MINISTRY OF HEALTH OF UKRAINE

ZAPORIZHZHIA STATE MEDICAL UNIVERSITY

Department of Social Disciplines

D. P. Sepetyi

FOUNDATIONS OF BIOETHICS AND BIOSAFETY

EDUCATIONAL MANUAL
for independent work
of students of the 1-st course
of II International Faculty

Field of study 22 «Health»

Specialty 222 «General Medicine»

Zaporizhzhia
2020
UDC 608.1/.3+614.253](075.8)
S48

Approved at the meeting of Central Methodical Council of ZSMU

and recommended for the use in the educational process
(protocol № 1 from 01.10.2020)

Author:
D. P. Sepetyi – PhD in Philosophy, Associate Professor, Associate Professor of the
Department of Social Disciplines, ZSMU

Reviewers:
N.V. Spitsya – PhD in Philosophy, Associate Professor, Associate Professor of the
Department of Social Disciplines, ZSMU
Y.A. Ganoshenko – PhD in Philology, Associate Professor, Associate Professor of
the Department of Cultural Studies and Ukrainian Studies, ZSMU

S48 Sepetyi D. P. Foundations of Bioethics and Biosafety: Educational

manual for independent work of students of the 1-st course of II
International Faculty. – Zaporizhzhia: ZSMU, 2020. – 97 p.

The manual contains themes, glossary, plans, reviews of the themes,

control questions and tasks for independent work in the discipline
Foundations of Bioethics and Biosafety. For the students of the 1-st
course of II International Faculty.

UDC 608.1/.3+614.253](075.8)

© Zaporizhzhia State Medical University, 2020.

 Contents
p.
Preface 4

Theme 1. Bioethics: subject, tasks, principles, the history of development, 6

and legislative foundations
Theme 2. Bioethical foundations of the professional activity of a physician, 17
and the relationship between medical staff, the patient and his family
Theme 3. The principles and ethical problems of biomedical research 25
Theme 4. Bioethical issues of new biomedical technologies: medical 31
genetics, genetic engineering and reproductive technologies
Theme 5. Social-philosophical aspects of ethical problems in medicine. 44
Bioethical aspects of transplantology and blood transfusion. Bioethical
problems of HIV-infection and other socially dangerous infections
Theme 6. Bioethical problems of life, dying, reanimation, and death 49
Theme 7. Foundations of biosafety. The healthy way of life as a condition 62
of its duration and development

Themes for a report 71

Test tasks for the final control 73

Recommended sources 94
References 96
 PREFACE

The development of science and technology in the contemporary world has

greatly enhanced human possibilities and, at the same time, posed a number of new
ethical problems and made some traditional problems more acute. This is
especially true of the scientific and technological development in the fields of
biology and medicine. New biotechnologies provided physicians with means to
cope with many deceases and bodily deficiencies and gave them great power over
human life and death, and large responsibilities. This gives rise to the requirement
that a contemporary physician should be well aware of the main bioethical
problems and what is involved in them; understand alternative possibilities and
attitudes with respect to these problems, reasons for and against these alternatives.
The proposed course, “Foundations of Bioethics and Biosafety”, purports to give
basic integrated grasp of this ethical dimension of medical profession.
Because the work program of the course does not include seminar lessons,
the independent work of students acquires special importance. This manual
provides guidance for such a work. It covers seven themes; for every theme,
students can find the plan for preparation, control questions and tasks, the glossary
of key terms, and the review of the theme. This enables a student to master the
theme and acquire good understanding of the corresponding problems and their
possible solutions. Tо consolidate this knowledge and check the level of a
student‟s mastery of the discipline, students a proposed to prepare a report (referat)
and undergo testing. The list of the topics for reports and control test questions is
posed at the end of this manual.
The results of the study are estimated on the two-point scale: "passed",
"failed". A student receives an assessment "passed" if he/she has completed all
kinds of works provided by the curriculum in the history of medicine, he/she
attended all lectures according to thematic plans or made reworks of absences in
proper time, and earned the total number of points from 120 to 200.

4
 Points are counted for
- homeworks - from 70 to 112 points;
- report - from 16 to 28 points;
- final testing - from 34 to 60 points.
Conversion of points according to ЕСТS
The amount of points for all Mark Rating on a national scale
types of educational activities ЕСТS
180-200 A
160-179 B
140-159 C
130-139 D
120-129 E passed
70-119 FX failed, with the possibility of
repeat test
0-70 F failed, with compulsory
repetition of discipline

5
THEME 1. BIOETHICS: SUBJECT, TASKS, PRINCIPLES, THE HISTORY OF
DEVELOPMENT, AND LEGISLATIVE FOUNDATIONS

Plan
1. Ethics as a philosophical discipline. Main ethical theories: virtue ethics,
consequentialism, deontology.
2. The definition, subject and tasks of biomedical ethics
3. The history of the development of biomedical ethics
4. The legislative foundations of bioethics
Key words: morality, ethics, moral philosophy, medical ethics, bioethics,
biotechnology, virtue ethics, consequentialism, utilitarianism, deontological
ethics, deontology, philosophy of medicine

Control Questions
1. What is the difference between biotechnology‟s being interdisciplinary
and multidisciplinary?
2. What advantages and disadvantages proceed from biotechnology‟s being
interdisciplinary?
3. What do you think might be advantageous and disadvantageous
about biotechnology‟s being multidisciplinary?
4. How do advances in biotechnology generate ethical problems?
5. What do you think might be the difference between an ethical problem and a
social problem?
6. Give two examples each of (1) an ethical problem generated by biotechnology,
and (2) a social problem generated by biotechnology?
7. Explain the meaning of terms „virtue ethics‟, „consequentialism‟, and
„deontology‟.

6
Task
1. Make a list of actions that are now possible thanks to biotechnology but
which weren‟t possible 100 years ago. Using your list identify at least one ethical
or social problem that is generated by this action.
2. Select a biotechnology that particularly interests you. Think of the ethical and
social issues you think might be generated by it. Describe them.

Recommended Reading
1. Beauchamp T. L., Childress J. F. Moral Norms // Beauchamp T. L., Childress J.
F. Principles of Biomedical Ethics. – New York: Oxford University Press,
2019. – P. 1-30.
2. Bryant J., Velle L. Ethics and Bioethics // Bryant J., Velle L. Introduction to
Bioethics. – Wiley-Blackwell, 2018. – P. 23-38.
3. Talbot M. Biotechnology and Bioethics: What it is All about? Ethical theories:
virtue, duty and happiness // Talbot M. Bioethics. An Introduction. –
Cambridge University Press, 2012. – P. 3-47.
4. Veatch R., Guidry-Grimes L. The Hippocratic Oath and Its Challengers: A
Brief History // Veatch R., Guidry-Grimes L. The basics of bioethics. –
London, New York: Routledge, 2019. – P. 18-36.

Review of the Topic

The definition, subject and tasks of biomedical ethics
Bioethics is an interdisciplinary field that has emerged to address normative ethical
issues in medical practice, research, and policy – the moral, legal, political, and
social issues raised by medicine, biomedical research, and life sciences
technologies.
Translated from Greek, bioethics means ethics of life
The object of bioethics is life in the broadest sense
Three broad spheres of bioethics:

7
 1) Academic bioethics - a sphere primarily focused on how theoretical and
practical aspects of medicine affect considerations such as special obligations or
responsibilities of clinicians, what is valuable, good, right, etc. in the biomedical
context and how one might go about providing systematic accounts of such
considerations.
2) Public policy and law bioethics – its concerns lies in how legal and extra-
legal institutions can and should be involved in the regulation of clinical and
research practices.
3) Clinical ethics - its focus is directly related to how the incorporation of
bioethics into clinical practice can help to improve patient care.
Some of the most important recent advances of medical science:
‒ Doctors and scientists can extend and create life in more ways than ever before.
‒ Life-support machines help a person‟s heart beat and lungs breathe.
‒ Experimental drugs keep life-threatening illnesses like cancer and heart disease
at bay for years.
‒ Babies are conceived in a petri dish.
‒ Scientists have even discovered techniques to manipulate human genes.
Benefits: less disease, longer life, less suffering
New responsibilities:
‒ The burden of deciding between life and death at times now rests with people.
‒ Resources like transplant organs and money to pay for expensive treatments are
scarce.
‒ Machines can keep a heart beating and lungs breathing, but is that a life the
patient would want to live?
‒ Researchers can investigate new drugs and treatments, but on whom will they
be tested, and what risks will patients face?
‒ Who decides?
Some of the most debatable bioethical issues:
‒ Should life be sustained mechanically when the brain's functions have ceased?

8
‒ Should potential parents be permitted to manipulate the genetic characteristics
of their embryos?
‒ Should society ration medical care to control costs?
‒ Should fetal stem cells be experimented upon in an effort to eventually palliate
or cure debilitating diseases?
‒ the responsibilities of researchers to subjects in clinical trials;
‒ the proper criteria for determining when a living organism has died;
‒ the allocation of scarce, life-saving medical resources;
‒ the subsidization of pharmaceutical products for those who may, as a result of
their genetic makeup, miss out on some of the benefits modem medicine has
brought.
According to H. T. Engelhardt, bioethics can be considered as the third stage
in the development of (modern) philosophy of medicine. On the first stage (16 th-
17th centuries), philosophy of medicine addressed issues of prescription and
classification. On the second stage (from 18th century), the field examined how
medicine justified its empirical claims. On the third stage (beginning with 1970s),
bioethics emerged as a distinct field within the philosophy of medicine. This stage
is characterized by the emergence of secular moral experts whom the public
accepted as guides, for medical decision-making and health-care policy.1
K. W. Wildes highlights the appropriateness of considering bioethics as a
branch of social philosophy. This is due to the following points:
‒ the controversies in bioethics often reflect deeper social and moral issues that
transcend the boundaries of medicine and ethics;
‒ the bioethical study of medicine demands study of society itself – the social
context of the practice of medicine;
‒ the interconnections between the scientific norms of medicine and society's
social and moral norms;

1
Engelhardt H. T. The Ordination of Bioethicists as Secular Moral Experts. – P. 61-63.

9
‒ medicine is a social construction: definitions of key medical concepts are
socially influenced;
‒ bioethics's grounding in social philosophy is also evident in bioethics‟s
involvement with aspects of public authority:
‒ bioethics considers questions involving the social allocation of resources, and
so it cannot be divorced from those contemporary questions of ethics and social
philosophy that are relevant to debates over distributive justice.2

The history of the development of biomedical ethics

In the history of the development of biomedical ethics, four stages are usually
distinguished:
1) formation of the foundations of the discipline in ancient societies;
2) formation of corporate medical ethics in Middle Ages;
3) deontological ethics of the Modern perid;
4) the bioethical stage.
On the first stage, contributions to the development of medical ethics were
made by prominent medical doctors and philosophers of India, Mesopotamia,
Egypt, Greece, Rome. Medical ethics was formed together with ethics generally.
Ethics is the science of morality (from Latin moralis - luck, customs, habits,
behavior, fashion). Foundations of ethics in the ancient Greek philosophy were laid
by Socrates (469-399 BC), and developed by Plato (427-347 BC) and Aristotle
(384-322 BC). The foundations of the medical ethics were laid by the famous
Greek physician Hippocrates (born about 460 BC; lived nearly 83 years), and the
school he founded.
The most important views of Hippocrates:
• treatment should be a scientific activity based on the monitoring of the course of
disease and the evaluation of the effectiveness of attempted treatments;
• medicine is to be separated from religion but not from moral sources;

