BIOETHICS AND

BIOTECHNOLOGY
INTRODUCTION

• Biotechnology, at its core, is

about understanding life and
using this knowledge to
benefit people.
INTRODUCTION

• Many see biotechnology as a

significant force in improving
the quality of people’s lives in
the 21st century.
INTRODUCTION

• Obviously, biotechnology is
intimately tied to science and
scientific knowledge, and is
also closely tied to ethics.
INTRODUCTION

• At the very least, biotechnology promotes a

certain vision of life, one in which some
things are viewed as good and to be
encouraged or pursued, and other things are
bad and should be avoided or eliminated.
 • At times, the relationship between
INTRODUCTION biotechnology and ethics is portrayed as one
of conflict.
INTRODUCTION

• There wasn’t an ethical

debate over whether to
search for a cure for cancer.
• The decision to pursue such
research was motivated by a
common vision that curing
cancer was the ethical thing
to do.
 • Many technological developments protect
people from illnesses and natural disasters,
INTRODUCTION
giving some people ‘‘liberation from the
tyranny of nature’’.
INTRODUCTION

• Some developments seem motivated by a

desire to find treatment at any price.
• Assisted human reproduction is a
particularly controversial area where
biotechnological treatment of infertility
leads to many ethical dilemmas.
INTRODUCTION

• Some are concerned that technological

developments lead to dehumanisation or
in healthcare lead to less emphasis on
caring.
INTRODUCTION

• Ethical concerns exist about

justice, and how fairly these
technological benefits are
distributed—both within
society and around the world.
INTRODUCTION

• The benefits of technology, realised and potential, point to a technological

mandate: biotechnology should strive to benefit people’s lives.
INTRODUCTION

• The distinction between a technological

mandate and the technological imperative
rests on the ultimate goals of biotechnology.
• Before addressing whether it can be done,
research must answer, ‘‘Why should it be
done?’’
THE GOALS OF
BIOTECHNOLOGY
• Ethics includes assessment of
the rights and wrongs of
specific technologies and
applications (like cloning or
genetic diagnosis).
THE GOALS OF
BIOTECHNOLOGY

• Aubrey de Grey (2006)

at Cambridge University
has suggested that
biotechnology should be
directed towards
‘‘engineered negligible
senescence.’’
THE GOALS OF
BIOTECHNOLOGY

• He stated, ‘‘I’m about

indefinite extension of
longevity... Average
lifespan would be in the
region of 1,000 years...
seriously.’’
THE GOALS OF
BIOTECHNOLOGY

• De Grey claims that

over the next 25 years,
enough progress will be
made in biotechnology
to allow people to
extend their lives long
enough to obtain the
next set of benefits.
THE GOALS OF
BIOTECHNOLOGY

• In this way, little by little,

people will live longer
and longer, effectively
preventing death.
THE GOALS OF
BIOTECHNOLOGY

• Developing the
necessary biotechnology
for engineered negligible
senescence assumes that
indefinite life extension
is good for humanity.
THE GOALS OF
BIOTECHNOLOGY
• This question is especially pertinent given
the limited resources available for
biotechnology.
• Resources are also needed for education,
to better distribute the healthcare
resources already available, and to
provide debt relief for poorer nations.
 • How much investment towards the goal of
THE GOALS OF indefinite life extension would be in keeping
BIOTECHNOLOGY with global justice?
THE GOALS OF
BIOTECHNOLOGY
• While people in developed
countries can expect to live
into their 80s, the average life
expectancy at birth in 2015
was still in the 50s in some
African countries (World
Health Organisation 2005).
 • These types of questions require ethical
evaluation.
THE GOALS OF
BIOTECHNOLOGY • Time should be taken to reflect on the
broader implications of pursuing
biotechnology.
THE GOALS OF
BIOTECHNOLOGY
• For example, the Center for
Responsible Nanotechnology
claims that ‘‘much industry
can be directly replaced by
molecular manufacturing.’’
 • The economic fall-out from such
developments would be immense, leading to
significant social changes with the potential
THE GOALS OF for good and harm.
BIOTECHNOLOGY
• These ethical issues need careful examination
even before the technological issues are
resolved.
 • The pressures of competing for funding,
making breakthroughs, securing intellectual
THE GOALS OF
property, and obtaining market share all push
BIOTECHNOLOGY
against calls for caution or time-consuming
reflection.
 • Technological development can seem like a
THE GOALS OF
motorway, everyone on the fast track to
BIOTECHNOLOGY
success.
 • Ethics, even when well intentioned, can seem
THE GOALS OF like a diversion or a road-block that prevents
BIOTECHNOLOGY biotechnology reaching its destination, or
delays it inexcusably.
THE GOALS OF
BIOTECHNOLOGY
• However, there is a growing
realisation that ethics must be
a part of the planning process
within biotechnology.
• In many areas of research,
ethics does impact the design
of scientific experiments.
THE GOALS OF BIOTECHNOLOGY

