Module 3

Module 3: BIOETHICS
Dr Ashwathanarayana R
Department of Genetics
Dayanand Sagar University, Bangalore
BIOETHICS
MORALS ARE BASED ON YOUR OWN PERSONAL BELIEF OR
JUDGMENT
MORALS ARE BASED ON YOUR OWN PERSONAL
BELIEF OR JUDGMENT
ETHICS– STUDY OF MORALS & HOW THEY AFFECT
CONDUCT. ETHICS IS A REFLECTION OF MORALITY
BIOETHICS- APPLICATION OF MORAL PHILOSOPHY IN

THE BIOTECHNOLOGY FIELD [BIOTECH RESEARCH,
RIGHT WRONG
TESTING, MANUFACTURING & PRODUCTION]
BIOETHICS
What is ethics?
“the rules of conduct recognized in respect to a
particular class of human actions or a particular
group, culture”
Bioethics: “a field of study concerned with the
ethics and philosophical implications of certain
biological and medical procedures,
technologies, and treatments, such as organ
transplants, genetic engineering, and care of
the terminally ill”.
BIOETHICS
• The study of the ethical and moral implications of new biological discoveries
and biomedical advances, as in the fields of genetic engineering and drug
research.
• Philosophy addressing questions of morality, understanding, and examining
moral life.
• According to Van Rensselaer Potter bioethics means “Biology combined with
diverse humanistic knowledge forging a science that sets a system of medical
and environmental priorities for acceptable survival”.
• Bioethics is the philosophical study of the ethical controversies
brought about by advances in biology and medicine.
• Bioethicists are concerned with the ethical questions that arise in the
relationships among life sciences, biotechnology, medicine, politics,
law, philosophy, and theology.
1911 - 2001
BIOETHICS
A classic bioethical decision

• One heart available → who should get it?
17-year old girl 40-year-old 70-year-old
school principal woman
BIOETHICS
A classic bioethical decision
• One heart available → who should get it?

40-year-old 70-year-old
17-year old girl woman
school principal
BIOETHICS
• The Tragedy of the Commons By Garrett Hardin, Science, 1968
BIOETHICS
Ethics and science
• 1860’s - Scientific method in medicine, Gregor Mendel
• 1928 - Penicillin discovered – widely used WWII
• 1920’s - Lead in gasoline, lead in paint
• 1931 - 30 states had sterilization laws on books
• 1932 - Tuskegee syphilis study initiated
• 1947 - Nuremberg - The Doctors Trial
• 1952 - First open heart surgery & Chlorpromazine
• 1953- Structure of DNA – Watson & Crick
• 60’s - Thalidomide, mercury, chronic hemodialysis, amniocentesis, informed
consent, IRB’s
• 70’s - Hastings Center founded, bioethics defined, Tuskegee noticed
BIOETHICS
Ethics and science
• 1973 – Roe V. Wade Unrestricted access to abortion
• 1978- First Test Tube ever born
• 80’s - Recombinant microorganism could be patented, lead is harmful to
developing brain
• 90’s - molecular biology, sequencing of human genome (other species),
Jurassic Park
• 1996 - Dolly the sheep is the first Mammal ever cloned
• 2000’s - US stem cell research restricted
• 2003- Human Genome project complete
• ? - Human cloned?
BIOETHICS
Types of bioethics
• Clinical Ethics
Withdrawal and Withholding Life Support, Doctor-Patient Relationship
• Research Ethics
Stem Cells, Gene Therapy
• Animal Rights
Euthanasia, Chimeras, Xenotransplantation
• Environmental Ethics
Genetically Modified Food, Air Pollution
• Biotechnology
Brain-computer interface, Department of Defense, Bioterrorism
• Public Health
Newborn Screen Blood Banks, Vaccinations, FDA
BIOETHICS
Basic bioethics principle/ pillars
There are seven pillars of bioethical decision making in healthcare.
These are:
1. Autonomy/Freedom/Dignity/ Respect - for people’s rights
2. Veracity- The duty to tell the truth, Truth-telling, honesty.
3. Privacy/Confidentiality- Respecting privileged knowledge.
Respecting the “self” of others
4. Beneficence- an act of charity or kindness, must be proportionate
to risks
5. Nonmaleficence- Do no harm- Experiment must stop if causes
harm
6. Fidelity- Strict observance of promises or duties
7. Justice- even distribution of benefits and risks throughout society
BIOETHICS
Basic bioethics principle
• Autonomy/Freedom/Dignity/
Respect:
• Greek:
❖autos “self” and
❖nomos “rule,” governance,” or “law”
• Self-rule that is free from both controlling
interference by others and from certain
limitations such as an inadequate
understanding that prevents meaningful
choice
(Beauchamp and Childress)
BIOETHICS
RESPECT:
• Autonomy/Freedom/Dignity/
Respect :
• the ability to make your own decisions. The
patient has the right to determine what can or
cannot happen during treatment by making an
informed, uncoerced decision (consent).
• The right to participate in and decide on a course
of action without undue influence.
• Self-Determination: which is the freedom to act
independently. Individual actions are directed
toward goals that are exclusively one’s own.
BIOETHICS
RESPECT:
• Veracity:
• The power of conveying or
perceiving truth
• Adherence to the truth; truthfulness.
• Habitual truthfulness; honesty
• Correctness and carefulness in one's
plan of action
• An established or verified fact, principle,
etc.
BIOETHICS
RESPECT:
• Privacy/Confidentiality:
• Respecting privileged knowledge. Respecting the
“self” of others.
• the state of keeping or being kept secret or private.
• Confidentiality is that practice which helps to
keep secret all information deemed desirable to
keep secret. The maintenance of secrecy refers to
the unrevealing of any data concerning the
company's business or technical processes that are
not already in public knowledge.
BIOETHICS
NONMALEFICENCE
• An obligation to not inflict harm on others
• First do no harm. “do no harm”. A healthcare
professional must not harm the patient.
• Distinct from Beneficence
• Obligations not to harm (rob or kill)