2
Wildes K. Bioethics as Social Philosophy

10
• "the love for the medical art is the love for humanity”;
• the doctor must enter the patient's home with the intention of bringing good and
avoiding harm and injustice.
The followers of Hippocrates formulated the famous code of medical ethics,
known as the Hippocratic Oath.
The second stage, of the formation of corporate medical ethics, was
connected with the emergence and spread of monotheistic religions (Judaism,
Christianity, Islam, and later) and with the establishment of medical faculties of
universities (X-XII centuries) and medical corporations. The bearers of medical
knowledge were usually priests and monks. The main consequences of the
formation of medical faculties in universities were the independence and wide
spread of the profession of a physician, the growth of its prestige. Graduates of
medical faculties make a "faculty promise", the content of which is close to the text
of the Hippocratic Oath.
The third stage, deontological was connected with the development of
modern science, and attempts to secure rational foundations for ethics. The
adjective “deontological” is due to the title of an influential book published in
1834, by the British philosopher and lawyer Jeremy Bentham, "Deontology, or the
science of morality". The main idea of the book is that ethics (moral estimation)
should be based on the calculation of usefulness: an action is good or bad, deserves
approval or censure depending on its tendency to increase or decrease the general
amount of happiness in society.
The fourth stage, bioethical, is usually dated from the end of 1960-s of the
beginning of 1970-s. The word “bioethics” was first used in 1969 by medical
researcher Van Rensselaer Potter to describe his idea of studying the link between
human values and biological knowledge. The bioethical stage is connected with the
emergence of important new institutions. So, in 1971, André Hellegers founded the
Kennedy Center for Bioethics at Georgetown University – “a university-based

11
locus both for theoretical reflection on issues in the field as well as for the training
of the new profession of clinically engaged philosophers and ethicists”.3
In 1974, USA Congress established the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research. The
commission was set the task “to identify the ethical principles which should
underlie the conduct of biomedical and behavioral research with human subjects
and develop guidelines that should be followed in such research.”4 The most
important results of the work of the Commission were formulated in the document
titled “The Belmont Report”. Three main principles were identified:
- the principle of respect for persons, which should underlie the guidelines for
informed consent;
- the principle of beneficence, which should guide the assessment of risks and
benefits;
- the principle of justice as a guidance for fair selection of subjects of
experiments.
Although these principles were formulated for biomedical research, they can
be applied to clinical practice as well. A short time after the Belmont Report, the
members of the Commission James Childress and Tom Beauchamp made this
generalization in the book Principles of Biomedical Ethics (1979), which has
become one of the most influential works in bioethics. In the next decade, several
other ethicists tried to develop a general framework of biomedical ethics on
different foundations. So, Robert Veatch in the book Theory of Medical Ethics
(1984) proposed to ground bioethics in the influential version of an ethical contract
theory advanced by John Rawls. H. Tristram Engelhardt, in Foundations of
Bioethics (1986), reworked and applied to medicine Immanuel Kant‟s thesis of
autonomy as the essence of the moral life; he advanced theoretically grounded

3
Engelhardt H. T. The Ordination of Bioethicists as Secular Moral Experts. – p. 78.
4
Jonsen A. The History of Bioethics as a Discipline. – p. 38.

12
arguments for the prioritization of principles, such as respect for the freedom of
individuals, over consequentialist and utilitarian considerations.
K. W. Wildes explains the emergence of bioethics as due to the following
main factors:
‒ advances in medical knowledge and technology;
‒ the development of large medical bureaucracies;
‒ the rise of moral pluralism.5
H. T. Engelhardt emphasized the importance of such factors as
‒ the deprofessionalization of medicine;
‒ the secularization of society;
‒ a socially perceived need for guidance in questions of medical research and
health care.6
To understand the specificity of bioethics, as compared with earlier stages of
medical ethics (traditional medical ethics, coming down to Hippocrates), the
following comparative table can be useful

Traditional medical ethics Bioethics

two main sources of moral the two traditional sources were no longer able to
guidance: guide medicine because of “moral pluralism”:
1) the tradition of professional people not only hold different moral views on
physician ethics; topics (e.g., abortion), but work out of different
2) the teachings of the moral frameworks and with different moral
dominant theological ethics methodologies.

primarily concerned with the the realization of the important roles of

conduct of physicians; nonphysicians in the ethical choices present in
the ethics of the guild medicine

paternalistic model of the procedures like informed consent

5
Wildes K. Bioethics as Social Philosophy
6
Engelhardt H. T. The Ordination of Bioethicists as Secular Moral Experts

13
relationship between the have come to play a central role
physician and the patient in both clinical and research ethics

A key part of the classical A wide range of views among physicians – on

notion of a profession was that issues ranging from abortion to physician-
professions had distinctive assisted suicide and the economic structures
moral dimensions. The underlying medicine – about what is or is not
importance of the notion of an appropriate behavior.
internal ethics of physicians It becomes more and more difficult
to sustain claims based on an internal morality of
medicine

the prominence of theologians Bioethics “pushed religion aside”.

As bioethics became
a form of “public” discourse,
it moved to the more "neutral" languages
of philosophy and law
and away from the "closed" languages
of the medical profession
and theological discourse.

The legislative foundations of bioethics

Bioethics is based on the foundation of human rights formulated in the General
Declaration of Human Rights (1948) and the European Convention for the
Protection of Human Rights and Fundamental Freedoms (1950). More specifically,
bioethical issues are regulated by such international documents as
‒ Nuremberg Code (1947);
‒ The Declaration of Helsinki;
‒ The Declaration of Geneva (The International Medical Oath);
‒ International Code of Medical ethics (World Medical Association, 1949)

14
‒ The Convention on Human Rights and Biomedicine (Bioethics Convention),
approved by the Committee of Ministers of the Council of Europe in 1996;
‒ General Declaration of the Human Genome and Human Rights (UN, UNESCO,
1997).
In Ukraine, important bioethical issues are regulated by The Constitution of
Ukraine, the Ethical Code of Ukrainian Doctor (approved by the Decision of the
Ukrainian Medical Council Protocol, January 27, 2006), Foundations of the Law of
Ukraine on Health Care, and other normative documents.

Glossary
Morality (from Latin: moralitas, lit. 'manner, character, proper behavior') is the
differentiation of intentions, decisions and actions between those that are
distinguished as proper and those that are improper. Morality can be a body of
standards or principles derived from a code of conduct from a particular
philosophy, religion or culture, or it can derive from a standard that a person
believes should be universal.
Ethics or moral philosophy is a branch of philosophy that involves
systematizing, defending, and recommending concepts of right and wrong conduct.
Medical ethics is a system of moral principles that apply values to the
practice of clinical medicine and in scientific research. Medical ethics is based on a
set of values that professionals can refer to in the case of any confusion or conflict.
These values include the respect for autonomy, non-maleficence, beneficence, and
justice.
Bioethics is the study of the ethical and social issues generated by
biotechnology.
Biotechnology is the application of science and technology to living
organisms and their parts, or to products and models of living organisms, in the
hope of producing understanding, goods or services.
Virtue ethics are normative ethical theories which emphasize virtues of
mind, character and sense of honesty. Virtue ethicists discuss the nature and

15
definition of virtues and other related problems that focus on the consequences of
action. These include how virtues are acquired, how they are applied in various
real life contexts, and whether they are rooted in a universal human nature or in a
plurality of cultures.
Consequentialism is the class of normative ethical theories holding that the
consequences of one's conduct are the ultimate basis for any judgment about the
rightness or wrongness of that conduct. Thus, from a consequentialist standpoint, a
morally right act (or omission from acting) is one that will produce a good
outcome, or consequence.
Utilitarianism is a family of consequentialist ethical theories that promotes
actions that maximize happiness and well-being for the affected individuals.
Deontological ethics or deontology (from Greek δέον, deon, "obligation,
duty") is the normative ethical theory that the morality of an action should be based
on whether that action itself is right or wrong under a series of rules, rather than
based on the consequences of the action. It is sometimes described as duty-,
obligation- or rule-based ethics. Deontological ethics is commonly contrasted to
consequentialism, virtue ethics, and pragmatic ethics. In this terminology, action is
more important than the consequences.
Philosophy of medicine is a branch of philosophy that explores issues in
theory, research, and practice within the field of health sciences.

16
THEME 2. BIOETHICAL FOUNDATIONS OF THE PROFESSIONAL
ACTIVITY OF A PHYSICIAN, AND THE RELATIONSHIP BETWEEN
MEDICAL STAFF, THE PATIENT AND HIS FAMILY
Plan
1. Bioethical foundations of the professional activity of a physician
2. Models of the relations between a physician and a patient
3. Bioethical aspects of the relationship between medical staff, the patient and his
family
Key words: informed consent, confidentiality, medical secrecy, paternalistic
model, engineering model, collegial model, contract model, psychotype.

Control Questions
1. What are the conditions for restricting a patient's right to privacy?
2. How is the patient's right for confidentiality ensured de jure and de facto?
3. What does the principle of informed consent mean?
4. What is included in the doctor-patient interaction system?
5. Give characterisation of paternalistic, engineering, contractual and collegial
models of doctor-patient relationships.
6. Describe the main patients' psychotypes.
7. Which of the patients' psychotypes is the most problematic and why?

Task
Think of the relative advantages and disadvantages of different models of the
relationship between a physician and a patient. Which model do you find the most
optimal to date? Explain why do you think so in the form of an essay for 2-3 pages.

Recommended Reading
1. Beauchamp T. L., Childress J. F. Professional – Patient Relationships //
Beauchamp T. L., Childress J. F. Principles of Biomedical Ethics. – New York:
Oxford University Press, 2019. – P. 327-384.

17
2. Childress J. Who should decide? Paternalism in health care. – Oxford University
Press, 1982. – 264 p.
3. Zaporozhan V.M., Aryayev M.L. Bioethical Bases of a Doctor`s Professional
Activity // Zaporozhan V.M., Aryayev M.L. Bioethics. – Odessa: Odessa State
Medical University, 2008. – P. 63-111.
4. Veatch R., Guidry-Grimes L. Principle- based Approaches to Moral Problems in
Bioethics // Veatch R., Guidry-Grimes L. The basics of bioethics. – London,
New York: Routledge, 2019. – P. 63-79.

