded’, as in the case of Gloucester in King Lear. They can learn lessons from time to time, playing many parts, such as Kent, the disavowed, democratically committed planner who does not renounce to speak truth to power; Edgar in his role of ‘Poor Tom’, the insurgent planner who acts outside the formal framework of institutionally established procedures; or Hamlet instrumentally using the creativity of the players, that is, involving alternative subjects and skills that are different from the technically orthodox approaches. Consequently, we do not believe that, even in Italy, there is a pure technical expertise (and related tradition) in planning, not only according to our personal research experience but also on the basis of recent Italian planning debates [33]. Even those who state this—in academic writings or in public reasoning—as soon as they are engaged in planning practices, change their minds or are just speaking rhetorically. They play, and so, at the end, we can consider their assumption just another play within the play.

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4 Conclusions Throughout this chapter, we have described and analysed the role ethics play in urban studies, and in planning in particular. By stating that planners play multiple roles in multiple dramas, we make an obvious reference to their ethical agendas and perspectives. In urban studies, ethics are too often invoked as theoretical principles, but ethics in practice are an entirely different matter. Acknowledging the connections between theory and practice, as well as between politics and techniques, can foster the need of a more structured and stronger ethical approach in these disciplines. The analysis of planning and planners as actors could be applied to other disciplines as well; given the contemporary situation we are experiencing, geopolitics would be the ideal field for such further analyses—something we will strive to accomplish in due time. The Ukrainian war calls for our reflections on a renewed concept of ethics and social justice [34], and we believe our duty, as both researchers and activists, is to enquire how we can make ethics become a beacon in dealing with all the topics of power in its special effects.

References 1. Sauer CO (1956) The agency of man on the Earth. In: Thomas WL (ed) Man’s role in changing the face of the Earth. The University of Chicago Press, Chicago, pp 49–69 2. Phelps NA, Tewdwr-Jones M (2008) If geography is anything, maybe it’s planning’s alter ego? Reflections on policy relevance in two disciplines concerned with place and space. Trans Inst Br Geogr 33(4):566–584. ISSN: 1475-5661. https://www.jstor.org/stable/30135334 3. Henderson G (2009) Ethics. In: Gregory D, Johnston R, Pratt G, Watts M, Whatmore S (eds) The dictionary of human geography, 5th edn. Wiley-Blackwell, Chichester, pp 211–213 4. Iveson K (2011) Social or spatial justice? Marcuse and Soja on the right to the city. City. Anal Urban Chang, Theory, Action 15(2):250–259. https://doi.org/10.1080/13604813.2011.568723 5. Rossi U, Vanolo A (2012) Urban political geographies. A global perspective. SAGE, London 6. Rawls J (1971) A theory of justice. Harvard University Press, Cambridge 7. Young IM (1990) Justice and the politics of difference. Princeton, Princeton University Press, p 38 8. Harvey D (1973) Social justice and the city. Arnold, London 9. Harvey D (1989) The condition of postmodernity. Blackwell, Oxford 10. Lefebvre H (1968) Le droit à la ville. Anthropos, Paris 11. Purcell M (2016) Possible worlds: Henri Lefebvre and the right to the city. J Urban Aff 36(1):141–154. https://doi.org/10.1111/juaf.12034 12. Picone M, Lo Piccolo F (2014) Ethical e-participation: reasons for introducing a ‘Qualitative Turn’ for PPGIS. Int J E-Plan Res 3(4):57–78. https://doi.org/10.4018/ijepr.2014100104 13. MacIntyre A (2007), After virtue. A study in moral theory, 3rd edn. University of Notre Dame Press, Notre Dame 14. Blackledge P (2009) Alasdair MacIntyre: social practices, marxism and ethical anti-capitalism. Polit Stud 57(4):866–884. https://doi.org/10.1111/j.1467-9248.2008.00770.x 15. Healey P, Gilroy R (1990) Towards a people-sensitive planning. Plan Pract Res 5(2):21–29, 26. https://doi.org/10.1080/02697459008722784 16. Forester J (1989) Planning in the face of power. University of California Press, Berkeley

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17. Dewey J (1927) The public and its problems. Swallow Press/Ohio University Press, Athens 18. Healey P (2009) The pragmatic tradition in planning thought. J Plan Educ Res 28(3):277–292. https://doi.org/10.1177/0739456X08325175 19. Forester J (1999) The deliberative practitioner: encouraging participatory planning processes. MIT Press, Cambridge 20. Habermas J (1981) The theory of communicative action: reason and the rationalization of society. Beacon Press, Boston 21. Habermas J (1989) The theory of communicative action. Lifeworld and system: a critique of functionalist reason. Beacon Press, Boston 22. Habermas J (1996) Between facts and norms. Polity Press, Oxford 23. Healey P (2012) Re-enchanting democracy as a mode of governance. Crit Policy Stud 6(1):19– 39, 21. https://doi.org/10.1080/19460171.2012.659880 24. Forester J (2009) Dealing with differences. Oxford University Press, New York 25. Forester J (2013) Planning in the face of conflict. American Planning Association Press, Chicago 26. Healey P, Underwood J (1978) Professional ideals and planning practice. Prog Plan 9(2):73– 127. https://doi.org/10.1016/0305-9006(78)90005-3 27. Healey P (1992) A planner’s day: knowledge and action in communicative perspective. J Am Plan Assoc 58(1):9–20. https://doi.org/10.1080/01944369208975531 28. Crosta PL (2010) Pratiche. Il territorio “è l’uso che se ne fa”. FrancoAngeli, Milan 29. Lo Piccolo F (2009) Multiple roles in multiple dramas: ethical challenges in undertaking participatory planning research. In: Lo Piccolo F, Thomas H (eds) Ethics and planning research. Ashgate, Farnham, pp 233–254 30. Lo Piccolo F (2015) Neither Cordelia nor Polonius: ethical implications for planning in the face of blatant and hidden imbalances of power, status and rights. In: Hillier J, Metzger J (eds) Connections. Exploring contemporary planning theory and practice with Patsy Healey. Ashgate, Farnham, pp 79–93 31. Thomas H (2005) Pressures, purpose & collegiality in UK planning education. Plan Theory Pract 6(2):238–247, 239. https://doi.org/10.1080/14649350500185118 32. Lo Piccolo F, Thomas H (2008) Research ethics in planning: a framework for discussion. Plan Theory 7(1):7–23. https://doi.org/10.1177/1473095207085663 33. Bianchetti C, Balducci A (eds) (2013) Competenza e rappresentanza. Donzelli, Rome 34. Walzer M (2006) Just and unjust wars: a moral argument with historical illustrations, 4th edn. Basic Books, New York

Toward Virtuous Machines: When Ethics Meets Robotics Antonio Chella , Arianna Pipitone , Francesco Lanza , and Valeria Seidita

Abstract In very few years, the rapid evolution in Robotics research will lead to the designing and developing of intelligent autonomous robots behaving like humans. Robots will become pervasive and soon become part of humans’ lives. Beyond the technological aspects, to reach these objectives, the researchers and the roboticists must propose novel theories and find how to implement them to allow robots to align with social, moral, and legal cues. Roboethics aims to discuss ethical problems related to the design and use of autonomous robots. It aims at defining the conduct codes to instill virtuous AI in robots. This paper aims to overview the available issues and the proposed approaches to face the Roboethics problems, and it discusses artificial phronesis as a new way to face Roboethics problems. A possible implementation based on BDI agents is then outlined.

1 Introduction Facing ethical issues for robots and autonomous systems has an ancient origin: the concern and moral perception of automata, robots, or protorobots date to the ancient Greeks. The first traces can be found in Politics by Aristotle. He highlights how, if possible, the creation of tools or instruments that abide by orders implied a change in the ancient Greek world’s social organization and economic system. Mythical descriptions of robots have been given throughout all antiquity. Ovid talked about “social robots” in the Metamorphoses, crafting stories with moral messages. Also, the Hero of Alexandria built sophisticated automata, thus opening the discussion on their impact, including its ethical consequences. In the 1940s, American science fiction writer Isaac Asimov formulated the Three Laws of Robotics, presented in a short film three years later. Asimov is popularly A. Chella (B) · F. Lanza · V. Seidita Department of Engineering, University of Palermo, Palermo, Italy e-mail: [email protected] A. Pipitone Department of Human Studies, University of Palermo, Palermo, Italy © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 L. Congiunti et al. (eds.), Ethics in Research, UNIPA Springer Series, https://doi.org/10.1007/978-3-031-24060-7_7

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considered a pioneer of Artificial Ethics. He argued the importance of some form of morality for machines when interacting with humans and the need to instill ethical behaviors in their intelligence, revealing conflicts and problems that robotics researchers up to that point had not explored. These laws were intended to help robots resolve conflicting situations involving humans and focus on protecting humans. Still today, the Roboethics literature frequently references Asimov’s Three Laws. Currently, autonomous systems assist people in daily life, but the impact of ethics is not always clear. Indeed, robots and autonomous systems invade people’s privacy: these systems continuously monitor their private space. Examples concern how they trace and keep people’s searches on the Web by personal devices or infer their preferences based on choices and actions. As a result, machines can be personalized over time based on their inputs. They can better answer the specific user’s request, keep decisions autonomously, or ask permission to act. While in some situations, the evidence of ethical evaluation is clear (safe machines, guns, military scenarios), there are many other situations in which the impact of ethics is less clear. For example, it is the case of the home-assistant systems that interact with people and then intercept their habits, personal dialogues, etc. They are becoming pervasive systems, and people are not fully aware of them. Robots may assume many facets, such as state-of-the-art apps or autonomous safety control systems. The importance of instilling moral skills into these systems is essential: they must evaluate the convenience of making decisions according to subjective parameters, taking into account norms, laws, and sensitivity rules while maintaining human safety. Many works attempt to automate moral behaviors in artificial systems in the literature, but the process is still at the beginning. The autonomous and safe virtuous agent is still a dream of roboticists. This chapter aims to present an overview of the efforts and methods contributing to the definition of computational ethics models that instill ethical behaviors and morality in artificial agents. Thus, the paper concerns the main computational approaches in Roboethics, analyzing how artificial systems could implement the main ethical principles. Then, the article discusses such methods and how they could be combined to define sophisticated hybrid methods from the high-level to the top-down approaches. A proposal based on artificial phronesis is finally discussed, representing an interesting new approach in Roboethics. Implementation of artificial phronesis based on Belief–Desire–Intention (BDI) agents is then outlined.

