Ethics in Biotechnology

(Bioethics)
Bioethics Concepts
 What is Ethics?
• Definition:
– Ethics seeks to determine what a person should
do, or the best course of action, and provides
reasons why. It also helps people decide how to
behave and treat one another, and what kinds of
communities would be good to live in.
 What is Bioethics?
• A subfield of ethics that explores ethical
questions related to life sciences.
 Ethical Questions Raised by Advances
in Biology
• Should there be limits to how much people
modify the natural world using technology?
• Should all students be required to have
vaccinations?
• If you take a genetic test, who should know
the results?
 BRAINSTORM

What are some other examples of bioethical

questions?
 Bioethics

Offers ways to think about, analyze, and make

decisions about difficult ethical questions
related to biology and its applications.
 Definition
Ethics seeks to determine what a person should
do, or the best course of action, and provides
reasons why. It also helps people decide how
to behave and treat one another, and what
kinds of communities would be good to live in.
 You will face issues that your parents
never had to….

1- New inventions, processed food, and

biomedical procedures are in the news
everyday.
2- Stem cell, transplantasi, vaksinasi
 Let’s Explore……
Cases where people used technology to change
their bodies
 Why Ethics in Biotechnology
• New technology
• Plurality of moral convictions(confidence)
• Divergent economic, political, and social objectives
• Growing sensitivity of the public
• Doubts of the public about internal control
mechanism of scientific institutions and the
scientific community to adequately consider moral
implications of research and its consequences
• Complexity of ethical issues involved
 Morale and Ethics?
• „Morale″ ← Latin „mores″ : custom, habit
... indicates the distinction between what is good and what is
evil in the everyday life

• „Ethics″ ← Greek „ethos″ : tradition, habit

... the philosophical study of the principles at the basis of
morale
Etymology of the two words speaks one's mind:
both ethics and morale are the result of the society's evolution
towards "standard" behaviours.

Operational definition of morale:

„... those standards everyone wants everyone to follow, even if
everyone else´s following them means having to follow them
oneself.″ (M. Davis)
 Morale & Ethics
THREE BASIS OF RESTRAINT (REPRESSION)

Level Enforcement Restriction Example

LEGAL INSTITUTIONS USUALLY FREE, Freedom to
UNLESS RIGHTS experiment,
INVOLVED unless illegal
ETHICAL GROUP AGREED BY THE Do No (direct)
GROUP Harm (to patient)

MORAL SELF EVEN IF EVERYONE Will Refuse if

SAYS YES, I WILL there is
NOT INDIRECT
HARM
The Bioethical
Challenge

Is Biotechnology Morally Acceptable?

Bioethics

Bioethics: A discipline dealing with the ethical

implications of biological research and applications,
such as : organ transplants, genetic engineering”
 Pengertian Bioetika
1. Bioetika ialah suatu disiplin baru yang menggabungkan
pengetahuan biologi dengan pengetahuan mengenai sistem nilai
manusia, yang akan menjadi jembatan antara ilmu pengetahuan
dan kemanusiaan, membantu menyelamatkan kemanusian, dan
mempertahankan dan memperbaiki dunia beradab
2. Bioetika ialah kajian mengenai pengaruh moral dan sosial dari
teknik-teknik yang dihasilkan oleh kemajuan ilmu-ilmu hayati.
(Honderich Oxford, 1995)
3. Bioetika bukanlah suatu disiplin ilmu. Bioetika telah menjadi tempat
bertemunya sejumlah disiplin, diskursus , dan organisasi yang
terlibat dan peduli pada persoalan etika, hukum, dan sosial yang
ditimbulkan oleh kemajuan dalam kedokteran, ilmu pengetahuan,
dan bioteknologi. (Onara O’Neill, 2002
4. Bioetika mengacu pada kajian sistematis, plural
dan interdisiplin dan penyelesaian masalah etika
yang timbul dari ilmu-ilmu kedokteran, hayati,
dan sosial, sebagaimana yang diterapkan pada
manusia dan hubungannya dengan biosfera,
termasuk masalah yang terkait dengan
ketersediaan dan keterjangkauan
perkembangan keilmuan dan keteknologian dan
penerapannya. (Draft Declaration on Universal
Norms on Bioethics, UNESCO, 2005)
Ciri:
1. Interdisiplinerilitas -melibatkan ilmu biomedis,
hukum, ilmu sosial, teologi, dll.
2. Internasionalisasi –problem-problem etis
yang ditimbulkan dalam perkembangan ilmu-
ilmu hayati bersifat internasional
3. Plularitas -banyak golongan dan pandangan
diikutsertakan
 Two Kinds of Ethical Arguments Used to
Evaluate Concerns Over Biotechnology
• Extrinsic objections say the possible
consequences of some biotech applications
are objectionable, but others may be
acceptable
GMOs are wrong because risks outweigh
benefits.
• Intrinsic objections say the process of
biotechnology is objectionable in itself
GMOs are wrong , no matter how great the
benefits.
 Tugas
• Apakah saudara bisa menerima tanaman
transgenik?
• Ya
• Tidak
1. Extrinsic objections

