Bioethics - Comprehensive Notes

INTRODUCTION AND BIOETHICS PRINCIPLES

• Bioethics: A discipline at the intersection of Humanistic Sciences (particularly Ethics) and Biological Sciences.
• Ethics: The study of morality using philosophical tools and methods. Known as moral philosophy, ethics delves into the meaning of moral concepts and evaluates moral judgments.
• Philosophy: Examines life's significant questions through critical reasoning, logical argument, and reflection.
• Descriptive Ethics: The scientific study of morality, investigating actual beliefs, behaviors, and practices that constitute people's moral experience.
• Ethics (Philosophical): Deals with life's questions.
• Descriptive ethics: Investigates real-life moral questions.

MAIN BRANCHES OF ETHICS

• Normative Ethics: Seeks and justifies moral standards (principles, rules, virtues, theories) to guide actions and judgments. Asks whether an action is right or a person is good.
• Metaethics: Studies the meaning and justification of basic moral beliefs.
• Applied Ethics: Uses moral norms and concepts to resolve practical moral issues, applying principles and theories to answer everyday moral questions.

BIOETHICS

• A subfield of ethics that addresses ethical questions such as:
  • The permissibility of abortion.
  • Justification for abortion based on prenatal genetic testing.
  • Selecting embryos based on sex or genetic characteristics.
  • The use of human embryos in medical research.
  • The prohibition of human cloning.
  • Truthfulness of healthcare professionals with patients.
  • Life-prolonging treatment for severely impaired newborns.
  • Physician-assisted suicide for terminally ill patients.

ORIGIN OF BIOETHICS

• Term coined in the United States by Van Rensselaer Potter, an oncologist who observed correlations between oncological diseases and environmental damage caused by humans.
• Potter proposed bioethics as a bridge between biology (study of the living) and ethics.
• Bioethics addresses scientific considerations through a dialogue between scientists and humanistic scholars.
• Important Contributions:
  • Aldo Leopold's "Land Ethics": Advocates for the Earth to be safeguarded and protected, not exploited.

BIOETHICS PRE-HISTORY

• Issues at the intersection of science and ethics were discussed before the term bioethics was coined.
  • Atomic bomb.
  • Human experimentation.
• The Nuremberg Code:
  • Resulted from the Nuremberg Trials after Nazi human experiments in concentration camps.
  • Established ethics committees to protect the rights, safety, and well-being of research participants.
  • Considered the first document of bioethics, regulating the principle of person consent to experimentation.

INPUT FROM THE CHURCH

• The rise of Bioethics received also an important input from Church in relation to emerging issues straddling science and ethics which involves also religious aspects, such as:
  • Introduction of the contraceptive pill.
  • Isolation of DNA by Friedrich Miescher.
  • First organ transplants.
  • Development of resuscitative medicine.
  • Introduction of dialysis.
  • Intensive care effectiveness.

TUSKEGEE STUDY

• From 1932 to 1972, the United States Public Health Service (PHS) and CDC conducted a study on nearly 400 African American men with syphilis.
• The men were not informed about the experiment's nature, and treatment was withheld even after advancements made it available.
• The result was over 100 deaths, 40 wives infected, and 19 children born with congenital syphilis. Violated ethical standards.
• The Belmont Report: Ethical principles and guidelines for research involving human subjects formed.
• Three core principles were: autonomy, beneficence, and justice.

DEFINITION OF BIOETHICS

• Warren Reich (1978): “The systematic study of the moral dimensions - including moral vision, conduct, and policies - of the life and health sciences, using various ethical methodologies and with an interdisciplinary approach”.
• It involves the moral study of life and health sciences including social and environmental health problems.

IMPORTANT AREAS OF BIOETHICS

• Clinical Bioethics: Ethical issues in clinical practice.
• Environmental Bioethics: Human-environment relationships.
• Animal Bioethics: Ethical considerations in animal research.
• Social Bioethics: Ethical issues involving vulnerable populations such as people with disabilities or prisoners.

THREE CENTRAL PRINCIPLES OF BIOETHICS

• Autonomy: Respect for a person's self-governance to make their own choices.
• Nonmaleficence: Avoid causing harm to others.
• Beneficence: Actively promote others' well-being and prevent harm.
• Justice: Fair distribution of resources and treatments.