Review of the Topic:

Bioethical foundations of the professional activity of a physician
Ethical and philosophical foundations of Hippocratic medicine:
- Do no harm!
- physician as a helper of nature (hygienic and dietary rules);
- the sanctity of life.
“I will follow that system of regimen which, according to my
ability and judgment, I consider for the benefit of my patients, and
abstain from whatever is deleterious and mischievous.”
This fragment explicitly states two important principles that a physician
should follow in his/her relationship with a patient: the principle of help and
support and the principle of non-harming.
World Medical Association issued a number of important documents that
formulate basic ethical principles of medical ethics, such as the Declaration of
Geneva (1948), the International Code of Medical Ethics (1949, adopted by the 3th
General Assembly of the WMA).
In 1974, the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research had issued the Belmont report, in which the
principles of respect for persons, beneficence, and justice were identified as the
foundation of the ethics of biomedical research. This framework was developed
and applied to medical practice in general by T.L. Beauchamp and J.F. Childress in

18
the book “The Principles of Biomedical Ethics” (1979). It distinguishes four basic
ethical principles in medicine:
1. The principle of respect towards autonomy presupposes respect towards
personality and protection of people with limited autonomy (children, patients
with mental disorders, etc.).
2. The principle of non-harming implies, that a medical worker must not act
in a way, that is practically harmful to a patient.
3. The principle of aid and comfort says that a medical worker must operate
on the behalf of a patient‟s wellbeing, show mercy and benefaction.
4. The principle of justice is directed at the observance of just distribution of
both social welfare (for example, possibilities of effective health protection) and
social duties (for example, taxes).
Recent transformation in medical ethics: from the ethics where the
dominant principle is that a physician should do what he judges to be the best for
the health of the patient (paternalistic attitude) to the ethics in which the principle
of respect for the patient’s autonomy is supreme.
The respect for the patient’s autonomy involves
• patients‟ being informed;
• knowing something of the physician‟s values;
• being assured the physician is acting for their best interests;
• retaining veto power over suggested treatments;
• enjoying a variable degree of freedom depending on personal values.7
Limitations to the principle of the patient’s autonomy
1) immaturity, mental disorder, etc.;
2) conflict with a physician‟s autonomy (his/her human or professional values);
3) danger for other people (for example, the refusal to be vaccinated).
The Declaration on the Promotion of Patients‟ Rights in Europe
(Amsterdam, 1994)

7
Schneider C. The Practice of Autonomy: Patients, Doctors, and Medical Decisions

19
• the principle of veracity: the actions or rules are morally right, if they are
directed at granting truthful information and have a goal of avoiding
dishonesty in mutual relations;
• the principle of informed consent: a competent adult patient should not be
exposed to medical interference without his/her informed and voluntarily
consent; it aims at choices that are optimal not only from the medical point of
view but also from the point of view of the person‟s values.
Key aspects of informed consent:
1) A special procedure of receiving the patient‟s or examinee‟s voluntarily
consent.
2) Adequate information about
- the aims of the planned interference;
- its duration;
- expected positive consequences for the patient;
- possible unpleasant sensations, risk for life, physical and/or sociopsychological
well-being;
- the existence of alternative treatment methods and their comparative efficiency;
- the rights of the patients or examinees and the ways of their protection.
The Constitution of Ukraine, Chapter 2, article 28:
“Nobody can be subjected to medical, scientific or other
experiments without his/her voluntarily consent”.
The principle of confidentiality. The information about a patient that is
given to the doctor or obtained as a result of medical investigations can not be
passed to a third person without this patient‟s permission. Only the patients‟
confidence in the absolute observance of confidentiality provides frankness,
which is essential for the medical workers‟ normal professional activity. By
protecting confidentiality a physician protects not only his patients‟ but also his
own personal interests.

20
Models of the relations between a physician and a patient
J. Childress (1982), to describe different types of physician-patient relationship,
use metaphors: parent-child, partners, contractors, technician-client, friends.
Accordingly, 5 basic models of the relationship in health care can be distinguished:
paternalistic (from the Latin pater - the father), collegial, contractual, friendly,
technical.
Paternalistic model is based on a centuries-old tradition of medical practice.
The center of decision-making is a medical professional, in particular, a physician
who possesses authority within an asymmetric and hierarchical relationship with
the patient (analogy with that of a pastor and parishioners, parents and children).
Collegial (partnership) model:
• opportunities to realize the values of an autonomous personality;
• partnership of healthcare professionals and their patients on the foundation of
the recognition of the value of health;
• the equality of both parties in the interpretation of these values, including
health, along with the respect for the personal autonomy of all parties;
The prototype of the model is the "adult - adult" relationship.
Contractual model: medical professionals should make a series of specific
contracts with their patients. It often allows to achieve the best compromise
between the ideals of partnership with the emphasis on equality and autonomy and
the realities of medical practice, where mutual trust cannot be guaranteed.
Friendship model is based on the view that a good physician is always a
friend to a particular patient and all patients. The model implies that the patient
trusts the physician, and the friendship of the physician is manifested in the desire
to provide effective technical assistance and goodwill. The modal makes its moral
focus on achieving equality, autonomy and the rights of both parties.
Technical (engineering) model is patterned on the relationship between the
technician (or engineer) and the client. The body of the patient is compared with
the mechanism, and the disease is interpreted as its disorder, which the physician,
as an engineer or technician, have to eliminate. The physician offers or provides

21
technical services to the patient as a consumer. The treatment process reduces to
manipulations with the patient's body.

Bioethical aspects of the relationship between medical staff, the patient and his
family
In the bioethical context, the relationship between medical staff, the patient and his
family are considered in the light of diverse economic, political, cultural and
transcultural relations. The main concern is the interests of the patient as a
consumer of medical services and society as a whole, not the interests of the
medical corporation. However, medical employees are recognized to have not only
responsibilities but natural rights as well.
A special role in the relationship between patients and medical staff belongs
to nurses, who face the full range of moral problems encountered by physicians
and, besides, additional problems arising from her professional role. Like a
physician, a nurse sometimes is forced to choose: either to do what she thinks will
promote the well-being of the patient, or to act on the basis of the esteem for the
choice of the patient. Like the Hippocratic Oath for physicians, there is a similar
ethical code for nurses, called The Florence Nightingale Pledge:
“I solemnly pledge myself before God and in the presence of this
assembly, to pass my life in purity and to practice my profession
faithfully. I will abstain from whatever is deleterious and mischievous,
and will not take or knowingly administer any harmful drug. I will do
all in my power to maintain and elevate the standard of my profession,
and will hold in confidence all personal matters committed to my
keeping and all family affairs coming to my knowledge in the practice
of my calling. With loyalty will I endeavor to aid the physician in his
work, and devote myself to the welfare of those committed to my
care.”
In the Pledge, we see a number of ethical principles that we have already
met when discussing the ethical principles of the relationship between a physician

22
and a patient: the principle of help and support, the principle of non-harming, the
principle of confidentiality.
The role of the family. The physician should not only be a good diagnosticist
and therapist, but also have training in psychology, pedagogy, sociology and
cultural issues. It is necessary to help family members to adjust to the care of the
patient, to properly orient them in matters of treatment. From the beginning of the
disease, the patient plays a new role in the family - the "role of the patient", which
implies certain rights and obligations.
The tasks of the physician in his/her work with the patient's family:
- to form a correct view of the disease;
- to help family members change their lives under new conditions, stimulate
adaptation reactions;
- to promote the involvement of the patient in the life of the family and prevent
misconduct.

Glossary
Informed consent is a process for getting permission before conducting a
healthcare intervention on a person, or for disclosing personal information. A
health care provider may ask a patient to consent to receive therapy before
providing it, or a clinical researcher may ask a research participant before enrolling
that person into a clinical trial. Informed consent is collected according to
guidelines from the fields of medical ethics and research ethics.
Confidentiality (privacy) - an attitude toward information that forbids
making it public.
Medical secrecy - the obligation of medical professionals and other persons
who have got information about a person's decease, medical examination, intimate
and family aspects in the process of performing their professional or official duties
not to disclose this information except for cases envisaged by the legislation.
Paternalistic model implies that the physician, after careful examination of
the patient's condition, establishes the most appropriate treatment for each specific

23
situation, aimed at full recovery. The last word in the choice of treatment options
remains with the physician.
Engineering model: the patient is perceived by the doctor as an impersonal
mechanism. Treatment reduces to manipulations with the patient's body.
Collegial model: the patient is considered as equal in his/her interaction with
the physician. In order to play one's role, the patient must obtain from the
physician sufficient information about his/her health status, treatment options,
prognosis, possible complications, etc. In this case, the patient can participate in
the elaboration of specific decisions regarding the treatment; he/she exercises the
inherent right of the individual for the freedom of choice.
Contract model: interaction between a physician and a patient is based on
a contract. Patients enter into a health care contract with a hospital or through an
insurance company. Each party to such an agreement has its obligations and each
achieves its benefits.
Psychological types (psychotypes) - a characteristic of a person in terms of
psychology. Because there are many psychological schools, there are different
classifications of psychological types. Any human psychotype is a generalization,
an attempt to group similar qualities that are often observed together, character
traits, temperament features, behavior and other traits of personality.

24
THEME 3. THE PRINCIPLES AND ETHICAL PROBLEMS OF BIOMEDICAL
RESEARCH
Plan
1. The main ethical principles of biomedical research. The Nuremberg Code and
the Declaration of Helsinki.
2. Ethical principles of testing with animals.
3. The principles of clinical research.
4. Ethical committees, their functions and impact
Key words: placebo, experimental units, treatment group, double-blind study,
randomization.

Control Questions
1. What are the main international documents that regulate scientific research in
medicine?
2. What is the content of the Nuremberg Code and its significance for the
regulation of biomedical experiments?
3. What are the ethical principles of animal research called the "three R"?
4. What legislative documents regulate medical research in Ukraine?
5. What legislative documents regulate medical research in your country?
6. What are Ethical committees? When and for what purpose they were
established?

Task
Write an essay (1-2 pages) on how the principles of biomedical ethics influence
experimental research in the world and in your country.

Recommended Reading
1. Beauchamp T. L., Childress J. F. The Distinction between Clinical Ethics and
Research Ethics // Beauchamp T. L., Childress J. F. Principles of Biomedical
Ethics. – New York: Oxford University Press, 2019. – P. 360-370.

25
2. Bryant J., Velle L. Humans and Hon-Human Animals // Bryant J., Velle L.
Introduction to Bioethics. – Wiley-Blackwell, 2018. – P. 265-284.
3. Bunge M. Trial // Bunge M. Medical Philosophy. Conceptual Issues in
Medicine. – World Scientific, 2013. – P. 129-150.
4. Veatch R., Guidry-Grimes L. Social Ethics of Medicine: Allocating Resources,
Health Insurance, Transplantation, and Human Subjects Research // Veatch R.,
Guidry-Grimes L. The basics of bioethics. – London, New York: Routledge,
2019. – P. 234-268.

Review of the Topic

The main ethical principles of biomedical research. The Nuremberg Code and the
Declaration of Helsinki
During the last two centuries, medicine greatly improved and attained the powers
to deal successfully with great many deceases and health problems that were
incurable before. To a great extent, this was due to the change in the method of the
evaluation of the efficiency of medicines. Two or more centuries ago, it was based
on individual cases of medical practice, which didn‟t provide the sufficient data for
the objective reliable evaluation. The mistake post hoc ergo propter hoc, when the
fact that an event B (such as patient‟s health restoration) happened after and event
A (such as taking a certain medicine) was taken as the indication that B happened
because of A (that the medicine at issue is efficient for treatment of this decease)
was rife, and really efficient medicines rare. From 19th century, and especially in
20th century, much more reliable methods – systematic scientific research in
laboratories and clinics – were widely introduced.
Besides beneficent consequences for science and medicine, biomedical
research is connected with ethical problems and requires adequate regulation. The
importance of this was made obvious by Nazi‟s crimes during the 2 nd World War,
which included biomedical research with Nazi‟s victims in concentration camps –
awful sufferings and deaths of human beings on which theses experiments were
held by German scientists. After the War, there was the great trial in Nuremberg

26
and a hot discussion about biomedical research that resulted in an important
document, the Nuremberg Code.
The Nuremberg Code (1947) is a set of research principles focused on the
rights of human participants rather than the interests of scientists. The central
principle was that in all biomedical research with human participants, their
voluntary consent is absolutely essential. Other important provisions were:
- the research should be expected to bring fruitful results for the good of society
that overweigh the risks involved;
- all unnecessary physical and mental sufferings should be avoided;
- no research should be conducted where there is a reason to believe that death or
disability injury will occur;
- the degree of risk to be taken should never exceed that determined by the
humanitarian importance of the problem to be solved.
The principles of the Nuremberg Code were developed in the Declaration of
Helsinki, first adopted in 1964, and later many times readopted with revisions and
improvements. This document is widely considered as the main international
normative document that regulates biomedical research with human participants.
The Declaration
- emphasizes that “The well-being of the human subject should take precedence
over the interests of science and society”;
- reaffirms the principle of informed consent and requires that the consent should
be in writing;
- warns against participation, if a potential participant is in dependent
relationship with researcher;
- stipulates limitations on the use of placebo;
- requires that participants should be expected to have medical benefit from
research.

