An Introduction to Ethics and Bioethics PDF

PAGE 1 UNIVERSITÄTSMEDIZIN NEUMARKT A. M. CAMPUS HAMBURG https://edu.umch.de www.umfst.ro An introduction in the problematics PRESENTER Associate 2024 25 November Prof. Dr. Cosm...

PAGE 1 UNIVERSITÄTSMEDIZIN NEUMARKT A. M. CAMPUS HAMBURG https://edu.umch.de www.umfst.ro An introduction in the problematics PRESENTER Associate 2024 25 November Prof. Dr. Cosmin Popa of ethics and bioethics Qui prodest? PAGE 2 What are the courses of this subject? Why should this subject be studied? What does the knowledge acquired in this subject help in medical practice? What are the aims and objectives of this subject? What is the structure of this course? What will be the exam procedure? Is it a compulsory or optional subject? How much is this course credited with? Purposes PAGE 3 To describe the main directions of medical ethics, bioethics and medical deontology, from the past until the present. To define and explain the most important differences between medical ethics, bioethics and medical deontology. To discuss the issue of ethical dilemmas within the field of medicine. Medical Ethics, Bioethics, Deontology PAGE 4 Medical Ethics is the code that establishes the moral regulations and rules in the medical field. Medical Bioethics is the code that explores certain questions or dilemmas related to the medical sciences and life problems from an ethical point of view. Medical Deontology can be defined as the domain that deals with all the behaviors, attitudes and moral habits of the doctors manifested in a medical activity (Singer & Veins, 2008). Ancient times PAGE 5 A major contribution to medical ethics was made by ancient healers in ancient Greece. The contribution brought by Hippocrates in the field of medical ethics is still found today within the professional standards or medical deontology. Hippocrates based his medical practice on evidence. Hippocrates of Kos 460 BC - 370 BC Doctors at the time were interested in diagnoses, syndromes (Source: https://en.wikipedia.org/wik or diseases, trying to gather as much adjacent evidence as i/Hippocrates#/media/File:H ippocrates_rubens.jpg) possible (Kleisiaris, Sfakianakis, Papathanasiou, 2014).  "The Code of Hammurabi" PAGE 6 It was developed in Babylonia, ancient Mesopotamia, by the king Hammurabi, and included 282 rules. The Code of Hammurabi were the first law code from the history of humanity. From the perspective of law, the principle applicable in this code was lex talionis. The Code of Hammurabi (1754 BC) (Source: https://en.wikipedia.org/wiki/Code_of_Ham This code established clear rules regarding the commercial murabi#/media/File:Hammurabi_stele_amn h_ny.JPG) changes and punishments applied for those who broke the law (Durant, 2001 in Mark, 2018). Iluminism period PAGE 7 Philosophy, especially modern philosophy, links the concept of dignity to that of human rights. Man viewed from this perspective has inherent inviolable rights, a fundamental right being to be Immanuel Kant German respected and to respect. philosopher 1724-1804 (Source: https://upload.wikimedia.org/wikipedia/ Immanuel Kant shows that a person should be commons/f/f2/Kant_gemaelde_3.jpg) treated as a goal and not as a means.  Medical Ethics and mental health PAGE 8 From antiquity, both Greek and Roman philosophy there was concerned and faith, as well as the fact that philosophy can be used as an effective treatment for mental illness. In the popular sense, madness is present in the epic, tragic, comic, poetic or historical literary works of antiquity. Tom Enters Mental Asylum by William Hogarth (1697 – 1764) Scholars of the time realize that the verbalization (Source: http://www.williamhogarth.org/Tom%20Enters% 20Mental%20Asylum%20William%20Hogarth.jpg) of suffering is a starting point for healing, or at least for relief (Simon, 2008). Legal aspects of medical ethics PAGE 9 The second half of the nineteenth century was marked by the writing of the first codes of medical ethics. During the 19th century, the first medical code of ethics and deontology was published under the auspices of the American Medical Association (AMA), which stipulated the rights of patients and their caregivers. The British Medical Association published its first code of conduct for doctors. In the Geneva Declaration, the World Health Organization (WHO) issued the world's first medical code of ethics, based on Hippocrates' oath (Steinberg, 2003). Medical bioethics PAGE 10 The analysis performed through medical bioethics is considered defining, when people want to make decisions about their behavior in a medical bioethics issue. Also, when it comes to disseminating new innovations and biomedical knowledge to the entire population, governments, organizations and communities use bioethics to make the best ethical decision (E.D.C., 2009). Medical bioethics (1) PAGE 11 Therefore, bioethics appears as a drastic revision of the concepts of professional medical ethics, which has been the basis of the relationship between doctors and patients for centuries. The emergence of medical bioethics is linked to criticisms of a medical code of ethics that no longer corresponded to absolutely remarkable medical discoveries after World War II. Medical bioethics is the result of teamwork, with physicians seeking together with philosophers, theologians, lawyers and social scientists, answers to new challenges in medicine such as: the definition of death, organ transplantation, reproduction and the use of life support systems. History of medical bioethics PAGE 12 The period following World War II can be considered a defining stage for medical bioethics. During this period, the origin and evolution of human experiments, the aspects related to genetic engineering, organ transplantation, as well as cessation of life support treatment are beginning to be discussed. The emergence of new reproductive technologies (Jonsen, 2003). The distorting factors in medical deontology PAGE 13 During the time, medicine was dominated by the paternalistic attitude. The physician frequently displayed this attitude in relation to the patient. In this dysfunctional model, the doctor was the one who decided what was best for the patient, and that was because he was the one who knew best. In parallel, a radical approach called Scientism was developed, based on a theory by the English philosopher Francis Bacon (1561-1626). This theory postulated that human happiness can only be achieved if there are science-oriented policies (Bauzon, 2009). Human rights and bioethics PAGE 14 Based on article no. 1 of the Universal Declaration of Human Rights and of the Council of Europe, Article 12 of the Universal Declaration on Bioethics and Human Rights states that cultural diversity cannot be invoked in any form to violate human dignity (UNESCO, 2011). Medical ethics vs. Medical bioethics PAGE 15 Medical ethics and bioethics interfere as sciences, and are even closely related, but nevertheless not identical. If ethics refers to medical practice and the problems associated with that practice, medical bioethics is a much broader science that refers to the moral issues that arise from the practice of biological sciences. Another major difference occurs at the level of conceptual traditions, bioethics not including the part of accepting traditional values ​(World Medical Association, 2009). Medical deontology (1) PAGE 16 Medical ethics can be seen as a professional duty, interfering with professional ethics in establishing rules, responsibilities - sometimes medical, sometimes legal - all of those being indispensable for the development of the medical profession. In fact, the concept of medical ethics and deontology establishes the ethical-moral coordinates of the medical profession. The doctor will take all necessary measures not to affect the patient's health through his actions. Medical Deontology (2) PAGE 17 The doctor is obliged to keep the entire confidentiality of the medical act, any professional secret being shared only at the express and legal request of the law enforcement bodies. The doctor is obliged to permanently improve his professional knowledge, by participating in congresses, seminars, or by studying articles, journals, books, which present the latest news in their specialty. Ethical dilemma PAGE 18 If the ability to discern exists and this has been proven by a court decision issued following another psychiatric examination, there is a conflict between the patient's decision not to take medication (despite severe depression or anorexia nervosa), while maintaining discernment. Ethical dilemma: Can the patient be forced to take his medication in this case? And if so, under what conditions? Answer PAGE 19 When a hospitalized patient refuses medical treatment, the physician's task is to ensure that the patient refusing treatment is truly informed and aware of all the risks and benefits of such a decision. Related to what is called informed consent, the process of informed refusal aims to guarantee the patient's right to self-determination (Schneider & Bramstedt, 2006).  