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Bioethics
Q
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Ethics: Ethics is the branch of study dealing with what is the proper course of action for man
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At a more fundamental
level, it is the method by which we categorize our values and pursue them
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Bioethics: The term bioethics is derived from bios (meaning life) and ethos (meaning behavior)
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Bioethics includes the study of what is right or wrong in new discoveries and techniques in
biology, such as genetic engineering and transplantation of organs
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In involves ethical rules that apply to everyone, the scientific ethical rules and morals, which are unique for
each individual
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Describe the concepts of bioethics
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The term was coined in 1926 by Fritz Jahr
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Concepts:
•
•
•

•
•

Bioethics is the application of ethics to the field of medicine and healthcare
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Bioethics principles: There are four principles which form the framework for moral reasoning:
1
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The healthcare professional should not
harm the patient
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2
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The notion that patients in similar
positions should be treated in a similar manner
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Beneficence: This principle considers the balancing of benefits of treatment against the
risks and costs; the healthcare professional should act in a way that benefits the patient
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Autonomy: Autonomy implies that the doctor is obliged not only to respect the free choice
of his patient, but more importantly, to facilitate in every reasonably possible way the
making of such a free choice by the patient
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Bioethics includes both medical ethics and environmental ethics
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➢ Genetics
➢ Brain imaging techniques
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Q
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Some common ethical issues:
•
•
•
•
•
•
•
•
•
•
•

Abortion
Euthanasia
Suicide
DNR
Determination of death
Cloning
Human experimentation
Birth control
In vitro fertilization
Stem cell technology
Homosexuality

Q
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The three broad types of ethics theories are:
1
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Non-consequentialist theories and
3
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2
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a
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This
approach states those who believe that the rightness or wrongness of an act depends on the
consequences are called consequentialists
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), then this is group
consequentialism
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In its strong form, utilitarianism considers the consequences for all sentient
beings; in its more modest form, it considers the consequences for all human beings
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The egoistic approach: The philosopher Ayn Rand is the proponent of this theory
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c
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➢ Implement systems that benefit all people
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a
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This theory states that being
moral involves doing things just because they are right – in other words, doing things for
the sake of duty
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and act solely because it is the right thing to do
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The rights approach: This theory states that each person has a fundamental right to be
respected and treated as a free and equal rational person capable of making his/her own
decisions
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The fairness or justice approach: This theory tells us to treat everyone in the same way
and not to show favouritism or discrimination
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d
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This type of theory recognizes that individuals and circumstances are unique
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a
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According
to virtue-based theories, ethics is about what sort of person one should strive to become
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honesty, fairness,
kindness, faithfulness, generosity, prudence, integrity, bravery, etc
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The feminist approach: This approach is concerned with the totality of human life and
how this life comes to influence the way we make ethical decisions
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Describe the principles of bioethics
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2
...

4
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The healthcare professional should not
harm the patient
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Justice: Benefits and risks should be fairly distributed
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Beneficence: This principle considers the balancing of benefits of treatment against the
risks and costs; the healthcare professional should act in a way that benefits the patient
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Autonomy is the capacity for selfdetermination
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Describe the application of principles of Belmont report
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Respect for persons
2
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Justice
They are discussed below:
1
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Informed consent is a process in which the subject has an understanding of research and its risks
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Information
ii
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Voluntariness
2
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The nature and
scope of risks and benefits must be assessed in a systematic manner
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3
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There must be
fair procedures and outcomes in the selection of research subjects and they must avoid exploitation
of vulnerable populations like women, children and prisoners
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Describe the ethical principles of public health
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Public health should address principally the fundamental causes of disease and requirements for
health, aiming to prevent adverse health outcomes
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Public health should achieve community health in a way that respects the rights of individuals in
the community
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Public health politics, programs and priorities should be developed and evaluated through processes
that ensure an opportunity for input from community members
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Public health should advocate and work for the empowerment of disenfranchised community
members, aiming to ensure that the basic resources and conditions necessary for health are
accessible to all
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Public health should seek the information needed to implement effective policies and programs that
protect and promote health
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Public health institutions should provide communities with the information they have that is needed
for decisions on policies or programs and should obtain the community’s consent for their
implementation
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Public health institutions should act in a timely manner on the information they have within the
resources and the mandate given to them by the public
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Public health programs and policies should incorporate a variety of approaches that anticipate and
respect diverse values, beliefs and cultures in the community
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Public health programs and policies should be implemented in a manner that most enhances the
physical and social environment
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Public health institutions should protect the confidentiality of information that can bring harm to
an individual or community of made public
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11
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12
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Q
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Principles of medical ethics:
1
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3
...