27
Ethical principles of animal research
The Three R's (3R's) are guiding principles for more ethical use of animals in
testing:
 Replacement
 Reduction
 Refinement
The aim is to improve animal welfare and scientific quality where the use of
animals can not be avoided. The principles are implemented in many testing
establishments worldwide and have been adopted by various pieces of legislation
and regulations.
Replacement – preference for non-animal methods over animal methods
whenever it is possible to achieve the same scientific aims.
Reduction – preference for methods that enable researchers to obtain
comparable levels of information from fewer animals, or to obtain more
information from the same number of animals.
Refinement – preference for methods that alleviate or minimize potential
pain, suffering or distress, and enhance animal welfare for the animals used.

The guiding principles of the biomedical research with human participants

Phases of Clinical Trials:
1) Researchers test a small group of twenty to eighty healthy patients to
evaluate a drug‟s safety, set dose ranges, and determine if there are any side
effects.
2) A larger group of one hundred to three hundred people receive the drug.
These participants generally have the disease the treatment targets. During this
phase, researchers evaluate how effective the treatment is and continue to assess its
safety. If a treatment appears to be acceptably safe and effective, it moves on to
Phase 3 testing.
3) Research involves even greater numbers of people with the disease,
usually around one thousand to three thousand subjects. Testing in this phase

28
monitors effectiveness, safety, and side effects. It also compares the treatment with
any existing treatments for the disease. As more people are tested over longer
periods of time, researchers might discover rare side effects.
Phases 1-3 are the condition for a potential treatment to be approved
(licensed) by responsible state institutions.
4) Trials collect information about long-term effects and usage (often occurs
after the treatment is approved for general use).
Mario Bunge on the degrees of the excellence of experiments. There
standards: silver, golden, platinum.
“Silver standard”. It is not enough to check what happens after the stimulus
is applied; it is also necessary to check what happens with the organism when the
stimulus is not applied. Any biomedical experiment involves two groups of
organisms: experimental and control.
“Golden standard” (Randomized Clinical Trial): randomized, placebo
controlled, double-blind clinical trial.
“Platinum standard” = “Golden standard” +
the explicit formulation of the mechanism of action
Basic ethical principles of biomedical research, as formulated by the
National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research in the Belmont Report:
Principle applies to Guidelines for
Respect for Persons Informed Consent
Beneficence Risk/Benefit Assessment
Justice Fair Selection of Subjects
Assessing Risk and Protecting Patients. It is critical for researchers to
explain all known risks before the trial. If a new risk emerges during the trial, the
researchers should inform all participants.
Eligibility requirements are aimed to exclude people who have a greater risk
of being harmed in the trial. They include age, sex, type and stage of disease,
previous treatment history, and general medical condition. However, this gives rise

29
to the problem of “compassionate use” policy for terminal patients that do not meet
formal eligibility requirement but for whom experimental drugs are the last hope.

Glossary
A placebo (/pləˈsiˈboʊ / plə-SEE-boh) is an inert substance or treatment which is
designed to have no therapeutic value. Common placebos include inert tablets (like
sugar pills), inert injections (like saline), sham surgery, and other procedures.
In the design of experiments, treatments are applied to experimental units in
a treatment group. In comparative experiments, members of a control
group receive a standard treatment, a placebo, or no treatment at all. A placebo
control group can be used to support a double-blind study.
A double-blind study is one in which some subjects are given an ineffective
treatment (in medical studies typically a sugar pill) to minimize differences in the
experiences of subjects in the different groups; this is done in a way that ensures
no participant in the experiment (subject or experimenter) knows to which group
each subject belongs. In such cases, a third, non-treatment control group can be
used to measure the placebo effect directly, as the difference between the responses
of placebo subjects and untreated subjects, perhaps paired by age group or other
factors (such as being twins).
Randomization: For the conclusions drawn from the results of an
experiment to have validity, it is essential that the items or patients assigned to
treatment and control groups be representative of the same population. In some
experiments, such as many in agriculture or psychology, this can be achieved by
randomly assigning items from a common population to one of the treatment and
control groups.

30
THEME 4. BIOETHICAL ISSUES OF NEW BIOMEDICAL TECHNOLOGIES:
MEDICAL GENETICS, GENETIC ENGINEERING AND REPRODUCTIVE
TECHNOLOGIES
Plan
1. The new medical technologies and the problems of bioethics.
2. The problem of the rights of embryos and abortion.
3. Bioethical problems of new reproductive technologies.
4. Bioethical problems of genetic engineering
5. Bioethical problems of cloning and stem cell research.
Key words: embryo, abortion, assisted reproductive technology (ART), in vitro
fertilisation (IVF), egg donation, surrogacy, genetic engineering, genetic
modification, genetic manipulation, somatic cell nuclear transfer (SCNT),
cloning, reproductive cloning, therapeutic cloning.

Control Questions
1. Do we have the right to life from conception? If not when do we acquire the
right to life? What are maim views on this issue and arguments of their
supporters?
2. What are main moral issues of egg donation and surrogacy?
3. Think of the ways in which governments might allow for the right of a child to a
decent childhood consistently with recognising adults‟ rights to found a family?
4. Do you think that therapeutic cloning is morally acceptable? What
arguments pro and cons do you know?
5. Why will clones always have „confused and ambiguous‟ family relationships? Is
the fact that clones will always have confused and ambiguous family
relationships reason to believe that reproductive cloning should be banned?
6. Do you think that reproductive cloning will ever be morally acceptable? Why do
you think so?

31
Task
1. Find out more about why the Warnock Committee decided that therapeutic
cloning is morally acceptable until the 14th day:
http://www.publications.parliament.uk/pa/cm200607/cmselect/cmsctech/272/27205.htm
Make a summary (1-2 pages).
2. Read this debate on cloning between two scientists on Online
Newshour: http://www. pbs.org/newshour/health/cloning.html
Make a summary (1-2 pages).

Recommended Reading
1. Bryant J., Velle L. Life Before Birth // Bryant J., Velle L. Introduction to
Bioethics. – Wiley-Blackwell, 2018. – P. 41-82.
2. Mooney C. Genetic Testing and Engineering. Stem Cell Research and Cloning
// Mooney K. Bioethics. – Lucent Books, 2009. – P. 66-92.
3. Talbot M. Cloning. Reproduction // Talbot M. Bioethics. An Introduction. –
Cambridge University Press, 2012. – P. 93-202.
4. Veatch R., Guidry-Grimes L. Reproductive Choice and Advancing
Technologies: Ethical Challenges in the Creation of Humans // Veatch R.,
Guidry-Grimes L. The basics of bioethics. – London, New York: Routledge,
2019. – P. 216-233.

Review of the Topic

The new medical technologies and the problems of bioethics
Common characteristics of the most innovative developments in biomedicine:
• The aspiration to achieve the most fundamental control over bioprocesses and
biostructures, on the molecular level.
• Aim at the creation of radically new states, processes, structures, objects, etc.,
which are anomalous from the point of view of natural biological regularities
and deeply artificial.

32
• These developments already have (and will exert in the future) a great impact on
morality and value systems, stimulate a revision of traditional notions and social
norms.
The main bioethical issues due to these developments concern:
• human genetics: human genome, biotechnology and gene therapy, cloning and
stem cells;
• human procreation: human sexuality, natural reproduction, artificial
insemination, natural regulation of conception and contraception, sterilization;
• embryo: human embryo, abortion, prenatal diagnosis, operations on human
embryos;
• the final phase of human life: pain and euthanasia, abusive therapy, palliative
evaluation, brain death and organ transplantation;
• use of transgenic plants for food purposes.

Bioethical problems of new reproductive technologies

Great scientific advances concerned with reproduction, procedures such as in vitro
fertilization (IVF) and surrogacy allow childless individuals to become parents.
However, these procedures raise objections, such as that medical intervention is
moving too close to “playing God”, and a number of new bioethical questions,
such as:
• When does life begin?
• When egg donors and surrogates are involved, who is the rightful parent?
• Does everyone have the right to become a parent no matter their age or personal
situation?
• Who should decide?
Assisted reproductive technology (ART) means all fertility treatments in
which both eggs and sperm are handled. It involves surgical removal of eggs from
a woman‟s ovaries, combining them with sperm in the laboratory, returning them
to the woman‟s body or donating them to another woman. Such technologies are in
vitro fertilization (IVF), egg donation and surrogacy. At first, ART helped married

33
women who could not conceive naturally because of fallopian tube blockages.
Later, the range of people interested in ART widened: it includes healthy couples
who wanted to avoid a genetic disease such as cystic fibrosis or hemophilia, and
opens a controversial door to parenthood for old women, single mothers, and
same-sex partners.
Ethical problems raised by ART:
• ART research and procedures destroy and endanger human embryos, whose
moral status and the right to live is a matter of heated bioethical argument. In a
typical treatment cycle, doctors remove and fertilize several eggs. Of the
embryos that develop, they select a few to implant. What happens to the others?
Options:
- destroyed,
- made them available for research,
- donated to another infertile couple,
- frozen indefinitely.
• ART is very expensive and usually accessible only for rich people.
In vitro fertilization (IVF). In 1978, first healthy child born as a result of in
vitro fertilization. Early success rates were low, but they improved over time. By
2005, 35 percent of IVF cycles resulted in a live birth.
Egg donation. Egg donation raise the following main criticisms:
• Infertile couples can search egg donation databases by race, height, eye color,
blood type, and education. Sperm banks provide the same opportunity for
selecting a future child‟s characteristics. Eggs from smart, pretty women are in
the greatest demand and carry the highest price. Critics fear this trend
demonstrates how donor databases encourage couples to select desirable traits
for their child. They believe favoring attractive and intelligent donors is a step
closer to eugenics, the practice of encouraging reproduction in people with
desirable traits.
• The price of an egg is too high. Typically, donors receive several thousand
dollars for their eggs. With eggs in short supply, the price for donation continues

34
 to increase. Some people believe selling eggs is unethical. They believe eggs
should be treated like hearts and kidneys and donated freely through a national
donor system. The donors disagree.
Surrogacy. If a woman is unable to carry a child in her body, doctors can use
ART to place an embryo in a surrogate mother‟s uterus. The embryo can be created
from the prospective parents‟ egg and sperm. In this case the child is not
genetically related to the surrogate mother.
Surrogacy removes natural limits of the age of mothers. Naturally, the elder
women is, the less likely is that she can become mother. With surrogacy, a child
can be born by the surrogacy mother and then is given to the genetic mother, with
no age limitations. So, the Romanian woman Adriana Iliescu became mother at the
age sixty-six, the oldest on record. This raises a new ethical questions: How old is
too old for parenthood? Is it fair to bring a child into the world with parents who
will be in their seventies and eighties when the child enters high school? In
England doctors refused to treat a woman in her fifties, claiming she was too old
for the stress of motherhood. As The British secretary of health explained, “There
are deep ethical considerations, and the child‟s welfare must be considered. A child
has a right to a suitable home.”8
With all ethical questions raised by ART, the problem of decision-making is
burning. Who should decide, and on which rules and considerations should guide
such decisions? Without any substantial governmental regulation, doctors decide
every day which families and children they will create and which they will not. As
Applegarth points out, the decision-making requires answering difficult questions

and balancing interests of a number of people: “Who is our patient? Is it the two
people sitting in front of me? The child potentially created? The donor of the
gamete? We have to consider all of these people when we‟re making these
decisions.”9

