Biotechnology Regulations Overview
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What distinguishes ethics from morals?

  • Ethics is subjective while morals are objective.
  • Ethics is concerned only with laws, while morals are not.
  • Ethics is the theory driving right/wrong while morals are personal. (correct)
  • Ethics changes with public opinion while morals remain constant.
  • Public views of morals remain unchanged over time.

    False

    Ethics is often described as a _______-based discipline.

    dilemma

    Match the ethical issues with their appropriate descriptions:

    <p>Human cloning = The process of creating a genetically identical organism Genetic engineering = Manipulating an organism's DNA Assisted reproduction = Techniques to help individuals conceive Patient confidentiality = Keeping patient information private</p> Signup and view all the answers

    What is the primary focus of the deontological (Kantian) ethical approach?

    <p>Duty and obligations</p> Signup and view all the answers

    The deontological approach is flexible and considers the consequences of actions.

    <p>False</p> Signup and view all the answers

    Who primarily developed the deontological approach?

    <p>Immanuel Kant</p> Signup and view all the answers

    According to Kant, we should treat others as ends in themselves, and not as means to an ______.

    <p>end</p> Signup and view all the answers

    Match the ethical approaches with their characteristics:

    <p>Deontological = Focuses on duty and obligation Virtue Ethics = Emphasizes inherent character traits Consequentialism = Focuses on the outcomes of actions Utilitarianism = Promotes the greatest good for the greatest number</p> Signup and view all the answers

    What is the primary focus of Utilitarianism?

    <p>The outcomes of actions</p> Signup and view all the answers

    What is a major disadvantage of the deontological approach?

    <p>It is based on subjective opinions.</p> Signup and view all the answers

    Deontology emphasizes the outcomes of actions rather than the intentions behind them.

    <p>False</p> Signup and view all the answers

    Who developed the Utilitarian Approach in ethics?

    <p>Jeremy Bentham and John Stuart Mill</p> Signup and view all the answers

    What is an example of virtue ethics?

    <p>Giving your seat to someone who requires it on the bus</p> Signup and view all the answers

    The phrase 'the ends justify the means' is associated with __________.

    <p>Utilitarianism</p> Signup and view all the answers

    Virtue ethics is widely accepted and used in modern decision-making.

    <p>False</p> Signup and view all the answers

    Match the following ethical theories with their characteristics:

    <p>Consequentialism = Emphasizes outcomes and benefits Deontology = Focuses on duties and rules Virtue Ethics = Centers on moral character Utilitarianism = Greatest good for the greatest number</p> Signup and view all the answers

    What is a significant advantage of the Utilitarian Approach?

    <p>It provides a method for quantitative analysis</p> Signup and view all the answers

    Utilitarianism is considered a form of Deontological ethics.

    <p>False</p> Signup and view all the answers

    Name one disadvantage of the Utilitarian Approach.

    <p>Inability to predict the future</p> Signup and view all the answers

    Which definition of death is considered the traditional view?

    <p>Somatic/Circulatory death</p> Signup and view all the answers

    A fetus is considered to have moral standing due to possessing self-awareness.

    <p>False</p> Signup and view all the answers

    What happens to a person's moral standing at the point of death?

    <p>They lose full moral standing.</p> Signup and view all the answers

    The cessation of an integrated system must be __________ for a person to be considered dead.

    <p>irreversible</p> Signup and view all the answers

    Match the definitions of death with their descriptions:

    <p>Somatic death = Cessation of the cardio-pulmonary system Whole-brain death = Loss of all brain function Higher-brain death = Permanent loss of consciousness Functional death = Inability to perform life-supporting functions</p> Signup and view all the answers

    Which of the following is a principle of bioethics that focuses on not causing harm?

    <p>Nonmaleficence</p> Signup and view all the answers

    The principle of beneficence includes the action of preventing harm.

    <p>True</p> Signup and view all the answers

    What does the principle of justice advocate for?

    <p>Fair and equal treatment of individuals.</p> Signup and view all the answers

    Nonautonomous individuals include _____ and children.

    <p>infants</p> Signup and view all the answers

    Match the ethical principles to their definitions:

    <p>Nonmaleficence = Not causing harm to others Beneficence = The action of helping someone Justice = Treating people fairly and equally Autonomy = The capacity to make one's own decisions</p> Signup and view all the answers

    Which of the following defines moral standing?

    <p>The extent to which moral norms apply to an individual</p> Signup and view all the answers

    All humans have full moral standing regardless of their condition.

    <p>False</p> Signup and view all the answers

    What are the important components of being autonomous?

    <p>No external bias or pressure, capacity to make decisions, freedom, and being informed.</p> Signup and view all the answers

    What defines death according to the whole-brain definition?

    <p>When all brain functions cease irreversibly.</p> Signup and view all the answers

    The higher-brain definition of death is legally adopted in most jurisdictions.

    <p>False</p> Signup and view all the answers

    At what gestational age do proponents of the higher-brain definition believe full moral standing begins?