• Obligations to help others (rescue a drowning child)
• Withholding and withdrawing life-sustaining treatment
• Intended effects and merely foreseen effects

BIOETHICS
BENEFICENCE
• Providing a benefit to another
• Principle of beneficence: a moral obligation to act for the benefit
of others
• Protect and defend rights of others
• Help persons with disabilities
• Rescue persons in danger
• an act of charity or kindness. A healthcare professional must act for
the benefit of the patient with no other motives.
• The principle and obligation of doing good and avoiding harm.
• This principle counsels a provider to relate to clients in a way that will
always be in the best interest of the client, rather than the provider.
BIOETHICS
FIDELITY-
• Strict observance of promises or duties.
• faithfulness to a person, cause, or belief,
demonstrated by continuing loyalty and
support.
• the degree of exactness with which something
is copied or reproduced.
• fidelity, allegiance, fealty, loyalty, devotion,
piety mean faithfulness to something to which
one is bound by pledge or duty. fidelity implies
strict and continuing faithfulness to an
obligation, trust, or duty
BIOETHICS
JUSTICE
• Providing fairness in healthcare decisions. A healthcare
professional must treat all individuals equally with an
equitable distribution of resources.
• Fair and just distribution of social burdens, benefits,
opportunities and allocation of positions
• Justice and Distributive Justice: fair, equitable and
appropriate distribution determined by social norms
❖ Access to Health Care
❖ Selection of Research subject population

BIOETHICS
JUSTICE
• The principle that deals with fairness, equity and
equality and provides for an individual to claim that to
which they are entitled.
➢ Comparative Justice: Making a decision based on
criteria and outcomes. i.e.: How to determine who
qualifies for one available kidney. 55 year old male
with three children versus a 13 old girl.
➢ Noncomparative Justice: i.e.: a method of
distributing needed kidneys using a lottery system.
BIOETHICS
• Bioethical topics include cryonics, which is when a person is
frozen in hopes of being revived and cured from an illness or to
simply be brought back to life
• “Plastic” surgery or cosmetic surgery: Surgery that is not
medically necessary is also a bioethical topic. This is done in the
form of rhinoplasty (nose jobs), breast enhancement, and
liposuction to name a few
• Stem cell research: Stem cells are naturally occurring in the
human body. They repair and revive other cells to replace dead
tissue, and can divide to take the place of cells that have specific
functions. Stem cells can be used to repair a multitude of
problems and have been used by scientists to help with the
effects of, Alzheimer’s, Heart disease, Spinal cord injuries
BIOETHICS
•What is cloning?
•Asexual reproduction
•Examples?
•Bacteria, fungus
•Plants-cutting – potato
•Farm animals
1997 - 2003
BIOETHICS
IVF – In Vitro Fertilization
• Baby conceived in a test tube and implanted in a Uterus
• Available since 1986
• About 100,000 IVF kids in U.S.
• Often creates extra embryos some would like to use for Stem
Cell research.
• U.S. - About 400,000 frozen embryos (unregulated)
• England – 52,000 (regulated by government).
Should a mother be legally liable for drinking or doing drugs while