Lawrence Kohlberg – PAGE 20 model of moral development Psychologist Lawrence Kohlberg issued the so-called model of moral development. From the perspective of Kohlberg, moral development is a separate and individual domain of development. Moral judgment/decisions are based on the personal values and principles of the person. The capacity of moral decision-making is developed through six specific developmental stages (Giammarco, 2016). Exercice 1 PAGE 21 For this exercise you need the following: 1. A sheet of paper. 2. A pen. Your task is to: 1. Read the story presented in the next slides. 2. Deliberate and argue your opinion regarding the case presented. Note: please write down all your observations/opinions. Moral dilemma – Heinz case PAGE 22 A woman was on her deathbed. There was one drug that the doctors thought might save her. It was a form of radium that a druggist in the same town had recently discovered. The drug was expensive to make, but the druggist was charging ten times what the drug cost him to produce. He paid $200 for the radium and charged $2,000 for a small dose of the drug. The sick woman's husband, Heinz, went to everyone he knew to borrow the money, but he could only get together about $1,000 which is half of what it cost. He told the druggist that his wife was dying and asked him to sell it cheaper or let him pay later. But the druggist said: “No, I discovered the drug and I'm going to make money from it.” So Heinz got desperate and broke into the man's laboratory to steal the drug for his wife. Should Heinz have broken into the laboratory to steal the drug for his wife? Why or why not? (Kohlberg, 1981). Ethical question PAGE 23 Do you think that everything that can be scientifically proven is ethical? Please argue why! The ethical and moral decision in medicine PAGE 24 The goal-based approach, also known as consequentialism. The duty-based deontological approach Right-based deontological moral thinking (Foster, 2011). Conclusions PAGE 25 There is a clear difference between medical ethics, bioethics and medical deontology. Medical ethics establishes the moral concepts involves in the medical deontology. Bioethics completed the filed of moral regulations and contributed to elaboration of deontological rules in the field of medical practice and research. Moral dilemmas can appear in medical practice, the way to solve this kind of ethical problems being to apply the ethical concepts/regulations from the perspective of medical deontology.  References Foster, C. (2011). Human Dignity in Bioethics and Law, Oxford:Hart Publishing. PAGE 26 Giammarco, E.A. (2016). The measurement of individual differences in morality, Personality and Individual Differences, 88:26–34. Kleisiaris, C.F., et al., (2014). Health care practices in ancient Greece: The Hippocratic ideal, J Med Ethics Hist Med, 7:6. Kohlberg, Lawrence (1981). Essays on Moral Development, Vol l. I: The Philosophy of Moral Development. San Francisco, CA: Harper & Row. UNESCO, (2011). Casebook on Human Dignity and Human Rights, Bioethics Core Curriculum, Casebook Series, No. 1, UNESCO: Paris, 144 pp. Schneider, P.L., Bramstedt, K.A., (2006), When psychiatry and bioethics disagree about patient decision making capacity (DMC), J Med Ethics;32:90–93. World Medical Association (2009). Medical Ethics Manual. Retrieved from: https://www.wma.net/what-we- do/education/medical-ethics-manual/, accessed November 28, 2020. Bauzon, S. (2009). The rise of Bioethics in East-Central Europe from 1989 to nowadays. Romanian J Bioethics; 7(3): 96-100. Jonsen, A.R. (2003). The Birth of Bioethics. New York: Oxford University Press. Mark, J. J. (2018). Hammurabi. Ancient History Encyclopedia. Retrieved from: https://www.ancient.eu/hammurabi/, accessed November 28, 2020. Kleisiaris, C.F., Sfakianakis, C., Papathanasiou, I.V. (2014). Health care practices in ancient Greece: The Hippocratic ideal. J Med Ethics Hist Med; 7:6. Singer, P.A., Veins, A.M. (2008). The Cambridge Textbook of Bioethics. Cambridge University Press: Cambridge (United Kingdom).  PAGE 1 UNIVERSITÄTSMEDIZIN NEUMARKT A. M. https://edu.umch.de www.umfst.ro CAMPUS HAMBURG PRESENTER: Associate Consent, truth telling and Prof. Dr. Cosmin Popa 2024 27 November confidentiality in relation with the patients Purposes PAGE 2 To define medical consent and confidentiality and their relevance to medical profession; To understand the rules of medical consent and confidentiality; To explore the exceptions from the general laws of medical consent and confidentiality; To acknowledge the historical aspects regarding the ethics of medical consent and confidentiality; To explore the factors involved in medical decision-making; To analyze critically particular clinical cases. Medical consent PAGE 3 Can be defined as an act through which the patient takes a decision autonomously, in relation to his free will, in order to authorize a medical intervention (Beauchamp & Faden, 2004). The medical consent should include three important components: - disclosure; - capacity; - voluntariness Consent can be elaborated in two forms: - explicit; - implicit. Medical consent PAGE 4 The voluntary consent honors the individual’s right about making informed choice; The information has to be conveyed in a way using a format and language the patient will understand properly; Information that is absolutely necessary and relevant for his decision making process; Physicians should inform the patient and ask his or her questions regarding the benefits and risks associated with a medical intervention; Patients have the right to raise questions or to initiate discussions on various topics; The physician should offer all the details that are necessary to enhance the probability of an autonomous decision (Pattinson, 2020). Medical consent origins PAGE 5 The roots of the medical consent go back to the medieval ages to address issues regarding sword fights; First consent models contained terms regarding unlawful physical contact, assault, and constraining the freedom of another person without his or her agreement; The term “informed consent” was first used in relation to a patient’s approval of a medical procedure in U.S. in the 20th century (Kumar, 2013); The Nuremberg Code was adopted to establish the ethical procedures involved in clinical research, and described the value of voluntary consent in detail; The development of the Mental Capacity Act enables the law to declare in advance the legal status of a medical action in relation to a certain person.  Valid consent from the perspective of law PAGE 6 If the consent is intended to obtain coercion/deception that consent is considered unlawful. If the doctor did not offer all the information regarding a medical procedure to a patient, even though the consent is valid, he/she can be accused of liability in negligence. The court can not promulgate decisions regarding the medical treatment of individuals. A valid consent does protect the doctor against the public policy (Pattison, 2020).  Ruling of voluntary consent PAGE 7 According to the World Medical Association (WMA) Declaration of the Rights of the Patient: “The patient has the right to choose freely and change his/her physician and hospital or health service institution, regardless of whether they are based in the private or public sector” (WMA, 1981, p.2); and “The patient has the right to self-determination, to make free decisions regarding himself/herself. The physician will inform the patient of the consequences of his/ her decisions. A mentally competent adult patient has the right to give or withhold consent to any diagnostic procedure or therapy. The patient has the right to the information necessary to make his/her decisions. The patient should understand clearly what is the purpose of any test or treatment, what the results would imply, and what would be the implications of withholding consent.” (WMA, 1981, p.2).  Ruling of voluntary consent PAGE 8 The Sidaway y Bethlem Royal Hospital refers to an important case judged in the Hourse of Lords court of UK, highlighting the importance of informed consent in medicine; A woman, Ms. Sidaway, underwent a surgery for relieving her shoulder and neck pain; She accused her doctor for not informing her regarding the risk that the intervention could lead to partial paralysis, given that she was seriously disabled after the operation; A rule concerning medical negligence was promulgated after the case was judged, stating that it is the surgeon’s duty to inform a patient regarding the possible risks before proceeding to the medical intervention (operation).  Therapeutic privilege (exception) PAGE 9 It refers to situations when doctors may not disclose the entire information with the purpose of protecting the patient from the harm of would be caused if the patient would reject the treatment; This approach must be narrowly used; However, the American Medical Association oppose the use of therapeutic privilege, arguing that it diffuses the concept of physician’s duty to communicate truthfully with patients; Therefore, therapeutic privilege must take place only after the physicians evaluate critically the moral principles that justify information withholding (Richard, Lajeunesse & Lussier, 2010).  