Ethical Challenges in Clinical Experimentation and Vaccines

By Fausto Martinez & Andrea Iannone –

Bioethics is the discipline that studies human behavior in healthcare and life sciences. It also examines values, rational, and moral principles at the basis of decisions in medicine and biology. Bioethicists recognize that mankind has always pursued greater knowledge, and that the goal of scientific research is to obtain concrete benefits for patients. Therefore, bioethicists are often concerned about the researcher or doctor on one hand, and the patient as the subject of experimentation on the other. In between them lie a vast array of recent technological developments (for example, biotechnology) that stimulate a series of questions. Is science “unstoppable” or does it have limits? Is biomedical technology truly morally neutral? Is emphasizing the human utility of scientific investigation and experimentation ethically relevant?

Researchers addressed these and other questions at the third symposium by A.S.I.E.R.I (Asociación de Investigadores Españoles en la República Italiana, the Association of Spanish Researchers in Italy) on May 18, 2018, at the the Real Academia de España en Roma, Italy. The topic of the conference was “Responsible Innovation and Research”. Further discussion centered on the I-Consent project, funded by the European Union Horizon 2020 Programme. Briefly put, the project aims to improve guidelines on informed consent in vulnerable populations under a gender perspective.

 

Innovation and research can be defined as “responsible” if they respect human rights. Based on the ethical and juridical principles of the Universal Declaration on Bioethics and Human Rights, human rights are human beings’ inherent moral and legal entitlements to dignity, liberty, and equality at any historical moment, in any context. Therefore, the human dignity of both the patient and the researcher must be respected in scientific research and medical practice.

Since they can experience pain, distress and lasting damage, animals are also entitled to humane treatment in medical and scientific research. Whenever possible, appropriately licensed scientists should experiment with specimens with lower neurophysiological sensitivity, thus reducing the number of live vertebrates involved. When animals with higher pain sensitivity are necessary for experimental purposes, researches are advised to adopt techniques to avoid suffering, stress, or injury.

During the symposium, Prof. Alberto García, Director of UNESCO Chair in Bioethics and Human Rights at Università Europea di Roma and the Pontifical Athenaeum Regina Apostolorum, underscored the importance of respecting the human patient’s privacy. This process includes compliance on the part of the experimenting institution with data collection and sharing regulation being paramount. Patients have a right to know what data is collected, with whom it is shared, and how they can rectify or delete it – if they so choose – in the future.

According to García, non-discriminatory and non-stigmatizing medical research practices ensure the equal treatment of patients. He also stated that patients’ rights need to be observed not only during research, but also after its completion. Once a drug has been released onto the market, there must be a phase of pharmaceutical vigilance to monitor identify and evaluate previously unreported adverse reactions to the drug.

 

 

In his last point, Garcia discussed the I-Consent project. In particular, our UNESCO Chair will explore and analyze baseline knowledge of IC for the development and validation of ethical issues concerning informed consent in translational/clinical research and vaccination. Clear informed consent procedures ensure that patients’ dignity is upheld. Informed Consent is a document of utmost important for a patient since it allows him to voluntarily decide to participate in research. However, the research’s objectives are often not shared with the concerned stakeholders. That is why informed consent must become a process during which patients have the essential information clearly presented to them. Innovative tools, such as videos, comic strips, or apps might favor communication among all stakeholders. If not, those unable to consent – often the most vulnerable among us – risk seeing their human rights violated.

 

 

 

Law Interfaces with the Head Transplantation Idea

By Giulia Bovassi –

 

Abstract – 

As we are almost arrived at the final stage of an articulated and dynamic academic itinerary, which guided the interdisciplinary reflection around the approaching of the prevented attempt of head transplantation on a human being, prepared in China by the neurosurgeon Sergio Canavero since 2015, it becomes urgent the need to understand also the juridical significance of an event whose hypothesis of success imposes a renewed ability (to be defined) to consider the identity and the person, whose protection calls for the respect and dignity that, as a human being, it embodies, through the uniqueness and unrepeatability proper of every subject. So what could be said about this originality of a “patient-synthesis” of two extraneousnesses?