AUTONOMY

• Respecting Autonomy: Autonomous individuals should be allowed to exercise self-determination.
• Restrictions: Not violating their ability to choose their own paths.
• Choices: Personal choices must be fully informed.
• Informed Consent: Patients should receive information to freely consent to or decline the treatment.
• Paternalism: Overriding a person’s actions for their own good.

NONMALEFICENCE

• Due Care to avoid harm:
  • Due care is expected by health professional.
  • Minimizing the harm or chance of harm is a due care of helath professionals.
• Avoiding Harm: Do not cause unnecessary injury or harm to those in our care.
• Violation: Intentional actions or recklessness that injures a patient. Professionals must exercise due care to minimize harm.

BENEFICENCE

• Actively promote the well-being of others and prevent or remove harm to them. Health professionals are obliged to help others.

JUSTICE

• Refers to people getting what is fair or what is their due.

LAWS, ETHICS AND MORALITY

• Laws: Societal rules or regulations related to welfare and safety, with penalties for non-compliance.
• Ethics: Relates to moral principles, guiding complex decisions without legal enforcement.

PHYSICIAN-PATIENT RELATIONSHIP: PATERNALISM AND PATIENT AUTONOMY

• Duties and Rights:
  • Healthcare provider's duty of beneficence: Use medical expertise to do good and avoid harm.
  • Patient's right: Skilled beneficence and respect for autonomous choices.
• Conflicts: Beneficence and autonomy can be conflicting.
• Foundations: Patient Autonomy is foundations for relationship between patient and physician.

PATIENT AUTONOMY

• Deliberation about options, freedom to choose, and act accordingly.
• Exercise autonomy in choices and actions, free from external pressure.
• The principle allows to exercise his capacity for self-determination.
• Informed Consent: To make choices regarding the treatment, medicine developed the doctrine of informed consent.

PATERNALISM

• Overriding actions or decision-making for someone's own good.
• Ancient Era: Hippocratic tradition; paternalistic, deciding unilaterally what is best for patients.
• First hyppocratic Oath referred to the principle of “do no harm”, the prohibition of euthanasiaand the prohibition of abortion.
• Modern Emphasis: Patient rights to know facts and make choices regarding medical treatment.

TWO DIFFERENT TYPES OF PATERNALISM

• Weak Paternalism: Directed at those with diminished autonomy (e.g., psychotic, severely retarded, extremely depressed, and acuely addicted).

• Strong Paternalism: Overriding actions or choices of someone substantially autonomous.

DEBATE REGARDING DOCTOR'S ROLE

• Can authorities assume that health and prolonged life must take absolute priority in the patient’s value orderings?
  • This point leaves open the question of whether health and life are of ultimate, or indeed any, intrinsic value, or whether they are valuable merely as means.
• Health as a necessary condition. The value of individual autonomy, together with life of a certain quality, were possible ways of taking precedence over the value of mere biological existence.
• The bioethical debate should include the concept of quality of life.
• The most fundamental right is the right to control the course of one’s life including decisions in life-or-death medical contexts.

FOUR MODELS OF PHYSICIAN-PATIENT INTERACTION

• Models emphasizing different understandings of:
  • The goals of the interaction.
  • Physician’s obligations.
  • The role of patient values.
  • Conception of patient autonomy.
  • The patient comes to know more clearly who he is and how the various medical options bear on his identity.
• Paternalistic Model (Parental or Priestly Model):
  • Ensuring patients receive the interventions that best promote their health and well-being.
  • The physician presents the patient with selected information that will encourage the patient to consent to the intervention the physician considers best.
  • The patient will be thankful for decisions made by the physician even if the patient would not agree initially with them.
    *Informative Model (Scientific, Engineering, or Consumer Model):
  • Physician provides the patient with all relevant information for the patient to select the medical interventions he or she wants.
  • Patient values are well defined and known.

*Interpretive Model:
* Elucidating the patient’s values and what he or she actually wants.
* The physician assists the patient in elucidating and articulating his or her values and in determining what medical interventions best realize the specified values.
*Philosophical bioethics, Policy-oriented bioethics, Cases analysis:

• The independent value of self-determination or freedom of choice plays a relevant role in expression of the dignity and inviolability of patient individuality.