The obligation to know versus the right not to know PAGE 10 If patients refuse to hear the relevant to their condition or treatment, they should formulate reasonable arguments for this; For example, this approach may involve cases in which the risks are not immediate (e.g., in conditions that are not yet diagnosed, and information involve only a discussion regarding a predisposition or probability to develop a disease on the long run); On the other hand, when patients refuse to know the information because they intend to avoid that their relatives could find out the diagnosis, this approach is not appropriate (Davies, 2020). Refusing treatment PAGE 11 Especially in cases of life-prolonging treatment, the refusal could have major legal implications. To be considered legal, such a decision must meet the following requirements: (1) it should involve competent adult patients (aged 18 or older); (2) be valid (the patient must be well informed before making a decision); (3) be applicable to the specific treatment that is refused, must be explicit, written, signed and witnessed. Bolam test as the standard of medical care PAGE 12 Endorsed by the House of Lords as a standard in medical care; This implies that a group of health professionals decide if the acts of another doctor falls into the category of medical negligence of not; That is, if a physician applies a procedure that could make him or her guilty of negligence, he or she will be considered blameless if his decision upon the procedure is thought to be reasonable or appropriate, according to other significant medical opinions; In other words, a physician is considered negligent if he/ she doesn’t act as a rational/reasonable person in a given medical context.  Situations when consent is not mandatory PAGE 13 When emergency treatment is necessary to save patients’ life, but they are unconscious; During an intervention, when an additional emergency procedure is needed; Consent can be postponed in cases of severe mental disorders if patients’ cognitive abilities and reasoning are temporarily impaired, but they should be informed regarding the treatment for their physical conditions as soon as possible; If a severe mental disorder is involved, a proxy of the patient should approve the medical decisions (e.g., forced hospitalization); If there’s an infectious disease and refusing to consent would be a risk to other people; In cases when the person is not able to provide basic hygienic conditions for the management of a disease, he or she can be taken to another place without their agreement.  Involuntary treatment PAGE 14 The right to reject treatment can be breached in certain conditions, mostly in the case of severe psychiatric disorders and infectious diseases; Assessing decision-making capacity of patients is required; One of the most important arguments regarding involuntary treatment/ hospitalization is preventing suicide (Sjöstrand, Sandman, Karlsson, Helgesson, Eriksson & Juth, 2015); Another argument is that the period of involuntary treatment provides the patient with a necessary time to recover, possibly to restore autonomy (especially in psychiatric contexts), eventually encouraging a rational decision-making regarding health choices in the future.  Involuntary treatment PAGE 15 However, when deciding to apply involuntary treatment, physicians should be careful regarding the changes suffered in the medic-patient relationship; Factors regarding the patient circumstances, as well as law-related factors can influence physicians’ attitudes towards the implementation of involuntary treatment; Some physicians declared that they purposely do not tell patients all the options they have, so that they will immediately opt for the hospitalization, as the best treatment opportunity (Sjöstrand, Sandman, Karlsson, Helgesson, Eriksson & Juth, 2015). Even if this procedure serves the best interests of the patient, it still represents a lack of absolute honesty and transparency from the doctors. Is this ethical or not?  Malpractice: Montgomery’s case PAGE 16 Nadine Montgomery, a patient with type 1 diabetes, was pregnant with her first child, and she was about to born through vaginal delivery. Due to the fact that women with a diagnosis of diabetes often have bigger babies, there is an increased risk for some complications during delivery when compared to women from the general population. One of the situations that may occur in about 10% of the cases is shoulder dystocia, which can affect the health status of the mother and the baby. When Nadine born her child, shoulder dystocia occurred and, even if the medical team tried to intervene, there was a time delay between the delivery of the baby’s head and his shoulder. Therefore, the blood circulation through the umbilical cord was impaired, and the newborn child suffered a brain hypoxia.  Malpractice: Montgomery’s case PAGE 17 Despite that Mrs. Montgomery claimed that she tried to discuss her preoccupation concerning vaginal delivery problems, her doctor failed to inform her about the probability that a shoulder dysocia could occur during delivery, since he considered that the risks were too small, even if she had a diagnosis of diabetes, as well as that the caesarian section would not be the best decision for the mother. The ethical committee position was that doctor’s omission did not meet criteria for passing the “Bolam test” (i.e., it was not considered rational) and it raised major risks for the health of the mother and the child. However, in the majority of cases, when shoulder dysocia occurred, the obstetricians usually resolved the situation through a standard set of procedures. Source: However, it was argued that, in such situations, if patients communicate https://unsplash.com/photos/6 sl88x150Xs their concerns regarding a procedure, physicians should answer.  Malpractice: Montgomery’s case PAGE 18 The judgment relied upon a tort law that underscores the duty of the surgeon to inform the patient regarding potential risks before undergoing a medical intervention, as well as the fact that, when the patient raises some questions, the physician should promptly address them; Citing this rule of negligence, the Supreme Court decided that Mrs. Montgomery’s doctor was guilty, given the failure to disclose an important risk for the baby to the mother before delivery; The General Medical Council supported the decision, stating that it is the physician’s duty to convey all the relevant information regarding a condition or medical act to a patient. Source: https://www.supremecourt.uk/cases/uksc-2013-0136.html  Confidentiality PAGE 19 There is a general moral consensus that doctors should protect medical information regarding the patient; The legal obligation of maintaining confidentiality is dependent on the type of information; Usually, this refers to very intimate or personal information, as well as the doctor-patient relationship situation; According to the General Data Protection Regulation (GDPR), personal data refers to “any information relating to an identified or identifiable individual”, which includes medical records or archives; While the general law of confidentiality also applies to deceased people, data protection law does not.  Confidentiality PAGE 20 The foundations of medical confidentiality are the following principles: Patient’s right to autonomy; The doctor-patient relationship should involve mutual trust (assumed promise from the heath professional); Doctors should act in the best interest of their patients, and their actions should have positive effects on them.  Confidentiality PAGE 21 The Hippocratic Oath talks about the importance of confidentiality in medical practice, stating that anything a doctor may observe or find out regarding his patients during his work “should not be disclosed”, instead it should be treated “in complete confidence”; Nowadays, the General Medical Council (GMC) still acknowledges that fact, but also proposes that personal information concerning a patient’s life or condition can be disclosed in situations when privacy would harm the patient or other people; For example, such circumstances are when the patient plans to commit suicide, or to hurt other people, as well as various behaviors of the patient could be life- threatening for him/her or others (e.g., a person may not be able to drive due to various conditions, such as poor eyesight, so giving him the permission to drive a vehicle could be dangerous).  Exceptions to the confidentiality rule PAGE 22 When the patient consents with the information sharing and it is disclosed for a good purpose (e.g., disclose to other doctors for treating the patient); Generally, disclosure is permitted in three situations that involve public interest: “(1) to prevent serious harm of the individual to whom the information relates or others; (2) to prevent, detect or prosecute serious crime; or (3) where there is a clear benefit to the public” For example, when information regarding a case are relevant for establishing the effectiveness of an intervention, they should be disclosed; Anonymising personal data regarding medical cases is recommended for teaching or research purposes, but the person should be informed and consent to the use of private information.  