What it has been discussed up to this penultimate formative meeting about the contact between apprehension and curiosity, hybrisand equilibrium, within and proper of the order, which, during the seminar occurred on 25 May 2018 at the Ateneo Pontificio Regina Apostolorum, consulted the law, which has prepared, through the influential protagonist voices of the session, instruments already in use and those that would emerge hypothetically, having to face the introducing of dangers for the protection of physical integrity, the life of the person, the inviolability of fundamental assets that it embodies, introduced by the post-modern review of the relationship the subject maintains with his own freedom and, therefore, with action, responsibility and good; terms sometimes considered stagnant if they’re not brought back to the individualist fragmentation, often claimed in social relationships. Law does not remain inert in front of the flow of these particularizations, trying tirelessly to position the corresponding duty to the announcing right. Focusing on this, it does not isolate a single facet; it rather opens quite a number of correlations about the truth of what everyone, as an individual and then collectively in a local and global territory, implements through the moral act, an evaluation to which science and technology can not be subtracted because of their impact on the total existence of extraneous beings, enveloped by the birth of a relationship of trust, need, suffering and help; a delicate alliance that makes intellectual abilities available to the other. “Who are we“, is this a question which has become poor? The approach to the realty of what is often commonly found between science fiction and utopia rushes to the intervention of international communities, transcends the particular turning to universality with a view to a single common purpose, which is bare humanity, the dignity that it brings with itself.This is a brief introduction, which recalls the introduction held by the coordinator of the GdN, F. Alberto Carrara, together with the other academic authorities which were partecipating, the UNESCO Chair in Bioethics and Human Rights director, the jurist Alberto Garcia, and the rector of the European University of Rome, the theologian F. Pedro Barrajon, simply to infer as many times it has been rightly pointed out by the various speakers of the round-table seminar: when we discuss about the work that an individual does on other individuals, human beings, it is not possible to paraphrase the actions in reductionist disordered parts of an equally reductive operative mechanism, and it is this precise vision that prevents true equality, pointing the reificated bodies as interchangeable “containers“, which can be mastered, ending up on going to the detriment, and no longer at the service, of good.

Cephalosomatic anastomosis: which legal relevance? Implications and consequences in the light of the constitutional principles, of the normative dispositions by inferior hierarchical source and of the euro-unitary law“: this is the opening speech by Esq. Emanuela Cerasella who provided, from the very beginning, food for the thought. The lawyer, in fact, admonished Dr. Canavero and the only apparently isolated experience of ethical, legal and deontological cover aimed at his experimentation, removed from human treatment, painted with raw technicality. Well, as noted by the lecturer, “science is increasingly dealing with sacred moments of our existence, such as the birth, the life, the death and for these reasons they are the object of protection of our legal system“; reason why, as anticipated in the introductory section, that type of reality which is idealized by the neurosurgeon can’t pretend to be decontextualised from the already existing reality and its consequences. “Trenched behind mere technicalities and non-answers“, he defines an impervious obstacle to overcome in the imaginary that could be concretized by the successful outcome of the operation: the current legislation, starting from the Constitution of Italy, places the person in a relational context at the center of his interest, which is of primary importance in relation to the State, and it therefore protects the autonomous management of his personal liberty, from which the informed consent itself derives; it protects the right to life, to the physical and psychological integrity of every individual; principles which are in constant relation with the rules of lower hierarchical source, such as civil and criminal law. The example touched by Esq. Cerasella refers to the art. 5 of the Italian Civil Code, which prohibits acts of disposition of one’s own body in order to cause permanent damage; a norm that, through the help of a reading mediated by the laws of the so-called lesiglation of heterogeneity, which autonomously regulate special cases in the light of the hierarchically superior regulations, act on the issues related to transplantation between living or from corpse, just to remain within this specific area of ​​interest.There’s a striking case, an historical fact that led to the editing of this article in the Italian Civil Code, dated back to 1934: a young boy from Naples who surrended to sell his own sexual gland for financial compensation, in favor of an elderly American affected by azoospermia. This historical fact provoked an alarming suspicion: the presentiment that the body had suddenly become object of commercialization or negotiation; a completely new concept, decisively significant also from the cultural point of view, so much so that even today the requests underlying the subsequent regulation on enacting acts of one’s own body are deeply felt (bear in mind the illicit trafficking of organs). Another interpretative problem refers to art. 50 of the Italian Criminal Code, concerning about the consensus of the entitled person, whose genesis is a much closer speech to the Constitution of Italy, in addition placing itself to the art. 579 of the Criminal Code, which governs the killing of the consenting party. These two examples contribute to the essential reading in our reasoning about the body-head transplantation, also in light of the Treaties and International Conventions, designed to protect the fundamental human rights; it could be wondered what is required to legal judgment in response to the cephalosomatic anastomosis, an operation that is proposed beyond the cases already documented and addressed by law, namely beyond the therapeutic purpose, excluded from Dr. Canavero’s practice as witnessed by the personal challenge in which he founds the genesis of his studies; and the answer is that the suitable location (of cephalosomatic anastomosis) lies in the pure experimentation ended in itself, prevented by national and international prohibition. These are the fluid characteristics of a physician who defines himself a laborer, a technician, who does not consider to reason about the life he takes on responsibility but operates on an human being as a mechanic would work with the car he is taking charge.