pregnant? This of course would cause harm to their unborn child.
BIOETHICS
Reproductive Technologies
Challenges:
Potential:
• Commodification of life
• Assist infertile
couples in having • Legal issues/problems
children • Racism
• Address causes of • Economic inequality
infertility • Abuse
• Confusion family roles
(traditional family)
• Ethical concerns: scarce med.
resources, selfish motives,
eugenics
BIOETHICS
Reproductive Technologies
BIOETHICS
Face transplants
• Potential: • Challenges:
• Assisting severely injured • Donor concerns
persons • Family concerns
• Addressing psychological • Legal concerns
concerns • Descrimination
• Giving people a chance at
a normal life
BIOETHICS
Stem Cell Research

Importance:
➢ ‘Blank cells’ (unspecialized)
➢ Capable of dividing and renewing
themselves for long periods of time
(proliferation and renewal)
➢ Have the potential to give rise to
specialized cell types (differentiation)
BIOETHICS
Stem Cell Research

Ethical Debate:
• Destruction of human embryos
• Creation of chimeras (animals with human cells and organs
• Destruction of frozen embryos not being used
Ethical Guidelines:
1) Do not let chimeric animals mate (could lead to conceiving a
human being)
2) Do not allow human stem cells to become a part of animal’s
brain or injected into other primates
3) Embryos should not be allowed to develop more than 14
days
BIOETHICS
Human Cloning
Two types of cloning:
A) Therapeutic: Cloning for
medical purposes. Cloning
tissues. Allowed and legal in
U.S.
B) Reproductive: Cloning to Ethical Issues:
create a duplicate human 1) Cloning human beings
being. Condemned and illegal 2) Playing God
in the U.S. 3) Moral and legal status of clones
4) Abnormalities in perfecting the procedure
5) Aesthetic concerns (moral revulsion,
abomination, “yuck factor”)
BIOETHICS
Genetic Engineering
Benefits: Ethical Issues:
• Address genetic abnormalities 1) Designer babies and Eugenics
• Cure diseases 2) Gene Therapy may undermine free
• Tailor medicine and diet to will and autonomy (turning off
specific individual needs certain genes that determine
• Locate genes that cause various behavior; “religious gene” or “gay
diseases, conditions and traits gene”)
3) Experimentation: (1) Are desperate
individuals giving their true consent?
2) Abuse
4) Upsetting the balance in nature
BIOETHICS
Genetic Modification of Food and animal

BIOETHICS
Genetic Modification of Food and animal

Ethical Concerns:
• Weighing benefits & risks:
❑ Benefits: Longer healthier lives
❑ Risks: Unknown risks
• Interfering with nature
• Animals can be modified to include pharmaceuticals in their
milk
• Genetic manipulation in order to harvest organs (pigs and
heart valves)
• Cloned animals in food supply
BIOETHICS
Xenotransplantation
Pros: Cons:
• Reduces organ • Animals are GE
demand • Animals destroyed for
• Replacement of the harvesting
heart, lungs, liver, & • Rejection of organs by
kidneys human immune
• Biochemical profile of system as foreign
pigs & human are • Retro viruses
similar • Viral infections
• Genetic similarities • Human must refrain
with primates from procreating
BIOETHICS
Genetic Screening
Ethical Concerns:
• Privacy
– People have a right to privacy
• Public access to records
– Who should have access to your
personal medical records?
– Data Banks
• Conflicts of Interest (Employment,
Insurance)
• Genetic Discrimination
– Discriminating people based on
condition and predisposition
– Genetic Profiling
BIOETHICS
Legal impact of biotechnology
• There has been a lot of controversy regarding GMOs or Genetically Modified
Organisms with respect to our food which we eat and also the farming patterns that
we have adopted.
• Legal aspects are those concerning the protections that law or regulations should
provide.
• The globalization of biotechnology brings not only new economics prospects but
also new risk.
• According to cautionary principle these risks could be avoided by implementing