*Deliberative Model:
* Helping the patient to determine and choose the best health-related values that can be realized in the clinical situation.
* Physician and patient engage in dialogue about what kind of health-related values the patient could and ultimately should pursue.

APPROPRIATE MODEL

• Under different clinical circumstances, different models may be appropriate.
• The ideal physician-patient relationship is the deliberative model.

INFORMED CONSENT

• Voluntary agreement to medical treatment or experimentation based on sufficient information.
• Ethical Ideal: Patients should have the ultimate say.
• Legal Requirement: A voluntary patient’s consent based on the information by physicians who have a duty to disclose information about the patient’s illness, the proposed treatment, its risks and benefits, and treatment alternatives.
  • Competence: the patient is competent to decide.
  • Adequacy: the patient gets an adequate disclosure of information.
  • Understanding: the patient understands the information.
  • Voluntariness: the patient decides about the treatment voluntarily.
  • Consent: the patient consents to the treatment.
• Persons who are incompetent cannot give informed consent, in which case the burden of decision-making falls to a surrogate.
• Requisites: The nature of the procedure, the risks of the procedure, the alternatives to the proposed procedure,
• Voluntarily: Is given voluntarily without any autonomony rob.
• Philosophical Bioethics: philosophical theory on ethical problems arising in clinical practice and biomedical research.
• Policy-oriented Bioethics: achieve an agreement between parties, to build policies, regulations, and laws.
• Cases Analysis.

INFORMED CONSENT IN ITALIAN LEGISLATION

• Historical Context:
  • silent revolution since its course has been slow and gradual.
  • the Welby and Englaro cases.
• Article 32 of the Italian Constitution: To establish the patient’s right to independently make choices regarding therapies.
• Advance Healthcare Directives (Living Will):
• Through advance healthcare directives, the moral autonomy of individuals is respected even in those conditions in which they cannot express their will, be it temporarily and permanently.
• Law no. 219/2017:
  • Reaffirms the principle of informed consent and establishes advance treatment provisions.

Articles of the Italian Constitution:

• Article 2: Recognizes and guarantees the inviolable rights of the person, both as an individual and in social groups where human personality is expressed.
• Article 13: Personal liberty is inviolable.
• Article 32: Concerns the right to health.

Articles of the Charter of Fundamental Rights of the European Union:

• Article 1: Human dignity is inviolable.
• Article 2 and 3: Concern the right to life and the right to the integrity of the person.

THE CONCEPT OF PERSON IN ITALIAN CONSTITUTION

• “human dignity” lacks real meaning and is vague.
• the state recognizes all the inviolable rights of the person.
• the notion of “subject” has a formal nature, a unifying center of the rights and duties.

CHARACTERISTICS OF HUMAN BEING

• A real human being who works, has a body, and has different social and economic conditions.
• The Constitution protects the rights of the person both as an individual and as a social being.
• Also considers the family and social relationships in which the patient is inserted.
• Each individual has its own set of values, and should be allowed to make choices based on it.
• Autonomy is the means through which lawgivers established respect for the person, respecting its specific individuality and its possibility of reaching its full potential.

LAW AND CARE RELATIONSHIP

• Enhancement of the care relationship in article 5 is highlighted.
• Shared care planning.
• The goal is to realize a patient-centered care in which individuals with complex medical and social needs may receive treatments in accordance with their values, needs, and preferences.
• In the case of chronic diseases or those characterized by an inevitable poor prognosis, ‘shared care planning can be carried out between the patient and the physician’.

ADVANCE DIRECTIVES (ADS)

• Prepared when the person is able to in the future when one loose the capacity for self-determination.
• Article 4 (paragraph 1) establishes that ‘every competent person can express his/her own will regarding health treatments, as well as consent or refusal with respect to diagnostic tests or therapeutic choices and to individual health treatments’.
  ADs should first acquire adequate medical information on the consequences of his/her choices’.

THE END-OF-LIFE AND ASSISTED SUICIDE ISSUES

• The right to die, a concept based on the opinion that human beings are entitled to end their life.
• Should be allowed to end their own life or undergo voluntary euthanasia in the context that they are not capable to continue living.

EUTHANASIA

• The practice of intentionally ending life to eliminate pain and suffering.
• Categorized in different ways, which include voluntary, non-voluntary, and involuntary:
  • Voluntary: Conducted with consent.
  • Non-voluntary: Conducted on a person who is unable to consent due to their current health condition.
  • Involuntary: When euthanasia is performed on a person who would be able to provide informed consent, but does not.