2 Proposals in Roboethics When roboticists and engineers face the design of moral machines, they must consider challenging implementation issues. Ethical values are difficult to implement on a robot as they depend on unpredictable events, broad cultural and social contexts, subjective sensitivity, emotional involvements, and, generally, unforeseeable issues. Furthermore, the available information on a specific scenario could be inappropriate

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or incomplete for covering all possible moral aspects, and predicting all events is not always feasible. Despite all such limitations, artificial ethics research has been going on, and many computational methods form the theoretical backbone for building simple forms of moral machines. Of course, today, the complete virtuous and ethical machine, which is never wrong and always able to solve conflicts autonomously by widely acceptable ethical behaviors, does not exist. Relying on these theories makes it possible to design and implement routines for running and simulating ethical processes while observing and testing the implications in a robotic social context. All existing computational models attempt to instill ethical behaviors into artificial systems’ intelligence, falling into five main categories [1]: top-down, bottom-up, hybrid, the models of reality, and the artificial phronesis methods. The main differences concern the strategies to resolve conflicts and the moral modalities to face decision-making processes.

2.1 Top-Down Methods According to Wallach et al. [2], top-down strategies in Roboethics arise from considering the top-down outcomes from high-level reasoning systems related to the moral theory to apply general ethical principles/rules/laws. In the engineering field, top-down methods usually decompose a task into subtasks. Each sub-task implements a smaller sub-behavior and is arranged with the others to realize more complex behaviors. With the top-down approaches, it is then possible to prescribe and embed the desired ethical behavior by combining rules, each corresponding to an atomic ethical behavior. Generally, a top-down approach identifies the most specific ethical behavior and combines it with other ones to obtain a desired complex moral outcome. In a few words, artificial systems whose ethical intelligence is based on a top-down method are rule-based systems. The typical structure consists of an antecedent part and a consequence part. These parts represent the event and the action to be taken that correspond to that event. If an event is modeled as the antecedent part of some rules, then the artificial system will take the specific behavior ascribed by the consequent part of the rules. Consequentialism figures out such a rule’s structure. Along the same line, the commandment ethical model highlights the existence of a set of commands to follow when a specific situation occurs. The classical utilitarian and deontological views may be considered the two main top-down approaches as they provide general principles for implementing ethical behaviors (i.e., the rules). However, the approach has problems. The rules’ antecedent parts can often conflict, generating a stalemate. Identifying the background data necessary for formalizing rules/principles/laws could be the same for different rules, leading to conflicting consequences.

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The first attempt to overcome these limitations is to focus on a specific domain (war domain, safe domain, medical domain, school domain, and so on) and to define a set of rules, sufficiently extensive, tailored to ethically appropriate behaviors for that domain. For example, the “do not kill” rule will be more relevant for the war domain than the school domain, whereas the “take care of health” rule will be more relevant for the medical field than the war one. The rules become domain-dependent, and ethical domain experts play an essential role in this scenario. However, that approach has flaws, and it adds further problems. The more extended the domain to investigate is, the more complex the resulting rules and their combinations are. The complexity of the moral system grows exponentially with the increasing domain complexity. Moreover, the strategy does not bypass the rule conflict because the rules could be incompatible, leading to computationally intractable situations. Another solution is to add principles for resolving rule conflicts and meta-rules governing the rules. The result is a complex parametric system for which it is challenging to explain how the competition is solved. Given the high number of parameters and the combinatorics explosion, it is impossible to trace the decision processes and the rules’ ramifications. The system is not transparent, not allowing users to understand why and how the ethical decision was taken, thus evaluating the ethical acceptance of a choice unsuitable. Another strategy consists in organizing the hierarchical subsumption of rules, according to which the first rule subsumes the next one in the hierarchy. The Golden Rule or Asimov’s laws are examples of how the order of the laws could solve a possible conflict. Other aspects should be considered when implementing top-down systems, such as the unconscious evaluations of humans depending on personal inclinations, cultural sensitivity, etc. They form a set of unsolved features that are difficult to face in a computational model. Implementing ethical behaviors and controls by a group of rules remains one of the most challenging problems in Roboethics.

2.2 Bottom-Up Methods A moral theory based on the specification of a set of commands or rules is not the only way philosophers and psychologists conceive morality. Roughly, the bottomup approach supporters claim that an explicit and unambiguous moral theory cannot exist and that humans learn ethical behaviors by experiences and depending on the social context. The ability to morally evaluate a situation is a cognitive skill like others. Children may acquire it through specific developmental processes depending on the received education, sensitivity, and, in general, the context in which they are plunged. From an engineering point of view, this approach is like the bottom-up approach of systems design, in which the starting points are the available tools and data. Then, the system behavior is built by integrating them purposely.

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Typical bottom-up systems are open-ended systems. They learn from the environment by collecting information and predict the outcomes by observing external events according to previous choices. A machine based on bottom-up morality can be roughly described as having the ability to learn what is right, what is wrong, and what is ethically acceptable and morally favorable. It can self-adapt its decision-making strategies through the acquisition of experiences. Summarily, the ability to solve a conflict arises from trials and errors, from which the system learns from mistakes or successes. There are many ways according to which it is possible to simulate some aspects of the ethical human developmental processes. The tendency is to use existing tools considered typical for autonomous learning tasks, such as the evolution simulation [3]. For example, greedy-search algorithms, which are the base of unpredictable learning systems, attempt to simulate the evolution of humans’ abilities to find suitable solutions. These algorithms tend to be more innovative and more robust than humans themselves. They could be applied in solving ethical conflicts because they search for a locally optimal solution by recursively dividing the set of observations. Another kind of learning is the associative form. In this case, the ability to solve conflicts depends on the associations the system establishes between previous choices and the feedback it receives (good or bad). Whatever learning strategy is used, finding an optimal solution is not guaranteed. This fact may lead to unstable and unreliable ethical machines.

2.3 LIDA: Integrating Top-Down and Bottom-Up Strategies The top-down and bottom-up approaches have advantages and limitations yet discussed. The integration of some aspects seems to represent the best resolutive approach. The resulting hybrid moral system would maintain features from bottomup and top-down methods. Other cognitive faculties, such as affection, emotions, and empathy, could also be added. Integrating top-down and bottom-up aspects is the main problem in hybrid approaches. Choosing the factors to consider from one theory is not trivial. Moreover, the protocol establishing how the bottom-up and top-down processes interact is another critical challenge. One of the most relevant frameworks based on the hybrid approach is LIDA [2], a cognitive architecture that attempts to automatize Baars’ Global Workspace Theory (GWT) [4]. Briefly, GWT is a model of consciousness that aims to define a high-level theory of human cognitive processes. The global workspace looks like a blackboard. Different methods “look” at the blackboard and interact and form combinations/coalitions. Each combination results from other processes and a different way of interacting with the same techniques. A set of combinations implements a specific cognitive function. For example, some varieties may give a semantic sense to the perceived data from the environment. Other combinations may manipulate the results of the focus of attention. The combinations compete on the blackboard, and some of them win.

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The winning combinations occupy the blackboard, representing the active cognitive function at a time. According to GWT, the processes that occupy the blackboard are conscious. The content of the blackboard is then broadcast to all methods that look at it. It allows recruiting other processes to select an action that deals with the current situation. LIDA is inspired by GWT theory to implement a hybrid system able to make decisions depending on many features (such as moral considerations, emotions, and so on). According to the blackboard metaphor, LIDA orchestrates and creates coalitions between the bottom-up sensory data and the top-down processes. Then, LIDA infers the current state meaning and predicts the results from different techniques in the same context. When facing morality [2], LIDA integrates the bottom-up structure with the topdown knowledge of moral principles. It balances rights and duties and computes a level of morality. This level estimates one action’s contribution to the total utility amount. LIDA attempts to model a complete moral agent, according to which it can manage emotions and affections, and it is equipped with other “suprarational” skills, such as a sense of self and the other. However, the proposed model is not fully implemented yet. Still, it provides some interesting working hypotheses that could explain how moral decisions can be made and are influenced by other faculties.

3 Artificial Phronesis Sullins [5] proposed a theoretical framework based on “artificial phronesis,” a term used by Aristotle to describe abilities related to practical thinking and the virtues of thought. According to Sullins, the behavior of an ethical agent should be guided by the phronesis to perform virtuous actions. Therefore, he draws attention to the ability of an agent to acquire the ability to perform moral acts. The choice of a virtual action in a difficult ethical situation cannot result from any logical conclusion as in an AI inference system, such as “If the situation (x) then action (y).” Instead, it is a habit or practice of the agent, which requires a careful analysis of all possible entities involved in the ethical problem and the study of the results of the possible actions. At the same time, each moral problem is unique. Therefore, it would be implausible to consider a solution found through a system based on learning systems such as neural networks. A training set with many examples is required, which is not always available. Instead, Sullins proposes a computational framework for artificial phronesis loosely based on the action of playing a social game: “Ethics and morality might be seen as a kind of complex, high stakes, a social game that human agents play with one another. Given that computers have proven to be adept at playing games, the game of ethics should be eventually solvable.” [6]. Here, we sketch a framework inspired by artificial phronesis composed of two interacting agents: the agent for problem classification and case analysis. The agent

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for problem classification analyzes the characteristics of the situation to extract meaningful features, such as the context, which the agent is, who the patient is, when a particular urgency exists, etc. This agent functions like an agent who evaluates the current chessboard situation. The agent for case analysis works closely with the agent for problem classification. After an initial analysis of the problem at hand, received by the agent for problem classification, this agent starts a search in several different repositories to find similar and related ethical cases. Possible repositories are the ethical case study databases the ethics research community provides. The agent can also search through websites and social media to analyze and search for similar and related cases. Finally, the agent can launch a search query by asking a human mentor for help. As mentioned above, the two agents interact continuously in a recurring loop: when the agent for case analysis finds cases that are of interest and show certain similarities to the problem at hand, then it queries the agent for problem classification to analyze better the similarities of the characteristics of the cases found in terms of context, agent, patient, etc. The agent for problem classification can then refine its case analysis accordingly, for example, by better accounting for the patient’s role or context. This refined analysis can, in turn, open new possibilities for the agent for case analysis and so on. When the two agents agree on a list of related cases or a combination, the planner starts a planning phase in which several plans on the issues found are generated. These plans are ranked according to urgency and confidence. Therefore, a possible plan may be chosen instead of another possible method because it is faster or more reliable. The system’s internal model can also simulate a plan before execution to better assess its confidence. Finally, the general agent will move according to the program. Then, as in a game such as Chess or Go, the agent’s move results are re-evaluated to decide whether to continue or change strategy. Depending on the agent’s operations’ general results, the outlined system receives adequate feedback and adapts better. Therefore, the system will acquire an appropriate operational capability in the long run, i.e., a kind of phronesis.