    <p>24 weeks</p> Signup and view all the answers

    The whole-brain death definition partakes in the law of the majority of __________.

    <p>countries</p> Signup and view all the answers

    Match the definitions of death with their characteristics:

    <p>Whole-Brain = All brain functions cease irreversibly Higher-Brain = Some brain functions remain, but no higher functions Somatic/Circulatory = Full pumping of blood occurs Neurological = Based on brain functions and reflexes</p> Signup and view all the answers

    Which definition suggests that full moral standing begins earlier in the development process?

    <p>Somatic/Circulatory death</p> Signup and view all the answers

    Manipulating sperm or eggs is considered less controversial than dealing with fetuses.

    <p>True</p> Signup and view all the answers

    What is one of the controversies surrounding the higher-brain definition of death?

    <p>What constitutes 'higher' functioning</p> Signup and view all the answers

    Study Notes

    Course Information

    • Course name: BIOTECH 4BS3/SEPT 6BS3: Biotechnology Regulations
    • Instructor: Dr. Rashid Abu-Ghazalah
    • Email: [email protected]
    • TA: Mr. Nicholas Damjanovic
    • Email: [email protected]
    • Office hours: Schedule a meeting by email.
    • Course materials: Consult the course outline and Avenue To Learn for course dates, expectations, and deadlines.

    Topics

    • Bioethics
    • Research & Development in Industry
    • Regulations (Canada, U.S., international)
    • Documentation
    • Quality Systems
    • Safety regulations

    Expectations

    • Read the course outline
    • Attend online lectures
    • During discussions, respectful debates are expected; no right or wrong answers.
    • Three assignments
    • One project
    • One midterm
    • One final exam (details to follow)

    Ethical Decision-Making

    • Utilitarian Approach: Developed by Jeremy Bentham and John Stuart Mill.
      • Focuses on the greatest good for the greatest number.
      • "The ends justify the means."
      • Values and quantifies everything.
    • Consequentialism: One route to making ethical decisions focusing on impact or outcome. Utilitarianism is a form of consequentialism.
    • Deontological Approach: Developed primarily by Immanuel Kant.
      • Focuses on absolute principles and duties (rules that cannot be broken).
      • The "means" are as important as the "ends."
      • Based on the motivation behind an action.
    • Virtue Ethics: Originated from Aristotle.
      • Focuses on character traits.
      • The decision-maker must have good character.

    What is Ethics?

    • Derived from the Greek word "ethos," meaning "custom" or "habit."
    • The philosophical study of principles in moral decision-making.
    • Considers life's "big" questions through logic, reflection, and critical reasoning.
    • A "dilemma-based discipline."
    • Differs from morals, as ethics is the theory driving right/wrong while morals are personal.

    Bioethics

    • A subspecialty of ethics specifically focused on biotechnology and biological research.
    • Examines the ethical, social, and potential outcomes of biological and medical technologies.
    • Includes important issues such as:
      • Research
      • Euthanasia
      • Human cloning
      • Genetic engineering
      • Assisted reproduction
      • Consent and confidentiality of patients
      • Life and death

    Ethical Decision-Making Examples

    • Example 1: Is stealing food morally acceptable?
      • Considerations: Desperate hunger; loaf of bread visible.
      • Utilitarian: Beneficial outcome outweighs minor cost to store..
      • Deontological: Wrong to steal.
    • Example 2: Whose life is more valuable?
      • Considerations: Firefighter arriving at scene of a car accident in a river; various victims with differing needs.
      • Utilitarian: Prioritize saving the most lives..
      • Deontological: Cannot cause harm to any life no matter the consequence.
    • Example 3: Full Disclosure vs. Profit
      • Considerations : Biotech merger with a larger company; CEO knowing risk to the technology being merged.
      • Utilitarianism : Benefit of a deal that saves the small company and the jobs.
      • Deontology : Obligation to disclose the truth.

    Moral Principles for Bioethics

    • Principlism: Use of established principles (autonomy, nonmaleficence, beneficence, justice) to support decision-making.
    • Autonomy: Individual's right to make choices.
    • Nonmaleficence: Avoid causing harm.
    • Beneficence: Do good.
    • Justice: Treat people fairly and equitably.

    Moral Standing

    • To whom moral norms apply?
    • Depends on the individual or entity.
    • Questions regarding moral standing for those who are not human, fetuses, or those lacking mental capacity.

    Defining Death

    • Somatic death : Cessation of all bodily functions.
    • Whole-brain death: Cessation of all brain functions is irreversible including the brainstem.
    • Higher-brain death: Irreversible cessation of higher brain function.

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    Description

    Explore the fundamentals of Biotechnology Regulations in this quiz. Covering topics like bioethics, industry research and development, and international safety regulations, this quiz aims to enhance your understanding of the regulatory landscape. Perfect for students enrolled in BIOTECH 4BS3/SEPT 6BS3.

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