appropriate technology structuring.
• Law appears to be the right way to structure and organize technological actions. It
would be desirable to research and compare the rights of genetic engineering in
different countries as well as international regulations.
BIOETHICS
Steps taken by the Indian Government
• The Indian government has entered into a number of biotechnology cooperation
agreements with various countries in an effort to foster additional growth in this
sector.
• Karnataka, Tamil Nadu, Andhra Pradesh, Maharashtra have taken out their specific
policies to boost the biotechnology sector in their respective areas.
• Key step taken by the state governments includes
❖ Announcing separate biotechnology policy for their states.
❖ Setting up of task forces with experts to guide them on policy issues, setting up
of exclusive biotechnology parks with agriculture and health biotechnology as
key areas.
BIOETHICS
Biotechnology Laws in India
• Recombinant DNA safety guidance 1990, were released by DBT and these
guidance were further revised in 1994.
• The revised guidance are in respect of safety measure for the research activates,
large scale use and also the environmental impact during field applications of
genetically altered material.
• Further research in transgenic plants and Guidelines for toxicity and allergenicity
evaluation of transgenic seeds and plant part 1998” mainly there to check the toxic
by-products from GMO crops and seeds.
• IBSC- Institutional biosafety committee- nodal point of interaction with a
commercial organization/ applicant company involved in r DNA research for the
implementation of rDNA guidelines.
• GEAC- Genetic Engineering Approval Committee- In case of large scale filed trials,
deregulation and commercialization permission GEAC is constituted under Ministry
of Environment, Forest and Climate Change.
BIOETHICS
Biotechnology Laws in India
• Import and shipment of Transgenic Materials: All imports of seeds and planting
materials etc. will be allowed freely subjected EXIM policy guidelines and the
requirements of the plants, fruits and seeds. (Regulations of import in India- 1989)
shall required permission granted by the plant protection advisor, Government of
India.
• Commercialization of GM/ Transgenic crops in India: Transgenic crops/ varities
are tested to determine their agronomic value for at least two seasons under the
All India Coordinate project trials of ICAR in coordination with the tests for
environment and biosafety clearance as per EPA before any variety is
commercially released in the market.
BIOETHICS
Socioeconomic impact of biotechnology
1. It can improve health and reduce hunger simultaneously-
Biotechnology has helped to improve the nutritional content of
our food supply. Necessary vitamins and minerals can be
produced in croplands and this reduces health issues that are
related to a lack of nutrients. At the same time, biotechnology
also improves cropland yields and nutritional density, so people
can eat less and still receive the same nutritional values. That
allows more people to have the food they need.
2. It creates flexibility within the food chain- Biotechnology can
also help croplands be able to produce foods that may not be
possible under “regular” conditions. Using concepts from this
field of study, it is possible to grow crops in the desert. It is
possible to create crops that are naturally resistant to pests.
Although the amount of land our planet can provide is finite,
biotechnology allows us to be able to use more of it for what we
need.
BIOETHICS
3. It offers medical advancement opportunities.
Biotechnology allows us to look within just as easily as we can
look to the outside world for advancement. Studies that involve
the human genome have allowed us to understand more about
genetic diseases and some cancers, creating more effective
treatments for them – and sometimes cures. It has allowed us
to explore the reasons behind certain birth defects to
understand the importance of folic acid. That makes it possible
to extend average human lifespans.
4. It allows us to preserve resources: Biotechnology gives us
an opportunity to extend the lifespan of our food supplies.
Practices that include salting foods to preserve them date back
beyond Biblical times. Freezing and drying foods as methods of
preservation have been known for centuries. Pasteur pioneered
an approach of heating food products to remove harmful
elements so they can be preserved for an extended period.
BIOETHICS
BIOETHICS
5. It helps us minimize or eliminate waste products: According
to National Geographic, the footprint that humanity leaves on
our planet from waste is quite extensive. Biotechnology allows
us to create waste products that have better biodegradable
properties. It allows us to manage landfills more effectively.
That way we can begin to minimize the footprint being left for
future generations.
6. It can reduce infectious disease rates: Biotechnology has
helped us to create vaccines. It has helped us be able to create
treatments that reduce difficult symptoms of disease. It has
even helped us to learn how infectious diseases can be
transmitted so their transmission can be reduced. That allows
us to protect those who are most vulnerable to these diseases,
giving them a chance to live a happy, fulfilling life.
BIOETHICS
7. It reduces the consumption of pesticides: Studies from
different countries show that transgenic Bacillus thuringiensis
(Bt) crops can reduce chemical pesticide use with positive
economic, environmental, and health effects. They help in
controlling soil pollution as the use of synthetic pesticides is
reduced. Bt crops help in protecting beneficial insects. It can
easily feed an increasing population due to increased yields in
a short time.
8. It increases the economic status of the farmers in
developing and poor countries: Because of less using of
pesticides due to BT gene integration, because of less water is
needed to grow this plant due to integration of drought
resistance genes the cost of the production is reduced. Growing
the BT related crops over the time increases the economic
status of the farmers in developing and poor countries.
BIOETHICS
Some issues in biotechnology
ethical issues
legal issues
social issues
economic issues
environmental issues
BIOETHICS
Genetically modified food:
Any food or food ingredient that comes from
genetically modified organisms (GMOs)
1 Safety issues GM tomatoes with
• long-term effects on human health? longer shelf life
• new genes or their products cause allergies?