A. Unsafe for consumers

“Frankenfoods”
2. Extrinsic objections

B. Unsafe for environments

“superweeds”
– Herbicide resistance - canola
gene flows into weedy
relatives
– Bt toxin kills monarch
butterfly larvae
 Extrinsic objections
C. Unfair to small farmers

“Rich get richer,

poor get poorer”
Vandana Shiva
Monocultures of the Mind

She has established Navdanya, a movement for biodiversity

conservation and farmers' rights
 The Business
of Science
Challenge

Does the business of biotechnology corrupt the purpose

and integrity of the process of the science?

Or can business and scientific partnerships be beneficial

for society?
 The Business of Science
• Critics:
– Focusing on profits contradicts the purpose of science to
enhance or improve the quality of life
– Biotechnology commodifies life and leads to reductionist
science

• Advocates:
– The spiraling costs of R & D required to bring a product to
market justifies the closer ties of science and business
– This relationship has been beneficial to society and has
contributed to the public good
Ethical arguments against GM foods

1. Extrinsic objections

2. Intrinsic objections

GM foods are wrong no matter how

great the benefits may be.
Intrinsic objections
GM foods are wrong because it’s wrong to:
1. Play God
2. Invent world changing
technology
3. Cross species boundaries
4. Reproduce by nonsexual
means
5. Disrupt integrity, beauty,
balance of nature
6. Harm sentient beings
Intrinsic objections

1.We should not

play God
Intrinsic objections
1. Don’t play God

Counter-examples:
– High tech medicine
– God wants us to
genetically engineer
food
Intrinsic objections

2. We should not
change the world
through new
technology
Intrinsic objections

2. No world-changing
technology

Counter-example:
Agriculture
Intrinsic objections

3. We should not
cross natural
species boundaries
Intrinsic objections

3. Don’t cross species

Counter-examples:
• Hybrid wheat
Intrinsic objections

4. We should not
use nonsexual
means to
reproduce
Intrinsic objections

4. Don’t reproduce
nonsexually

Counter-examples:
• GIFT and in vitro
• Plant cuttings
Intrinsic objections
5. We should not
disrupt the
integrity,
beauty and
balance of
creation
Intrinsic objections

5. Don’t disrupt nature

Problems:
• An extrinsic objection
• Is / ought problem
Intrinsic objections

6. We should not
harm sentient
beings
Intrinsic objections
6. Don’t harm sentient
beings

Problems:
• An extrinsic objection
• Meat-eaters accept
harm to animals
 Extrinsic objections
• Unsafe for consumers?
Food allergens, toxins

• Unsafe for environment?

–Unintended effects on nontarget organisms
–Gene flow, development of resistant weeds

• Unfair to small farmers?

Rich get richer, poor get poorer
 Extrinsic objections

• Support: Regulatory oversight

on case-by-case basis
• Do not support:
a ban on all GM crops
Ethical arguments FOR GM foods
Potential to improve:
– Diets in developing countries
– Efficiency of food production
– Safety and purity of food
– Agricultural sustainability
– Diversity of agro-ecosystems
Enhanced nutrition

Vitamin A Rice
Iron Enhanced Rice
Amino Acid Balance
Insect resistance
• Bt corn
– Insect resistance from
Bacillus thuringiensis
– Non-toxic to humans
– Target insect: corn borer
– 40% U.S. Corn crop Bt
– Potential to reduce
insecticide use
Disease resistance
• Potatoes
• Squash
• Tomatoes
• Corn
• Rice
• Canola
• Soybeans
• Grapes
• Cantaloupes
• Cucumbers
Genetic engineering in microbes:
Enzymes
• Recombinant Chymosin
– Enzyme used for cheese
making
– Originally from calf stomach
– Bovine gene expressed in
GRAS microbes
– FDA approved 1990
– Now used in 70% of U.S.
cheese
Recombinant amino acids

• Aspartame
– Artificial sweetener
– Made from aspartic acid
and phenylalanine
– Used in 5,000 products
• Monosodium glutamate
Recombinant alpha amylase

• Used to make HFCS

(high fructose corn
syrup)
• Gras status in 1995
• 10% U.S. corn crop
processed into syrups
The Challenge of
Consumer Choice

Does society have an ethical obligation to

maximize consumer knowledge and
choice?
Consumer Choice – The Issue of Labeling
• Advocates of consumer labeling criticize efforts
NOT to label food containing genetically modified
organisms. They argue: “If biotech foods are safe
and risk free, then why are you afraid to let us
know what we are buying?”