Head/body transplantation, cephalosomatic anastomosis, as you prefer: a traveling journey through a science-fiction experimentation in search for immortality and juridical reflections on the centrality of the human being: a man, a person, a juridical subject; a body, a head, a unity“: it is already fully exhaustive the title of the second intervention proposed by Esq. Tania Cerasella, who deepened further what anticipated in the previous report, particularly starting the exposition on the original inspiration that directed the career of the Turinese professor, guided by the attraction to immortality, addressed to a human being still unknown. As claimed by the lawyer, this experimentation hasn’t any balance between risks and benefits for the patient, since the best result obtained by the surgeon was a timing score on two corpses; it’s an experimentation surrounded by logical correlations on the motivations close to the purely technical and non-medical valence of the operation, since in the second case the comparison with the juridical rule, as well as with ethics, would be imperative: respect and dignity of the person, patient, sick human being, the free consent and the authenticity of this concession, therefore the intellectual honesty in the promising ostentation addressed to the suffering, between disillusionment and feasibility, so the responsibility as an agent person, as a doctor. It should be emphasized that the current laws on transplantation regulate the matter expressly prohibiting the operation for some organs, such as gonads and brain, even if, talking about the latter, it would be more correct to talk about head-body transplantation, since the criterion of brain death already implies a condition incompatible with the donation of a clinically non-functioning brain. Who is the real recipient of head transplantation? As Esq. Cerasella explains, the individual juridically does not exist, he materializes in three different denominations: person, human being and juridical subject. When we refer to the concept of person, we address a subject who is owner of rights and duties, who acquires legal capacity with birth and extinguishes it with death; through this capacity the person becomes subject and in them human being is found again, here lays the unity. Our epoch and, at the same time, the technological revolutions we are witness, articulate demanding modalities on the meaning we want to attribute to human being: if he is an all-encompassing unitotality of body, spirit, psyche or there’s splitting, fracture, between intellectual capacity and body, following a parallel track that slips to considerations on the quantifiable. Body-support, body-tomb, body-object of commodification: how do we address the body today and how law address it? The body has always been in the subject-object binomial, as the lecturer explains, constituting in its parts a “res”, a collection of tissues and organs, as a whole object of power and not of property, towards we must namely guarantee juridical protection, index of inviolability and inalienability of the components with respect to the whole. The concept of unavailability takes over too: despite being and having a body, we can not exercise arbitrary autonomy on it, that is why the law is called to limit, circumscribe what a human being freely can do with and on his body. In this regard we have a comparison with the disturbing pathological condition of patients affected by BIID (Body Integrity Identity Disorder): people who suffer from disorders related to their identity, where the subject does not perceive the harmony between himself and the body to which he is “forced”, idealizing a body different from its own, in this case amputated, asking to be able to cause permanent lesions on his limbs, reaching so paraplegia, tetraplegia, often suicide if he’s hampered in getting hurt.We are not too far from the reasoning involved in the case of the head transplantation, although the terms are in many respects antipodes: in both cases and in situations of rectification of the attribution of sex, that often are united in the battles for their legal legitimacy to those of BIID, we could see the need for a reasoning to mark with strenght the good of the patient, discerning between normal and abnormal for that same good that goes beyond a principle moved by the simple will of the individual, as he could find satisfaction in the technique. In short, closing as Esq. Cerasella left us, “having moral justice within us“.