4 Cognitive Agents Supporting Artificial Phronesis The artificial phronesis described above proposes to guide ethical behavior through argumentation that considers several questions. All these questions led to the proposal to design an ethical agent described in this section. From an implementation point of view, the described model is easily feasible by using a Belief–Desire–Intention (BDI) multi-agent system [7]. Belief–Desire– Intention (BDI) is a paradigm that strongly involves the deliberation abilities of the agent. Deliberation is based on a continuous sense-act loop during which beliefs are evaluated [8]. The model in [7] has been recognized as a helpful paradigm for implementing agents that behave like humans, with the same ability to perform intentional, practical reasoning and means-ends analysis. Furthermore, BDI agents

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can decide what to do and which actions are included in their repertoire based on a collection of data obtained by sensing. Given all these features, they can also perform actions based on considerations of moral values and ethical issues. Therefore, moral values and ethical questions are additional input from the motivation module. Beliefs, desires, and intentions characterize a BDI agent: beliefs are the information the agent has about the world (objects, norms, rules, etc.) and about itself; desires are all possible states of affairs an agent can reach; and intentions are the states of affairs an agent commits to execute. The intention is usually thought of as a specific operation that the agent intends to do, a practical line of reasoning. In the literature, BDI agents are implemented using the Jason programming language. In the logic of Jason, a computer program is something that knows to select actions to pursue a goal, often on behalf of humans and without their input. Jason works with a reasoning cycle that requires sensing the environment, updating one’s knowledge base, and reasoning about specific concepts in the knowledge base to activate the process that leads to selecting an intention and a plan for proceeding. As Jason implements BDI agents, it differs from other programming languages in handling the declarative phase. Jason allows defining a set of beliefs that represent knowledge about the state of the environment: e.g., objects and their attributes present in the background. What is unique about Jason and belief set representation is that it can represent elements of the physical environment in which the agent lives and abstract elements such as norms, mental states, and rules. Our proposal concerns extending the belief representation to include ethical issues. In previous work, we modified Jason’s reasoning cycle to include modules for managing events, plans, and intentions in the selection process, to include what we call motivations in addition to traditional beliefs. We propose to have ethical issues in the form of norms, rules, and ethical values in the motivation computation process. In this way, we can consider everything that concerns the ethical aspects of robot behavior already in the analysis and design phase. Ethical elements can be genuinely implemented by appropriately adapting and modifying known and applied technological solutions.

5 A BDI Implementation of Artificial Phronesis This subsection will outline the implementation of agents equipped with artificial phronesis to manage ethical issues. Figures 1 and 2 schematize the reasoning process that agents implement and are illustrated by Sullins in his framework. Ethical reasoning can be performed when multiple agents, including humans, are present simultaneously. In this phase, we consider artificial agents named Problem Classification Agent (PC), Case Analysis Agent (CA), and Planner Agent (P) (Fig. 1). At the beginning of the process, the two agents, PC and CA, interact continuously. First, the environment or situation is analyzed to produce a context, i.e., a formalization of a problem. Then, CA uses the context as input to search for similar issues

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Fig. 1 A BDI implementation of artificial phronesis

Fig. 2 The reasoning cycle of JASON [9]

to those represented (possibly interacting with a human). Selecting an ethical case identical to the initial point generates a new situation for analysis, which is not yet a change in the environment. The latest problem is then re-evaluated. After an agreement is reached, the planner is called, and it selects a plan and then an action. In turn, the activity influences the environment, and thus a new situation is created. Then, the cycle begins anew. The elements of this process are implemented using the practical reasoning engine that underlies the BDI paradigm and, thus, the JASON interpreter. Figure 2 shows the reasoning cycle of the JASON interpreter. At the beginning of its work, a BDI agent updates its list of beliefs and perceives messages from other agents by formulating them in terms of different beliefs. In brief, at the beginning of each reasoning cycle,

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an agent updates itself, and its mates. So, in Jason, a plan consists of a triggering event, a context, and a body. The developer generates the plan offline and can then tap agent P (the planner agent in Fig. 1). The program provides an agent with information about responding to external events and achieving its goals. The triggering event defines the possibilities that can activate a plan, and the context determines the conditions under which a plan can be applied. The body represents the actions to be performed. Each belief change (or message reception) creates a new event. The processing of events leads to selecting a plan that has a context that makes it applicable to that context. The three elements of the plan and the beliefs are the elements that allow artificial phronesis to be realized. It should be noted that artificial phronesis can only occur in a multi-agent system context, making Sullins’ proposed framework perfectly related to the BDI paradigm. Once PCs and CAs agree on the context, the event that triggered the reasoning cycle is then unified with a plan from a plan library, and an action that affects the environment is generated. Next, the intention update mechanism is used to re-evaluate the impact of their actions. Selecting the intention, i.e., a particular desire, corresponds to what Sullins considers the tendency to pursue something that makes one feel good. Each time a cycle ends, an action is generated. The move is updated with some negative or positive reward indicating that this action contributed negatively or positively to the desire. Finally, an action can be simulated to anticipate its outcome, which can be used as a new situation for evaluation. Then, after a certain number of cycles in which further agreements are reached, the real action is put into practice.

6 Conclusions For centuries, since humans have been able to reflect on themselves and their actions, ethical values and moral behavior have been discussed. The subject is strongly linked to cultural, social, and historical aspects, and its feeling has undoubtedly changed over time. Over the years, several theories of ethics have been developed. They all focus on human behavior and actions to ensure excellent and judgmental unethical behavior. Ethical-normative aspects become particularly urgent when you find yourself in unknown situations or when so-called dilemmas arise. Dilemmas are situations in which the difficulty in making decisions is strongly related to the current state and background of the person. In any case, the activation of a specific behavior is guided by a kind of practical argumentation. In attempting to bring the concept of ethics back to robotics, one cannot ignore the practical difficulties of implementing technically cumbersome processes because they are based on several highly unpredictable factors. This paper described the main approaches reported so far by researchers to construct autonomous and adaptive machines capable of assessing ethical standards

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and activating morally excellent and acceptable behaviors. Then, we illustrated a proposal for an ethical robot based on artificial phronesis using the BDI agent paradigm. The studies carried out in Roboethics are still at an early stage; in the coming years, we will have to deal with the profound changes that the presence of robots will bring to our lives. We believe that one way to deal with the ethical question of robots is to see the robot not as a mere element that responds to commands under the influence of “if–then–else” processes but as one that thinks and works together as a human does when working in a team. Therefore, the robot must acquire and learn a set of personal elements humans typically earn throughout their lives. To achieve this, constant interaction with humans is fundamental, as seen from the concepts of artificial phronesis. Acknowledgements The authors would like to thank John Sullins for the discussions and suggestions about the topics of the paper.

References 1. Allen C, Smit I, Wallach W (2005) Artificial morality: top-down, bottom-up, and hybrid approaches. Ethics Inf Technol 7(3):149–155. https://doi.org/10.1007/s10676-006-0004-4 2. Wallach W, Allen C, Smit I (2008) Machine morality: bottom-up and top-down approaches for modelling human moral faculties. AI Soc 22(4):565–582. https://doi.org/10.1007/s00146-0070099-0 3. Hallinger P, Wang R (2020) The evolution of simulation-based learning across the disciplines, 1965–2018: a science map of the literature. Simul Gaming 51(1):9–32. https://doi.org/10.1177/ 1046878119888246 4. Baars BJ (2005) Global workspace theory of consciousness: toward a cognitive neuroscience of human experience. Prog Brain Res 150:45–53 5. Sullins JP (2019) The role of consciousness and artificial phron¯esis in AI ethical reasoning. In: AAAI spring symposium: towards conscious AI systems 6. Sullins J (2016) Artificial phronesis and the social robot, In: Seibt J et al (eds) What social robots can and should do. IOS Press. https://doi.org/10.3233/978-1-61499-708-5-37 7. Rao AS, Georgeff MP (1995) BDI agents: from theory to practice. In: Proceedings of the first international conference on multi-agent systems (ICMAS-95), vol 95, pp 312–319 8. Bratman ME (1987) Intention, plans, and practical reason, vol 10. Harvard University Press Cambridge, MA 9. Bordini RH, Hübner JF, Wooldridge M (2007) Programming multi-agent systems in AgentSpeak using JASON, vol 8. Wiley, Chichester

How the Love of Truth Affects the Role of the Researcher: References to the “Third Mission” of Universities and References to the Field of Business Economics Studies Marcantonio Ruisi Abstract This chapter discusses and highlights the role and, therefore, the responsibility of the researcher, of the scholar, in the context of a university institution, which is not usually limited to knowledge, but also to its transfer into the sphere—in primis—of the universitas studiorum, as well as scolarium (in addition to magistrorum), starting with the concept of “truth” and, subsequently, that of “love”1 . Certain prescriptive considerations, which could involve the aforementioned role and, therefore, the ethics of the modus operandi of the researcher in question, with inevitable references to the purposes of their work and their goal of progress for mankind and society, will tendentially be implicit both throughout and subsequently. Regarding society and broadening the perspective from the individual researcher to the organisation to which they belong, we also take a look at the Third Mission of universities as a privileged area in which to exercise the aforementioned responsibility at an institutional level and, moreover, with a focus on business and economic studies, which represent the author’s field of scientific interest.