• Any research involving human or animal participants will be scrutinised by ethics

committees.
THE GOALS OF
BIOTECHNOLOGY
• The methodology must
conform with ethical codes
and guidelines.
 • An argument can be made that publicly
funded research should be conducted in ways
that conform with society’s values.
THE GOALS OF
BIOTECHNOLOGY • ‘‘When the nation decides an activity is
worth its public money, it declares that the
activity is valued, desired, and favored’’
(President’s Council on Bioethics 2004, p. 38).
THE GOALS OF BIOTECHNOLOGY

• Therefore it is important to ensure that what is publicly funded is ethically

acceptable in society.
• The goal of relieving suffering is widely accepted, yet it must be balanced against
other societal goals.
• The ethics of proposed biotechnological developments must be scrutinised
carefully.
ANY QUESTION ?
GOOD CLINICAL PRACTICE (GCP)

• Good Clinical Practice (GCP) is a process that incorporates established

ethical and scientific quality standards for the design, conduct, recording and
reporting of clinical research involving the participation of human subjects.
GOOD CLINICAL PRACTICE (GCP)

• Compliance with GCP

provides public assurance that
the rights, safety, and well-
being of research subjects are
protected and respected,
consistent with the principles
enunciated in the Declaration
of Helsinki.
DECLARATION OF HELSINKI

• Declaration of Helsinki as a
statement of ethical principles
for medical research involving
human subjects, including
research on identifiable
human material and data.
DECLARATION OF HELSINKI

• The Declaration binds the

physician with the words,
“The health of my patient will
be my first consideration,”
and the International Code of
Medical Ethics declares that,
“A physician shall act in the
patient’s best interest when
providing medical care.”
GOOD CLINICAL PRACTICE (GCP)

• In 1975, a WHO Scientific Group was convened to specifically consider all

aspects of the evaluation and testing of drugs and to formulate proposals
and guidelines for research in the field of drug development.
• These reports formed the basis for WHO’s “Guidelines for good clinical
practice (GCP) for trials on pharmaceutical products”, published in 1995.
GOOD CLINICAL
PRACTICE (GCP)
• GCP provides a basis both for
the scientific and ethical
integrity of research involving
human subjects and for
generating valid observations
and sound documentation of
the findings.
GOOD CLINICAL PRACTICE (GCP)

• GCP not only serves the interests of the parties actively involved in the research
process, but also protects the rights, safety and wellbeing of subjects and ensures
that investigations are scientifically sound and advance public health goals.
PRINCIPLES OF GCP

• Principle 1: Research involving humans should be scientifically sound and

conducted in accordance with basic ethical principles, which have their
origin in the Declaration of Helsinki.
• Three basic ethical principles of equal importance, namely respect for
persons, beneficence, and justice, permeate all other GCP principles.
PRINCIPLES OF GCP
PRINCIPLES OF GCP

• Principle 2: Research
involving humans should be
scientifically justified and
described in a clear, detailed
protocol.
PRINCIPLES OF GCP

• Principle 3: Before research involving

humans is initiated, foreseeable risks
and discomforts and any anticipated
benefit(s) for the individual trial subject
and society should be identified.
• Research of investigational products or
procedures should be supported by
adequate non-clinical and, when
applicable, clinical information.
PRINCIPLES OF GCP

• Principle 4: Research involving humans should be initiated only if the

anticipated benefit(s) for the individual research subject and society clearly
outweigh the risks.
• Although the benefit of the results of the trial to science and society
should be taken into account, the most important considerations are
those related to the rights, safety, and well-being of the trial subjects.
PRINCIPLES OF GCP

• Principle 5: Research
involving humans should
receive independent ethics
committee/institutional
review board (IEC/IRB)
approval/ favourable opinion
prior to initiation.
PRINCIPLES OF GCP

• Principle 6: Research involving

humans should be conducted in
compliance with the approved
protocol.
PRINCIPLES OF GCP

• Principle 7: Freely given informed consent should

be obtained from every subject prior to research
participation in accordance with national culture(s)
and requirements.
• When a subject is not capable of giving informed
consent, the permission of a legally authorized
representative should be obtained in accordance
with applicable law.
 • Principle 8: Research involving
PRINCIPLES OF
humans should be continued only if the
GCP
benefit-risk profile remains favourable.
 • Principle 9: Qualified and duly licensed
medical personnel (i.e., physician or, when
PRINCIPLES OF
appropriate, dentist) should be responsible
GCP
for the medical care of trial subjects, and for
any medical decision(s) made on their behalf.
PRINCIPLES OF GCP