5
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7
...

9
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A physician shall uphold the standards of professionalism, be honest in all professional interactions
and strive to report physicians deficient in character or competence, or engaging in fraud or
deception, to appropriate entities
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A physician shall respect the rights of patients, colleagues and other health professionals and shall
safeguard patient confidence and privacy within the constraints of the law
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A physician shall, in the provision of appropriate patient care, except in emergencies, be free to
choose whom to serve, with whom to associate and the environment in which to provide medical
care
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A physician shall, while caring for a patient, regard responsibility to the patient as paramount
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Q
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Prominent ethical codes:
1
...

3
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Oath of Hippocrates (4th BC)
Nuremberg code (1947): Issue of human experimentation
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It is the first serious
attempt to medical community to regulate itself
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4

5
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CIOMS stands for the Council for International Organization of Medical
Science)
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Write down the differences between Autonomy and Beneficence
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2
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4
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Autonomy
Autonomy implies that the doctor is
obliged not only to respect the free choice
of his patient, but more importantly, to
facilitate in every reasonably possible way
the making of such a free choice by the
patient
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1
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Able to exercise free will in making a
personal decision
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Autonomy is a self-governing fact
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Exercise clinical judgement
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Euthanasia is an example of autonomy
when the patient wants it
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It’s going beyond the minimum standard
required
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Medical paternalism is an example of
beneficence
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Q
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1
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3
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The challenge is to negotiate the optimal balance between promoting
and protecting public health as well as human rights
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This is true in peacetime and in
times of conflict and extreme political repression
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The central
idea of the health and human rights approach is that health and human rights act in synergy
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5

Q
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Differences between law and ethics:
1
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3
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5
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7
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Law is a set of rules and regulations
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1
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3
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Violation of law is not permissible which
may
result
in
punishment
like
imprisonment or fine or both
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Law has a legal binding
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5
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Ethics is a set of guidelines
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Ethics is abstract
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6
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7
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Q
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IRB reviews the following items:
1
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Research design: It includes the following informationa
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Is there a reasonable statistical plan?
▪ Does it require more subjects than can reasonably be enrolled?
c
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4
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Confidentiality
Risk benefit
Justification

Q
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Common ethical problems:
1
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Abortion: When does life begin? Is it ethical to terminate a pregnancy with a birth defect?

3
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Birth control: Should it be available to minors?

5
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Organ donation: Must a relative donate an organ to a sick relative?

7
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Patient rights: Do you have the right to refuse treatment?

9
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What is the meaning of authorship?
An author is broadly defined as the person who originated or gave existence to anything and whose
authorship determines responsibility for what was created
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Authorship is an explicit way of assigning responsibility and giving credit for intellectual work
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Authorship practices should be judged by how honestly they reflect actual contributions to the final
product
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Q
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Gift authors: A gift author is one who may have a slight relationship with the study or the article, but who
would not be considered an author according to the International Committee of Medical Journal Editors
(ICMJE) guidelines
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A frequent example is the head of department of
the PhD supervisor being named in all articles
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Ghost authorship: A ghost author is a person who should be listed as an author, but has been excluded
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These are usually commissioned (and often paid) by pharmaceutical companies to produce a paper from
raw data
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Ghost authorship is more common in some journals than others, and there are guidelines for such articles
developed by the European Medical Writers Association
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Ethical issues: There are important ethical issues to understand with both honorary and ghost authorships
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Providing
guest or honorary authorship just to try to make a paper more prestigious or legitimate undermines the work
that has gone into the research, and could damage the findings in the long run
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Q
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For example, a patient who has had bypass surgery may want to continue
to smoke or a patient with pneumonia may refuse antibiotics
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As long as the patient meets the criteria for making an autonomous choice (the patient
understand the decision at hand and is not basing the decision on delusional ideas), then the physician should
respect the patient’s decisions even while trying to convince the patient otherwise
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List the human rights
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We are all born free and equal: We are all born free
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We
should all be treated in the same way
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Don’t discriminate: These rights belong to everybody, wherever our differences
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The right to life: We all have the right to life and to live in freedom and safety
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No slavery: Nobody has any right to make us a slave
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5
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6
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We are all equal before the law: The law is the same for everyone
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8
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9
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10
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The people who try us should not let
anyone tell them what to do
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We are always innocent till proven guilty: Nobody should be blamed for doing something until it
is proven
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12
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nobody has the right to come
into our home, open our letters, or bother us or our family without a good reason
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Freedom to move: We all have the right to go where we want in our own country and to travel as
we wish
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The right to seek a safe place to live: If we are frightened of being badly treated in our own country,
we all have the right to run away to another country to be safe
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Right to nationality: We all have the right to being to a country
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Marriage and family: Every grown-up has the right to marry and have a family if they want to
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17
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Nobody should
take our things from us without a good reason
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Freedom of thought: We all have the right to believe in what we want to believe, to have a religion
or to change if we want
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Freedom of expression: We all have the right to make up our own minds, to think what we like, to
say what we think and to share our ideas with other people
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The right to public assembly: We all have the right to meet our friends and to work together in
peace to defend our rights
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21
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Every
grown-up should be allowed to choose their own leaders
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Social security: We all have the right to affordable housing, medicine, education and childcare,
enough money to live in and medical help if we are ill or old
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Worker’s rights: Every grown-up has the right to do a job, to a fair wage for their work and to join
a trade union
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The right to play: We all have the right to rest from work and to relax
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Food and shelter for all: We all have the right to a good life
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26
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Primary school should be free
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Our parents can choose what we learn
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Copyright: Copyright is a special law that protects one’s own artistic creations and writings; others
cannot make copies without permission
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28
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29
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30
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Q
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Common ethical problems:
1
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3
...