• transfer of antibiotic resistance genes
produces ‘superbugs’?
BIOETHICS
2 Ethical issues
• is it playing God?
• should vegetarians eat GM plants that
contain animal genes?
3. Social and economic issues
• Increases the dependence of food supply
on developed countries and affects the
living of farmers in developing countries
BIOETHICS
• In 1994, genetically modified tomatoes hit the
market in the US as the first commercially
available genetically modified crop. GM
tomatoes have since disappeared.
• Tomatoes were the first genetically modified
foods to come on the market. Today, they are no
longer cultivated.
• Puree made from GM tomatoes was once a
success in Great Britain. The EU Member States,
however, could not agree on approval.
BIOETHICS
4 Environmental issues
• GMOs may replace the wild types,
reduce biodiversity, or upset the ecological
balance.
• produces ‘superweeds’
• speeds up the evolution of resistant
population of pests
BIOETHICS
• Could insect resistance arise in with
BT corn? YES
• A refuge is an area of non-Bt corn
that has been planted to produce
susceptible insects that can mate
with any resistant insects that
emerge from the Bt crop. An
essential aspect of the refuge is that
you want to produce insects from this
BIOETHICS
• Could insect resistance arise in with BT corn? YES
BIOETHICS
• Could insect resistance arise in with BT corn? YES
Insects that feed on the Bt-enhanced plants are continuously exposed to the lethal Bt toxin,
not intermittently exposed, as when Bt is sprayed. The plants kill most of the insects, but a
few bugs will survive because of random mutations that make them resistant. They'll not
only survive, but they'll gain a reproductive edge, breeding with each other to create strains
of Bt-resistant bugs that could dominate an area.
To forestall this catastrophe, farmers create "refuges" -- fields planted with the original,
non-Bt-modified crops. In these refuges the pests' reproduction will be free of the selection
pressures favoring resistant mutants. The few Bt-immune individuals will be
overwhelmed by the wild-type, Bt-susceptible insects. And when the resistant bugs mate
with the wild-type individuals, their offspring will be vulnerable to the Bt toxin.
BIOETHICS
Cloning: lack of genetic variations
1 Ethical issues
• low success rate
death of embryos justified?
100
implantation
% survival
50
2 Economic issues
•worth investing the money?
0 2 4 6 8 10 12 14 16 18
day of pregnancy
BIOETHICS
• clones of endangered animals will still have no place to live
• spend money on habitat conservation instead?
• clones are ‘unnatural’ ‘sub-humans’?
• relation of the clone with the nucleus
donor and the donor’s family?
• could the clone experience his/her own
life?
• cloning lowers the value of life?
BIOETHICS
1 Ethical issues
• Human reproductive cloning for “Risk of abuse”
• what happens if rich people use the technology to produce
servants?
• what happens if Adolf
Hitler clones himself?
• what happens if someone
allows only the ‘best’
people to be cloned?
BIOETHICS
Human Genome Project:
1 Ethical issues
• diagnosis of a genetic disease before available treatment causes
anxiety?
I’m sorry.
There is no
Oh no. cure for the
disease.
BIOETHICS
2 Legal issues
• who can own or gain access to personal genetic information?
• how can we prevent discrimination against people with
particular genotypes and misuse of genetic information?
• how can we prevent This man has a high risk
discrimination against of developing a fatal
genetic disease.
people with particular
genotypes and misuse We’d better refuse
his insurance
of genetic information? application.
BIOETHICS
2 Legal issues
• can the presence of a certain gene be used as evidence to prove
someone guilty or innocent?
My client didn’t do it.
His gene did it.
BIOETHICS
3 Social issues
• how is the public perception of an individual affected by his/her
genetic information? Go! He has a gene
related to violence.
4 Social issues
• can the same benefits be obtained
from less expensive alternatives?
BIOETHICS May I change my
Some issues in biotechnology eye colour using
gene therapy?
Gene therapy:
1 Ethical issues
• when should gene therapy be used?
• acceptable for genetic enhancement?
• is it playing God?
• causes unforeseeable harmful effects on future generations?
BIOETHICS
Gene therapy:
1 Ethical issues
• Is it right to replace a 'defective' gene with a 'normal' one?
• Is the answer the same for a gene which causes the bearer pain, as it is where the gene
has a merely cosmetic effect?
• Who decides what is 'defective' and what is 'normal'? A 'defective' gene may actually
confer some other advantage, e.g. sickled RBC gene.
• Is there a danger that we shall in time reduce the variety so essential to evolution, by the
progressive removal of unwanted genes or, by combining genes from different species,
are we actually increasing variety and favouring evolution?
• Where a gene probe detects a fatal abnormality, what criteria, if any, should be applied
before deciding whether to carry out an abortion?
BIOETHICS
Gene therapy:
2 Legal issues
• how can we obtain informed consent from
seriously ill patients or embryos?
• how can we prevent misuse of gene therapy to produce a ‘perfect’
human race-- Eugenics?
3 Social issues • widens the social class gap?
4 Economic issues