In respect to the specific issue of informed consent, expanded until the recall of certain key points shown off by the transhumanist movement, the third interesting intervention of the meeting attended by dr. Luigi Piero Martina, about the interaction between law and head transplantation, proposed a rich analysis on the biogiuridic aspects between the patient’s legal status and informed consent. Firstly accompanying the listeners through the creative inlets of a situation of complicity between a possible head transplantation and two consenting patients, a not simple link since the terms, entirely internal to the context, would be “legal status” on the one hand and “legalidentity” on the other; then taking a break within the differentiation between “curative” and “demolitive” as a result of the legal precedents already known in literature, arrangements subtended to “physiological, wide, connatural question on consent even from a legal point of view“. The consensus problem is linked both to the sudden evolutionary movements of technological and medical innovation, and to the social role that medicine, therefore its officials, cover nowadays. In some respects, there seem to be a paradoxical coexistence between unlimited trust and blind mistrust, which is the cause of uncertainty and of the structural disintegration of the dialogical alliance between doctor and patient, in which the legitimacy doesn’t lie in the competent authority of the exerciser but in the patient’s consent; a relationship that today needs content, substance and metamorphosis, that could clean up the performance from automatism and render the impact on existential life, so that it could persist the task of restoring the lost status of health from which doesn’t derive the urgency for the improvement seeked by the current positive eugenics, contrary to the principle of equality.Since the ’60s significant changes, new equipments, marked the human exercise in the time of life and death, practicing between two independent individualities: the one that demanded trust and the one that gave confidence, the opportunity to dispose of life, of death and health. Informed consent is born as a circularity whose beginning is the information and its end is the choice of the patient aware of the technical elements inherent to his decision, exchanging and sharing elements of diagnostic and therapeutic certainty/uncertainty, shifting the error of looming over the nebolous sky of antagonistic solitudes, supporting instead reciprocity, the meeting between dual wills. How do you configure informed consent in the case of two patients willing to lend themselves to the cephalosomatic anastomosis?Dr. Canavero would apply a procedure which, in order to be carried out, clearly implies a high risk disproportionate to the percentage of effective benefit to be expected for the patient and the preliminary death of one of the two subjects of the operation, holding up more, as explained by the lawyer, the similarity between the procedure and the Physician-Assisted Death (PAD), between what is defined as “consent to kill” with the consent of the patient to let potentially deadly procedures take place on himself. Which freedom of decision are we talking about in the patient’s figure? Can such an acceptance be called authentically free? The study of the Turinese neurosurgeon implies that “the head of subject A and the body of subject B are discarded, while the body of subject A and the head of subject B are connected as a living entity“. Who will be the new subject?The intuition has quickly deduced he is subject A, according to a “neurocentric” or “cerebrocentric” approach of law, in which the patient A would regain consciousness with intact memory and remembrances, having however circulatory and respiratory functions of the second patient, the subject B. Law will face an unknown specimen of a symbiont, hybrid human being: will it talk about “half people” and formulate their legal status? What is given as a juridical utopia touches current events, approaching the so-called phenomenon of gender ideology and transgender drift: in both cases there is a pragmatic banalization of the body, object of unstable adaptability, where you can be anyone eliminating the necessity to be someone first, male or female, in favor of the indeterminate, normalizing the abnormal as it is raised by the ideology of standardization. The same correlation in transhumanist thought invokes the liberation from biological slavery, fatally from the natural law, then escaping from the roots or any “solidity“, as explained during the opening lesson of the Masterclass, horizontally divinizing the autopoiesis of the human being in a Promethean rush.

