LECTURE 11: BIOETHICS

FALL 2022
Quality Assurance
 MORAL STANDARDS

• Being able to distinguish between right and wrong

• To make decisions based on that knowledge is considered
“having good morals”
• But there are some differences in people’s beliefs of right and
wrong…
• As a result, people have different morals than others
• Ethics is the study of moral standards and how they affect
conduct/behavior of individuals in society
 ETHICAL EXERCISE

• A family pulls up to the Grand Canyon in their car.

The parents get out to check out a refreshment stand
and lock the car doors, leaving three young children
asleep in the back seat. Brake not set, after they are
some distance away, the car slowly begins to roll
toward the cliff. You are the only one who notices. A
large man is standing close to where the car is
headed. You could push him in front of the car, which
would stop is rolling, but he would either be crushed
or pushed over the edge.
• What would you do?
 BIOETHICS – BIOTECHNOLOGY
WITH A CONSCIENCE
• Bioethics is the study of decision-making as it applies to moral
decisions that must be made due to emerging advances in biology,
medicine, and technology
• Many of the new biotechnologies can be controversial
• Force us to think about our personal feeling and beliefs and what is right
or wrong
• Recent controversial topics may include:
• Genetically modified foods
• Testing for genetic diseases or conditions
• Vaccines – COVID-19 currently
• Designer babies
• CRISPR technology can be used for the gene-editing of human
germlines
• Gene therapy can be used to deliver the desired genes directly into
cells
• Embryo research and harvesting stem cells
• Is an embryo a person? A potential person?
 BIOTECHNOLOGY RAISES MANY TYPES
OF QUESTIONS…
• Can this be done?
• Should this be done?
• How can it be done in the right?
• Where do we cross the line?
• Who decides what is right and wrong when it comes to scientific advances and
new biotechnologies?
• Who decides which testing, experimental techniques, or products should be
allowed and under what circumstances?
• Who makes public policy for scientific products, scientific productions, and
scientific information?
• Should decisions makers be individual citizens, scientists, religious groups,
government agencies, or nongovernmental organizations?
 BIOTECHNOLOGY REGULATIONS

• Biotechnology industry is heavily regulated

• Biotechnology products must be evaluated and examined before they are available
for use
• It takes 7-10 years of development and testing to bring a new biotechnology
product to the Canadian market
• Many different agencies provide regulatory guidelines
• To name a few… Health Canada, Environment Canada, Canadian Food Inspection
Agency (CFIA), Fisheries and Oceans Canada and Environment Canada, and Health
Canada's Pest Management Regulatory Agency are responsible for determining if
biotechnology products are safe for Canadians and their environment
 ETHICAL QUESTIONS CANNOT BE
TESTED…

• Cannot use scientific methodologies to find an answer to ethical questions

• The position one takes on an ethical issue are based on personal feelings,
values, and beliefs…
• You can learn more about a biotech product/technique/application but
determining whether is it moral, is not an objective decision with a clear right
or wrong…
• It is a subjective decision in which a wide range of positions can be argued…
HOW TO DEAL WITH BIOETHICS AS A
BIO-TECHNICIAN/RESEARCH
PERSONNEL

• Ensure accurate data collection

• Follow honest data reporting
• Follow safety rules and protocols - some possible areas where controversy
from the bioethical point might arise
• Scientific personnel should be capable in analyzing and examining situations
• Have specific strategies set for examining any bioethical issues
• Your research institute or biotechnology company may have already
developed and implemented policies about issues or ethical practices
• Typically developed by committees
• includes scientists, business personnel, regulatory staff all working
together to create these policies
• Ask about them!
 STRATEGY FOR VALUES CLARIFICATION

• Identify and understand the problem or issue. Learn as much as possible about
the issue.
• List all possible solutions to the issue.
• Identify the pros and cons of adopting each solution. Examine the
consequences of adopting one solution as opposed to another. Consider
financial, medical, personal, social, environmental, and legal aspects.
• Based on the pros and cons for each solution, rank all the solutions from best
to worst.
• Decide if the problem is important enough to take a position. If it is, decide
what your position is and be prepared to describe and defend it.
 GENETIC TESTING IN
MEDICINE

