Clinical Ethics Lecture 3 - Nile University

Biosecurity and Research Bioethics [APBI304]  Lecture 3 The Pillars of Clinical Ethics By Dr. Mariam Gamaleldin Assistant Professor of Molecular Biology  02 What are clinical ethics? “Cli...

Biosecurity and Research Bioethics [APBI304]  Lecture 3 The Pillars of Clinical Ethics By Dr. Mariam Gamaleldin Assistant Professor of Molecular Biology  02 What are clinical ethics? “Clinical ethics is a practical discipline that provides a structured approach to assist health professionals in identifying, analyzing, and resolving ethical issues that arise in clinical practice.” – NSW Ministry of Health, Australia APBI304 Why are clinical ethics important? Because clinical ethics: 1. Assist in making medical decisions. 2. Ensure that patients get the finest treatment possible. 3. Reduce the moral dilemma and load on the doctor. 4. Make it easier to evaluate clinical circumstances when the necessary criteria are supplied. I am not a doctor: why do I still need to know the pillars of clinical ethics? 1. The pillars of clinical ethics are also the core principles of all ethics and must be applied regardless of the profession. APBI304  I am not a doctor: why do I still need to know the pillars of clinical ethics? 2. When the biotechnologist develops biopharmaceuticals, they should keep in mind the ethics of how it will be used on the patient. APBI304  What are the four pillars of clinical ethics? Non-maleficence Beneficence Respect for Autonomy Justice What is the history of these four pillars? Beneficence and non-maleficence existed since Hippocrates (c. 460 – c. 370 BC). However, autonomy and justice appeared later in history. APBI304 APBI304 Respect for Autonomy Beneficence Non-maleficence Justice The four pillars of clinical ethics  Pillar I: Respect for Autonomy What is autonomy? ✓In Greek „auto“ = self “nomos“ = governance. Therefore, autonomy is self-governance. ✓“Autonomy” was once meant to denote a city's independence, but it is now used to characterize an individual. What is the definition of personal autonomy? ✓To be free from external influence and rule oneself. ✓To be free of constraints that may impede personal decision-making, such as misunderstandings. APBI304 What are the conditions of autonomy? 1. Intentionality: To perform a behavior as the actor intended. There are no shades or degrees of intentionality; it is a binary concept: an action is either purposeful or it is not. 2. Understanding: A sufficient (not necessarily complete) level of awareness of the effects (risks or rewards) of the decision being taken. There are several levels of understanding. 3. Non-control: Having no significant internal or external influences (such as coercion or manipulation) (e.g., mental illness). Influence varies in intensity. APBI304  “Respect for autonomy”: Definition: “To acknowledge the autonomous agent/patient’s right: Recall lecture 1: (1) to hold views, Every right has a corresponding (2) to make choices, obligation (3) and to take actions based on their Right Obligation values and beliefs. Autonomy Respect for (4) Such respect involves respectful autonomy action, not merely a respectful attitude.” – Tom Beauchamp and James Childress (American philosophers) APBI304  “Respect for autonomy”: Types of Obligation: 1. Positive obligation i. Providing information that is necessary to enable agents or patients to make decisions on their own. ii. Ascertain that the agent/patient is aware of the options and willing to choose for themselves. 2. Negative obligation Not exerting any kind of control over the agent or patient. APBI304  How is the positive obligation carried out? Informed consent: When a patient grants informed consent, they acknowledge that they are aware of the potential benefits and hazards of the operations or treatments being performed on them by their doctor or other healthcare providers. Why do we need informed consent? Nazi doctors saw people as "things" with no agency rather than as autonomous individuals, so they did experiments on people with horrific and fatal results. For this reason, informed consent was integrated into human rights following the Nuremberg trials in the 1940s and beginning in the 1970s. APBI304  Schools of informed consent First school of thought Second school of thought This school requires the patient The second school of thought to "autonomously authorize" the holds that simply informing a operation after fully knowing its patient of the risks associated causes and effects, rather than with the recommended therapy merely agreeing to have it or course of treatment is enough. performed on him or her. e.g., if the patient agrees to have Although more practical, this an operation on his right ear, the viewpoint disregards the patient's doctor can not decide by himself autonomy! to operate on the left ear (patient Anna Mohr’s case in 1905) Q: Which school of thought is morally correct? A: the first school, because it practices true respect for autonomy. APBI304  Components of the informed consent Threshold elements Types of elements Information elements Consent elements (preconditions) Competence Disclosure Decision (to comprehend and The elements decide) Recommendation Authorization Voluntariness (to decide) Understanding APBI304 Components of informed consent 1. Threshold elements: Means that the subject/patient has to have the level of competence that allows them to understand the information they are being given and to make a decision based upon the provided information. Voluntariness means that the subject has to have a choice and be able to make that decision for themselves without coercion or manipulation. APBI304 Components of informed consent (cont.) 2. Information elements: Means that physicians and healthcare professionals have to: Disclose the information regarding the causes and consequences of the chosen procedure, Give advice based on the information provided Make sure that the patient/subject understand the information provided. 