• Consumers with food allergies, vegetarians, and

those with religious dietary restrictions have a right
to know

• Consumers should be able to choose the type and

quality of food they consume, and the production
system they want to support with their food dollar
 Consumer Choice –
Opposition to Labeling
• Labeling is unnecessary because biotech foods
contain genetic material from other natural
products - nothing is added that does not
already exist in nature
• Organic labeling standards exist. If you are
opposed to consuming genetically modified food
ingredients, simply buy organic!
• Labeling does not change consumer behavior
• Why must everyone pay for the cost of labeling
that is demanded by a few?
Key Challenges of Agricultural Biotechnology

• Can we capture the potential benefits of

agricultural biotechnology in a fair and equitable
way for today’s and future generations?
• Can we balance the interests of human society and
the environment using biotechnology?
• Can biotechnology contribute to sustainable
agricultural systems?
• How should we frame the biotechnology issue?
 Universal Declaration on Bioethics and
Human Rights

Universal framework of
Principles and Procedures
Article 6: Consent
Article 19: Ethics Committees
Article 9: Privacy and
Confidentiality Article 21: Transnational
Practices
Article 11: Non-discrimination
and Non-Stigmatization
Article 13: Solidarity and
cooperation
 Universal Declaration on Bioethics and
Human Rights: Principles

Article 9 Privacy and Confidentiality

The privacy of the persons concerned and the

confidentiality of their personal information
should be respected. To the greatest extent
possible, such information should not be used
or disclosed for purposes other than those for
which it was collected or consented to,
consistent with international law, in particular
international human rights law.
 Universal Declaration on Bioethics and
Human Rights: Principles

Article 11 Non-discrimination and non-stigmatisation

No individual or group should be discriminated
against or stigmatized on any grounds, in
violation of human dignity, human rights and
fundamental freedoms.
Article 13 Solidarity and cooperation
Solidarity among human beings and international
cooperation towards that end are to be
encouraged
 Universal Declaration on Bioethics and
Human Rights: Principles
Article 15 – Sharing of benefits
Benefits resulting from any scientific research and its applications
should be shared with society as a whole and within the international
community, in particular with developing countries. In giving effect to this
principle, benefits may take any of the following forms:
(a) special and sustainable assistance to, and acknowledgement of, the persons and
groups that have taken part in the research;
(b) access to quality health care;
(c) provision of new diagnostic and therapeutic modalities or products stemming
from research;
(d) support for health services;
 Universal Declaration on Bioethics and
Human Rights: Principles

Article 15 – Sharing of benefits : Continued….

(e) access to scientific and technological knowledge;

(f) capacity-building facilities for research purposes;
(g) other forms of benefit consistent with the principles set out in
this Declaration.

2. Benefits should not constitute improper inducements to participate

in research.
 Implementing Universal Principles at the
National Level
The Role of the International Bioethics Committee (IBC) in
Implementing Universal Principles at the National Level:

• A multidisciplinary, multicultural body of experts with a global scope

• A mandate to elaborate the principles contained in the UDBHR, with an
aim to facilitate their implementation at country level
• Reports produced on:
 Consent
 Social Responsibility and Health
 Human Vulnerability and Personal Integrity:
IV. Vulnerability in Human participant Research
o IV.1. ‘Double Standard’ research
o IV.2. Equivocal donations
o IV.3. Inappropriate research
o IV.4. Social vulnerability
o IV.5. Vulnerability as a result of lack of research
 Implementing Universal Principles at the
National Level
Article 19 Ethics committees
Independent, multidisciplinary and pluralist ethics committees
should be established, promoted and supported at the appropriate
level in order to:
a. Assess the relevant ethical, legal, scientific and social issues
related to research projects involving human beings;
b. Provide advice on ethical problems in clinical settings;
c. Assess scientific and technological developments, formulate
recommendations and contribute to the preparation of guidelines
on issues within the scope of this Declaration;
d. Foster debate, education and public awareness of, and engagement
in, bioethics.
Implementing Universal Principles at the
National Level
Article 19 Ethics committees

Key national actors in translating universal norms and principles into

domestic reality through:
• Building and regulating research ethics infrastructure
• Formulating National Research Guidelines
• Provide policy advice concerning elaboration of research
protocols
 Etika Stem Cell
• Stem Cells:

• Suatu sel prekursor yang berpotensi untuk berkembang

menjadi berbagai macam sel yang berbeda (sel beta
pancreas, kondrosit, sel neuron, dll).

– Stem cells dapat membelah tanpa batas untuk menggantikan sel

lain  sehingga berperan seperti suatu sistem perbaikan sel
dalam tubuh.
– Setiap stem cell dapat membelah menjadi sel lain yang
terspesialisasi maupun menjadi stem cell yang baru.
Kegunaan Stem Cell
• Pembuatan sel dan jaringan untuk terapi medis.

• Contoh penyakit yang berpeluang untuk

diterapi menggunakan stem cells adalah
Parkinson, Alzheimer, kerusakan pusat system
saraf, stroke, diabetes, rheumatoid arthritis,
luka bakar, infark jantung, dll.