• right to invest a large sum of money for the benefit of a few
patients? any alternatives?
BIOETHICS
Stem cell therapy:
1 Ethical issues
• human embryos are destroyed to obtain embryonic stem cells
2 Legal issues
• how can we ensure that the technique would not be used in
human reproductive cloning?
3 Social issues
• the public become used to the destruction of human life?
BIOETHICS
Public education of the process of biotechnology involved in
generating new forms of life for informed decision making
• There is an increasing trend for multilateral environmental agreements to
contain provisions on public participation, which place the responsibility
on governments to engage in awareness raising and participation activities.
The rationale is that public involvement is critical to the effectiveness of
any regulatory framework. Some relevant examples from the multilateral
arena, which enshrine public participation.
• Rio Declaration on Environment and Development (UNCED 1992) states
Principle 10 thus clearly links environmental issues with public
participation. The key elements are appropriate access to information,
facilitating awareness and participation in decision-making processes, and
access to judicial and administrative proceedings.
BIOETHICS
• The Cartagena Protocol on Biosafety (Secretariat of the Convention on Biological
Diversity 2000) places a clear obligation in Article 23 on Parties to
promote and facilitate public awareness, education and participation,
including access to information, and also requires mandatory public
consultation and disclosure of results of decisions to the public in the
decisionmaking process.
• Public awareness plays a crucial role in ensuring informed policy and
decisions. However, ‘public awareness’ may be misused as a code for
public education about the benefits and safety of GMOs. In this respect,
proponents of the technology see participation as a key to ensuring that a
skeptical and worried public accepts the technology
BIOETHICS
• One purpose of public participation is to increase the awareness of the
public and the regulators. Such increased awareness increases the ability
to identify relevant social and ecological changes. An awareness and sense
of the known issues, questions and concerns related to biosafety in a
country helps participants to identify the knowledge they have that is
relevant, and thus to inform policy.
• Public participation and public awareness are thus intrinsically linked.
Participation is impossible without information being shared and accessed
effectively. On the other hand, sharing information and raising awareness
invites participation because it enables the public to consider issues and
form opinions on them.
BIOETHICS
• Public participation is relevant throughout all stages of assessment and
regulation of genetic engineering and GMOs. This includes participation in
national policy discussions, in the development, implementation and review
of national biosafety frameworks (NBFs), policies and laws, in evaluation
of risk assessments and specific applications, and in monitoring processes.
• The identification of problems, needs, priorities, and options in relation to
the sustainable use of biodiversity is critical at an early stage of any
discussion about GMOs and biosafety. Public participation is important at
this stage, as the use of biodiversity needs to be socially as well as
environmentally sustainable, for example, in relation to food security,
cultural integrity and poverty reduction.
BIOETHICS
• A wider public debate on the role of genetic engineering and on what
alternatives and options are available for a country is also needed. While,
for example, the Cartagena Protocol on Biosafety’s framework on public
participation may be limited. once participatory exercises on biosafety are
initiated, wider socio-economic, ethical and moral issues are invariably
raised.
• Processes that are unresponsive to such public demands for a more broadly
defined approach to regulation are likely to lack credibility and legitimacy
Such a broadly defined approach is needs-driven, rather than technology-
driven.
BIOETHICS
• Public participation is also crucial in the development, implementation and
review of national biosafety frameworks (NBFs,) policies and laws. However, it
is not just a matter of inviting the public to participate once an NBF has been
developed. What is needed is also public input into the determination of the
proper scope of an NBF. Questions such as what should be addressed within the
NBF and who gets to frame the framework all need to link with the relation to
society’s needs, problems, priorities, and options.
• For instance, public participation in monitoring can help local people to work
with policy makers to decide how changes should be monitored (for example, in
helping to design and adapt methodology, in collecting and analyzing data), what
criteria should be used, and how results should be acted upon
BIOETHICS
Participation in monitoring: Bt cotton in Andhra Pradesh, India as a case
study
• Three varieties of Bt cotton were commercially planted for the first time in
2002 in central and southern India. From the first year of planting, there
were conflicting reports as to what benefits or otherwise were associated
with Bt cotton. In such situations, it is clear that local level information and