Genetic information and confidentiality PAGE 23 Recent developments in medical science, especially in reproductive techniques, can lead to complex genetic links between people; For example, recent technologies involve the fact that genetic material from more than two people can contribute to the conception of an embryo; Also, modern genetic testing may reveal important information concerning the relatives of Source: https://unsplash.com/photos/_y4LGVTeBwQ a person and familial relations. Genetic information and confidentiality - case PAGE 24 “A couple, Robert and Hannah, have a baby who is born with an undiagnosed genetic disorder. Robert and Hannah wish to know the chance that any future child of theirs will be similarly affected. To answer this questions, the genomes of Robert and Hannah, and the baby are sequenced and compared. This analysis reveals that Robert was not in fact the baby’s biological father and that the baby’s condition is the result of the unfortunate combination of a sequence in Hannah’s genome with that of whoever was the biological father of the baby.” Source: https://unsplash.com/photos/8lFeOQJUGgY Genetic information and confidentiality - case “The baby’s disorder is genetically like a classical PAGE 25 recessive inheritance. This means that the chance of any child of Hannah’s having the condition depends on who is the biological father. If it is the same man as the father of her baby than the chance is 25 per cent. A future baby who is the biological child of Hannah and Robert, however is very unlikely to have the disorder. This is because Robert has two copies of the normal gene that will prevent his children from having the disorder.” (Dunn & Hope, 2018) Should the doctors tell Robert that he is not the father of the baby? Source: https://unsplash.com/photos/8lFeOQJUGgY Should they be honest with Robert, or rather tell him that the condition is a consequence of a new mutation? Genetic information and confidentiality - case PAGE 26 There is a dilemma regarding the respect for autonomy; The assumed promise should be establish before the testing procedure; Telling the results to Robert could affect family relations and stability, so many doctors could evoke the best interests and avoiding harm principle for keeping the secret; However, there is no certainty that hiding the fact that Robert is not the biological father of the baby from him would be better than telling him the truth; Such serious ethical issues should be resolved on the basis of existing theories regarding privacy, but particular contexts should be taken into account when making a decision. The personal versus the joint account model PAGE 27 Personal account model - the information should be known only by a single person (the direct bystander); There can be situations when withholding the disclosure would do more harm to patients or their proxy. Source: https://unsplash.com/photos/VMFrQvH7bso Joint account model - relevant medical information should be shared by more than a single person in several circumstances (such as genetic data); So, all members who could be directly affected by that information should have the right to know it. Conclusions PAGE 28 There are several general principles governing the rules of medical consent and confidentiality. It is the physicians’ duty to provide information to their patients. Competent adult patients always have the rights to autonomy and self- determination, as well as free choice. Any patient choice regarding his or her medical status and/or treatment must be respected, as long as it is informed. There are some exceptions to medical consent and confidentiality that should be taken into consideration in complex medical contexts.  References PAGE 29 Pattinson, S.D. (2020). Medical Law and Ethics. 6th ed. London: Sweet & Maxwell. Beauchamp, T.L. & Faden, R.R. (2004). Informed Consent II. Meaning and elements of informed consent. In: S.G. Post. Encyclopedia of Bioethics, 3rd ed, vol.3. New York: Macmillan Reference USA. World Medical Association (1981, 1995, 2005). Declaration of Lisbon of the Rights of the Patient. Retrieved from: https://www.wma.net/wp-content/uploads/2005/09/Declaration-of-Lisbon-2005.pdf, accessed November 26, 2020. Global Health and Human Rights Database (1985). Sidaway v. Bethlem Royal Hospital and Ors. Retrieved from: https://www.globalhealthrights.org/health-topics/medicines/sidaway-v-bethlem-royal-hospital-governors-and-ors/, accessed November 26, 2020. Richard, C., Lajeunesse, Y. & Lussier, M. (2010). Therapeutic privilege: between the ethics of lying and the practice of truth. J Med Ethics; 36:353-357. Davies, B. (2020). The right not to know and the obligation to know. J Med Ethics; 46: 300-303. National Health Service. Overview: Consent to treatment. Retrieved from: https://www.nhs.uk/conditions/consent-to- treatment/, accessed November 26, 2020. Sjöstrand, M., Sandman, L., Karlsson, P., Helgesson, G., Eriksson, S., Juth, N. (2015). Ethical deliberations about involuntary treatment: interviews with Swedish psychiatrists. BMC Med Ethics; 16(37): 1-12. The Supreme Court of the United Kingdom (2015). Case details: Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (Scotland). Retrived from: https://www.supremecourt.uk/cases/uksc-2013-0136.html, accessed November 27, 2020. Dunn, M. & Hope, T. (2018). Medical Ethics: A Very Short Introduction. Oxford: Oxford University Press.  PAGE 1 UNIVERSITÄTSMEDIZIN NEUMARKT A. M. https://edu.umch.de www.umfst.ro CAMPUS HAMBURG PRESENTER: Associate 2024 2 December Clinical ethics and bioethics in relation Professor dr. Cosmin Popa with different systems of thinking Purposes PAGE 2 To describe the most important systems of thinking involved in ethics; To understand the contribution of philosophical concepts to present medical practice; To acknowledge the most important regulations involved in the medical profession nowadays; To apply the theoretical frameworks to real medical situations.  Liberalism PAGE 3 John Lock was an English thinker who introduced modern liberalism; He defined a political movement that encourages human freedom; Free expression of beliefs, attitudes and the right to have distinct opinions are especially supported from a liberalist perspective; Social equity is fostered, meaning that all people from a society should have the same rights; During the second half of the 20th century, federal insurance John Locke programs invoking the liberal idea of equity start to appear, English philosopher and physician 1632 – 1704 such as Medicare or Medicaid, to ensure that poverty would Source: https://en.wikipedia.org/wiki/Liberalism#/ not be a barrier to health services. media/File:John_Locke.jpg  Social contact theory PAGE 4 It states that people have to establish some form of agreement between them so that a society can be functional; Thomas Hobbes was one of the first philosophers to describe modern social contract theory; According to his view, people from a society should share identical obligations and rights, while the absolute authority was thought to be religion and God; In his book The Racial Contract, Charles Mill advocates for the need to be aware of social inequity between races in the political Thomas Hobbes context; English philosopher (1588 – 1679) The perspective of social contract set up the basis for Source: https://en.wikipedia.org/wiki/Thomas_H understanding the way most social interaction work, especially obbes#/media/File:Thomas_Hobbes_by _John_Michael_Wright_(2).jpg the behavioral rules that characterize professional relations. René Descartes (1596-1650) PAGE 5 Descartes was one of the most important pioneers of modern philosophy; He replaced the traditional idea that knowledge comes from sensations, arguing that they are not a reliable source of information regarding reality; Instead, he focused on the human mind’s ability to think and associate concepts as the most suitable method to determine the truth; Through his famous statement “I think, therefore I am”, Descartes attempted to suggest absolute certainty; From his perspective, the mind and the body are distinct Source: https://en.wikipedia.org/wiki/Ren%C3%A9_Descartes#/media entities. /File:Frans_Hals_-_Portret_van_Ren%C3%A9_Descartes.jpg The Cartesian method PAGE 6 Descartes tries to achieve a single goal through this method: to find the truth. Four major stages are issued within this approach: (1) Replacing the authority method with the free examination method. (2) The division of each of the problems examined in as many parts as will be found necessary: ​the rule of analysis. (3) Guiding thoughts in order, starting from the simplest and easiest things to know, to the most complex: the rule of synthesis. (4) The application and experimentation of all discovered truths, in order to prove hypotheses. Moral ideas of Descartes PAGE 7 Recognition of the religion in which the person was born and one’s decision to admit only just and unobtrusive ideas. The person's decision to persevere on the chosen path and not to deviate from this path, if one finds it to be good to follow. Resignation and self-control, when man is confronted with events beyond his powers. The use of all human power in the search for truth with the help of reason. The use of will in the containment of passions and their subordination in all human actions. Immanuel Kant (1724-1804) PAGE 8 Our ability to know and comprehend the surrounding space is confined only to the surrounding reality as experienced by our senses and reason and not to the transcendent realm; Accordingly, moral imperatives of the human being are also incapable of gaining