• Genetic testing is the analysis of DNA sequences in

order to learn if an individual has specific “genes of
interest” thought to cause inheritable diseases

• Genetic tests are used to diagnose diseases, to

identify increased risks of potential health problems,
and chose appropriate medical treatments

• Many types of genetic tests

• Diagnostic
• Prenatal
• Carrier testing
• Newborn screening
• Karotyping
 ETHICAL ISSUES RELATED TO
GENETIC TESTING

• Genetic discrimination
• Limiting access to genetic information so that so that
employers or insurers cannot discriminate against individuals
because of their genotypes
• The Genetic Information Non-discrimination Act (GINA)
prohibits health insurance companies from using genetic
information to make coverage or rate decisions (do not extend
to life insurance, disability insurance or long-term care
insurance)
• Canadian law now prohibits any person from requiring an
individual to undergo a genetic test or to disclose the existing
results of genetic tests
 ETHICAL ISSUES RELATED TO
GENETIC TESTING

• Diagnosis of one individual immediately reveals the risk

that other family members may be affected, based on the
rules of inheritance
• Should family members of a patient diagnosed with a
genetic condition, be informed of the test results and their
potential risk?
• What are the moral obligations of the patient and the
physician?
• Should the physician who has diagnosed the patient inform
the family of the disorder and recommend testing? What
about patient confidentiality?
 GENE THERAPY

• Gene therapy involves introducing, removing, or changing

genetic material to alter how a protein or group of proteins is
produced in a cell, to alleviate/treat or cure diseases that are
inherited/ genetic in origin

• Functional genes are used to replace or improve the function

of a defective gene to correct a medical condition

• Some barriers to gene therapy…

• How can expression of the therapeutic gene be controlled in the
patient?
• What happens if therapeutic genes are overexpressed or shuts off
after it has been introduced?
• How can scientists safely and efficiently target only the cells and
tissues that require the therapeutic gene without affecting other
cells in the body when the gene is not needed?
• How many cells must express the therapeutic gene to treat the
condition effectively?
 CHALLENGES FACING GENE THERAPY:
THE CASE OF JESSE GELSINGER

• 18-year-old Jesse Gelsinger had a genetic disease called ornithine transcarbamylase (OTC)
deficiency, which prevents the body from breaking down ammonia, a metabolic waste product
• The excessive buildup of ammonia, often causes death soon after birth,
• Patient’s diet is immediately adjusted and monitored throughout their entire life
• Gelsinger lived on a strict non-protein diet and controlled his liver disease
• Gelsinger volunteered as a subject for a gene therapy experiment (in which an adenovirus
vector carrying a normal OTC gene was injected into his liver) to help test the safety of this
treatment for newborns afflicted with OTC.
• After receiving the injection, he had a negative immune system reaction and four days later, he
died
• Issues? Informed consent and conflict of interest…
• Gelsinger was informed that previous subjects had received adenovirus without serious
complications… but this was not true!
• Reports began to emerge that past research subjects and experimental animals had become
sick from the vector
• Some of the scientists involved in this clinical trail, had a financial interest in the development
of the adenovirus vector being used in the OTC gene therapy trial.
 GENE EDITING

• The mechanism of CRISPR/Cas-9 genome editing can be

generally divided into three steps: recognition, cleavage, and
repair.
• The designed RNA directs Cas-9 and recognizes the target
sequence in the gene of interest through complementary base
pairing
• Cas9 enzyme cuts the DNA at the targeted location,
• Once the DNA is cut, researchers use the cell's own DNA
repair machinery to add or delete pieces of genetic material, or
to make changes to the DNA by replacing an existing segment
with a customized DNA sequence.
• Used to treat diseases including an eye disorder (Leber
congenital amaurosis) and a muscle disorder (spinal muscular
atrophy)
• Think about it… Should people be allowed to use gene
therapy or gene editing to enhance basic human traits
such as height, intelligence, or athletic ability?
 ETHICAL ISSUES RELATED TO COST OF
DRUGS AND TREATMENTS

• Some drugs and treatments are extremely expensive

• Insurances may not cover the cost of certain drugs and treatments
• Ex. tissue plasminogen activator, used to break up clots that cause heart
attacks and strokes
• Some individuals who require these drugs/treatment may not have access!
 INSULIN

