Biotechnology Regulations Overview
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Questions and Answers

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 (B)

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 (D)</p> Signup and view all the answers

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

<p>False (B)</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 (D)</p> Signup and view all the answers

What is a major disadvantage of the deontological approach?

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

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

<p>False (B)</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 (B)</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 (D)</p> Signup and view all the answers

Utilitarianism is considered a form of Deontological ethics.

<p>False (B)</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 (C)</p> Signup and view all the answers

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

<p>False (B)</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 (B)</p> Signup and view all the answers

The principle of beneficence includes the action of preventing harm.

<p>True (A)</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 (A)</p> Signup and view all the answers

All humans have full moral standing regardless of their condition.

<p>False (B)</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. (D)</p> Signup and view all the answers

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

<p>False (B)</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 (A)</p> Signup and view all the answers

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

<p>True (A)</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

Flashcards

Ethics vs. Morality

Ethics is the theoretical study of right and wrong, while morality is individual beliefs about right and wrong.

Moral changes

Public perception of right and wrong can change. Even laws can be changed, as seen in the Roe v. Wade example.

Bioethics

The study of ethical issues in modern science and medicine.

Bioethics issues

Bioethics examines issues like research, assisted reproduction, euthanasia, cloning, and genetic engineering.

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Ethics research

Concerns about ethics in research, like patient consent and confidentiality.

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Utilitarianism

An ethical theory that focuses on maximizing overall happiness or well-being for the greatest number of people. It's a consequentialist approach, meaning the morality of an action is judged by its consequences.

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Consequentialism

An ethical system that judges the morality of an action based on its outcomes or consequences.

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Jeremy Bentham

A philosopher who helped develop utilitarianism.

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John Stuart Mill

A philosopher who further developed and refined utilitarianism.

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Greatest good for the greatest number

The central principle of utilitarianism; actions should aim to achieve the best outcome for the largest possible number of people.

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Stakeholders

Individuals or groups affected by a decision or action.

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Utilitarian Approach

An ethical decision-making process focusing on weighing benefits and costs to all stakeholders, ultimately aiming for the greatest overall good.

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Consequential Ethics

An ethical framework where the morality of an action depends entirely on its outcome.

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Moral Standing

The quality that makes an entity worthy of moral consideration, meaning they have rights and interests that deserve respect.

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Personhood

The state of being a person with full moral standing, often linked to self-awareness and rational thought.

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Somatic Death

The traditional view of death, defined by the irreversible cessation of an integrated system, primarily the cardio-pulmonary system.

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Whole-Brain Death

A definition of death based on the irreversible cessation of all brain functions, including the brainstem.

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Higher-Brain Death

A definition of death based on the irreversible cessation of higher brain functions, like consciousness and awareness, while the brainstem remains functional.

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When does moral standing begin?

The question of when a being gains the right to moral consideration and protection. This is particularly relevant in the context of abortion debates.

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Moral Standing and Gestational Age

The relationship between the development of a fetus and the concept of moral standing. Different views exist, with some placing moral standing at 24 weeks (liberal view) and others at 8-12 weeks (conservative view).

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Circulatory Death and Moral Standing

A view that places moral standing very early in pregnancy, potentially as early as the beginning of blood circulation. This is a very conservative view.

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Higher-Brain Death and Moral Standing (Liberal View)

This view places full moral standing at 24 weeks of gestation, suggesting that higher brain functions determine when a being has moral rights.

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What is autonomy in healthcare?

Autonomy in healthcare means having the ability to make your own decisions about your medical care, free from external influence or pressure. It involves being informed about your options, risks, and benefits, and having the capacity to understand and consent to treatment.

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What are some examples of nonautonomous individuals?

Nonautonomous individuals are those who lack the capacity to make their own healthcare decisions due to factors like drug addiction, serious mental illness, or being a child. They may need others to make decisions on their behalf.

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Nonmaleficence

The ethical principle of avoiding harm. This means not intentionally causing harm to others, either through acts of commission (doing something harmful) or omission (failing to do something beneficial).

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Beneficence

The ethical principle of doing good. It involves actively promoting well-being and helping others. This includes preventing harm, removing harm, and actively taking actions that improve another person's health or situation.

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Justice in healthcare

The ethical principle of treating people fairly and equitably in healthcare. This means distributing resources and benefits fairly, ensuring equal access to care, and avoiding discriminatory practices.

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What is the definition of a person?

The definition of a person can be complex. It goes beyond just being a human being and involves considering physical characteristics, mental capacities, and philosophical perspectives. This concept is essential in bioethics when discussing moral standing and the ethical treatment of individuals.

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Deontological Ethics Approach

An ethical approach that focuses on the morality of actions based on absolute principles and duties, regardless of their consequences.

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Kant's Golden Rule

Treat others as ends in themselves, not as means to an end. Respect their inherent worth and autonomy.

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Deontological Advantage

Provides clear and consistent ethical guidelines based on absolute principles.

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Deontological Disadvantage

Can be inflexible and fail to consider specific circumstances or potential consequences.

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Virtue Ethics

Emphasizes the character of the person making the decision, focusing on inherent traits like honesty and compassion.

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Virtue Ethics in Action

Giving your seat to someone in need on a bus is an example of virtue ethics.

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Virtue Ethics Disadvantage

Subjective and open to interpretation because different people may have differing ideas of what constitutes a virtuous character.

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Practical Wisdom in Virtue Ethics

Using common sense and judgment to make ethical decisions based on good character.

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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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