access to the transcendental principles put forward by God and, therefore, every human being must reassess the fundamental moral questions such those related to the origins of death or suffering according to the experienced reality and reason. Source: https://en.wikipedia.org/wiki/Immanuel_Kant#/ media/File:Kant_gemaelde_3.jpg Thomas Robert Malthus (1766-1834) PAGE 9 An Essay on the Principle of Population – in which he claimed that population growth decreases the food ratio per capita and, in the end, this situation will lead to a Malthusian catastrophe (wars, famine, diseases, and even the wipe-out of the human race). Two solutions - positive checks imposed on society which will raise the rate of mortality among the population – hunger, war, diseases, random killings; preventive checks – contraception, abortion, birth control, prostitution, postponement of marriages, celibacy; Source: all of these will prevent the negative checks. https://en.wikipedia.org/wiki/Thomas_R obert_Malthus#/media/File:Thomas_Ro bert_Malthus_Wellcome_L0069037_- crop.jpg Sir Francis Galton (1822-1911) PAGE 10 Proposed the term eugenics in his book named Inquiries into Human Faculty and Its Development; The improvement of the race; Influenced by Darwin’s discoveries and agreeing with the implementation of his theories in a social form (the so called social Darwinism), he encouraged those families of good racial stock and fortune/intelligence to inter-marry; He also asked for State legislative measures against those incapacitated by mental illness or different hereditary defects, measures meant to single out and isolate these Source: people from intermixing with healthy people. https://en.wikipedia.org/wiki/Francis_Galton#/m edia/File:Sir_Francis_Galton,_1890s.jpg Adolf Hitler and the Nazi Regime PAGE 11 1938 – raging public campaign against those suffering from hereditary defects; The so-called program “Gnadentod” – “Merciful Death” (Conroy, 2017); An order signed by Hitler in October 1939 authorized the killing of those “unwanted” under the name Aktion T4; The odd thing that triggered the launch of the program was a letter received by Hitler from the parents of a handicapped Poster from around 1938 stating the costs of genetic conditions to society child, requesting his permission to kill their son through an Source: https://upload.wikimedia.org/wikipedia/com assisted medical procedure (Schmidt, 2007). mons/3/32/EuthanasiePropaganda.jpg  Adolf Hitler and the Nazi Regime PAGE 12 Until August 1941, over 70 000 people were officially killed in different mental facilities across Germany and Austria, from which 5 000 were children (Proctor, 1998); The SS carried out unofficially the killing of another 200 000 people by using deadly gas in mobile vans or concentration camps all along the Nazi-controlled territory (Ernst, 1991); In the Holocaust scholarship, the forced sterilization and the use of euthanasia for those mentally-ill, for handicapped people or those bearing any racial deformity according to the racial eugenics preached by the Third Reich are perceived as the starting points of the industrialization of death engineered Auschwitz Concentration camp by the Nazis in the occupied territories from the East (Convey, Source: https://unsplash.com/photos/_Muc5b5kY9E 2017). Prejudices related to medical ethics PAGE 13 "As long as the doctor is a good and informed clinician, professional ethics does not matter.” "Ethics is taught in the family, not in medicine.” "Medical ethics is learned by observing the way doctors behave, not from books or courses.” These are only half-truths, in fact, more and more medical schools around the world are focused on implementing programs that include bioethics and medical ethics in students training. AMA Code of Medical Ethics PAGE 14 Describes the most important ethical values in medical profession; Emphasizes the value of a good doctor-patient relationships, as well as quality interpersonal relationships between professionals, for medical cases management; Also, informed consent, communication and the process of decision-making are discussed; Doctors should seek to maintain patients’ privacy and confidentiality, manipulating medical information and records with caution; Beyond general aspects, certain situations should receive special attention, from an ethical framework; Such situations include the following: genetic testing, caring for patients at the end of life, organ procurement and transplantation, medical research, caring for community, as well as financing and health services delivery. The moral dimensions of medical liability PAGE 15 Respecting the moral dimensions of professional responsibility, doctors should carry out their activity in good conditions, this having a beneficial effect in the development of self-control. In other words, the moral dimensions of the profession have a guiding role in what the physician can do ethically and morally and what is forbidden to him or her. These limits contribute to an improved performance of the medical act, because both the doctor and the patient fully understand the context and the ethical way in which a certain medical act is performed (AMA Journal of Ethics, 2015).  Ethical and legal principles of medical practice PAGE 16 This category includes the entire deontological code of the medical profession. Here we mention: Doctors will take all necessary measures not to affect the patient's health through their actions. Doctors are obliged to keep the entire confidentiality of the medical act, any professional secret being shared only at the express and legal request of the law enforcement bodies. Doctors are obliged to permanently improve their professional knowledge, by participating in congresses, seminars, or by studying articles, journals, books, which present the latest news in their specialty. General medical ethics PAGE 17 The obligation of respecting professional and conduct norms require that doctors act with due diligence, ensuring that any medical intervention they perform, or any professional decision they make complies with the professional norms and obligations as well as specific rules of conduct. From the point of view of professional independence, doctors are obliged to insist and defend their professional independence, any determination of the medical act or of the professional decision for reasons of economic or administrative profitability being forbidden. The doctor-patient ethical relationship PAGE 18 Regarding the character of the doctor-patient relationship, it will be an exclusively professional one and will be built on a basis of respect for human dignity, understanding and compassion for suffering. Doctors will dedicate all their science and skill to the interest of their patients and will do their best to ensure that the decision is correct and the patient benefits from maximum guarantees in relation to the concrete conditions, so that his health does not suffer. The doctor will maintain professional secrecy and will act in accordance with the legal right of each person to respect his or her privacy, in terms of information about his or her health. The principles of relationship PAGE 19 The relationship between doctor and patient is one of the most important aspects of therapeutic practice. Also called a therapeutic relationship, it builds slowly, but once consolidated, it has a therapeutic effect on behalf of the patient. Communication, empathy, congruence are mandatory attributes in the doctor- patient relationship. When the patient feels understood and accepted, his confidence in the doctor and in the medical act increases, which contributes to a better management of the entire therapeutic process. Medical professional secrecy is one of the most important aspects of medical ethics and deontology. The disclosure of confidential information related to the patient by the doctor, has not only ethical consequences, but also legal ones. Medical professional training PAGE 20 Physicians, through the knowledge they’ve acquired, must take fair care of any patient, regardless of race, nationality, sex, religion, or sexual orientation. The doctor will also avoid any words, gestures or attitudes that could negatively affect the patient. The right to medical care is guaranteed by law, so the doctor will provide medical care to any person in physical or mental suffering, not conditioned by the patient's social status, political affiliation, or other factors that may influence the medical act itself. It is forbiden to.... PAGE 21 Exercise the medical profession in conditions that could compromise the professional act or could affect the quality of the medical act, with the exception of vital emergencies; Issue a medical document of convenience or for obtaining an illegal or immoral benefit; Issue a medical document for which there is no professional competence; Influence clients by taking advantage of the position held or through onerous promises and, failing to be compliant with the rules of publicity of medical activities; Use, invoke or leave the impression of holding professional titles, specialties or professional skills inconsistent with reality; Violate the fundamental principles of practicing the medical profession. Moral decisions and behaviors PAGE 22 There are two main perspectives