8
Quot. in Mooney K. Bioethics. – p. 21.
9
Quot. in Mooney K. Bioethics. – p. 22.

35
Bioethical problems of medical genetics and genetic engineering
Medical genetics – the field of medicine, the science that studies heredity and
variability in different populations of people, the manifestation and development of
normal and pathological features, the dependence of diseases on genetic or
epigenetic abnormalities. The task of medical genetics is to identify, study, prevent
and treat hereditary diseases, to develop ways of preventing the impact of negative
environmental factors on human heredity.
Moral problems of medical genetics:
• the morality of diagnosing of a pathological condition of a person in the absence
of effective methods of its treatment;
• the moral responsibility of mankind and society for the health not only of people
that live now but also of future generations;
• keeping medical secrets, the confidentiality of genetic information;
• voluntary genetic testing of individuals and screening of the population;
• the availability of medical and genetic care for different social strata;
• moral problems of eugenics – the science that studies and develops ways and
methods of active influence on the evolution of mankind, the improvement of its
nature;
• moral problems of gene therapy, etc.
The Human Genome Project. In 1990, a massive international project to
better understand human genes was started. By 2003, the Human Genome Project
mapped the complete set of human DNA and identified the genes contained. More
than fourteen hundred disease genes were identified. Part of the project was the
Ethical, Legal and Social Implications (ELSI) program - the world‟s largest
bioethics program. Some issues the program studied:
• Who should have access to personal genetic information, and how will it be
used?
• How does personal genetic information affect an individual and society‟s
perceptions of that individual?
• Should testing be performed when no treatment is available?

36
• Should parents have the right to have their minor children tested for adult-onset
diseases?
• Where is the line between medical treatment and enhancement?
Genetic Testing is used to diagnose disease or identify the patient as a
carrier of the genetic disease, to assess a person‟s risk of getting certain diseases.
There are gene tests for more than thirteen hundred diseases, with many more in
development. After testing positive, patients have a better understanding of their
risk of getting the disease. As a result, they may decide to alter their diet and
lifestyle to reduce other risk factors. They may be more diligent about medical
exams and paying attention to warning symptoms. They may also decide to
undergo aggressive preventative treatment.
Privacy concerns: genetic test results could cause social embarrassment or
discrimination. Insurance companies can raise premiums or refuse to cover
individuals who test positive for expensive diseases. Knowing genetic test results,
employers might not hire a candidate who will have future health problems,
costing the company time and money. Even current employees worry their jobs
may be at risk if employers learn they have tested positive for a disease that will
require time off and expensive treatments.
Preimplantation Genetic Diagnosis (PGD): In case of in vitro fertilization,
genetic testing for an embryo before it is implanted in the uterus. This allows
screening out embryos with positive results. Usually, this is used for screening for
abnormal chromosomes that may lead to miscarriage, chromosome disorders such
as Down syndrome, and genetic diseases like cystic fibrosis. However, the wider
and more trouble-raising use is possible – to select characteristics based on
preference. Already, it is possible to test embryos for inherited deafness or a
predisposition to arthritis or obesity. Genetic tests can easily be used to select a
baby‟s sex.
Some ethical problems with PGD:
• PGD is not infallible.

37
• At what point are we engaging in eugenics and not accepting the normal
diversity within a population?
• In the United States, PGD is not regulated, so the decisions on what testing is
appropriate and ethical are made by doctors and their patients.
• The high cost of PGD may be a barrier to some families. If only the wealthy can
afford to screen out genetic disability and disease, some fear PGD may be the
first step toward a genetic class divide. The wealthy become genetically
healthier, while the poor are left to deal with disease and disability.
Genetic engineering – a complex of techniques aimed at transferring some
kinds of genetic information into the structure of cells of a living creature.
Using gene therapy for treatment. Somatic gene therapy attempts to treat a
specific disease by replacing defective or missing genes. To deliver the normal
DNA into a patient‟s cells, scientists use viruses as the vehicle, which can produce
negative (dangerous) side-effect. An outstanding example is treatment of severe
combined immune disorder (SCID).
In 2000, French scientists reported a breakthrough in a study of infants with
SCID. They took bone marrow cells from each child in the study, and added
viruses to carry healthy immune system genes to these cells. Then they injected the
modified cells back into the patients‟ bone marrow. The virus copied the new
healthy genes in the patients. Within three months, the infants were home, living
like normal children. Within ten months, doctors declared their immune systems
completely normal. Despite their success, unintended consequences arose three
years later. Three of the ten infants developed leukemia, and one died. That
happened because the viruses that were used to deliver healthy genes could trigger
cancer if they lodged in a patient‟s DNA near a cancer-causing gene.

Stem Cell Research and Cloning

Reproductive cloning. In 1997, there was the first case of cloned mammal, sheep
named Dolly. Dolly was the exact DNA replica of the first ewe, from whose
genetic material she was created. In addition, her birth occurred without the

38
involvement of a male parent. This complex procedure is called reproductive
cloning.
The cloning of Dolly, a mammal, indicated that human beings can be cloned
as well. End this gave rise to the debate about the permissibility of human cloning.
In reaction to this debate, ethics councils and legislatures around the world
condemned the use of cloning to produce a human child. This attitude was
supported by the United Nations. In 2005, UN backed a worldwide ban on all
forms of human cloning.
One reason why human cloning is recognized impermissible is that it
involves experiments with and destruction of human embryo‟s. As William B.
Hurlbut, a Stanford University ethicist, points out, “A decent society doesn‟t build
the foundations of its biomedical science on the creation and destruction of human
embryos.”
Therapeutic cloning. Cloning can be used not for reproduction but in
therapeutic purposes. In this case, the embryo is not grown into a baby but is
instead used to harvest stem cells. Stem cells have the ability to renew themselves
through cell division and can become, or differentiate into, a range of specialized
cell types. Scientists envision a future where they would be able to grow these
stem cells into other tissues and organs, which could then be transplanted into
patients.
The expected possibilities of therapeutic cloning:
- cloned brain cells would treat Parkinson‟s disease, and new pancreatic cells
would treat diabetes;
- the use of organs cloned from a patient‟s own cells would eliminate the
needless deaths of people waiting on organ transplant lists;
- organ rejection would no longer be a problem for transplant patients,
eliminating the need for a lifetime of expensive antirejection drugs.
There are two main types of stem cells - adult stem cells, found in adult
tissue, and embryonic stem cells. Their use in therapeutic purposes has comparative

39
advantages and disadvantages and, in case of embryonic stem cells, raises hot
ethical debates.
Adult stem cells:
- help to repair the body and replenish normal turnover of blood, skin, or
intestinal cells;
- are limited in the range of cells they can become;
- have been used successfully to treat leukemia and other bone and blood
cancers;
- no embryos are destroyed and donors knowingly give consent;
- no ethical problems with the use in research and therapies.
Embryonic stem cells:
- do not have the limitations of adult stem cells;
- the unique ability to become any one of the cell types in the human body
(pluripotency), which allows the cells to develop into virtually any type of
tissue or organ in the human body;
- embryos are used and destroyed, and so the problem of the ethical
permissibility arises.
The stem cell debates. In 1998, James Thomson at the University of
Wisconsin became the first scientist to remove stem cells successfully from a
human embryo. The process destroyed the embryo. Contemporary technologies of
the extraction of embryonic stem cells also involve destruction of embryos. This is
the reason for a hot ethical debate: whether such research and use of human
embryos is permissible. Supporters believe that stem cell research brought hope to
the millions of people living with and dying of serious diseases. Opponents protest
against the destruction of an embryo. Pope John Paul II described the Catholic
Church‟s opposition to stem cell research by writing, “Human embryos obtained in
vitro are human beings and are subjects with rights; their dignity and right to life
must be respected must be respected from the first moment of their existence.” 10

10
Quot. in Mooney K. Bioethics. – p. 89.

40
Critics of stem cell research also opposed the creation of embryos specially for
research use.
A partial solution of the problem can be provided by a new technology
introduced in 2007. Researchers discovered a way to take adult skin cells and
regress the cells back to an embryonic state. The reprogrammed adult cells, called
induced pluripotent stem cells, or IPS cells, seemed to offer the same promise of
embryonic stem cells without making or destroying human embryos. They
provided scientists a way to produce genetically matched cells without cloning or
egg donation. However, the use of induced pluripotent stem cells have serious
limitations:
1) IPS cells are still very preliminary, and they will need a lot of work before
you can say that they would be better or equivalent to embryonic stem cells.
2) The risk of cancer: reprogramming the adult cells involves viruses that
sometimes turn off tumor-suppressing genes, causing a cancer to grow out of
control, and a gene known to increase the risk of cancer.
Another partial solution of the problem can be the use of stem cells extracted
from cord blood. Cord blood is the blood remaining in the umbilical cord and
placenta after birth; it is a rich source of stem cells. These stem cells have the
ability to become many types of body cells and can be used to repair or replace
damaged cells in the body. While not as versatile as embryonic stem cells, cord
blood stem cells have an advantage over bone marrow stem cells. When used in
transplants, cord blood cells are less likely to trigger rejection in patients. Cord
blood technology can be used to treat over seventy types of genetic illnesses.
Generally, the prospects of stem cell therapies are still for from clear. So far,
they are not clinically applicable. In labs, growing the cells into heart cells, nerve
cells, or whatever tissue is needed has proven extremely difficult. The actual
survival of the cells is too poor. Many scientists believe effective stem cell
therapies are still years away from human trials. The more immediate use for stem
cells may be for researching and understanding disease. That knowledge could
develop more conventional medicines and therapies.

41
Glossary
An embryo is an early stage of development of a multicellular organism. In
general, in organisms that reproduce sexually, embryonic development refers to the
portion of the life cycle that begins just after fertilization and continues through the
formation of body structures, such as tissues and organs.
Abortion is the ending of a pregnancy by removal or expulsion of an embryo
or fetus before it can survive outside the uterus. An abortion that occurs without
intervention is known as a miscarriage or spontaneous abortion. When deliberate
steps are taken to end a pregnancy, it is called an induced abortion, or less
frequently "induced miscarriage". The unmodified word abortion generally refers
to an induced abortion.
Assisted reproductive technology (ART) includes medical procedures used
primarily to address infertility. This subject involves procedures such as in vitro
fertilization, intracytoplasmic sperm injection (ICSI), cryopreservation of gametes
or embryos, and/or the use of fertility medication.
In vitro fertilisation (IVF) is a process of fertilisation where an egg is
combined with sperm outside the body, in vitro ("in glass"). The process involves
monitoring and stimulating a woman's ovulatory process, removing an ovum or
ova (egg or eggs) from the woman's ovaries and letting sperm fertilise them in a
liquid in a laboratory. After the fertilised egg (zygote) undergoes embryo culture
for 2–6 days, it is implanted in the same or another woman's uterus, with the
intention of establishing a successful pregnancy.
Egg donation is the process by which a woman donates eggs to enable
another woman to conceive as part of an assisted reproduction treatment or for
biomedical research. For assisted reproduction purposes, egg donation typically
involves in vitro fertilization technology, with the eggs being fertilized in the
laboratory; more rarely, unfertilized eggs may be frozen and stored for later use.
Egg donation is a third party reproduction as part of assisted reproductive
technology.