1 On the “Truth”: Conceptual References According to classical philosophy,2 in logical terms, truth concerns the conformity, i.e., the correspondence of knowledge to reality. In addition to, and even before, a logical truth that pertains to intelligibility by the human mind and a morality that pertains to the desire and respect for things in their order and their degree, we need to consider an ontological truth that pertains to things as they are (in the substance of their existence). This transcendental dimension (from the essential properties of every being, which are transcendental: at least unum, verum and bonum) is questioned by modern philosophy, finding—simplifying the matter—a departure of the same from classical realism and its approximation to the subjectivism that led various

M. Ruisi (B) Department of Economics, Business and Statistics, University of Palermo, Palermo, Italy e-mail: [email protected] © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 L. Congiunti et al. (eds.), Ethics in Research, UNIPA Springer Series, https://doi.org/10.1007/978-3-031-24060-7_8

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authors to come up with definitions (and, consequently, to trace a “truthful relationship”) which refer, in turn, to certainty (Descartes), effectiveness (Vico), coherence (Hegel), praxis (Marx), utility (James), exposition as the revelation of the being (Heidegger), experimental verification (Carnap), etc. There were two main defining points of view on the concept of truth in the development of Western philosophical thinking: objectivist-universalist and subjectivist-relativist. Turning to a functional taxonomy, we can distinguish between philosophical, scientific, and religious truths. The first (metaphysical) usually pertains to the ultimate meaning of life and history and leads back to the Absolute; the second refers to human progress and concerns—lato sensu—the phenomena of the world to be discovered and dominated; the third concerns revelation and faith and, consequently, the salvation of the individual and humanity. On the subject at hand and, therefore, with reference to the role of the researcher, and beyond any further conceptualisations,3 in which an objectivist-universalist perspective is congenial, we consider it worthwhile to carefully consider a scientific concept of truth, without necessarily adhering to utilitarian and pragmatic opinions according to which a proposition is true if it contributes to extending knowledge or, in any event, the dominion of man over nature; having specified the above, we feel obliged to premise the conviction that if mankind’s progress ultimately represents the term of reference for truth, then what we need to strive for is basically the search for the truth of the world and of mankind, which requires an interdisciplinary perspective and, as will be mentioned below, passionate interior motivation supported by the exercise of suitable virtues (from virtus, a firm and constant disposition to act properly, also known as habitus or habit). Interpreting the thinking of John Paul II,4 Tanzella Nitti5 emphasises that “[…] human intelligence is closer to the truth when it understands the relationships that exist between the various branches of knowledge and when it puts itself in a position to be able to grasp their essence. The truth is presented as “a complex unity” […] which can be accessed from many complementary perspectives”. One of the risks that hyper-specialisation of knowledge has sown over the last centuries and decades, in particular, is the loss of the “universality” of knowledge, hence the continuous challenge of a balance between in-depth study and generalisms, or rather between specialisms and unity of knowledge.

2 For “Love”: The Motivational Drive in Search of Truth for the Common Good Love for the truth, for the truth of the world and mankind, is eminently love for the world and mankind, certainly not a hedonistic (even concupiscent) inclination whose aim is the possession of knowledge itself, least of all that of the (vain) honours of research or, in any case, obtaining self-referential results that do not improve mankind and, indirectly or directly, society and the ecosystems of reference, but only feed the

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egocentric narcissism of the individual researcher or of the team or of the institution they work for. Speaking of love implies speaking of a benevolent relationship, of a projection that transcends the self and is directed towards the you, even the extended one of the whole of humanity; however, it is an inclination towards good (one’s own and that of others) and therefore truly ethical. University should be the elective channel par excellence, in which knowledge and its advancement should find—at least in filigree—a congenital declination for its unselfish transmission and, therefore, follow the path of the common good, the good of all mankind and all of the man.6 There is no misunderstanding of the words of John Paul II7 who, referring to Aquinas and speaking of the truth, reiterates: “I am talking about the truth sought, loved, taught and defended, which is and must be like the soul of the university, because it is the profound life of human reason: ‘Perfectio intellectus est verum’, said St Thomas”; it is not a matter of exercising an operational desire for research, perhaps detached, it must be characterised by loving dedication, by a heartfelt desire for transmission, by respect and reverence for the object of interest, precious and therefore worthy of care, protection, defence. Summarising and recapitulating that which has been considered so far and borrowing the words of Tanzella Nitti,8 “the university must be a place for the search for truth and the transmission of knowledge, a truth free of ideologies and sceptical or renunciative attitudes, a place of dialogue and interdisciplinary openness, where the person is placed at the centre of the educational enterprise and knowledge becomes a service, a source of personal and social responsibility”. The same author argues elsewhere that “[…] mankind enters science as logos, as ethos and as pathos”.9 Not infrequently, guidelines for training new generations of researchers see exclusive attention being paid to the method, the rigour of its application and the consistency of the path implemented. Beyond any ethical considerations, we cannot imagine an activity carried out coldly, entrusted to an aseptically algorithmic approach, metaphorically speaking (setting aside the metaphor, perhaps that is how certain promoters of Artificial Intelligence applied to scientific investigation would like it to be). Proceeding along the paths of knowledge must imply a loving passion for the search and transmission of truth, which cannot even be imagined as being devoid of the joy with which we embrace the mission of unravelling the frontiers of mankind’s knowledge to better its progress; hence, we go beyond mere otaku,10 the passion that risks being self-centred on self-realisation, opening up to the happiness that anthropological personalism leads back to taking charge of the good of the other; which then links the happiness of the self to that of the you. “[…] According to the personalist principle, a person progresses in the direction of their perfection (beatitude) to the extent that they respect and, as far as possible, promote the human dignity of others”.11

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3 The Researcher’s Task and Their Working for Good We have already spoken about how the researchers need to carry out their work, about the motivations that inspire their daily effort to investigate, and briefly outlined the purposes of the context (the university) in which they operate. Once more, in reference to John Paul II’s thinking, we are convinced that the university should be “a true community that experiences the responsibility and joy of seeking the truth, finding and communicating it in all areas of knowledge”.12 Of these words—in primis— “responsibility” stands out, which is the awareness of employing one’s ability to give answers to scientific—lato sensu—questions, to the whys that preordain the course of research or that manifest themselves in its unfolding; but also the awareness of taking on the right and duty (duty of justice) of transferring the results of one’s work. Sharing results, above all the participation in the fruits of the investigative work with the scientific community and students, is the socialisation of knowledge supported by what Samek Lodovici13 defines as a profound “sociality of good”, the one expected of university, seen as a nursery where the main aim is to nourish desire, which translates into research work, for the good of mankind. The aforementioned responsibility, which implies preparation and competence (as well as certain virtues, such as humility and tenacity), is fundamental; but be careful, as stated in the previous paragraph, to put aside the joyful undertone of the investigative work and the transfer of knowledge; be careful to put aside the implications and, above all, the ethical assumptions of the investigation. A memorable speech by John Paul II,14 a former professor in Krakow and Lublin, given at a meeting with university professors, traced the guidelines, agreed with here, for the role of scholar and academics, interpreting the main responsibilities as follows: “the younger generations expect new summaries of knowledge from you; not encyclopaedic in nature, but humanistic. Freedom of research, which is so precious, cannot mean indifferent neutrality in the face of truth. Universities are increasingly called upon to become laboratories, in which a universal humanism is cultivated and developed, open to the spiritual dimension of truth. The diakonia of truth represents an epochal task for universities. It makes reference to the contemplative dimension of knowledge that draws the humanistic trait of each subject […]. The diakonia of truth is the seal of free and open intelligence. Only by embodying these convictions in everyday behaviour the university lecturer can become a bearer of hope for personal and social life”. The researcher’s contribution to the formation of humanistic and not eminently scientific knowledge should be intrinsic in their academic and educational traits (universitas studiorum); after all, nowadays this awareness seems to be becoming gradually more widespread in all universities, at least in Italy, as shown in their strategic plans, in their social report, in the inaugural speeches of the academic year given by rectors, in the planning of courses of interdepartmental research and sometimes even in the definition of the educational offering itself. We spoke earlier about logos and pathos in research, overlooking the aspect of ethos. If the intellect is freely called upon to illuminate the paths towards truth, this implies the exercise of prudence as a virtue that regulates the work of practical reason;

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its task is to favour the selection of the most useful means for attaining the purpose,15 which is good based on reason. On the other hand, according to Peláez16 : “the transition from true knowledge to prudent decision requires a deliberation based on a practical judgment, which includes both the morality of the activity to be taken and the useful means to achieve the desired good”. In other words—continues the author— “prudent judgment not only requires that the purpose of human actions is taken into account, but also that the method of implementation should be in accordance with the truth”. Prudence is a commitment to knowing the truth, the good based on reason; it is the virtue that allows us to progress from the knowledge of reality to the accomplishment of good (mankind knows and decides: it perceives reality and orders the will and the actions17 ). “It is necessary for the prudent to know the general fundamental principles of reason as well as the particular circumstances of the things for which actions are carried out […]”.18 Knowledge of the general principles (as well as, in the case under consideration, of the investigative method and its epistemological presuppositions) is, in fact, a presupposition of the action that cannot remain detached from the knowledge of specific reality,19 nor in the final analysis the implications of acting. Prudence allows us to apply the general principles to the specific case, thereby guiding the decision and, therefore, the concrete action. Virtues are not given; they are cultivated and exercised. According to Pieper,20 educating towards prudence means: “the objective evaluation of the concrete situation of concrete actions and the ability to transform this knowledge of reality into a concrete decision”. Knowledge of the truth (good based on reason) must be followed by the physical will to achieve it and this calls into question the exercise of other virtues such as justice, fortitude, and temperance, to mention those that classical philosophy defines as cardinal virtues.21 Simplifying and exemplifying, the passion for the search for truth must, among other things, refer to proper behaviour in the process undertaken without forcing the conclusions obtained starting from certain hypotheses that are also loyal and recognise the merits of others, without the undue appropriation of the results; at the same time it must, for the sake of justice, recall the ability to reconcile the time dedicated to research and that dedicated to personal affections (as is the case when planning the work of a team), as well as the social promotion of the context of reference. This implies the strength, not only in keeping the direction of research focused without discouragement, but also in knowing how to put respect for people before the spasmodic search for results, thereby also calling into question the virtue of temperance, in the sense of balance, the correct amount and moderation. These are joined by, among others, the virtues—considered important by the author—of humility and gratitude (not mere sentiment, but indeed habitus). The humility of someone who recognises themselves as “small” in the face of the greatness of truth, and in this recognising themselves, being grateful for the honour intrinsic in the task of doing their utmost for mankind’s progress and, therefore, for the results achieved (for discoveries unveiled with amazement and emotion). It is easy to see—as Tanzella Nitti22 recalls—that “in the scientific field there are many who believe that a stable, universally accessible truth is no longer compatible with the perspectives of contemporary philosophy of science and epistemology”; “[…] the attempt to bring the notion of truth—truth of the world and truth of