on morality and ethical behavior: moral objectivism - morality can be determined through rationality, and absolute truths can be established through reasoning; moral relativism - rejects the idea that morality can be universal, arguing that it varies according to different cultural contexts. Source: https://unsplash.com/photos/tuKlMfOKhDQ Moral decisions and behaviors PAGE 23 Duty-based theories, such as the moral theory of Immanuel Kant, argue that absolute moral principles should exist, and an action must be judged according to the rational reason behind it; this perspective views morality and ethics in a more absolutist way; Utilitarianism evaluates the moral value of an action as a function of its utility in terms of consequences on everyone influenced by a certain decision; the context in which a behavior occurs is often important for establishing its morality. Moral decisions and behaviors PAGE 24 In contrast to utilitarian and duty-based perspectives, virtue ethics evaluates morality on the basis of character values; Such moral traits are thought to be good by their nature, correlating with human thriving, as a matter of an universal set of standards; In other words, a virtuous person will not act in opposition with his or her moral responsibilities or principles; Virtue ethics dates back from Ancient Greece, when Aristotle proposed a framework based on moral values. Source: https://unsplash.com/photos/gkrf6kHp8Mk Malpractice case 1 PAGE 25 In 2009, PA presents himself at the emergency room from a public hospital from Reghin, Romania. He is consulted by the physician on duty for the night (from midnight to 07:00 o’clock in the morning), and three EKGs are performed at 00:35, 02:00, and 07:00 o’clock, respectively. The physician on duty (who is not a cardiologist) fails to recognize that the patient had suffered an acute myocardial infarction, and to ensure that he is transported to a specialized unit to be treated. As a result, PA dies soon after his visit to the hospital. After PA’s death, his family members had suffered moral damages, which means that PM had started to withdraw herself from her social network, changing her behavior, and PES had given up college studies due to financial difficulties. The family took legal action against the physician in 2016, pretending a large amount of money as a compensation. Source: http://portal.just.ro/289/Lists/Jurisprudenta/DispForm.aspx?ID=28 Malpractice case 2 PAGE 26 CM was one of doctor H’s patients during her pregnancy. Doctor H performed a cerclage removal intervention during which CM suffered a hemorrhage. As a result, H decided that a cesarean section should be conducted in the same day. Although the surgery went fine and was completed successfully, CM accused the doctor for lacking duty diligence because she forgot two textile products in her abdomen (that are typically used during a C-section to hold the body tissue). After the anesthetic effect was gone, CM started feeling intense pain in her abdomen, claiming that H misdiagnosed her with a biliary colic. Despite all her efforts to respect the medical recommendations, her condition did not improve soon after discharge. Therefore, CM contacted one of her relatives, who was a surgeon, for advice. She was later operated again by a surgeon, TM, who discovered the fabric measuring about 10 cm in her body. CM stated that her experience was terrible afterwards, given that her bowel was affected too, and so, she had to use a colostomy bag, which caused her severe humiliation. H argued that the intervention was successful and all the medical procedures were well performed, stating that CM’s symptoms could be due to other factors, so that the malpractice (medical error) can’t be proven. She also denied deciding the diagnosis of billiary colic. Moreover, she mentioned that the textile products are counted before and after such a medical intervention. She also invoked that CM was informed regarding the risks of the procedure, and signed the voluntary consent before the medical intervention. Source: http://portal.just.ro/180/Lists/Jurisprudenta/DispForm.aspx?ID=844 Malpractice PAGE 27 The two situations were categorized as a penal sentence (Case 1), and a civil sentence (Case 2), and the final resolution of the court involved the accusation approval (partially) for Case 1, while the accusation was rejected of accusation for Case 2. Source: https://unsplash.com/photos/0lrJo37r6Nk Would the results be other than that if we’d apply different systems of thinking? Are there any other factors involved (e.g., the complexity of a medical procedure that should be taken into account)? Source: https://unsplash.com/photos/iwzaTMpBD7Q Conclusions PAGE 28 Different philosophical theories and systems of thinking influenced the way we look at ethics and morality in present. The entire professional activity of the doctor is dedicated exclusively to the defense of life, health and physical and mental integrity of the human being. The therapeutic relationship between doctor and patient provides trust and leads to the efficiency of medical treatments. Decision-making may vary according to different perspectives, but ethical decision-making should involve a set of professional principles applied in daily medical practice. References PAGE 29 1. American Medical Association. Code of Medical Ethics overview. Retrieved from: https://www.ama- assn.org/delivering-care/ethics/code-medical-ethics-overview, accessed December 07, 2020. 2. Convoy, M. (2017). Nazi Eugenics. Precursors, Policy, Aftermath. Stuttgard: Ibidem Press. 3. Ernst, K., Willi, D., Volker, R. (eds.). (1991). The Good Old Days—The Holocaust as Seen by Its Perpetrators and Bystanders. New York, NY: Konecky & Konecky. 4. Klosko, G. (Ed.). (2011). The Oxford Handbook of the history of political philosophy. New York, NY: Oxford University Press. 5. Marshall, J. (1998). Descartes's Moral Theory. New York, NY: Cornell University Press. 6. Ministry of Justice from Romania. Civil Sentence. Demands. Retrieved from: http://portal.just.ro/180/Lists/Jurisprudenta/DispForm.aspx?ID=844, accessed December 03, 2020. 7. Ministry of Justice from Romania. Penal Sentence. Work Negligence - Physician. Retrieved from: http://portal.just.ro/289/Lists/Jurisprudenta/DispForm.aspx?ID=28, accessed December 03, 2020. 8. Pattinson, S.D. (2020). Medical Law and Ethics. 6th ed. London: Sweet & Maxwell. 9. Proctor, R.N. (1989). Racial Hygiene: Medicine Under the Nazis. Cambridge Massachusetts: Harvard University Press. 10. Schmidt, U. (2007). Karl Brandt: The Nazi Doctor—Medicine and Power in the Third Reich. London: Hambledon Continuum.  PAGE 1 UNIVERSITÄTSMEDIZIN NEUMARKT A. M. CAMPUS HAMBURG https://edu.umch.de www.umfst.ro Genetic interventions. Everything that can PRESENTER: Associate 2024 4 December Prof. dr. Cosmin Popa be scientifically proven - is it also ethical? Purposes PAGE 2 To understand the evolution and the main ethical concerns related to genetic interventions; To acknowledge the main purposes of research involving humans; To recognize the main ethical principles of research involving humans; To analyze comparatively and determine the ethical status of various research designs. Brief history of genetic interventions PAGE 3 During 19th century, Sir Francis Galton first introduced the term “eugenics”, advocating for the selective reproduction of people with specific desirable traits; At the beginning of the 20th century, the American Breeder’s Association was created for the study of eugenics, and John Harvey Kellogg invented the Race Betterment Foundation; Logo from an Eugenics Conference (1921) Source: In America, this movements culminated in forced https://en.wikipedia.org/wiki/Eugenics#/media/File:Eugenics_co ngress_logo.png sterilization policies for people with mental illness and minorities.  Brief history of genetic interventions PAGE 4 During 1930s, forced sterilizations were ruled for Puerto Rican women, a policy that was motivated by socio- economic purposes; Up to a half of people were sterilized in America between 1970 and 1975, some of these procedures possibly being performed during other medical interventions, without voluntary consent; Equal Rights March (Washington, 1963) Eugenics status in Europe - the actions of Adolf Hitler in Source: https://unsplash.com/photos/U2F-bYmuEqU Nazi Germany included genocide and the promulgation of the Law for the Prevention of Hereditary Disease Offspring. Under this circumstances, a lot of people with mental or physical disabilities were killed using gas or lethal injections.  Current status of genetic interventions PAGE 5 After World War II and the abolition of Hitler’s policy, eugenic tendencies decreased. As medical and technological sciences evolved, genetic and embryo research developed as well, and new reproductive and gene editing techniques emerged; At present, genetic research typically focuses on: improving assisted reproduction through the selection of most appropriate gametes; improving the development process and the quality of in vitro embryos; advancing the use of differentiated cells for therapeutic purposes (e.g., stem cells).  