42
 Surrogacy is an arrangement, often supported by a legal agreement,
whereby a woman (the surrogate mother) agrees to bear a child for another person
or persons, who will become the child's parent(s) after birth.
Genetic engineering, also called Genetic modification or Genetic
manipulation, is the direct manipulation of an organism's genes using
biotechnology. It is a set of technologies used to change the genetic makeup of
cells, including the transfer of genes within and across species boundaries to
produce improved or novel organisms. New DNA is obtained by either isolating
and copying the genetic material of interest using recombinant DNA methods or by
artificially synthesising the DNA. A construct is usually created and used to insert
this DNA into the host organism.
Somatic cell nuclear transfer (SCNT) - the technology in which the nucleus
from a somatic cell (an ordinary body cell) of an organism is inserted into the de-
nucleated egg of another (female) member of the same species (or even that of
another species as with chimera), and triggered into developing as an embryo.
Cloning is the process of producing genetically identical individuals of an
organism either naturally or artificially. In nature, many organisms produce clones
through asexual reproduction. Cloning in biotechnology refers to the process of
creating clones of organisms or copies of cells or DNA fragments (molecular
cloning). Beyond biology, the term refers to the production of multiple copies of
digital media or software.
Reproductive cloning: the use of SCNT to produce human embryos to
implant into the wombs of women. This will produce human babies with genomes
identical to the nucleus donors.
Therapeutic cloning: the use of SCNT to produce human embryos
genetically identical to the nucleus donor. These embryos are then used for
research, or for the harvesting of stem cells, then destroyed.

43
THEME 5. SOCIAL-PHILOSOPHICAL ASPECTS OF ETHICAL PROBLEMS
IN MEDICINE
Plan
1. Social justice and socio-ethical obligations in medicine
2. Bioethical aspects of transplantology and blood transfusion
3. Bioethical problems of HIV-infection and other socially dangerous infections
4. Medical errors and iatrogeny
Key words: organ transplantation, autograft, xenograft, medical error,
iatrogenesis.

Control Questions
1. What are the main ethical problems and approaches with respect to just
distribution of medical recources?
2. What are the main ways of organizing national health care systems, and how
they relate to the problem of social justice in medicine?
3. What are the main ethical problems of transplantation?
4. What are the criteria of the death of a person that allow taking organs for
transplantation?
5. Give the definition of the term "medical error".
6. What is iatrogenesis? What are its main kinds and causes?

Task
Study the main international regulations on transplantation. Prepare a report (2-3
pages) on the main provisions of these regulations.

Recommended Reading
1. Zaporozhan V.M., Aryayev M.L. The Social Ethics of Medicine. Separate
Ethical Problems of the Clinical Medicine // Zaporozhan V.M., Aryayev M.L.
Bioethics. – Odessa: Odessa State Medical University, 2008. – P. 198-212, 222-
230.

44
2. Talbot M. Human justice: the developed and developing worlds // Talbot M.
Bioethics. An Introduction. – Cambridge University Press, 2012. – P. 371-392.
3. Mooney C. Decision Makers // Mooney K. Bioethics. – Lucent Books, 2009. –
P. 23-37.
4. Veatch R., Guidry-Grimes L. Social Ethics of Medicine: Allocating Resources,
Health Insurance, Transplantation, and Human Subjects Research // Veatch R.,
Guidry-Grimes L. The basics of bioethics. – London, New York: Routledge,
2019. – P. 234-268.

Review of the Topic

Ethical problems of transplantology
Organ transplantation is a medical procedure in which an organ is removed from
one body and placed in the body of a recipient, to replace a damaged or missing
organ. The sources of organs for transplantation may be corpses, alive donors,
artificial organs, animal organs (xenotransplants), fetal tissues.
The main ethical problems of transplantology are
‒ justifiability of the redistribution of medical resources for the development of
transplantology;
‒ financial issues of making transplantation operations;
‒ problems of particular stages: constatation of the death of a person on the brain
death criteria; explantation of an organ or tissues from a corpse or a living
person; distribution of the available organs of tissues.
Ethical and legislative regulation of after-death explantation of organs and
tissues of humans involve three alternative approaches:
‒ procedural;
‒ based on the presumption of consent;
‒ based on the presumption of the lack of consent.
The distribution of organs for transplantation is based on the moral
principles of utility and equality. To achieve justice in the distribution, a number of

45
considerations should be taken into account, such as donor-recipient compatibility,
the time of waiting, the emergency, the distance between a recipient and an organ.

Ethical problems of AIDS (HIV). AIDS is an incurable decease caused by

HIV-infection. HIV is a virus transmitted through liquids that enter human body,
usually with sexual intercourse of blood. In 30-40% a baby of a HIV-infected
mother is born HIV-infected.
The main ethical problems that arise with respect to HIV-infected patients
are:
‒ informed consent to checkup and treatment;
‒ issues of social health;
‒ politicisation of the disease;
‒ the problem of the stigmatisation;
‒ confidentiality and the attitude of medical workers to a terminal disease.
The information about the positive result of the checkup on HIV leads to
cardinal changes in the life of a person. A patient faces a difficult dilemma: either
be honest and undergo the risk of rejection, or conceal the truth and endanger the
life of the partner. The best way to prevent the promulgation of HIV is education
and support for responsible sexual behaviour that involves care for the partner.
In blood transfusions, the physician that takes blood should ensure that the
donor is not HIV-infected. The HIV-checkup is necessary.

Medical mistakes. Medical mistake is an action of a medical worker that

results in unintended negative effects. Causes of medical mistakes can be divided
into objective and subjective.
Objective causes include:
‒ inadequacy of the available relevant information: rapid "aging" of scientific
knowledge, insufficient reliability of the available data, redundancy of
information;
‒ lack of time for taking decision;

46
‒ unavailability of necessary methods of diagnostics and treatment;
‒ limited medical knowledge.
The main subjective causes are:
‒ specific features of the personality of the physician and his/her emotional state
at the time of performing his/her work;
‒ the lack of experience and/or qualification that is not due to professional
ignorance.
In order to prevent medical mistakes, a physician should follow
deontological rules that involve the full competence as a form of professional
integrity; constant careful checkup of the patient; rational caution; the capability to
take decisions in difficult circumstances; full integrity with respect to professional
duty.

Iatrogenesis. Iatrogenesis is health-damaging mental frustration of a patient

due to the incorrect imprudent statements or actions of a medical worker.
Iatrogenic disease is a disease that arise because of negative impact of the
physician‟s behaviour or other medical factors on the mental state of a patient.
Iatrogenic diseases develop in the conditions that involve emotional lability,
distrust, and fear. The typical kind of a physician‟s behaviour responsible for
iatrogenesis are mistaken diagnosis, inept explanation of the patient‟s condition or
of particular manifestations of the decease, uncautious talk of a physician with
other people about the patient‟s health. The prevention of iatrogenesis requires
tactfulness and tolerance, understanding of the psychology of the patient,
individual approach. Beneficent psychological climate and the healing role of
conversation are of primary importance.

Glossary
Organ transplantation is a medical procedure in which an organ is removed from
one body and placed in the body of a recipient, to replace a damaged or missing

47
organ. The donor and recipient may be at the same location, or organs may be
transported from a donor site to another location.
An autograft is a transplant of tissue to the same person. Sometimes this is
done with surplus tissue, tissue that can regenerate, or tissues more desperately
needed elsewhere (examples include skin grafts, vein extraction for CABG, etc.).
A xenograft is a transplant of organs or tissue from one species to another.
An example is porcine heart valve transplant, which is quite common and
successful. Another example is attempted piscine-primate (fish to non-human
primate) transplant of islet (i.e. pancreatic or insular tissue) tissue.
A medical error is a preventable adverse effect of care ("iatrogenesis"),
whether or not it is evident or harmful to the patient. This might include an
inaccurate or incomplete diagnosis or treatment of a disease, injury, syndrome,
behavior, infection, or other ailment.
Iatrogenesis - an adverse effect on a person, resulting from activity of one or
more other persons acting as healthcare professionals or promoting products or
services as beneficial to health. Includes all adverse unforeseen outcomes as well
as foreseen outcomes from medication or other medical treatment or intervention.

48
THEME 6. BIOETHICAL PROBLEMS OF LIFE, DYING, RESUSCITATION,
AND DEATH. EUTHANASIA
Plan
1. The problems of life, dying, resuscitation, and death in philosophy and history
of different cultures
2. The human rights to live and to die with dignity
3. Euthanasia: the concept, active and passive euthanasia. Iatrotanasia
4. Palliative care. Hospices.
Key words: euthanasia, passive euthanasia, active euthanasia, palliative care,
hospice.

Control Questions
1. What are/were the views on euthanasia of different religions and philosophers?
2. Why is the problem of euthanasia became more acute in the 20-th century?
3. What is the difference between active and passive euthanasia?
4. How do different countries in the world treat euthanasia?
5. Which kind of euthanasia - active or passive - is more likely to be morally
justifiable, and why?
6. Can iatrotanasia be morally justifiable?
7. What are the main principles of palliative care in hospices?

Task
Write an essay ( 2-3 pages) about your personal attitude towards euthanasia.
Provide reasons for your attitude. Discuss the arguments of the opposite side.

Recommended reading
1. Bryant J., Velle L. Decisions at the End of Life: When May I Die and When
Am I Dead // Bryant J., Velle L. Introduction to Bioethics. – Wiley-Blackwell,
2018. – P. 159-178.

49
2. Mooney C. The End of Life // Mooney K. Bioethics. – Lucent Books, 2009. –
P. 38-52.
3. Talbot M. Aging and Death // Talbot M. Bioethics. An Introduction. –
Cambridge University Press, 2012. – P. 203-246.
4. Veatch R., Guidry-Grimes L. The Principle of Avoiding Killing // Veatch R.,
Guidry-Grimes L. The basics of bioethics. – London, New York: Routledge,
2019. – P. 152-170.