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mankind—back to the centre of university debate does not cease to be a quite courageous cultural endeavour, willing to take on critical evaluations and reviews by the dominant intelligentsia”.23 “Nowadays, the latter [truth] is understood in a reductive way, as certainty in the logical field, verifiability or evidence in the empirical field, as authenticity in the anthropological field, as profit and efficiency in the economic sciences, as consensus in the analysis in communication sciences and sociology…”.24 Nonetheless, it is believed that discussion on the subject cannot be stifled. The truth must remain at the centre of the broadest and most transversal reflection, since it is the cornerstone of the mission of university institutions and their academic bodies; it could not be otherwise and we are basically heartened by the emblem that is still in vogue of one of the most prestigious universities in the world, at least one that is considered among the best—Harvard—on which three books report the syllables VE-RI-TAS. That under consideration does not exclude that the work of the individual researcher, their individual path, has to face scepticism and failure, far from it! However, if there is intellectual honesty devoid of ideologies and prejudices, these feelings and findings, which probably provide evidence of pluralism and freedom of research, should be able to be overcome, in corrective or at least mitigating terms. When it comes to universities, when it comes to truth, its “cornerstone”, we are convinced that the issue inseparably implies at least gnoseological, epistemological, and ethical aspects, without overlooking the (basic option) anthropological one. It is up to the researcher to summarise the multiple aspects and follow a path that is in service to the truth, which, it is worth reiterating, is ultimately the truth of the world and (above all) of mankind, therefore in an anthropocentric vision, for the progress of mankind in respect and harmony with the wider context of reference.

4 Initial Summary Considerations and References to the “Third Mission” of Universities In light of what has been considered so far, Benedict XVI’s warning echoes: “without truth, without trust and love for the truth, there is no social responsibility or conscience, and social action is at the mercy of private interests and the logic of power, with disruptive effects on society, especially in a society in the process of globalization, in difficult moments such as the present”.25 Love for the truth that concerns the world and mankind must drive university scholars and the university community: different subjects are needed, but they need to interact profoundly, different, but mutually respectful perspectives are needed; it is also necessary for those same researchers to humbly strive to wear different focal lenses and look at reality from various angles, in a “kaleidoscopic” manner. Teamwork should be favoured, calm and relaxed (even better if affable) discussion within the local academic school, free from jealousies, but rather experienced in a spirit of sharing and mutual support, precisely because the progress sought is not ultimately that related to one’s career or prestige (per se), but the progress of mankind and society. Sharing is then called

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upon to extend over the wider national and international school of reference, beyond certain protectionist resistances that some universities manifest by “denying” their researchers the opportunity to communicate the research path and the initial results of their work, in compliance with the metrics and reward systems and, in any case, ratings and ex ante university fundraising. Sharing, joint participation, comparing ideas, projects and results among researchers seem the essential path if we sincerely wish to achieve the aforementioned progress of mankind and society; this is what we must reach out for and towards which we need to channel our institutional and personal energy. Unlike in the past, when the mission was mainly focussed on research and teaching with concrete indirect and asynchronous repercussions on real life, nowadays it has been understood that the commitment to the common good calls upon university institutions directly through involvement to promote the transfer of knowledge and technology from laboratories to the territory and to the market, summarised as the “Third Mission” of universities. As reiterated in the European Commission’s Green Paper, “Fostering and Measuring ‘Third Mission’ in Higher Education Institutions”,26 that “Mission”, as it was called into question, relates to the transfer to the market and social context of the results of research (and is therefore necessarily linked to this). The “Final Report on the Third Mission” by the Commission of Experts for the evaluation of the Third Mission of ANVUR also heads in the same direction: “the TM concerns the relationship of universities and research institutions with society and with economic development through transforming, making available and circulating the knowledge produced by research work”.27 After all, the “Third Mission”—argues the aforementioned Green Paper—takes on continuous learning and training activities that are established among universities and external partners, as well as disseminating knowledge regarding various subjects in the territory of reference through museum systems and university collections. “The current debate aims to recognise, bring to light and also measure a whole group of little-known activities, which do not create objects or services that can be exchanged on the market, but have an impact on well-being and social evolution through “public goods”28 ; attention is thereby directed not only towards the “exchange value” of knowledge,29 but also to that of “public” worth. That being considered bring enrichment to the discussion of the role of the university researcher, their responsibilities, the challenges they face, their good working, working with a view to the common good that must represent their dominant passion.

5 Ethical References and Specifications in Economic and Business Research: Notes on Entrepreneurial Virtues If a researcher wishes to pursue the search for the truth of the world and of mankind, in the context of economic and business studies, the reference is to the object of their analysis, therefore it is the truth of the business even before that of the economic

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system of which is a cell, and inevitably its primary protagonist, the truth of the entrepreneur (and also of the manager). According to Gino Zappa,30 founder of “Economia aziendale” (this is Business economics, understood as a subject corpus according to Italian academic tradition), a company is “an economic institution destined to last which, to satisfy human needs, orders and continuously coordinates the production or the procurement and consumption of wealth”. It is the task of a researcher who investigates the principles of governance and the manifestations of the life31 of the company, to reference the reporting of said principles and said manifestations to the aforementioned purpose of satisfying human needs that preordain the survival and development of the economic institution as an institutional end in itself. In other words, a researcher who turns their interest to the field of studies specified herein must include at least a trace of the aforementioned ultimate purpose in their investigation and, therefore, the profound mission of every type of company, in the sense of its contribution to the progress of mankind, causes, and is affected in turn by, a wider economic and social development. The same purpose of research aimed at investigating the causes of performance and the metrics of its measurement, and therefore at understanding the genesis of business success, to give an emblematic example, leads the identification of success itself to the ultimate purpose mentioned and therefore the need to consider the corporate purpose beyond the achievement and growth of mere profit, so that it may be interpreted under the triple aspects of economic, competitive and social success in view of the survival and development of the company. All of the above, if this development is aimed towards the progress (good) of mankind and of all men, of those who undertake, of those who contribute to the undertaking, of those who are direct and indirect recipients of this undertaking, current and potential, or of those who—perhaps—are merely interfaces. Ethically speaking and calling into question the system of the Business Model Canvas of Osterwalder and Pigneur,32 orientation towards progress and therefore to the good of mankind (and of the company), implies that the objectives that we set ourselves when launching a specific product/service on the market must be good and therefore the related value proposition must be made available to the chosen target whose characteristics and desires are known; a good way (e.g. truthful and understandable) of communicating it and making it available (e.g. in a short period of time, in an economically viable manner, without hiding additional costs, etc.) to the various recipients; a good relationship with customers (e.g. based on the concept of caring); good resources and skills (e.g.—and lato sensu—of quality) and the activities put in place; good partners (capable of effectively supporting the business model, loyal, favouring a win-win logic) and types of relationships with them, as well as good (e.g. correct and transparent) paths set up to generate revenue flows and good investments made (hence effective and efficient structuring of the costs being borne). Another thing that should not be overlooked is an activity, usually omitted in business modelling, which relates to the planning and management of the product/service endof-life and therefore the depletion of the value generated for customers. That way, the issue of social responsibility and sustainability (among other things and above all environmental) of the offering comes directly into play. We just need to think of

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the respect and protection of the environment before, during and after the creation of products and services and their subsequent use, nowadays essential elements to define not only success, but also the raison d’être of a company.33 This is the ultimate truth of companies that we must always keep in mind: a company is an institution set up for the good of men, starting with that of the entrepreneur and the various categories of stakeholders, overflowing towards the ecosystems involved and all of society, or so it should be. That is the eminently ethical aspect of the company and of entrepreneurial actions (with the prior and consequent responsibility of the choices made34 ) which cannot be ignored by the work of the researcher who turns their attention to this area of investigation. Being Business economics a part of the broader area of the social sciences, the progress of the human community and in primis of the individual is an underlying and unavoidable purpose and, in any case, a horizon for both theoretical and empirical investigation. A good venture to give life to a good company that contributes to a good economic system and to a good society must inevitably be the backdrop, even if hidden from sight to any reflection that focusses on the company and the behaviour of its people. Suppose a good venture depends on know-how, but also on the behaviour of good entrepreneurs and good managers, as well as good collaborators and so on. In that case, the discussion on virtues acquires significant value. By examining the concept of virtue starting with the Aristotelian tradition, then the Thomist one and the more recent contribution of MacIntyre,35 the entrepreneurial (meta-) virtue can be traced back to the characteristic of the individual, the entrepreneur, taking the form of a deliberately encouraged disposition which, through will and actions, consolidates and improves the (otherwise practical) entrepreneurial activity, supporting the search for the good of the company, i.e. the specific one attributable to it (survival and development of the economic institution starting with the aforementioned satisfaction of the needs of the owners and of the various stakeholders, ultimately of their happiness) and the general one (the common good). Confirmation of the aforementioned meta-virtue is considered a necessary, although not sufficient, condition for an entrepreneurial initiative aimed at integral, sustainable and lasting business success and the realisation of a virtuous relationship (entrepreneur-company-market) based upon which virtuous entrepreneurs give life to and govern virtuous companies 1 and the latter, in turn, contribute to creating virtuous 1

The company, as a good place to live a good life, can hopefully become an environment in which and from which to seek and achieve the development of the company, but above all of the entrepreneur and of all the workers and, in any event, of the stakeholders. The company, as imagined, must then offer itself as an active place, as a laboratory in which to awaken the minds and hearts of the subjects involved in the face of massive attempts to sedate any capacity for thinking, to anesthetise any opportunity to experience amazement and wonder, to paralyse any intention of commitment (including social and civic ones), to suffocate the small and great hopes of living in a good place and living a good life. The company, therefore, above all because of its key players—in primis the entrepreneur—can in fact become, due to the time spent there and the energies that are often transfused into it, a school of virtue, a place in which to find oneself, find others and, therefore, enriched by the experience of “the self and the you”, dynamically return to finding oneself in the space and time of one’s own intimacy.

