Biotechnology Regulations Lecture 1

Biotechnology Regulations Course Information

• Course offered: Biotech 4BS3/Sept 6BS3
• Instructor: Dr. Rashid Abu-Ghazalah
• Instructor Email: [email protected]
• TA: Mr. Nicholas Damjanovic
• TA Email: [email protected]
• Office hours: Schedule meetings by email
• Course materials: Refer to the course outline and Avenue to Learn for dates, expectations, and deadlines

Topics in Biotechnology Regulations

• Topics to be covered include: Bioethics, Research & Development in Industry, Regulations (Canada, US, international), Documentation, Quality Systems, and Safety regulations.

Course Expectations

• Read the course outline.
• Attend online lectures.
• Healthy and respectful debates are expected during discussions (no right or wrong answers).
• Three assignments will be completed.
• One project will be submitted.
• One midterm exam.
• One final exam.

Ethics and Morals

• Ethics is derived from the Greek word "ethos" meaning custom or habit.
• Ethics is the study of principles in making moral decisions.
• Ethics deals with big questions using logic, reflection, and critical reasoning.
• Morals are internal and less likely to change over time, while ethics are external principles that can change over time.

Defining Ethics and Bioethics

• Ethics is the theory driving right and wrong, whereas morality is personal.
• Ethics is distinct from morality; one is theory the other is personal beliefs.
• Bioethics is specifically concerned with pertinent issues in modern times, such as research (including animal research), euthanasia, human cloning, genetic engineering, assisted reproduction, consent and the confidentiality of patients, life, and death.

What is Ethics?

• Major ethical doctrines/theories include: Altruism, Asceticism, Cognitivism, Consequentialism (Utilitarianism), Cynicism, Deontology (Kantian), Egoism, Epicureanism, Ethical Naturalism, Ethical Non-Naturalism, Ethical Subjectivism, Eudaimonism, Hedonism, Humanism, Individualism, Moral Absolutism, Moral Anti-Realism, Moral Nihilism, Moral Realism, Moral Relativism, Moral Skepticism, Moral Universalism, Non-cognitivism, Utilitarianism, and Virtue Ethics.
• Three main ways of making ethical decisions are consequentialism, utilitarianism, deontological, and virtue ethics.

Utilitarian Approach

• Developed by Jeremy Bentham and John Stuart Mill
• Focuses on producing the greatest good for the greatest number of people.
• The ends justify the means.
• Quantifies every outcome.
• Considers net benefits and costs to all stakeholders.
• Emphasizes consequences, not actions
• Quantitative approach to decision-making

Deontological Approach

• Derived from the Greek word "deon" meaning obligation or duty.
• Focuses on absolute principles that cannot be broken
• Developed primarily by Immanuel Kant
• Emphasis is on duty and the motives of the person performing the action, not the consequences.
• One absolute: The value of human life.

Virtue Ethics

• Originates from Aristotle.
• Focuses on the character traits of an individual rather than consequences.
• Focuses on moral agents.
• Emphasizes practical wisdom or common sense in decision-making.

Ethical Decision Making - Blending Approaches

• A mixture of the presented ethical approaches exists in many situations.
• Key objective: Gather information and consider the statistical probability of negative events, and their impacts.
• Respect other people's decisions.

Ethical Decision-Making - Examples

• Example 1: A hungry person stealing food is scrutinized using Utilitarian and Deontological approaches..
• Example 2: The firefighter chooses who to save. The question asks whether one life can be traded for another's.
• Example 3: A biotech company merger, where the CEO must decide whether or not to reveal potential issues to the larger company.
• Discussion, what do YOU think?
• Consider whether or not benefits outweigh the risks.

Moving Into Bioethics

• Bioethics is a subspecialty of ethics concerned with the implications of biological research and applications in medicine.
• The term was first coined in 1926, but the field emerged in the 1970s.
• Bioethics often considers social and moral aspects and potential outcomes resulting from the use of biological and medical technologies.
• The question is, should this be done instead of can this be done?

Why Bioethics?

• Rapid advancement in biomedical science.
• Perceived inadequacy of traditional ethics.
• Nuremberg war trials.
• Decreasing paternalism and deference.

Areas of Focus in Bioethics

• Access to medicines and healthcare devices.
• Genetically modified organisms.
• Assisted reproduction, human cloning, and the environment.
• End of life, organ trafficking, and protection of participants in therapeutic trials.

Ethics and Biotechnology

• Development of new technologies in biology and medicine.
• Questions concerning the need for guidelines and evaluation of existing policies.
• Debate on ethical issues even before development of specific technology.
• Historical examples such as the development of the smallpox vaccine and pre-clinical animal studies are discussed.
• Discussions of the need for public availability of clinical data for better access and clinical trial transparency.

Moral Principles of Bioethics

• Principlism: The use of principles that guide ethical decision-making.
• Includes autonomy, non-maleficence, beneficence, and justice.
• Drawbacks: These approaches are not always helpful in specific situations.

Principle: Autonomy

• Individuals have the right to make their own autonomous choices.
• Informed consent requires competence, disclosure of information, and recommendations.

Principle: Nonmaleficence

• Avoiding harm to others.
• Not subjecting patients to unnecessary risks.

Principle: Beneficence

• Doing good to others.
• Taking action to help others, rescue those in trouble, etc.

Principle: Justice

• Treating people fairly.

Moral Standing

• Addressing the question of who moral norms apply to.
• Identifying factors that determine a person (with a moral standing), humans including fetuses, adults, infants.

Defining Death

• Importance of defining death (complete loss of moral standing).
• Understanding different viewpoints and the concept of a person's moral standing.
• Defining death through the views of death: somatic, whole-brain, and higher-brain.

Explore the essential components of the Biotechnology Regulations course, including topics like bioethics, quality systems, and safety regulations. This course, led by Dr. Rashid Abu-Ghazalah, will emphasize practical applications through assignments, a project, and exams. Engage in respectful discussions while enhancing your understanding of regulations in the biotech field.