Ethical issues related to genetic interventions PAGE 6 The answer to ethical questions in the context of novel gene editing techniques largely depends on the established moral status of the embryo; Generally, it is assumed that an embryo has limited moral status, which progresses in a proportional manner, permitting research on embryos up until 14 days after creation; Some of the most important ethical issues that arise in genetic engineering are loss of human diversity and the inequitable Source: access to such technologies, as a function of socioeconomic status. https://unsplash.com/photos/tGYrlchfObE Are modern genetic engineering techniques the new form of eugenics? From gene editing to cloning? PAGE 7 The possibility of cloning individuals raised a major debate, especially among scientists, doctors, jurists, or psychologists; Common arguments against cloning include the absence of a personal identity owned by the cloned individual and the failure to comply with the dignity principle; Reproductive liberty from an utilitarian stance is the main argument supporting human cloning; At present, while mitochondrial replacement (i.e., which means Dolly – the first mammal cloned the substitution of mitochondria from the mother’s egg or in vitro Source: https://en.wikipedia.org/wiki/Dolly_(sheep)#/media/ embryo to prevent the transmission of genetic conditions, not File:Dolly_face_closeup.jpg involving a genetic copy as cloning) is considered a legal procedure, the standard cloning method is prohibited. Regulations of clinical research PAGE 8 Clinical research involves observational or interventional studies performed to optimize the health and life quality of participants, who represent diverse categories of people who may benefit from the obtained knowledge; The Nuremberg Code lists 10 principles regarding research that involves human beings, highlighting the importance of informed consent; Also, this document states that scientific research should be conducted only for the pursuit of maximizing the benefits for the society, and the study procedures should minimize any form of unnecessary harm; In case that a particular research causes serious suffering or impairment for participants, the scientist should immediately stop the study. Regulations of clinical research PAGE 9 The Declaration of Helsinki, first promulgated by the World Medical Association, describes the ethical guidelines for medical research involving human subjects; This act emphasizes the importance of protecting the “life, health, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects” (WMA, 2013); The 2004 Regulations, as well as The EU Regulation accentuate the importance of an existing ethical approval for starting clinical trials (interventional studies) with the purpose of exploring the efficacy of a treatment or medical intervention; Regarding the disclosure of information, the principle of “therapeutic privilege” - withholding medical information on behalf of the patient – is not applicable in research; The importance of informed consent PAGE 10 Through using informed consent, the person’s rights to self-determination and free decision-making are accentuated; It needs to incorporate the introduction to the study, its objectives, the characterization of the study sample (participants), and the procedures used in the research; The benefits and the potential risks (physical or psychological) associated with the study need to be highlighted; Noncoercive disclaimer principle – the participation must be entirely voluntary, and refusal to participate does not imply any negative consequences or punishment; Cultural and emotional barriers to its understanding should be taken into account and reduced by formulating the document in a simple language; Participants have the right to raise questions regarding the research. The principle of beneficence PAGE 11 This principle dates back to the Hippocratic saying “be of benefit, do not harm”; If applied in research, it refers to a scientist’s duty to conduct effective investigations, to promote the welfare of the research participants and the society as a whole; Most ethical theorists agree that research should maximize benefits, while reducing all possible sources of harm (non-malificence); Harmful effects may involve different life aspects, such as physiological, emotional, social and economical areas, which should be evaluated before performing a research; A debriefing procedure should be always conducted at the end of the study in order to discuss (or disclose the reasons beneath) the methods used during the research, as well as to give participants an opportunity to express their feeling in relation to the study. Using deception in clinical research PAGE 12 Deception means providing an alternative explanation regarding a study for participants, so that their responses will be valid, and it will be possible for researchers to draw conclusions upon the study; Another form of deception involves withholding specific information; This procedure is often used in clinical trials, when there is no other way that would help answer the research question and when the study can significantly contribute and advance the field; However, using deception must always be accompanied by a good explanation and potential harm should be reduced to minimal; Deception should not be used when the disclosure of information regarding the study would determine a reasonable person to deny the participation; A debriefing procedure must always be conducted in research that used deception. Using placebo in clinical research PAGE 13 Placebo refers to a substance or intervention that doesn’t contain active ingredients, while it can’t be separated from active (real) treatments; Typically, placebo is used as a comparison group when the research aims to investigate the efficiency of an intervention; Although disclosing the specific nature of groups in a study could compromise the results, each participant should know that its general design involves a placebo group, if that is the case; The consequences of receiving placebo should not be Source: harmful for a participant’s physical or psychological status; https://i0.wp.com/www.reviewingresearch.com/ wp- As soon as possible, participants enrolled in a control group content/uploads/2016/09/Placebo.jpg?resize=293 %2C300 should have access to active treatment (waiting list).  Unethical human experimentation PAGE 14 Most standardized guidelines concerning human research resulted from atrocities and unethical experimentation that occurred in Nazi Germany; Eduard Wirths was a chief camp physician at Auschwitz until 1945. He was particularly interested in the field of gynecology. His sterilization experiments on Jewish women involved the extirpation of their cervixes (Lang, 2011). He sent photographs of the cervixes and the specimens for study to Dr. Hinselmann, who was the developer of Dr. Eduart Wirths (1909-1945) colposcopy (Baggish, 2018). Source: https://en.wikipedia.org/wiki/Eduard_Wirths#/med ia/File:Eduard_Wirths.jpg Also, Dr. Wirths was involved in the selection of prisoners at the concentration camp.  The Tuskegee Study PAGE 15 The Tuskegee Study began in U.S. 1932 with the purpose of exploring the progression of syphilis and to justify treatment programs for African Americans. The study enrolled about 600 men, some of them with syphilis and some of them without the disease, who received some advantages for their participation, such as free meals and medical services. However, the research was performed without the consent of participants, who were told that they were treated for “bad blood”, but did not receive the proper cure for syphilis during the research, which lasted 40 years. Although penicillin started to be available in the 1940s, the Source: researchers did not give this medication to the sick participants. https://en.wikipedia.org/wiki/Tuskegee_Syphilis _Study#/media/File:Tuskegee-syphilis- During the course of the study, over 28 men died of syphilis, 100 study_doctor-injecting-subject.jpg men died due to related complications, and about 40 wives also contacted the disease (Pattinson, 2020).  The Milgram Experiment PAGE 16 Stanley Milgram was a psychologist and professor at Yale University who conducted a research to explore the issue of obedience in 1960s; He argued that the main reason of conducting the experiment was to investigate in depth the circumstances under which people are able to perform atrocities to others, such as the events involving genocide from World War II; Particularly, he wanted to see if only some people are obedient to authority figures, when they are requested to do something bad, inappropriate; Milgram enrolled people from the general population into his Stanley Milgram (1933-1984) research, without special characteristics; Source: https://en.wikipedia.org/wiki/Stanley_Milgra m#/media/File:Stanley_Milgram_Profile.jpg The participants were told that the investigation aim was the study of learning, Milgram using deception to avoid altering the results.  