Therefore, is the freedom from which the disoriented human being seeks enjoyment a known and knowable freedom?

 

 

What Does the Solidarity Mean to the Individual Citizen?

The UNESCO Chair in Bioethics and Human Rights participated in the final event of the EUROSOL project, within the Europe for Citizens Programme, in Madrid on May, 31, 2018. The conference finalized the year-long project, which involved eight countries (Italy, Spain, Lithuania, Bulgaria, Poland, Cyprus, England, and Germany). The scope of the project was not limited to analyzing statistics, data, and the situation of refugees in these countries. EUROSOL also focused on spreading the message of a welcoming Europe.

After a welcome by Mr. Pablo José Aledo Martinez, General Director of Altius Francisco de Vitoria Foundation, and the presentation of the EUROSOL project by Ms. Clara Ubeda, Project Coordinator of Altius Francisco de Vitoria Foundation, the first round table discussion began. Throughout the rest of the morning, participants were divided among four round tables discussions, in which they examined different aspects of what solidarity means to the individual citizen.

The first round table discussion, entitled “The Solidarity from a Political and Institutional Point of View,” gave an overview of what institutions, such as the city of Madrid, have been doing in Spain. The city founded a school to train volunteers to socially integrate the high number of migrants arriving mostly from Syria and Venezuela. There has been a recent increase in migrant arrivals, which has given fodder to cries such as: “They are invading us, and we’re paying for it! They’re stealing our jobs, we can’t afford that!” and “We should help them in their own countries, where they won’t die at sea!” The human sphere tends to be reduced to a financial issue, as if everything can be solved through money.

The second table focused on the topic: “Solidarity from the Point of View of Spanish Companies.” According to a press agent, it is crucial for companies to change how they run their business by creating goods and services within everyone’s reach to remain relevant. Companies have to look beyond their own bottom line and try to find new wide-ranging marketing solutions.

The third round table discussion entitled “Solidarity from the Citizens’ Point of View,” revealed how the Erasmus Plus program of the European Union gives the possibility to young volunteers from the Altius Francisco de Vitoria Foundation to understand the importance of social work and volunteering. Being a volunteer benefits not only those in need of legal, medical, or psychological assistance, but also the volunteers themselves. In other words, volunteers have the chance to increase their capabilities and skills, something important for their future careers. At the same time, they give hope to those who have nothing left.

The project’s partners presented their results at the final round table discussion (see the video below). On November 27, 2017, the Chair had organized a public forum in Rome titled “Debate and Dialogue – Refugees Threat or Opportunity?” as part of the EUROSOL project. Experts, students, and volunteers gathered to discuss the real perception of refugees and migrants in Italy and in Rome. The message that the media delivers is often to create walls instead of bridges. An old idea which fosters those negative thoughts to push away the one who is different, who has a different background, culture, or religion. As an UNESCO Chair that fosters the art and convergence in global ethics, we have the duty to spread a message of tolerance and positive inclusion for those who are living in vulnerable situations.

 

 

 

 

 

 

Masterclass in Neurobioethics “Neurobioethics and Transhumanism” Theology’s perspective on human head transplantation

by Giulia Bovassi –

 

How should theology interpret transhumanism? What can be said about the man’s relation to God, his spiritual striving, and his self-understanding? These are just some of the questions that emerged during the meeting on Friday April 20 during the speeches held by professors Giorgia Salatiello and Sr. Daniela Del Gaudio.

«A spiritual revolution» and a pure «technical» action are among the most highlighted points during latest session of the Masterclass in Neurobioethics, “Neurobioethics and Transhumanism.”, Dr. Sergio Canavero emphasized the possibility of a head transplantation of human beings, a possibility often met with precaution.