5
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7
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9
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Birth control
11
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Conflict of interest: A conflict of interest is a solution in which financial or personal considerations
have the potential to compromise or bias professional judgement and objectivity
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Plagiarism: Plagiarism means claiming others’ work as one’s own, essentially stealing from them
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This includes ‘borrowing’ or downloading visuals from the internet to use
without permission with stories
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Anonymous or unnamed sources: Although reporters sometimes use anonymous sources, most
news organizations have strict guidelines about when to use them
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The reporter and editor also have to determine whether it is wise to protect the sources
from harm from being an identified source
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But a revelation about suffering childhood sexual abuse may be
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Offending or distasteful content: Although it is sometimes impossible to publish a story without
offending or displacing someone, journalists must strive to keep the communications open and
accessible to a wide range of views without stopping to gratuitous offence
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5
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The mere selection of one story over another raises
the issues of value judgements
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Every issue has more than one side, and all sides should be
represented as much as possible
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Invasion of privacy: Being a legal issue often, it is also an ethical one
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7
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8
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Abortion: It has become a major ethical problem now a days
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10

Short Notes
Informed consent or Consent
Consent is defined as permissions for something to happen or agreement to do something
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This principle reflects the rights
of a person to determine what happens to their own bodies or what shapes the care and support they receive
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Informed consent is a voluntary agreement to participate in research
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Informed consent is
essential before enrolling a participant and ongoing once enrolled
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Obtaining consent involves informing the subject
about his or her rights, the purpose of the study, the procedures to be undergone and the potential risks and
benefits of participation
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Vulnerable populations (i
...
, persons,
children, pregnant women etc
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The legal rights of subjects may not be waived
and subjects may not be asked to release or appear to release the investigator, the sponsor, the institution
or its agents from liability for negligence
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The goal of
the informed consent process is to provide sufficient information so that a participant can make an informed
decision about whether or not to enroll in a study or to continue participation
...

Components of consent: Consent has three components:
•
•
•

Disclosure: Disclosure refers to the communication of relevant information by the clinician and its
comprehension by the patient
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Voluntariness: Voluntariness refers to the patient’s right to come to a decision freely, without force,
coercion or manipulation
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Informed consent is
the process through which researchers respect individuals autonomy, the fundamental ethical principle
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The principle of autonomy
implies that responsibility must be given to the individual to make the decision to participate
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The Nuremberg code states that the voluntary consent of the human subject is absolutely essential not only
to the safety, protection and respect of the subject, insofar the integrity of the research itself
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2
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4
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Procedures involved in the research
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All foreseeable risks and discomforts to the subject
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11

5
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7
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9
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Length of time the subject is expected to participate
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Statement indicating that participation is voluntary and that refusal to participate will not result in
an any consequences or any loss of benefits that the subject is otherwise entitled to receive
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Provider of consent: Adults must provide consent on their own belief
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Who should seek consent and when: The registered nurse providing the treatment, investigation or care is
responsible for ensuring that the person has given valid consent before the examination, treatment or care
begins
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Form of consent: The validity of consent does not depend on the form in which it is given
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Where a person is illiterate or unable to fully complete their
signature, but is able to provide valid consent, they must be able to make a mark on the form to indicate
consent
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Duration of consent: When a person provides valid consent for an intervention, that consent remains valid
for the duration of the intervention, unless withdrawn by the person during the course of the intervention
...