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markets; at the same time, virtuous markets favour virtuous behaviour on the part of the companies involved and virtuous business organisations facilitate the exercise of virtues by the entrepreneur and the various key players of the economic institution under consideration. According to Melé,36 the topic of virtues falls within the broader sphere of leadership, based on four pillars, four types of “skills”: technique-oriented (skills, typically), goal-oriented (e.g., problem-setting and problem-solving skills), relational-oriented (e.g., ability to work in a team and be part of the team spirit), and moral (the virtues themselves). It was a matter of the relationship of virtuosity (entrepreneur-company-market), which inevitably becomes a reference to the work of the institutions and to the system of rules that regulate them or emanate from them, and that virtuosity allows, and even favours and encourages; therefore, there is an unavoidable reference to the virtues that must characterise the work of (good) government of res publica directed towards the common good and consequently guided by a selfless (loving) passion for the progress of mankind, hence of the social organisations that it puts in place and of society as a whole.

6 Conclusions In summary, we understand how much the love for the truth of the world and of mankind, which must drive any researcher working on economic and business subjects, should ultimately lead them to an in-depth investigation of the conditions of the existence and the manifestations of life 37 and, subsequently, the principles of governance of the firm, without overlooking the broader institutional context, with the direct or indirect, explicit or implicit mission that the results of their work may, in any event, favour the good governance of the same, human progress (hence the focus on the virtues) of its various actors, as well as those of the wider economic and social system in question.

Notes 1. 2. 3.

4.

Ruisi M (2010) “Come l’amore per la verità interpella la funzione imprenditoriale e quella di docente universitario”, in Le nuove frontiere della SCUOLA, no. 23, pp 26–34. Mondin B (1994) Dizionario enciclopedico di filosofia, teologia e morale, Massimo, pp 898 et seq. Possenti V (2001) “Verità”, voce tratta dal sito di Documentazione Interdisciplinare di Scienza & Fede (https://disf.org/verita), 2002. Abbagnano N., Dizionario di filosofia, UTET, Turin, pp 1148 et seq. John Paul II (1980) speech to a group of “Nobel Laureates” participating in the interview organised by the “Nova Spes” association, Rome, 22-XII-1980, IGP2, 3 (1980/2), no. 5, pp 1780–1785.

How the Love of Truth Affects the Role of the Researcher: References … 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21.

22. 23. 24. 25. 26. 27. 28. 29.

30. 31. 32. 33.

34.

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Tanzella Nitti G (1998) Passione per la verità e responsabilità del sapere, Piemme, Casale Monferrato, p. 184. Pontifical Council for Justice and Peace (2004) Compendio della Dottrina Sociale della Chiesa, §165, p. 89. John Paul II (1989) Congress of the Catholic Universities and the Institutes of Higher Learning, Rome, 25-IV-1989. Tanzella Nitti, op. cit., p 253. Tanzella Nitti G. (2009) “La persona, soggetto dell’impresa tecnico-scientifica”, Paradoxa 3, no. 1, pp 96–109. Ruisi M (2019) Progettare Startup. Virtù imprenditoriali, modelli di business, piani di fattibilità, gamification, Giappichelli, Turin. Chalmeta G (1997) Etica applicata. L’ordine ideale della vita umana, Le Monnier, Florence, p. 78. John Paul II (1990) Omelia alla Messa per gli studenti e i docenti deli Atenei romani, Rome, 13-XII-1990. Samek Lodovici G (2017) La socialità del bene. Riflessioni di etica fondamentale e politica su bene comune, diritti umani e virtù civili, Edizioni ETS, Pisa. John Paul II (2001) Messaggio ai partecipanti al VI incontro Nazionale dei Docenti Universitari Cattolici, Vatican 4-X-2001. Mondin B (2000) op. cit., p 123. Peláez M (1995) Etica, professioni, virtù, Ares, Milan, p 49. Pieper J (1999) La prudenza, Mocelliana-Massimo, Brescia, p 33; ed. orig. Traktat über die Klugheit, Kösel Verlag, München, 1965. St Thomas Aquinas, Summa theologiae, II, II, 47, 3 (translation drawn from Pieper J., op. cit., 1999, p 31). Pieper J (1999) op.cit., p 76. Ibid., p 70. Ruisi M (2009) Antropologia ed etica aziendale. Note in tema di trascendentali e virtù imprenditoriali, Giuffrè, Milan. Samek Lodovici G (2010) L’emozione del bene. Alcune idee sulla virtù, Vita & Pensiero, Milan. MacIntyre A (1981) After virtue. A study in moral theory Tanzella Nitti G (1998) op. cit., p 132. Ibid., 1998, p 133. Ibidem. Benedict XVI, Caritas in Veritate, § 5. https://www.researchgate.net/publication/308745768_Green_Paper_Fostering_and_Measur ing_Third_Mission_in_Higher_Education_Institutions. https://www.anvur.it/wp-content/uploads/2019/03/Rapporto_CETM.pdf (p. 13). IIbidem. Etzkowitz H (1998) “The norms of entrepreneurial science: Cognitive effects of the new university-industry linkages”, in Research Policy, Vol. 27, pp 823–833. Clark B.R (1998) Creating Entrepreneurial Universities: Organizational Pathways of Transformation, Pergamon Press, New York, On the subject also see the framework of the European Commission https://www.oecd.org/site/cfecpr/EC-OECD%20Entrepreneurial%20Univ ersities%20Framework.pdf. Zappa G (1956) Le produzioni nell’economia delle imprese, I, Giuffrè, Milan, p 37. Zappa G (1927) Tendenze nuove negli studi di Ragioneria, S.A. Istituto Editoriale Scientifico, Milan, p 30. Osterwalder A, Pigneur Y (2010) Business Model Generation, John Wiley & Sons, New Jersey. Ruisi M (2020) “Rilievi interpretativi del concetto di successo per il fenotipo start-up e la sottostante funzione imprenditoriale del founder”, in Liber amicorum per Antonio Matacena, Franco Angeli, Milan, pp 414–425. Melé D (2012) Management Ethics. Placing Ethics at the Core of Good Management, Palgrave Macmillan, UK, p 137.

104 35. MacIntyre A (1981) op. cit. 36. Melé D op. cit. 37. Zappa G (1927) op. cit., p 30.

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The Humanization of Health Care: In-Depth Knowledge Regarding the Ethics of Dental Care in Oncological Patients Monica Bazzano, Rodolfo Mauceri, Daniele Montemaggiore, Rita Coniglio, Giuseppe Pizzo, Pietro Tozzo, Olga Di Fede, Vera Panzarella, and Giuseppina Campisi Abstract This chapter provides an illuminating insight into the processes of the humanization of care in order to increase specialist knowledge regarding the nature of the doctor-patient relationship. It will deal with the notion of care and its various aspects, including the existential dimension of the process of caregiving by means of a narrative (storytelling) interview. After a brief analysis of the changes which have affected medical science in past centuries, the focus of the paper will be directed to the remarkable transformation which clinical practice has undergone, by virtue of which the concept of the taking care of the patient has gained increasing attention. Thus, care can be provided by means of the narrative interview, not only as medical history but also as action: it recognises the patient’s world, in turn opening up the processes of the humanization of care in the field of dental medicine. The scientific community has long questioned the traditional medical approach, which is centred on disease, and it now pays ever more attention to the involvement of the patient in the process of diagnosis and treatment. Every time a patient sits down in front of a specialist, they bring with them stories, their own and ours, describing their stomatognathic system. A technically accurate medical history with information untouched by the doctor makes space for the narrative interview and ‘caring presence’ of the operator, to reflect on what it means to ‘care for the patient’. From the point of view of M. Bazzano · D. Montemaggiore · R. Coniglio · G. Pizzo · G. Campisi (B) U.O. di Medicina Orale e Odontoiatria per pazienti fragili —A.O.U.P. “P. Giaccone” di Palermo, Palermo, Italy e-mail: [email protected] M. Bazzano · R. Mauceri · R. Coniglio · G. Pizzo · O. Di Fede · V. Panzarella · G. Campisi Settore di Ricerca Clinica in Medicina Orale—Dip. Di.Chir.On.S.—Università degli Studi di Palermo, Palermo, Italy M. Bazzano · D. Montemaggiore · R. Coniglio · G. Campisi Personale Linea Progettuale 2.32 “Umanizzazione dell’assistenza specialistica odontostomatologica per il paziente fragile”—progetti obiettivo PSN 2016, Regione Sicilia, Italy P. Tozzo U.O.C. Odontostomatologia Ospedali Riuniti Palermo in comando presso U.O. Medicina Orale con Odontoiatria per pazienti fragili—Az. Ospedaliera Universitaria Policlinico “P. Giaccone”, Palermo, Italy © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 L. Congiunti et al. (eds.), Ethics in Research, UNIPA Springer Series, https://doi.org/10.1007/978-3-031-24060-7_9

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optimising care, it is therefore useful to rethink the relationship between dentist and patient: effective clinical practice is not possible without listening empathically to the patient’s story, their perceptions, and their experiences. It is necessary to reformulate settings to improve and render them more effective and, where possible, to include appropriate active listening strategies and adopt specific communication techniques. In this paper the authors will describe their vision of the humanisation of care in the form of a narrative.

1 Introduction In the last twenty years it can be said that there has been a progressive anthropological impoverishment in some fields of medicine, and only recently has the theme of the humanisation of care and its applications become a highly topical issue [1]. Today a radical change in patient care is being witnessed, with the patient viewed holistically, an active and participating subject, with their own needs and frailties, and not identified only by the disease from which they are suffering [2]. Thus, the concept of care has shifted from a purely clinical approach to a bio-psychosocial model, which introduces patient subjectivity, in that the patient plays an active role in their treatment. Given that every human being possesses a narrative identity, which should be listened to and accommodated, the concept of patient involvement is receiving ever-increasing attention in the field of health and, in the authors’ opinion, particularly in the dental field. This is supported by a number of specific features of the dental profession, one of which is the close physical relationship between dentist and patient, that is, a reduced proxemic distance. The pathway of humanisation and patient approach commences with a patient’s detailed medical history, which is obtained via active listening. This implies the adoption of specific communication techniques, as indicated in the reconfiguring of the various ‘contexts for action’ [3]. And it is precisely in these relational contexts that there is a growing need to invest in processes of humanisation because they serve to foster awareness and enhance communicative competence in order to accommodate and manage patients empathically [4]. Contexts involving doctor-patient communication regard complex relationships in which the following merge: an analysis of the health issue, empathy, a knowledge of the familial, sentimental and professional contexts, an awareness of choices and shared knowledge. Thus, an almost spiritual and stable relationship is created. In order to be effective, this relationship should go well beyond the duration of a visit or the writing of a prescription, to form a bond between two human beings: there can be no doctor without a patient and no patient without a doctor [5]. In this paper the patient’s right to be informed becomes a central issue. An awareness of a patient’s treatment and care, in addition to informed decision-making regarding issues such as informed consent, are the basis of good medical practice. The dentist is, therefore, expected to communicate effectively by emphasising the human dimension, that is, by learning to build a strong relationship of trust and co-operation

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with the patient in order to guide them towards what should be the common goal: oral health. Effective communication for the dentist also means understanding verbal and non-verbal language (e.g. posture, gestures, facial expressions), also paying attention to the patient’s requests and listening to their needs in order to develop empathy [6]. This relationship of assistance and care is established when a patient has a need and the other responds to that need [7]. This relationship regards an intervention of ‘taking care’ of the suffering patient with: an empathic welcome, attentive listening to multifaceted body language, emotional openness (which accommodates and understands experiences of suffering), and sensitivity to enable the dentist to empathise with another’s pain. This type of intervention offers support, which is appropriate to the patient’s state of mind. First of all, it is necessary to restore the autonomy and dignity of a patient in difficulty by means of activating their internal resources. The authors of this report will propose humanization strategies for ‘taking care’, which have been gleaned from the literature to lend support to a pathway of humanization in the context of the oral medicine and special needs patients of the National Health System.