knowledge are needed, based on farmers’ actual experiences. Participation
in monitoring can help shed light on what may be a confusing situation, as
it provides an opportunity for those directly affected to make their
experiences known.
BIOETHICS
study
• The Deccan Development Society (DDS) and the Andhra Pradesh Coalition
in Defence of Diversity (APCIDD), a coalition of over 140 civil society
groups in Andhra Pradesh, began monitoring Bt cotton, focusing
particularly on the cotton district of Warangal. The aim was to assess the
performance of Bt cotton vis-à-vis the claims made of increased yield,
reduced pesticides use and higher profits, and to make the experiences
available for public debate.
BIOETHICS
study
• The study involved all the stakeholders in the district – farmers who
cultivated Bt and non-Bt cotton, cotton scientists, officials of the State
agriculture department and the agricultural market committee, and the
manager of a ginning factory. Data collectors were village-based grass-roots
researchers from eleven local NGOs, who stayed continuously with farmers
and farming communities to record changing perceptions on Bt cotton
throughout the growing season. The focus was on small farmers who farm
under rain-fed conditions.
BIOETHICS
study
• The three-year study was carried out over each growing season, with
interviews conducted with farmers every two weeks (Qayum & Sakkhari
2005). Focus group discussions were also carried out. There was fortnightly
recording of data on field operations, use of fertilizers and pesticides, and
status of crop and pest damage, while scientists regularly visited the fields to
verify data collection. Participatory video was used by the DDS Community
Media Trust, a rural women’s media collective. The women, themselves poor
and marginal farmers, filmed and interviewed farmers, documenting changes
and analyzing the reasons for these changes with the farmers
BIOETHICS
study
• The methodology used over the three years was broadly the same, but with some
modifications made on the basis of experience, and to focus the study more specifically
on the experiences of small farmers. The needs and priorities of poor and marginal small
farmers were very much related in economic terms, so the main indicators used were
economic in nature and related to yield (and hence profit), costs (of seed, pesticides,
irrigation, etc.), pesticide reduction (because pesticides are expensive inputs), and net
income.
• The study obtained results showing that non-Bt cotton yielded less than Bt cotton,
incurred less expense. There was, significant reduction in pesticide use for Bt cotton
farmers, compared to non-Bt cotton farmers. As a result of the higher yields with Bt
cotton, earned 60% more on average than non-Bt cotton farmers.
BIOETHICS
Ethical concerns of biotechnology research and innovation.
• During the course of technological maturity, various technologies often challenge
existing ethical and regulatory norms, primarily due to their novelty.
Biotechnology is one of them.
• It is difficult to regulate the technology at this stage because their broader
implications on health, the environment, and national security are yet to be fully
understood.
• Regulatory apparatuses however will eventually have to catch up and a new
equilibrium is to be established. In this regard, we will delve into details of various
ethical conundrums surrounding biotechnology.
• The CRISPR is an acronym for Clustered Regularly Interspaced Short
Palindromic Repeats.
• It is a less than a decade-old gene-editing technology that has revolutionized the
field of medical research and biotechnology owing to its efficiency, simplicity, and
cost-effectiveness. It finds the target DNA sequence in the cell and performs
desired edits to the gene sequence, all by itself.
BIOETHICS
• Germline Editing concerns: Germline Editing involves making genetic
modifications to human embryos and reproductive cells (sperms/ egg cells). The
changes made in the germline are passed on to the subsequent generation. Thus,
the use of CRISPR technology in the process raises Ethical concerns like should
the unborn child not have a say in decision making of how they want their future to
look like.
• Biosafety Concerns: Genetic engineering technology, in the wrong hands, could
bring in new dangers. It can be used to make dangerous pathogens more potent. An
accidental or deliberate release of genetically engineered microorganisms or
viruses into the environment is also a cause of major concern.
• Ecological dis-equilibrium: As genetically engineered or modified organisms are
introduced, they can reduce the genetic diversity of the targeted population. As this
organism can spread to other populations through cross-breeding, it can also affect
the genetic diversity of these populations. Eg. BT Cotton can crossbreed with other
varieties of Cotton and change their genetic composition.
BIOETHICS
• Regulatory Bypass: Genetic engineering technology has brought into the market a
new way to produce genetically engineered crops. Using Genetic engineering
technology, there is no need to insert foreign DNA in a plant to make the required
changes. Hence, the plant would not be classified as transgenic. This will help in
bypassing regulations controlling the use of GM crops.