Review of the Topic

The problems of life and death in philosophy and history of various cultures
The topic of death is one that greatly troubled people of all times and cultures.
Human mortality is not merely a natural phenomenon but social phenomenon as
well. Throughout its history, mankind tried to make sense of death and of life in
the perspective of its mortality. The special awareness and importance of death is
reflected in all religions and rites, especially the rites of burials, which was
practiced in the eldest cultures, already with Neanderthals (more than about 40,000
years ago).
Spanish novelist and philosophers of 20-th century Miguel de Unamuno
emphasized the role of the rite of burials for religion:
“It has been said a thousand times and in a thousand books that ancestor-
worship is for the most part the source of primitive religions, and it may be
strictly said that what most distinguishes man from the other animals is that,
in one form or another, he guards his dead…; he is an animal that guards its
dead. … This cult, not of death but of immortality, originates and preserves
religions.”11
The fear of death has given rise, in many religions, to the idea of soul, as
non-material entity distinct from the body, and its immortality. There are two
major forms of this belief:

11
Unamuno M. Tragic Sense of Life. – New York: Dover Publications, 1954.

50
 1) the belief that the human soul, which was created by God, after the death
of the body can continue its existence in another world (Aid, the Kingdom of
Heaven, etc., - this belief is characteristic for monotheistic religions of Islam,
Christianity and Judaism);
2) the belief that the human soul, after the death of the body can be reborn in
another body (this belief is characteristic for religious traditions of India).
Philosophers, from ancient times, proposed their recipes of overcoming the
fear of death.
So, the famous ancient Greek philosopher Socrates suggested that “no one
knows whether death, which they in their fear apprehend to be the greatest evil,
may not be the greatest good”. Moreover, “this fear of death is indeed the pretense
of wisdom, and not real wisdom, being the appearance of knowing the unknown;
… conceit of knowledge, which is a disgraceful sort of ignorance”. He made a
more detailed discussion of this issue:
“… there is great reason to hope that death is a good, for one of two things:
– either death is a state of nothingness and utter unconsciousness, or, as
men say, there is a change and migration of the soul from this world to
another. Now if you suppose that there is no consciousness, but a sleep like
the sleep of him who is undisturbed even by the sight of dreams, death will
be an unspeakable gain. For if a person were to select the night in which
his sleep was undisturbed even by dreams, and were to compare with this
the other days and nights of his life, and then were to tell us how many
days and nights he had passed in the course of his life better and more
pleasantly than this one, I think that any man, I will not say a private man,
but even the great king, will not find many such days or nights, when
compared with the others. Now if death is like this, I say that to die is gain;
for eternity is then only a single night. But if death is the journey to
another place, and there, as men say, all the dead are, what good … can be
greater than this? If indeed when the pilgrim arrives in the world below, he
is delivered from the professors of justice in this world, and finds the true

51
 judges who are said to give judgment there, Minos and Rhadamanthus and
Aeacus and Triptolemus, and other sons of God who were righteous in
their own life, that pilgrimage will be worth making. What would not a
man give if he might converse with Orpheus and Musaeus and Hesiod and
Homer? … I, too, shall have a wonderful interest in a place where I can
converse with Palamedes, and Ajax the son of Telamon, and other heroes
of old … What would not a man give, O judges, to be able to examine the
leader of the great Trojan expedition; or Odysseus or Sisyphus, or
numberless others, men and women too! What infinite delight would there
be in conversing with them and asking them questions!” (Plato. Apology)
Another famous ancient Greek philosopher who paid much attention to the
problem of the emancipation from the fear of death was Epicurus. Epicurus was a
materialist and did not believe in the afterlife. His recipe against the fear of death
was as follows:
“Accustom yourself to believe that death is nothing to us, for good and evil
imply awareness, and death is the privation of all awareness… Death,
therefore, the most awful of evils, is nothing to us, seeing that, when we
are, death is not come, and, when death is come, we are not. It is nothing,
then, either to the living or to the dead, for with the living it is not and the
dead exist no longer.” (Epicurus. Letter to Menoeceus)

The human rights to live and to die with dignity. The problem of the right for
euthanasia. Active and passive euthanasia
Contemporary medicine makes a great contribution to the conditions that make the
average lifetime longer and longer. With life prolongation, the focus shifts away
from simply keeping people alive to helping them have a good quality of life.
With respect to people in very grave health conditions that cause great
suffering this raises the problem of the right to a dignified death – to dispose of
oneself, one‟s life and death, freely, at one‟s own discretion. One way to do it is
the refusal of treatment in situations in which it is too painful, unpromising, and

52
leads to the loss of human dignity. The California Natural Death Act (1977)
recognizes the rights of the terminally ill to refuse medical treatments and
interventions.
More active ways of terminating one‟s own life are more debatable. Some
religions, Christianity included, deny the right for a suicide because, according to
their doctrines, only God, who had given life to a person, is to take it away. The
person himself should not commit suicide, whatever are his sufferings – suicide is
considered as a grave sin.
On the other hand, supporters of the right for a suicide argue that, besides
suffering, some health conditions make the life of a person inconsistent so
miserable that it loses its dignity. It is the moral right of the human being to end his
life on his/her will in a dignified way rather than continue one‟s wretched
existence.
One of the ancient defenders of the dignified self-caused death (suicide) was a
Roman philosopher Lucius Annaeus Seneca, who wrote in the book titled “The
Moral Letters to Lucilius”:
“To a life, one should not always cling. For mere living is not a good, but
living well. Accordingly, the wise man will live as long as he ought, not as
long as he can. He always reflects concerning the quality, and not the
quantity, of his life. … Must I await the cruelty either of disease or of man,
when I can depart through the midst of torture, and shake off my troubles?
This is the one reason why we cannot complain of life: it keeps no one
against his will. … Every man ought to make his life acceptable to others
besides himself, but his death to himself alone.”
In the contemporary society, with weakening of the influence of religion, the
right for a suicide finds wider support. Anyway, a person who makes this final step
successfully cannot be punished any more in this world. The more burning issue
connected with the right for a suicide is one that has to do with the involvement of
another person in the causation of death of a person who wills to die. Usually, the
person involved is a physician. The issue is about the admissibility of euthanasia.

53
 Euthanasia (from Greek "easy death") – is helping a person to die, on his or
her will, in order to end suffering (active euthanasia) or withdrawal of medical
care that leads to death (passive euthanasia). Both kinds of euthanasia are
associated with a number of ethical problems that raise hot debates. They become
topics of movies such as “Million Dollar Baby” (2004), “The Sea Inside” (2004)

Ethical problems of resuscitation and passive euthanasia

The main ethical problems of resuscitation:
‒ The issue of saving the lives of incurable patients: are traditional medical
ethical principles, which prescribe fighting for life “to the end”, right if the
patient prefers "easy death“?
‒ In transplantation – the need to remove a “living” donor organ whose owner
should be irretrievably dead.
‒ The prolongation of a patient‟s life with the use of equipment: when switching
off the equipment (that will results in the patient‟s death) is morally justified?
The problem of the criterion of death. In traditional case, when the heart
stopped beating and the lungs ceased breathing (the irreversible cessation of the
cardiopulmonary system) the person was considered dead. However, situation has
changed with new technologies that allow reanimation, heart and lung transplants,
and long-term support of the partial functioning of the human body with technical
means. In this situation, a more adequate criterion of death is brain death –
the irreversible cessation of brain function. However, this criterion leaves an
important problem due to the fact that brain function is not an absolute matter but a
matter of degree. It is not the case that the brain always either functions or not; it
can function but partially, and it is not clear which functions are necessary and
sufficient for a person to be still alive. There are difficult cases in which brain
continues to perform some functions, but a person is likely to have no conscious
mental state and no chance of their recovery.
So, there is a clinical state called persistent vegetative state (PVS), when the
brain is severely damaged, so that there is no thinking, no feeling, no

54
consciousness. (For such a state to be recognized as permanent, the patient should
be in id during three months.) However, the patient is not entirely brain-dead. The
brain still performs a number of functions, and there can be appearances that
suggest that the patient is conscious: his/her eyes may be open and he/she may
utter sounds without meaning; he/she may appear to smile, grimace, or cough. The
difficult ethical problem is: whether the life (body-functioning) of such a patient
should be supported by artificial means (which are expensive and could be used for
saving other patients‟ lives) for an indefinitely long time?
On the other hand, there is the problem of mistaken diagnosis and the
difficulty to distinguish cases of persistent vegetative state from the cases of
locked-in syndrome, when a patient does have conscious mental states but is
incapable to express them. Some researches using the latest technical achievements
suggest that the percentage of such misdiagnosing is very high, nearly 40%. And
there are other researches that testify that people with locked-in syndrome rate
their quality of life unexpectedly high, so that stopping artificial support of their
lives cannot be considered a suffering-ending act of mercy.
In most countries, passive euthanasia – the withdrawal of medical care that
leads to the death of the patient – is allowed if there is en explicit and well-testified
will of the patient for this purpose. The debatable issues arise when the patient is
not in the state to make conscious sane decisions: the patient is unconscious and,
by all reasonable medical criteria, is not expected to ever come to consciousness,
or gravely demented (Alzheimer‟s decease, etc.). In such cases, should artificial
life-support be continued for an indefinitely long time? If not, when (in what
conditions) it should be stopped? Who is to decide? Is it the physician, or family
members?
To alleviate this problem, The Patient Self-Determination Act was adopted
in USA in 1990. According to the act, all hospitals must counsel patients
about living wills and health care planning. Patients are proposed to make an
advance directive ‒ a legal document in which a person sets out his wishes on
how his appointed „attorneys‟ (representatives) should organize his life, health,

55
property and affairs, should he become mentally incompetent. However, there are
some problems with applying advance directives: directives can be vague; it is
impossible for people to fine-tune their directives in the way of medical care in
advance; the future situations are complex, constantly changing, and often
unpredictable. According to 2004 study, two-thirds of doctors said they would
ignore advance directives in cases where a patient‟s prognosis remained hopeful or
family members disagreed.

The problem of ethical permissibility of active euthanasia. Jatrotanasia

Active euthanasia is helping a person to die, on his or her will, in order to end
suffering. In cases when a physician prepares means for a patient‟s death but the
decisive action (final step) is taken by the patient himself, active euthanasia is
called assisted suicide.
Basically, active euthanasia is ethically problematic because it involves the
moral dilemma: on the one hand, there is the duty of a physician to save human
life; on the other hand, there is the duty of a physician to alleviate suffering
and the right of a patient to dispose of one‟s life.
Active euthanasia is most usually opposed on religious grounds: only God
should decide when a person‟s life is taken away. Medical tradition is also not
favorable to active euthanasia. Recollect the Hyppocratic Oath:
I swear by … by all the gods and goddesses, making them my witnesses …
Neither will I administer a poison to anybody when asked to do so, nor will
I suggest such a course.
Opponents of active euthanasia raise a number of worries: Who defines
terminally ill? How will doctors ensure patients have exhausted all other pain
management options and are of sound mind to make this decision? Can the
legalization of euthanasia lead to pressure on the elderly, uninsured, and disabled
to choose suicide as the most cost-effective alternative? (However, with respect to
the last worry, there is the reply that there is no evidence for this in states where
euthanasia is legalized.) They are also afraid that legalizing euthanasia is a step

56
down a slippery slope that ends with the abandonment of the idea of the value of
human life.
Among contemporary physicians, attitudes toward active euthanasia are
divided. A number of medical organizations still follow the Hyppocratic attitude.
For example, the American Medical Association states:
“The power to assist in intentionally taking the life of a patient is
antithetical to the central mission of healing that guides both medicine and
nursing. It is a power that most health care professionals do not want and
could not control.”12
On the other hand, public opinion and legislation on this issue gradually
become more liberal. In USA doctor-assisted suicide became legally allowed first
in the state Oregon, in 1997. Today, active euthanasia at the request of an incurable
patient or doctor-assisted suicide is legalized in 8 US states, Netherlands, Belgium,
Colombia. According to Gallup poll in USA in 2004, 65 percent of people said a
doctor should be allowed to assist a suicide when a person was in pain and dying
from an incurable disease.
Supporters of the legalization of euthanasia believe that the choice of death
is an intrinsic human right. They argue that no harm is caused to any side, and that
the danger of misuse can be prevented by careful regulation. Besides, an important
consideration as the scarcity of medical resources, which can be used to save other
lives.
In countries where active euthanasia is legalized, a number of safeguards is
taken to prevent abuse. For example, Oregon‟s Death with Dignity Act requires
two separate requests, a written request with nonfamily witnesses, a second
doctor‟s review of the diagnosis and approval that the patient‟s judgment is not
impaired.
In other countries, active euthanasia remain legally forbidden and
punishable. So, in Great Britain, the penalty for assisting a suicide is 14 years‟