2 The Notion of Care from Hyginus to the Oral Health Care Practitioner (Understood as a Curative Presence) In its widest sense, the notion of care is a topic with deep roots, with a dimension which universally regards the existence of man. It is a theme present in classical culture with the writings of Plato and Aristotle, as discussed by Hyginus in the second century AD/CE, and then revisited by many philosophers, including Heidegger [8]. While crossing a river, Cura (or Aera Cura, a goddess) spotted some clayey mud. She thoughtfully gathered some and began to fashion a human being. While she was intent on pondering on what she had done, Jupiter intervened. Cura begged him to give the spirit of life into the human being. Jupiter willingly agreed. But when she wanted to name the human after herself, Jupiter forbade it and demanded that his own name be used. While Cura and Jupiter argued over the name, Terra (or Earth) intervened, demanding that the human being be named after Cura since she had given it a part of her own body. (Finally) The disputants elected Saturn as judge. He gave them the following fair decision: «You, Jupiter, having given the spirit, would take back the soul after death; you, Earth, having given the body, shall receive the body after death. But since it was Cura who had first fashioned the human being, as long as he lives, she shall possess it. However, since the controversy concerns the name, let it be called ‘homo’ since it is made of humus (earth)» (The Fable of Hyginus, to which Heidegger refers in Being and Time). Departing from the fable, Cura is the aspect which gave form and a raison d’être to a formless substance, thereby creating the possibility of existing, of being in this world and the next. This ancient fable reminds us that ‘caring’ for others is by no means marginal or transitory: it is so connected to the roots of the human being that

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it in some way shapes it, thereby giving it form. In the final sentence of the story, the author Hyginus expresses his concluding hope that “as long as homo (man) lives, may it be possessed by Cura (care)”. And it is Cura who has the task of being able to assist another down to his very roots, to his humus (earth). In the opinion of the authors of this paper, the primary role attributed to Cura regarding human life is significant: the vision of man as an object of care. And it is this Heideggerian conception of care which has aroused the authors’ interest in the idea of care as involvement and participation towards others: the relationship of being to others defines how ‘to care’. Furthermore, the authors of this paper are keenly interested in the point of view of ‘whomsoever has care’, that is, the person who acts according to what is good. Such a principle involves attempting to promote the ‘wellbeing’ of another which, today, according to the authors of this paper, cannot be separated from the empathic listening of the patient’s experience. This notion of care can create experimental contexts, which may assist another to ‘well exist’. Care, therefore, is not understood as ethics but rather as an ethically-informed practice [9]. It is essential to focus on the ethical what? Of the practice of care, to include the patient’s narrative as an indispensable element of contemporary medicine, which is based on the active participation of the patients in making choices [10]. There is a copious and relevant literature supporting this bio-psychosocial model, which underlines how narrative is a basic tool, with which to acquire, understand and integrate the different points of view of those touched by a disease and the care process [11, 12]. This is precisely how patients can become protagonists of their own care processes: through their own storytelling [13]. Only one example of care, which is the result of accurate information and dedication to patient care, suffices as the foundation of a practical model of humanisation. This model of dedication also involves the formation of a multi-disciplinary team (e.g. doctors of oral medicine, psychologists, dental nurse/health care assistants, oncologists), which is capable of integrating the various professional skills in order to provide increasingly holistic and effective care to the patient. Following a scientific approach, this multi-disciplinary team is increasingly oriented towards the centrality of the patient. Clearly, regarding the dental care of less frail patients, there may be fewer members in the team or they may have different competences. This includes the single freelancer, who, for example, is a professional figure: the dental assistant. In the specific case outlined in this paper and given that Oral Medicine is a branch of dentistry also dealing with potentially malignant lesions and oral cancer, patients often suffer from a considerable degree of anxiety. Hence the recommendation to adopt a multi-disciplinary approach: with the specialist’s support in assuaging unpleasant thoughts, it is beneficial to interact in the doctor-patient relationship, cognitively intervene to reconstruct dialogues, suggest relaxation techniques to desensitise powerful, negative thoughts, and support colleagues in the meta-communication of requesting feedback. The psychologist Paul Watzlawick was the first to introduce the modern concept of meta-communication, by communicating about the patient’s communication, a useful tool to the specialist for reflecting holistically on disease. This concept facilitates patient feedback, including basic feedback in the form of “having understood” or merely encouraging the patient to actively

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listen to the strategies regarding their treatment, as suggested by the oral health professional [14]. While the dentist mainly deals with patients with dental pathologies, albeit unpleasant in nature (including tooth decay and periodontitis), the oral physician, adopting the model of care outlined in this paper regarding frail patients, will usually work in conjunction with the psychologist. The latter requires treatment which plays particular attention to the repetitive negative thoughts, thereby implying an emotional role for the oral physician. Unfortunately, the fact that patients’ minds often have unrelenting and negative thoughts must not be underestimated (particularly in the field of dentistry). Indeed, it can be said that (even metaphorically) patients can have an overload of information, especially from the World Wide Web. On occasion, they do not, therefore, listen to doctors on account of dis- and misinformation, which is exacerbated as the patient waits to hear the results of a possible diagnosis. Such well-defined episodes are sometimes overlooked by health professionals due to pressing work commitments. This can lead to repetitive work routines, which in turn can risk damaging the doctorpatient relationship. It is precisely that on these occasions it is fundamental for dentist practitioners to be trained to listen to patients’ needs and to acknowledge their worries [15]. At a deeper level the care experience can be transformed into an existential event. Where possible, it is a requisite to ‘take care’ of this care experience, as experienced by patients and caregivers, although this is not always a given. In common with Heidegger, the authors of this paper hold that ‘being constitutes care’, therefore the presence of medical staff is a precursor to the giving of care. Indeed, it can be hoped that anyone would be capable of giving care by virtue of their existence. However, if we believe that care professionals are inclined to encouraging experiences of authentic care, the care context will change [16]. Training oneself in the practice of care implies training oneself for this change. Thus, gestures, language, and style in examining the patient will define the care context and denote the presence of a professional. Developing a professional ‘caring presence’, therefore, implies an understanding and transforming of the patient’s experience into a resource [17].

3 The Human Relationship as an Integral Component of Care The interest in optimising the humanisation of care stems from the growing dissatisfaction with the image of medicine as a purely technical-scientific activity, a fact which has dominated past centuries. The main objectives of the process of reformulating the approach and humanization of care vary, mainly focusing on re-evaluating the human relationship (as previously mentioned) as an integral part of the care pathway. The aim of this reformulation is to encourage the dentist to become aware of their resources, suggesting tools to foster effective communication in facilitating the relationship with the patient, and involving the latter in the decision-making

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process of patient care [18]. Care is also seen as action aimed at promoting patient autonomy, the entirety of which is facilitated by the relationship connoting care, the latter is characterised by intimacy, acceptance and closeness. Involvement is thus promoted in overcoming more passive participation with the patient following the dentist’s instructions (compliance). The latter involves a process of sharing and personalising health choices, thereby encouraging adherence and compliance with treatment instructions. In order to achieve this, it should be understood that being informed is the first instance of care,it is therefore of fundamental importance to share information and decisions regarding the patient’s condition with the patient [19]. This is also an ethical prerequisite as per Article 30 of the Medical Ethics Code (the Order of Doctor-Surgeons and Dentists in Italy or [20]: “information regarding serious or poor prognoses or those causing anxiety or suffering to the person must be provided with caution, using non-traumatising terminology and without excluding rays of hope…. The documented willingness of the cared for person not to be informed or to delegate information to a third party must be respected”. Relevant information derives from multiple clinical and non-clinical sources, and also from the active involvement of the patient [21]. Indeed, the notion of care necessitates a bidirectional relationship between the patient and health professional [22]. Moreover, it facilitates the patient’s contribution to the choice of treatment, as proposed by the oral physician [23]. The first revolution in the doctor-patient relationship was the introduction of informed consent, which obliged the doctor of the requisite of making the patient aware of their illness, who in turn assumed a degree of responsibility in the decisionmaking process. This also encourages greater acceptance of the treatment with a possibly improved therapeutic outcome. Regarding neoplastic diseases, the active participation of the Istituto Superiore di Sanità (the National Institute of Health) and the major scientific research and treatment institutes in the field of oncology, a helpline has been made available in Italy to collate information regarding the various types of cancer and their treatments, side effects and advice concerning how best to live with disease. The patient has the right/duty to be cognisant of their health, requesting clarification from the doctor, and to make an informed choice about whether to undergo a given treatment. The definition of informed consent has been outlined by the Supreme Court of Cassation (Cass. Pen, sentence no. 45126/2008). Informed consent is termed thus because it is preceded by detailed information, enabling the patient to make an informed choice; it includes the patient’s pathological state, recommended treatment, and related benefits and risks. The acquisition of informed consent is a facilitating intervention whose aim is to assist the patient to become aware of and autonomous in the decision-making concerning their state of health. Moreover, the acceptance of the dialogue approach in the legislation is indicated by Article 1, Paragraph 8 of Law No. 219, 2017, according to which “the ‘communication time’ between doctor and patient constitutes ‘care time’”. Thus, communication between the dentist/doctor and the patient is a necessary precondition of treatment, which in turn implies an acknowledgement of the treatment relationship and an awareness of possible treatment risks, to the extent that the patient is able or wishes to be made aware of them. The health professional