• Safety: It becomes a primary concern due to the possibility of off-target effects
(edits in the wrong place) and mosaicism (when some cells carry the edit but others
do not)
• Informed Consent: As the long-term impact of germline therapy remains
unknown, obtaining truly informed consent from prospective parents is not
possible. It has also been argued that the person directly affected, ie. the child
(embryo), has no way of providing consent.
• Justice and Equity: Genome editing, like many other new technologies, is
accessible mainly to rich people in society. This has the potential to increase
existing disparities in access to healthcare and other interventions.
BIOETHICS
• Playing God!: Genetic engineering technology will enable humans to create life from
non-living, inorganic matter. Indeed a role played by God till now. The concern is that
humans fail to recognize their limitations, for example, by overestimating their ability
to control complex ecosystems. Introducing structurally deep chemistry changes in
DNA within living systems could generate unpredictable and possibly lethal outcomes
by allowing natural selection to proceed through a competition between current life
forms and new ones using modified genetic codes.
• Organisms or machines?: A unique ethical concern about synthetic biology is that it
may result in the creation of entities that fall somewhere between living things and
machines.
• Misuse of knowledge: The accessibility and advantages of this technology make it a
potentially attractive instrument, for example, for bioterrorism.
• If there’s human error, then who will be liable?: For example, concerns have been
made that the SARS CoV2 virus which has brought the COVID pandemic was a result
of an accidental leak of a genetically edited virus from a laboratory.
BIOETHICS
• Harm to the environment: This concern is perhaps the most widely cited by those
opposed to GMOs. It is very difficult to predict what will happen in an ecosystem
where a new organism has been introduced-whether genetically modified or not. Take
weeds for example. If farmers introduce a herbicide-resistant marker into a plant, there
is the possibility those traits may be transferred to a weed, making it resistant to
herbicides as well.
• Bioterrorism: Governments are worried terrorists will use biotechnology to create
new Superbugs, infectious viruses, or toxins for which we have no cures. The use of
viruses and diseases as a weapon in warfare has been well documented in history.
Native Americans were infected by the British army in the 1760s when they were
given blankets from a smallpox hospital. During World War II, Japan released bombs
on China containing fleas infested with disease. In modern times, bioterrorists are able
to transfer diseases and viruses through explosives, food and water, and even aerosol
sprays. But the use of biotechnology as a weapon was banned by the Geneva
Convention.
BIOETHICS
• Laboratory/production safety: It's hard to protect yourself if you don't know what
you're working against. Some new technologies, usually non-biologicals such as
nanoparticles, make commercial production lines before they have been sufficiently
tested for safety. There is also concern about technician safety in laboratories- even
under secure conditions-when working with organisms of unknown virulence.
• Protecting Human Subjects in Clinical Trials- This issue has generated considerable
debate since 1999, when 18-year-old Jesse Gelsinger died while participating in a gene
therapy trial at the University of Pennsylvania. The institution was widely criticized
for failing to disclose crucial information on informed consent documents, relaxing
criteria for accepting volunteers, and enrolling volunteers who were ineligible. The
episode prompted a great deal of soul-searching among researchers and regulators, and
many universities began implementing new standards as a result of the harsh spotlight
that was cast on the clinical trial world.
BIOETHICS
• Fear of Horizontal gene transfer- There are many ways that gene can
transfer from one primitive organism to other primitive organism along
with many viruses causes mutation in humans and bacteria also causes
cancer disease in plants so there is little risk of horizontal gene transfer.
• Toxins and allergies in GMO- There is great debet is going with the gene
transfer to wild species may changes its expression and there is a threat
that from GMO crops or organisms fear of toxins and allergens production.

Module 3

Uploaded by

Copyright:

Available Formats

You might also like

Module 3

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Module 3

Uploaded by

Copyright:

Available Formats

Module 3: BIOETHICS

BIOETHICS- APPLICATION OF MORAL PHILOSOPHY IN

A classic bioethical decision

• One heart available → who should get it?

• Obligations not to harm (rob or kill)

• Intended effects and merely foreseen effects

❖ Selection of Research subject population

Should a mother be legally liable for drinking or doing drugs while

Stem Cell Research

Stem Cell Research

Genetic Modification of Food and animal

Genetic Modification of Food and animal

• According to cautionary principle these risks could be avoided by implementing

• new genes or their products cause allergies?

You might also like