3. Consent elements: Decision means that the patient/subject has to arrive at a decision Authorization means that the patient has to give permission or authorize the physician or healthcare professional to execute that decision as per agreement. APBI304  Threshold elements (preconditions): How to determine if the patient is competent to comprehend medical information and make medical decisions for themselves? When do we know that the patient is incompetent? It is generally assumed that a patient is competent unless certain conditions exist, such as: 1) Not being able to communicate or express a particular decision or choice. 2) Not being able to comprehend their own current situation and what can result from it. 3) Not being able to understand information related to the situation. 4) Not being able to weigh risks and benefits. 5) Not being able to make a decision that is judged as reasonable according to common-sense standards. APBI304 APBI304 Respect for Autonomy Beneficence Non-maleficence Justice The four pillars of clinical ethics  Pillar II: Beneficence: What is beneficence? In informal English: It is a term used to describe mercy, kindness, charity, etc. In medicine: it refers to any activity that benefits the person it is intended for when employed in medicine. In medicine, the doctor must also work to the patient's advantage; it is not enough to only prevent harm to others. What is benevolence? It is a propensity to act in others' best interests. APBI304 https://www.youtube.com/watch?v=481DviNjeVk Pillar II: Beneficence (cont.) Utilitarianism (recall lecture 1) is founded on the beneficence principle. There are two types of beneficence: 1. Positive beneficence: Is mainly about helping other people. 2. Utility: Requires that risks, costs, and rewards be balanced. APBI304  When is beneficence obligatory and when is it voluntary? The Parable of the Good Samaritan APBI304 Obligatory beneficence: Person X is obliged to help person Y when: 1. There is a chance that Person Y will lose or harm his or her life or other fundamental interests. 2. The activity of person X (alone or in collaboration with others) is crucial for avoiding the loss or damage to person Y's life or fundamental interests. 3. Person X's action may stop Person Y's life or essential interests from being harmed or lost. 4. Person X wouldn't experience any special issues or dangers as a result of the action. 5. Person Y will get advantages from person X’s behavior that would outweigh any risks or expenses they could incur. APBI304  Obligatory beneficence: Despite the fact that the Samaritan seems like he did a heroic act, The Parable of the Good Samaritan is a tale of obligatory beneficence (not voluntary beneficence). i.e. Stopping to help the dying man is an obligation, not a choice. What are the rules of obligatory beneficence? “1. Protect and defend the rights of others. 2. Prevent harm from occurring to others. 3. Remove conditions that will cause harm to others. 4. Help persons with disabilities. 5. Rescue persons in danger.” - Beauchamp and Childress, 1979 APBI304  The Tarasoff Case The psychologist informing the police about the murder intent is an act of ……………… APBI304 https://www.youtube.com/watch?v=sl4nTDFiyIE  McFall vs. Shimp case 1. Robert McFall’s was diagnosed with aplastic anemia, a fatal condition. 2. His bone marrow transplantation was advised by doctors in order to raise his chance of survival from 25% to 40%–60%. 3. Only his relative David Shimp agreed to Shimp McFall do a preliminary genetic compatibility test for the transplant, and it was successful. APBI304  McFall vs. Shimp case (cont.) 4. Shimp, however, declined to take a second compatibility test. 5. McFall filed a lawsuit against Shimp to compel him to perform the follow- up test and, if it came back positive, to contribute bone marrow. The judge determined that Shimp was not required by law to take the second test or give the bone marrow. But the judge also pointed out that Shimp was morally obliged to do the test and the donation! APBI304  McFall vs. Shimp case (cont.) Q: Was Shimp really morally obliged to do the second test and the donation as the judge had noted A: No Because 1) The procedure would not have provided considerable benefit to McFall (only an increase of probability of survival for 1 year from 20% to 40%-60%) 2) the procedure of bone marrow transplantation at the time of the case (1978) required 100-150 punctures in the pelvic bone, which can be painless under anesthesia. However, there was a risk of 1 in 10,000 death from anesthesia. Therefore, the risk that Shimp had to undergo was more than the benefit that McFall would receive. Nowadays, bone marrow transplantations are much simpler and more painless. APBI304  The issue of greater accessibility to experimental therapies You have a medication that is predicted to be a breast cancer cure. However, clinical studies for this medication are currently ongoing (an investigational drug). We are unsure of whether the side effects or issues are warranted by the level of safety or efficacy. Additionally, we are unsure if it is superior to current therapies. There are some female patients who desire to take the experimental medication but are not a part of the clinical studies. Q: Is Giving these female patients the experimental treatment obligatory beneficence or a non-obligatory moral ideal? APBI304 THANK YOU