ASSISTED SUICIDE

• “Intentionally helping a person take their own life by providing drugs for self-administration, at that person’s voluntary and competent request”.
• Mentally capable patients are entitled to turn down any treatment, even life- sustaining ones. Obviously, withdrawing life support may take a long time to lead to death, especially in younger patients, thus causing considerable and lengthy suffering, palliative care notwithstanding.
• It is an extremely controversial dilemma, which entails a rift between the right to life as an indisposable value, and the right to end one’s pain and suffering by passing away in a dignified fashion.
• Article 579 of the Criminal code, anyone guilty of consensual homicide is indictable.
• Article 580 sanctions any person who deliberately indices others to commit suicide, or reinforces the suicidal purpose, or in any way facilitates the fulfilment of such a purpose.
• The Italian Constitutional Court requested to the Italian legislature to amend the Article deeming it unconstitutional in its current form.

Requirements for Physician-Assisted Suicide:

• be stricken with an incurable illness causing unbearable, relentless physical and emotional suffering.
• The patient needs to be mentally competent to make free, informed decisions. It is the duty of specialists to verify whether such requirements have been met in order to request physician-assisted suicide.
• Physicians have no professional obligations If faced with patients requests for treatments contrary to the law, professional ethics, or to good clinical practices.

MEDICALLY-ASSISTED PROCREATION (MAP)

• Law no. 40 was strongly promoted by the political majority of that period, which had the open support of the Catholic Church hierarchies.
• Article 1, para. 1 solemnly requires the protection of all “persons” involved in procreation, including the human embryo.
• The access to medically assisted procreation was allowed only for married or stable heterosexual couples who were sterile (Article 5), and only if it were not otherwise possible to remove the impediment to natural procreation (Article 4, para. 1).
• Article 4, para. 3, Law no. 40/2004 prohibited access to heterologous techniques for procreation: only the gametes of the couple were available for the assisted procreation.
• Article 14, para. 2, Law no. 40/2004 says about the obligation of the physician to provide the “single and contemporary implant of the embryos at the maximum of three”.
• The conservation of the embryos was permitted only in the case of force majeure due to the woman’ s health condition and was not allowed beyond the time needed for the implant (Article 14, paras. 1 and 2).
• The intervention of assisted procreation might be refused based on the will of either of the applicants, but only up to the moment of the fertilisation of the egg (Article 6, para. 3).
• Article 13 prohibits any embryonal experimentation (para. 1), only permitting clinical and experimental research for therapeutic and diagnostic purposes, only if there are no alternative methods (para. 2).
• These prohibitions are supported by criminal sanctions (para. 4).
• Lawmakers, in fact, have seen fit to highlight, through the adverb “medically”, the kind of care that should be provided to those who are seeking parenthood.
  *MAP constitutes a complex course of action that makes reproduction a real, informed and heart- felt choice, starting from fertilization and all its implications. Nothing related to MAP is random or natural.

THE LEGAL STATUS OF THE HUMAN EMBRYO

• Give the human embryo the rights and recognition they deserve.
• Recognizing the human embryo as entitled to hold rights as an individual would necessarily entail the autonomy of the protected asset, with regard to which the legal entity would be protected “as of itself”, not as a means or tool for the use of others.
• Art. 1 of Civil Code, however, makes the rights given by law to the human embryo subject to its birth.
• Indeed, in the Civil Code, it is provided that the unborn, if born, may hold the right to own property received by legitimate or testamentary inheritance (Art. 462 Civil Code) or by means of donation (Art. 784 Civil Code).
• Art. 1 Civil Code plays a prominent role in a series of issues involving much deliberation in jurisprudential and doctrinal reflections, together with second thoughts and contrasting results. On the one hand, the classification of the human embryo as an individual holding rights – acknowledged in Law No. 40 of 2004 - is connected to the recognition that the human embryo is a biological reality, the unitary focus of interests already emerging from the Civil Code; on the other hand, it is new because it does not make the child’s rights related to its birth.

THREE DIFFERENT CONDITIONS IN HUMANS (IN RELATION TO MAP)

• Human embryo is a human lives in every sense.
• human embryo is a subject.
• legal capacity of legal code in civil code.