Nuremberg Code
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the
subsequent Nuremberg Trials at the end of 2nd World War
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The ‘doctors’s trial’ was the first of the war crimes trials; one of its outcomes was famous
Nuremberg code, a set of ethical guidelines for human experimentation
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2
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4
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6
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8
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10
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It
is the basis for human rights protection and promotion around the world and has been enrolled by all
countries
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The United Nations was all about promoting a better world through international co-operation, including in
the field of human rights
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It called on
governments and individuals to promote respect for human rights thorough education and government
policies
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Eleanor Roosevelt, the wife of US president
Franklin D
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Today there are 192 member states of the UN, all
of whom have signed in agreement with The Universal Declaration of Human Rights
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Literally, therefore, ‘autonomy’ means the state of being self-governed or self-sovereign; living
autonomously means living by a law that you impose on yourself
...

Beauchamp and Childress state that autonomy is the ‘Personal rule of the self that is free from both
controlling interferences by others and from personal limitations that prevent meaningful choice …
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’ Numerous social and political
philosophers express the same general idea
...
’
In medical ethics, autonomy implies that the doctor is obliged not only to respect the free choice of his
patient, but more importantly, to facilitate in every reasonably possible way the making of such a free choice
by the patient
...

To respect a person’s autonomy is to acknowledge his/her right to make choices and take action based on
his/her own values and belief system
...
Respect for patient autonomy involves not only ethical obligations to respect patient choices,
but also obligation to promote both patient autonomy and autonomous choice
...
This is an increase instance of
‘Medical Paternalism’, which according to Zenbaty, ‘Paternalism is the interference with a patient’s autonomy
justified by reasons referring exclusively to welfare; good, happiness, needs, interests or values of the person
being constrained
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2
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Presenting all treatment options to a patient
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Ensuring that a patient understands the risks and agrees to all procedures before going into surgery
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2
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Respect for autonomy is one of the fundamental guidelines of clinical ethics
...

For a physician, respect for autonomy includes respecting an individual’s right to self-determination
as well as creating the conditions necessary for autonomous choice
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When they choose to surrender some of their
privacy, they expect that what they say or what is done to them is kept confidential
...


Euthanasia
Euthanasia (Greek euthanatos, meaning easy death) refers to the practice of ending a life in a manner which
relieves pain and suffering
...
If death is not intended, it is not an act of euthanasia
...

2
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Voluntary euthanasia: Euthanasia conducted with the consent to the patient is termed voluntary
euthanasia
...

Involuntary euthanasia: Euthanasia conducted against the will of the patent is termed involuntary
euthanasia
...

2
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Active euthanasia: It entails the use of lethal substances or forces, such as administering a lethal
injection, to kill and is the most controversial means
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It involves the abuse – actual, apparent or
potential – of the trust that people have in professionals
...
In
certain circumstances, conflict of interest can result in prosecution
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Here, primary interest refers to the
principle goal of the profession or activity and secondary interest includes personal benefit
...

Examples or Scenarios:
1
...

3
...

5
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Accepting a gift from a vendor
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‘Getting even’ with those who might have wronged you
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Doing anything that might compromise objectivity in the reporting of the truth
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Narrowly defined, an author is the originator of
any written work and can also be described as a writer
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The two are
linked
...
Authorship is important to the reputation, academic promotion and great support of the individuals
involved as well as to the strength and reputation of their institution
...

Responsibilities of an author:
1
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3
...

5
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Present data honestly and accurately, not fabricate or falsify data
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Should avoid fragmentation and redundant publication
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Must submit to only one journal at a time
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Authorship abuse:
Guest authors: A guest author is somebody who did not contribute in any way to the research and writing
but is included in the in the author list because they confer extra credibility on the article
...

Guest or gift authorship is thought to be quite common
...
In some regions of the world, this is not only expected but
also required – so many authors will not realise that it is considered unethical to include these people
...

This term is most often used to identify authors who are professional (medical communications) writers
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The authors listed on the article may have undertaken the research, created and perhaps analysed the
data, but not written the article
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The guidelines required that the named authors
should have been involved with the article from the start and should lead the writing, and that any
involvement of professional medical writers must be acknowledged within the article (if they are not named
as an author)
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Although both can be used for valid reasons, they are often used for wicked or immoral purposes
...
Ghost authorship is likewise
problematic and unethical, as it does not provide credit where credit is due and can be used to manipulate
the data and findings
...
In involves ethical
rules that apply to everyone, the scientific ethical rules and morals, which are unique for each individual
...


6
...

8
...
The healthcare professional should not
harm the patient
...

Justice: Benefits and risks should be fairly distributed
...

Beneficence: This principle considers the balancing of benefits of treatment against the
risks and costs; the healthcare professional should act in a way that benefits the patient
...
Autonomy is the capacity for self-determination

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