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is obliged to provide the patient with the most appropriate information regarding the diagnosis, prognosis, outcome, possible diagnostic-therapeutic alternatives and foreseeable consequences of the choices made. In Italy and various other countries, training programmes regarding doctor-patient communication are becoming increasingly widespread at university level: Continuing Professional Development (CPD) for health professionals. This is the justification of the necessity of scientifically valid, precise and comprehensible information, which must be adapted and personalised to each patient; this information must also clearly indicate, as far as is possible, the expected risks and benefits of a specified treatment. And it is precisely at this juncture that teamwork comes to the fore: the integrated team provides an excellent opportunity for the patient to feel that their emotional needs are recognised, to experience a personalised relationship with health professionals, and to feel actively involved in decisions concerning their health, thereby encouraging compliance with the diagnostic and therapeutic process. This type of communication is a demanding process which commences with the reception as the initial phase of the approach, during which the foundations for building a functioning relationship, requiring constant training, are laid. This phase serves the doctor/dentist to assume responsibility for the patient and any requests. Relationship training provides the personal means for entering into a relationship, of identifying an appropriate emotional distance, permitting the doctor to enter the patient’s private space without being intrusive or influenced by the patient’s suffering. Thereafter, there is a phase of ‘illness narrative’ [24], a pivotal moment in the constructing of the clinical and psychological histories of the patient in order to arrive at a diagnostic assessment. The garnered information and its delivery by the patient are the basis for shaping future patient behaviour. Unfortunately, the communicative aspect of diagnosis-making is generally often neglected in the training courses for doctors and dentists, and the latter are often left to their own aptitudes and the particular engagement of an individual health professional [25]. While the latter is caught between the communicating of a possible diagnosis and an initial diagnosis, the patient faces a period between assessment and response, in turn an additional source of anxiety. The intensity of the patient’s worries will depend partly on their own emotional state and partly on the management of the communicative phase of the dentist [26]. These are often delicate situations, in which the patient’s anxiety is laid bare, to which the medical practitioner should respond assertively. It should also be emphasised that the patient’s experience is often characterised by an acute sense of panic, disbelief, protest, anger, anguish and fear. Diagnosis is that moment determining the transition from a state of health to the certainty of illness. This often leads to a phase of despair in which the patient is confused and angry. Thus, it is usually of limited use to continue communicating, especially since the patient could be upset on hearing their diagnosis. For this reason, a relationship of assistance should develop in a well-defined context, one which is friendly, protecting and using an appropriate communication style [27]. The humanising of care also involves providing a positive setting, in addition to living the Hippocratic Oath on a daily basis. This involves: preparing and structuring

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a message in content and form with comprehensible language, speaking with a clear, distinct voice and pronunciation, and using pauses and emphasising key information. Simple written instructions may be appropriate, on occasion summarising, asking for feedback, and displaying a feeling of empathy [24].

4 Reformulating the Relationship Between Doctor and Frail Patient (With a Need for Oral Care) and Revisiting Settings: How the Ethical Dimension of the Medical Professional is Changing Limitations to the most widespread approach to medical ethics are currently emerging [28]. Today, the vulnerability of cancer patients with special needs is emerging with overwhelming force, hence the necessity to strive for an approach offering ever more appropriate responses. Medicine should not merely be oriented as a technicalscientific activity but also as human practice imbued with an ethical dimension [29]. In line with the vision of humanizing care, a model of relational medicine will be proposed in which the disease is also studied with its emotional and existential implications, acknowledging the patient’s requests, where appropriate. It seems plausible to define clinical medicine as a relationship of care between two persons, the aim of which, where possible, is to heal the patient with the most appropriate tools, and this is also the case in the field of dentistry. A notion of healing does not suffice: the medical vision of the objective of ‘taking care’ of the sick should be redefined. It follows that medical care may be understood as a practical and personalised response to the needs of others, where the caregiver alleviates the patient’s discomfort of a given pathology, taking into account the complexity of the disease and considering the uniqueness of care provided. The notion of care will direct the practice of caregiving not only towards the empowerment of the patient: it will also offer practical assistance to patients with special needs, thereby delineating a more encompassing and meaningful frame of reference regarding the dental profession. Caring is thus a practice of ‘an authentic openness to another’, leading us to reflect on how fundamental it is to consider the empathic listening of another and the ethical dimensions of the dental profession. In the majority of cases, the training available in university contexts is predominantly theoretical [30]. Moreover, the transition to real interaction with the special needs patient is not easy, even for more experienced clinicians. Thus, when a recentlygraduated dentist is faced with a patient with special needs, they are confronted with conflicts and decisions with ethical implications, the medical practitioner is may well be unprepared to meet this challenge even after having completed specific courses on patient care. A period of training is therefore a prerequisite to dealing with these ethical implications. A process of humanisation and the adoption of an appropriate approach of such patients implies a reformulating of the doctor/patient relationship: in order to act with care, it is insufficient to have been the recipient of care as the

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former requires a different skill. Incorporating care into the doctor/patient relationship commences with a detailed medical history of the patient and active listening in adopting specific communication techniques, and creating and improving more effective care settings [31]. When interacting with patients as clinical experience, ethical dilemmas are generally more delicate, and best practice is not always easy to identify as it requires profound reflection on the context from which the dilemma arises [32]. Being familiar with the field of ethics is very different from behaving ethically [33]. Becoming a dentist and adhering to good practice is a process which begins in the formal context of the university lecture hall, to continue on a daily basis as professional practice. Personal practical knowledge is formed from experience in the field and it is continually evolving. Although only direct experience can truly complement professional ethical training, there are methodologies for encouraging an appropriate ethical approach in students. For example, one of the key concepts, according to Canadian scholar Diego Machado Ardenghi of the Faculty of Dentistry at McGill University in Montreal, is that of storytelling among academics. “If dental students are given the opportunity to talk about their clinical practice and analyse it, this storytelling, accompanied by reflection and comparison, will help them develop an awareness of their personal ethical knowledge and permit them to establish a connection between theory and practice” [34]. In order to optimise care in medical practice, it is essential to re-evaluate the dentist/patient relationship as there can exist no effective clinical practice without empathetically listening to the patients’ story, their schemata, perceptions and experiences. The aim of this re-evaluation tends to make care as humanised and as humanising as possible by all those medical professionals who choose to ‘commit’ to their patients [35]. This is with a view to establishing an intervention protocol, which, one the one hand, responds to the demands of understanding the care needs of specific patients, and, on the other hand, is the basis for the planning of a dedicated and continuous service in maintaining a satisfactory standard of oral health. Such a protocol represents a context in which a comparison can be made of reactions to specific diseases in order to learn about new strategies and techniques for managing the care/treatment plan [31]. An awareness of any experience of illness, be it chronic and/or incurable, can be a resource for the patient and their family.

5 Conclusion The aim of this narrative review literature is to stimulate a discussion regarding the experience of care, that is, care for others, humanized care; strategies for facilitating the doctor/dentist-patient relationship can be recommended with the aim of raising awareness in patients. In accepting these recommendations, doctors and dentists could work towards an informed and participatory approach, leading to improved patient compliance, especially in the case of oncological patients (head and neck and other parts of the body). Utilising the stories of patients and caregivers [36],

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interdisciplinary teams (also those who are the most flexible and basic in terms of multi-disciplinary characteristics) will be able to improve their interaction, provide more effective care and focus not on a single disease but on the individual as a complex system. The latter is facilitated by the means of narrative medicine, which advocates an awareness of a participatory approach, leading to sought after adherence, that is, the close adherence by the patient to diagnosis and treatment [28]. The main aim and authors’ wish in this paper is that it becomes an established diagnostic-therapeutic technique. Hence the justification for humanizing care not only implies leading the patient towards an ‘absence of disease’ but also to invest in training, retraining and consciousness-raising, to preserving the centrality of the person by caring for those conditions endangering their psycho-physical integrity, and paying particular attention to the health of the oral cavity [31]. Satisfactory oral health not only permits the ingestion of food but also communication and the leading of a positive social life, thereby contributing substantially to the physical and psychological well-being of the patient. When mention is made of the humanisation of dental care, reference is not only made to dentists, but also to other medical figures involved in the treatment of patients: oncologists, general practitioners, oral health professionals, dental assistants and, where necessary, physicians or other specialists. This includes: medical and healthcare professionals (nurses, dental assistants, and the administrative staff of healthcare facilities), caregivers, and family members, all of whom care about the health of their loved ones. Hence, the necessity to update and improve the various healthcare systems and related health care figures by making available new professional approaches and offering suitable training [37]. This notion of care also gives space for patients to discuss their options, share, and assert their self-esteem and autonomy to mitigate their sense of anxiety, thereby actively contributing to their own processes of care process and oral health. This also creates an opportunity for those health professionals involved in creating new ways of interaction by virtue of their patients’ feedback. Thus, CPD can be an opportunity with which to rediscover the meaning of one’s work and facilitate the process of empowerment [38], this is fundamental in encouraging the collaboration of patients and improve their decision-making regarding treatment. Today, pathways of humanization are an important and highly topical issue in the field of health care as the patient’s acceptance of proposed treatments and an awareness of care are of increasing importance. However, this development is yet to be widespread in the field of dentistry. Describing the motivation and knowledge behind processes of care, the authors of this research have outlined the creating of a revised setting and treatment pathway, which could be available to frail patients. However, the caregiver’s responsibility should not merely be understood as responsibility for the well-being of another; it also includes the responsibility for creating those experiential contexts facilitating in another the responsibility to search for one’s own well-being [9].

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Notes 1. Originally, ars used to be the translation of techne. There was a separation between technics and arts until the Modern Age, when gradually the term technics is used more in the field of utility, while art becomes a term used in the field of beauty, which value can be discussed. 2. Virtue—aretè, in the classical sense refers to the perfection of a being, in a way that a virtuous man is he who perfects his own human being, in a moral context, acting according to the good, and in the intellectual context, knowing according to the truth. Acknowledgements This work was realized with the support of “Linea Progettuale 2.32 “Umanizzazione dell’assistenza specialistica odontostomatologica per il paziente fragile”—progetti obiettivo PSN 2016, Regione Sicilia”.

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