GdN coordinator Fr. Alberto Carrara, discussed how many thinkers disregard a specific vision about human nature and consequently ethical action. He insisted that human acts cannot be isolated from a relationship with freedom, responsibility and dignity, which are decisive elements for every medical action. The doctor should join, assemble, restore the functioning between the living body and the deceased donor’s body. The doctor could, erroneously, glimpse a mere “producing” in what he is doing, reducing the meeting between doctor and patient to an approach between an operator and an object. In the body transplantation case, one’s original vocation is to take care for the other. Every ill person directs his fears and hopes to the other person’s competence, letting the doctor enter his lives in a concrete act of trust, both professional and human.

The two interventions, “Theological Anthropology Questions about the Recent Scenarios Raised by Transhumanism” by Prof. Giorgia Salatiello (Pontifical Gregorian University) and “The Creational Destination of Man to Immortality: Identity and Resurrection” by Prof. Sr. Daniela Del Gaudio (Pontifical Urbaniana University), extended the consideration to the central points of the Trans and Posthumanist movement, and theology, in some concepts of common interest (for example immortality, life, meaning of death, of freedom, of corporeality, of the person and the task entrusted to him when God is perceived in his origins), promoting an exchange as constructive as possible. In this sense, during the first intervention some themes, particularly suggested throughout the Masterclass’s opening lectures, re-emerged, confirming the fact that, using Prof. Salatiello’s words, «transhumanism constitutes a major challenge for theological anthropology»: to embrace a vision of the human being as a creature implies that our free action is not arbitrariness (without constraints, bare of foundations); greater dependence on God implies greater freedom because God places the creature free (in the Christian conception freedom is constitutively oriented to the good). The concept of  “person” is a notion that contains in itself the relationship with God, the uniqueness of the individual and, again, the free response to the loving call.

Transhumanist language often indicates a fluid, evolutionary view of the human being, together with the lack of distinction between him and artifacts or between man and animal. The individual (a term more commonly used precisely because it can underline the ontological poverty in the definition of person) is drastically reduced to the dualistic vision of himself.

Sr. Daniela Del Gaudio further analyzed the theological comparison in the light of eschatology, linking the substantiality of the human being as a relational being in his relationship with God and in the human being as integrated whole, whose soul informs the matter and whose identity is substantially shaped by the spiritual element. The body historically characterizes the person in the union through the spiritual trait, which remains when everything else changes. Facing the attempt of some doctrines to dissolve the unity of the human being through the subtraction of the soul, Prof. Del Gaudio spoke of «pneumatic realism», using Pope Benedict XVI’s expression, in response to thorny questions, such as the doubts about the identity of the resurrected bodies, if separated from the soul. In the resurrection, the soul will reshape the matter in that same form that «virtually preserves in itself», our corporeity will be transfigured and renewed on the model of Christ. The encounter with Christ marks a new life and following of Christ reveals the vocation to immortality, a call to eternal life. The Catholic Church affirms that there is a resurrection: our body preserves its identity in it and the human Ego subsists and survives, despite the dissolution of the body. Through Christ’s victory over death, which becomes a liberation and fulfillment. Here death, suffering, and pain finds new meaning and eternal life perpetuates the call to live with Christ, a communion that makes all other relationships more complete and alive.

At the conclusion of the round-table seminar, there was a debate on the ideas of the “Letter Placuit Deo to the Bishops of the Catholic Church on Certain Aspects of Christian Salvation” of the Congregation for the Doctrine of the Faith, in which explicit reference is made to two tendencies now widely spread, or from which certain school of thought seem to draw inspiration: neo-Pelagianism and neo-Gnosticism. The first consists in man’s effort to achieve salvation by himself, observable in the way he uses (or becomes a servant of) the technique, then robotics, technologies, etc; the second seeks a subjective salvation through the liberation from the body. Transhumanism contains tendencies toward both of these two approaches, «two temptations of the human being».

The question emerges: «Can the man who can dispose of everything also dispose of himself as he pleases?». This is an urgent question that must be answered to protect the fundamental rights of man so that he will be guarded, not dominated, by his neighbors and his works.