The Milgram Experiment PAGE 17 First, Milgram introduced each to other person, who was one of his colleagues, but the participants were told he was also a participant; That person had to play the role of a student, while the real participants had to play the role of a teacher; The setting used two different rooms (one for the teacher, and one for the student), but the learner was placed in an electric chair paired to an electric shock generated from the other room; After the student learned a set of words, the teacher has to test him; Participants were instructed by the experimenter (the authority figure) to give electric shocks to the learner every time he made a mistake, from slight intensity to severe (450 volts); Typical setting used in Milgram’s experiments The learner did not receive electric shocks, he only simulated that Source: https://en.wikipedia.org/wiki/Stanley_Milgram# he felt them, sometimes even claiming that he had a heart condition. /media/File:Milgram_Experiment.png The Milgram Experiment PAGE 18 In the original study, 65%, meaning two-thirds, of the participants continued to listen to experimenter’s instructions and went up to 450 volts; All the participants continued until reaching 300 volts. However, when the experimenter was dressed in casual clothes, not wearing a lab coat, the obedience level dropped to 20%; When the teacher was in the proximity of the student, obedience was reduced to 30%; Moreover, when the location was changed from Yale’s University, obedience levels also dropped to about 47%. Milgram performed debriefing at the end of the experiment. What do you think are the main ethical Source: problems involved in this research? https://unsplash.com/photos/TtsRE CywMmc  The Stanford Prison Experiment PAGE 19 The Prison Experiment was conducted by Phillip Zimbardo in 1973, with the purpose of investigating the causes of brutality in guards and prisons’ personnel (specifically, if this is more related to their personality or to the circumstances; A basement of the Stanford University was transformed in a prison setting; After performing a comprehensive psychological assessment to eliminate people who displayed tendencies towards psychopathology, Zimbardo enrolled 24 men in the study, who were stable and healthy, according to evaluation results; Participants were randomly assigned to either the role of a Phillip Zimbardo (born 1933) guard, or the role of a prisoner; Source: https://en.wikipedia.org/wiki/Philip_Zimbardo Finally, the study included 10 prisoners and 11 guards; #/media/File:Philip_Zimbardo_(cropped).jpg ID numbers were used to make prisoners anonymous and all guards wore identical uniforms The Stanford Prison Experiment PAGE 20 Zimbardo acted as a researcher, but also as a guard in the prison (he spoke about the guards team as “we”, identifying with them); Both guards and prisoners soon started to behave according to their roles; The guards start to exert their authority on prisoners, establishing rules, sometimes using their power to insult them and physical punishment (in the form of push-ups); During the second day in the prison setting, some of the prisoners act rebelliously, ripping off their numbers and using their beds to barricade the door; After this incident, the relation between guards and prisoners changed, with the guards becoming more aggressive and the Source: prisoners being more submissive. https://unsplash.com/photos/5WoAJZ Zie5c  The Stanford Prison Experiment PAGE 21 After less then 36 hours in the experiment, a prisoner (#8612) started suffering intense emotional distress; he started screaming, crying and raged; Two parents also requested to take their son back home; Zimbardo invited a priest, former prison chaplain, to evaluate the situation in the prison; While taking to the priest, another prisoner also started to cry hysterically; After these events, Zimbardo decided to stop the experiment after 6 days (instead of two weeks, the time interval that was previously Prisoner #8612 established; Source: https://stanfordprisonexperimentproject.files.w The experiment lead to important results regarding the way people ordpress.com/2017/11/prisoner8612.jpg comply with imposed social norms, the reasons for the brutal behavior being rather situational than dispositional. Was the Prison Experiment ethical?  The Little Albert Experiment PAGE 22 An experiment performed by behaviorist John Watson and his graduate student, Rosalie Rayner, who wanted to study classical conditioning in humans; The participant was a nine months-old boy (“Albert B”), who was exposed to a series of objects or animals, including a white rat, a rabbit, or burning newspapers; Initially, the boy expressed no fear regarding them; At a following exposure of the boy to the rat, the experimenter made a loud noise, hitting a metal pipe with a hammer; After repeated associations of the noise and the rat, the boy Source: https://upload.wikimedia.org/wikipedi started crying when he was exposed to the rat (because he was a/commons/c/cc/Little-albert.jpg also expecting the disturbing noise); After the conditioning, Little Albert started generalizing and fearing other similar objects (such as a fur coat or a white beard). Designing ethical research PAGE 23 Which of the presented studies do you believe is more unethical than others? Why? What are the main ethical principles that were violated in these studies? Do you believe that if one would change the design (in one of the studies or in more), that could resolve the ethical issues? Do you believe that the ethical issues could be resolved by changing the procedure applied in these studies? Source: https://unsplash.com/photos/cXkrqY2wFyc Conclusions PAGE 24 Genetic interventions started from eugenics and resulted in modern genetic engineering techniques, which are valuable tools for humanity, as long as they take ethical issues into account. Clinical research, and research involving humans in general, must always seek to enhance the information base regarding an important subject, and to improve the life quality of the participants. Informed consent and the principle of beneficence are crucial in any type of research involving human beings; Ethical principles go beyond the scientists’ desire to gain knowledge regarding a particular subject. References PAGE 25 1. Centers for Disease Control and Prevention. National Center for HIV/AIDS. The Tuskegee Timeline. Retrieved from: https://www.cdc.gov/tuskegee/timeline.htm, accessed Dec 09, 2020. 2. Emanuel, E. J., Grady, C. C., Crouch, R. A., Lie, R. K., Miller, F. G., & Wendler, D. D. (Eds.). (2008). The Oxford textbook of clinical research ethics. New York, NY: Oxford University Press. 3. Fouka, G. & Mantzorou, M. (2011). What are the Major Ethical Issues in Conducting Research? Is there a Conflict between the Research Ethics and the Nature of Nursing? Health Science Journals; 5(1): 3-14. 4. Fusco, E., Padula, F., Mancini, E., Cavaliere, A., & Grubisic, G. (2008). History of colposcopy: a brief biography of Hinselmann. Journal of prenatal medicine; 2(2), 19–23. 5. Getz, L.J. & Dellaire, G. (2020). Back to Basics: Application of the Principles of Bioethics to Heritable Genome Interventions. Science and Engineering Ethics; 26: 2735-2748. 6. Haney, C, Banks, W. C, & Zimbardo, P. G. (1973). Interpersonal dynamics in a simulated prison. International Journal of Criminology & Penology; 1, 69-97. 7. Lifton, R. J. (1986). The Nazi doctors: Medical killing and the psychology of genocide. New York, NY: Basic Books. 8. Milgram, S. (1963). Behavioral study of obedience. Journal of Abnormal and Social Psychology; 67, 371-378. 9. Pattinson, S.D. (2020). Medical Law and Ethics. 6th ed. London: Sweet & Maxwell. 10. The Council for International Organizations of Medical Sciences (2016). International Ethical Guidelines for Health-related Research Involving Humans (4th edition). Geneva: CIOMS publication. Retrieved from: https://cioms.ch/publications/product/international-ethical-guidelines-for-health-related-research-involving-humans/, accessed Dec 08, 2020. 11. Watson, J. B., & Rayner, R. (1920). Conditioned emotional responses. Journal of Experimental Psychology; 3, 1-14.  PAGE 1 UNIVERSITÄTSMEDIZIN NEUMARKT A. M. CAMPUS HAMBURG https://edu.umch.de www.umfst.ro The aging, life extinctions and the PRESENTER: Associate 2024 9 December Prof. Dr. Cosmin Popa definition of death  PAGE 2 Purposes 1. To better understand the concept of ageing and its descriptions; 2. To acknowledge the special issues regarding decision-making in medical contexts being raised when working with older patients; 3. To understand the concept of death, as well as the bioethical and legal circumstances involved in decisions of life extinction. Structure PAGE 3 1.1. Defining aging 1.2. Aging around the world. International policy frameworks on ageing 1.3. Changes associated with aging. Aging and medical care 1.4. Cognitive problems and decision-making in old age 1.5. Health Care Advance Planning 2.1. Definitions of death and types of life extinction decisions 2.2. Non-voluntary life extinction decisions 2.3. Discussion – medical case. Defining aging PAGE 4 Gerontology describes the study of human aging from various perspectives; There are two important attempts to define aging among gerontologists; First, aging is described as a phenomenon that explains the progressive decline of biological functions; Secondly, the definition of aging is directly related to death, meaning that it describes the Source: increases in mortality associated with age. https://unsplash.com/photos/uJrRY8gUm7E Aging trends around the world PAGE 5 There is a global trend that shows that rates of older adults are increasing wor