• Principle 10: Each individual

involved in conducting a trial
should be qualified by
education, training, and
experience to perform his or
her respective task(s) and
currently licensed to do so,
where required.
PRINCIPLES OF GCP

• Principle 11: All clinical trial information should be recorded, handled, and
stored in a way that allows its accurate reporting, interpretation, and
verification.
PRINCIPLES OF GCP

• Principle 12: The

confidentiality of records that
could identify subjects should
be protected, respecting the
privacy and confidentiality
rules in accordance with the
applicable regulatory
requirement(s).
PRINCIPLES OF GCP

• Principle 13: Investigational products should be manufactured, handled,

and stored in accordance with applicable Good Manufacturing Practice
(GMP) and should be used in accordance with the approved protocol.
WHO PRINCIPLES OF
GCP
• Principle 14: Systems with
procedures that assure the
quality of every aspect of the
trial should be implemented.
HUMAN RESEARCH

• A general definition of human research is: “Any

proposal relating to human subjects including
healthy volunteers that cannot be considered as an
element of accepted clinical management or public
health practice and that involves either (i) physical
or psychological intervention or observation, or (ii)
collection, storage and dissemination of information
relating to individuals.
 • This definition relates not only to planned
trials involving human subjects but to
research in which environmental factors are
HUMAN
manipulated in a way that could incidentally
RESEARCH
expose individuals to undue risks.” (World
Health Organization, Governance, rules and
procedures, WHO Manual XVII).
CLINICAL RESEARCH

• Before medical products can be

introduced onto the market or
into public health programmes,
they must undergo a series of
investigations designed to
evaluate safety and efficacy within
the parameters of toxicity,
potency, dose finding, and field
conditions.
CLINICAL RESEARCH

• Full information must be

documented on therapeutic
indications, method of
administration and dosage,
contraindications, warnings,
safety measures, precautions,
interactions, effects in target
populations and safety
information.
CLINICAL RESEARCH

• During the clinical research and

development process, most
medical products will only have
been tested for short-term safety
and efficacy on a limited number
of carefully selected individuals.
CLINICAL RESEARCH

• The conduct of clinical research

in accordance with the principles
of GCP helps to ensure that
clinical research participants are
not exposed to undue risk, and
that data generated from the
research are valid and accurate.
CLINICAL RESEARCH

• Guidance on various aspects of clinical research is available from several national

and international bodies:
- World Health Organization (WHO)
- the International Conference on Harmonization (ICH)
- the International Standards Organization (ISO)
- the Council for International Organizations of Medical Sciences (CIOMS)
- the European Agency for the Evaluation of Medicinal Products (EMEA)
- the United States Food and Drug Administration (FDA)
 • The conduct of clinical research is complex and this
complexity is compounded by the need to involve a
number of different individuals with a variety of
INVOLVEMENT expertise, all of who must perform their tasks
OF EXPERT skillfully and efficiently.
PEOPLE AND • The responsibility for GCP is shared by all of the
INSTITUTIONS parties involved, including sponsors, investigators
and site staff, contract research organizations
(CROs), ethics committees, regulatory authorities
and research subjects.
CLINICAL RESEARCH TEAM FOR ECCT

• Principal investigator: Prof. Sofia Mubarika, MD., M.Med.Sc., PhD. (Oncology and Histology)
• Investigator:
1. Prof. Mochamad Hakimi, MD. Sp.OG., PhD. (Bioethics and Biostatistic)
2. Rarastoeti Pratiwi, Ph.D. (Biochemistry and Molecular Biology)
3. Firman Alamsyah, PhD (Biophysics and Molecular Biology)
4. Dr. Eti Nurwening, MD. M. Kes, M.Med.Ed. (Pharmacology and Therapy)
5. Umi Solekhah Intansari, MD., M. Kes., Sp.PK(K) (Clinical Pathology)
6. Dr. Sitarina Widyarini (Anatomical Pathology)
SERTIFIKAT GCP

• Beberapa institusi, baik Kemenkes,

kampus dan organisasi profesi
kesehatan mengadakan workshop
Good Clinical Practice (GCP).
• Para peserta yang telah lulus
workshop, mendapatkan sertifikat
GCP dan dapat terlibat dalam
penelitian uji klinis.
ANY QUESTION ?
REFERENCES

• Donal O’Mathuna. 2007. Bioethics and Biotechnology. Cytotechnology.

53:113-119.
• World Health Organization. 2002. Handbook for Good Clinical Research
Practice (GCP). 1-20.