• Sir Frederick G Banting, Charles H Best, and James B Collip

(The Canadian trio) who discovered insulin famously sold
their patents to UofT in 1923 for $1 each
• Banting famously said,“Insulin does not belong to me, it
belongs to the world.”
• In 2022, the price of insulin has dramatically increased in
many countries
 ETHIC AL CHALLENGES RELATED TO
THERAPEUTIC RECOMBINANT
PROTEINS/DRUGS

• Issues of safety and efficacy (effectiveness)

• Ethical concern of harming rather than helping
• Dose at which the drug is effective with minimal side effects and toxicity
• Poses any carcinogenic or teratogenic hazards

• Humane treatment of animals in preclinical studies

• How many experimental animals will be the minimum needed to test the drug?
• Tested in the appropriate species?
• Choice of species can affect the action of the drug… ex.Thalidomide was found safe
in rodents, but later found to cause birth defects
 GM CROPS

• GM crops and genetically modified plants present several areas of concern…

• Must determine whether the alteration in the plant’s genetics provides some
benefit?
• Whether species integrity is maintained along with the genetic alteration?
• Is creating a “better species” is more desirable then trying to maintain and ”old
species”?
• Possible effect of altered plants on the ecosystem and on overall biodiversity?
• Spread of GM plants in the natural environment or other other areas beyond
where they are cultivated?
• Effects on nontarget species?
• How will the crop be used? Is it safe to feed to animals? Is it safe for humans? What
are the possible effects of cross-pollination between GM crop to other non- GM
crop species?
• Transfer of engineered genes?
 GM CROPS

Insect resistance:
• Bacillus Thuringiensis (Bt) is a bacteria that produces a
protein called Bt Cry1AB delta endotoxin
• This protein is toxic to insects, when ingested causes
death
• Bt gene is genetically inserted from the bacteria into
plant cells
• It results in significant resistance and protection against
insect damage in plants and crops, improving yield
• This decreases the amount of pesticides sprayed on
crops, which results in less runoff into forests and
streams
• Ex. Bt Corn, Bt Soybeans, Bt Potatoes
• Off target effects? On monarch butterflies?
 PROS AND CONS OF GM FOODS

• What are potential benefits of GM• What are potential risks of GM

foods? foods?
• Resistance to pests and diseases improving • Long-term health effects? Safe for humans or
crop yield and quality animals?
• Grow more easily in some environments (ex. • Potential allergic reaction
dry soil)
• Biodiversity loss
• Enhance the flavour, freshness (shelf-life),
and/or the nutritional quality of the food • Non-target effects
• Less herbicides and pesticide use • Species integrity
• More efficient farming • Decreased soil fertility
• Production of medicines • Cross-pollination
• Effective measure to reduce starvation crisis • Overproduction
• May help to keep food prices lower • Spread of GM crops to neighbouring
environments
 WHAT DO YOU THINK ABOUT GM
FOODS?

• What do you think about the production of

GM foods?
• To eat or not to eat?
• Would you be likely to buy GM foods if they
were cheaper? More nutritious? Stayed fresh
longer? Used less pesticides than traditional
agriculture practices?
• Do you think GM foods should be labelled?
 TEST #3

• TEST #3 is worth 10% of your overall mark

• Will be held in-person Wednesday. Dec 14th, 2022, starting at 10:30 am in
room K219 (NOT THE SAME as the lecture room)
• You will 1 hour and 15 minutes to complete the test
• If you are late, you will not be given extra time
• The test will cover all material from lectures with a main focus on:
• LECTURE 9: Plant/Agricultural Biotechnology
• LECTURE 10: Medical Biotechnology
• LECTURE 11: Bioethics
• LECTURE 2: Basic Skill of the Biotechnology Workplace and
• LECTURE 5: Insight Into Genetic Engineering - Recombinant DNA In
Biotechnology
 TEST #3

• It will consist of 31 multiple choice questions, and 4-5 short answer questions
(worth 19 marks) and one bonus question (worth 1 mark).
• The test will be out of a total of 50 marks.
• You WILL NOT BE allowed any notes, materials, and textbooks during the test.
• You WILL NEED a Georgian College student ID card to complete your test.
No other form of ID will be accepted.