12
Quot. in Mooney K. Bioethics. – p. 49.

57
imprisonment. However, the system of courts is such that in many cases this law is
not applied. The legal persecution loses much of its efficiency because of “suicide
tourism”: patients who want to undergo euthanasia can travel to other countries, in
which it is legalized. Euthanasia for such a “tourists” is practiced on a large scale
by Dignitas – an organization that helps people to die if they are able and willing
to travel to Switzerland, where assisting suicide is legal. On August 2015,
approximately 300 British citizens have travelled to Switzerland from the UK to
die at one of Dignitas‟ rented apartments in Zürich.
A further debatable issue is concerned with “double effect” of medical
prescriptions. Unlike in case of euthanasia, it is widely agreed that to keep a patient
comfortable, a doctor can prescribe as much of the drug as needed, even if it will
shorten the patient‟s life. However, the question arises: whether this is different, in
principle, from euthanasia? Is not this sort of gradual euthanasia?
The ethically controversial character of the right for euthanasia can be well
illustrated by the case of Jack Kevorkian – the physician who was called “Doctor
Death”, because in 1990-th, he helped more than 120 people achieve their deaths
(assisted suicide). He was also active campaigner for the right to die. In 1998, he
performed active euthanasia in the state where it was forbidden and criminal,
videotaped and aired it, - and, as a consequence, was convicted and imprisoned.
The activity of Kevorkian raised many strong criticisms not only on the
ground of general opposition to euthanasia, but because of his methods. It seems
that he was too enthusiastic about the right to die and carried away by campaigning
for it. “According to a report by the Detroit Free Press, 60% of the patients who
died with Kevorkian's help were not terminally ill, and at least 13 had not
complained of pain; Kevorkian's counseling was too brief and lacked a psychiatric
exam in at least 19 cases, 5 of which involved people with histories of depression;
Kevorkian failed to refer at least 17 patients to a pain specialist after they
complained of chronic pain, and sometimes failed to obtain a complete medical
record for his patients…”

58
5. Iatrotanasia
Iatrotanasia (from Greek "iatros" – doctor, and "tanatos" – death): a doctor
purposefully causes the death of a patient without his/her explicit will.
During World War II, Nazi Germany carried out a plan of iatrotanasia
against the mentally handicapped, crippled, and physically deformed. The Nazis
intended to purify their gene line and eliminate those they considered to be
unworthy of life.
These programs eventually evolved into the genocide of Jews.
Unlike euthanasia, iatrotanasia cannot be plausibly justified, even by
considerations of compassion to the patient undergoing strong suffering. The will
of the patient should be decisive: the physician‟s compassion to suffering and his
judgment that the patient‟s life is of so low quality that it is not worth continuation
cannot outweigh the physician‟s duty to save life supported by the patient‟s will to
continue living.

6. Palliative care. Hospices

Palliative care – a complex approach that aims to ensure the maximum quality of
life for a patient with a terminal illness and his or her family by preventing and
alleviating suffering through the early identification and accurate diagnosis
(assessment) of emerging problems and adequate treatment (in cases of pain
syndrome and other disorders of life), as well as providing psychosocial and moral
support.
According to current international requirements, palliative medicine should
be a necessary, integrated component of health care and social care. So, the
Declaration of the World Health Organization (1990) and the Barcelona
Declaration (1996) call upon all countries of the world to include palliative care in
the structure of their national health systems.
High quality palliative care is a good alternative to euthanasia as a way of
dealing with sufferings of terminally ill patients. So, in the US state of Oregon,
where physician-assisted suicide is legal, 45% of patients who considered

59
euthanasia desirable but tried and were given good palliative care changed their
view.
Hospice – a healthcare institution that provides palliative care to patients,
usually in the terminal stages of disease, and their families. Its specialists have
received special training in order to give organizational, methodological and
consultative assistance and coordination of primary, general and specialized
palliative care. The tasks of hospices are defined by the “Regulations on the
specialized health care institution of special kind "Hospice"”.
American Cancer Society, on its Web site, describes the philosophy of
hospice as follows:
“Hospice is a philosophy of care. … The goal of hospice is to enable
patients to continue an alert, pain-free life and to manage other symptoms
so that their last days may be spent with dignity and quality, surrounded
by their loved ones. … it focuses on quality rather than length of life. It
provides family-centered care and involves the patient and the family in
making decisions.”13
For most people, the greatest fears about dying are losing control, feeling pain, and
being alone. End-of-life care helps patients overcome these fears and experience a
better quality of life in their final days.

Glossary
Euthanasia (from Greek: εὐ θαναζία; "good death": εὖ , eu; "well" or "good" +
θάναηος, thanatos; "death") is the practice of intentionally ending a life to relieve
pain and suffering.
Passive euthanasia entails the withholding treatment necessary for the
continuance of life.

13
Cheyfitz K. Suicide Machine, Part 1: Kevorkian rushes to fulfill his clients' desire to die //
Detroit Free Press, March 3, 1997.

60
 Active euthanasia entails the use of lethal substances or forces (such as
administering a lethal injection), and is the more controversial.
Palliative care (derived from the Latin root palliare, or "to cloak") is an
interdisciplinary medical care-giving approach aimed at optimizing quality of life
and mitigating suffering among people with serious, complex illness. Within the
published literature, many definitions of palliative care exist; most notably, the
World Health Organization describes palliative care as "an approach that improves
the quality of life of patients and their families facing the problems associated with
life-threatening illness, through the prevention and relief of suffering by means of
early identification and impeccable assessment and treatment of pain and other
problems, physical, psychosocial, and spiritual."
Hospice care is a type of health care that focuses on the palliation of a
terminally ill patient's pain and symptoms and attending to their emotional and
spiritual needs at the end of life. Hospice care prioritizes comfort and quality of life
by reducing pain and suffering. Hospice care provides an alternative to therapies
focused on life-prolonging measures that may be arduous, likely to cause more
symptoms, or are not aligned with a person's goals.

61
THEME 7. FOUNDATIONS OF BIOSAFETY. THE HEALTHY WAY OF LIFE
AS A CONDITION OF ITS DEVELOPMENT
Plan
1. The notion of biosafety. Legislative foundations of biosafety
2. Biological safety of work in laboratories
3. Problems of biosafety of the use of genetically modified organisms (GMO)
4. Human health. Healthy lifestyle
5. Medical Psychology. Applied aspects of medical psychology in various fields of
biomedical ethics and deontology
Key words: biosafety, biosecurity, bioterrorism, agroterrorism, biological agent,
biological warfare, genetically modified organisms, lifestyle, healthy lifestyle, bad
habit, hypodynamia, stress, medical psychology, psychosomatics.

Control questions
1. What is the content of the concepts of biosafety and biosecurity?
2. What levels of the biological risks in laboratories are distinguished?
3. List the main potential threats to the biological nature of living organisms.
4. What is anthropogenic degradation of the environment?
5. What are main bioethical problems of genetic biotechnologies.
6. List and describe the risk assessment methods for biomedical technologies.
7. What is the content of the controversy about the development and use of
GMO? What reasons are adduced by the opponents and defenders of GMO?
8. How GMO are used in medicine?
9. Explain the notion of health and its levels.
10. What is healthy lifestyle? What are its main constituents?
11. What are main models of promoting healthy lifestyle? What are their relative
advantages and disadvantages?
12. What is the role of medical psychology in health promotion?

62
Task
1. Prepare a report ( 2-3 pages) about scientific assessment of the advantages and
risks involved in the development and use of GMO.
2. Look for an information about an aspect of healthy lifestyle that is not widely
known. Prepare a speech (2-3 pages) with a presentation (6-9 slides).

Recommended reading:
1. Biosafety and the environment [Електронний документ]. – Доступ:
https://www.cbd.int/doc/press/presskits/bs/cpbs-unep-cbd-en.pdf
2. Bryant J., Velle L. Genetic Modification and Synthetic Biology. Genetic
Modification of Plants // Bryant J., Velle L. Introduction to Bioethics. – Wiley-
Blackwell, 2018. – P. 181-228.
3. Nicolia A., Manzo A., Veronesi F., Rosellini D. An overview of the last 10
years of genetically engineered crop safety research // Critical Reviews in
Biotechnology. Published online 13 September 2013[Електронний документ].
– Доступ:
https://www.pps.net/cms/lib/OR01913224/Centricity/Domain/3337/peer%20rev
iewed%20meta%20study%20on%20GMOs%20copy.pdf
4. Healthy lifestyle: 5 keys to a longer life (Harvard Medical School)
[Електронний документ]. – Доступ:
https://www.health.harvard.edu/blog/healthy-lifestyle-5-keys-to-a-longer-life-
2018070514186

Review of the Topic:

The notion of biosafety. Biological safety of work in laboratories
Biosafety is the prevention, reduction, and elimination of the influence of
dangerous biological factors (agents) on people, animals, plants, and environment.
Biosafety of the work in laboratories is concerned with the prevention or
minimization of risks that bepend mostly on the following factors:
‒ specific features of the organisms on which experiments are to be held;

63
‒ specific useful features of the experimental animals;
‒ the used technologies and procedures;
‒ the isolating devices and means.
Depending on to the level of biological danger, biological objects are
classified into four groups.
Group I - the absence or low individual and social danger. Microorganisms
that are not potential pathogens.
Group II - moderate individual danger, low social danger. Pathogenic
microorganism that can cause decease but does not present serious danger for
personnel, population, farm animals and environment. Carelessness in laboratory
can evoke infection; however, it can be dealt with available treatment and
prophylactic means. The danger of spread is limited.
Group III - high individual and low social risk. Pathogenic agent that usually
evokes a serious decease but usually does not spread. Efficient treatment and
prophylactic procedures are available.
Group IV - high individual and social risk. Pathogenic agent that usually
evokes a serious decease and easily spreads. Means of efficient resistance are not
available.
Legislative foundations of biosafety. A number of legislative acts regulates
the issues of biosafety indirectly, by the formulation of the general requirements
for healthcare, protection of environment from the influence of dangerous factors
of physical, chemical, and biological nature. Some of the most important such acts
are «The Foundations of the Laws of Ukraine on Healhcare», the Law of Ukraine
«On Medicals», the Law of Ukraine «On the quality and safety of food products»,
the Law of Ukraine «On Pesticides and Agrochemicals», the Law of Ukraine «On
Ecological Expertise».

The problems of biosafety of the use of genetically modified organisms

Genetically modified organisms (GMOs) are organisms in which genetic material
(DNA) is modified in a way impossible in nature. At present, about 140 species of

64
different plants have been transformed. In recent years, genetically modified lines
of soy, corn, rapeseed, cotton, alfalfa, papaya and pumpkin have appeared on the
commercial markets. The world leaders in growing GM plants are United States,
Argentina, Brazil, Canada, and China. Among EU countries, the highest number of
reported GMO use belongs to France (28% of total EU countries), Italy (15%),
Spain (14%), and the United Kingdom (12%).
Objections over the development of GMO's:
- Whether food produced from GMOs is safe?
- What impact growing them will have on the environment?
- Whether they may provoke an allergic reaction?
- Whether the transgenes could transfer to human cells?
- Accusations that scientists are "playing God"
Defenses of GMOs:
- There is a scientific consensus that currently available food derived from GM
crops poses no greater risk to human health than conventional food.
- With more than 1,700 studies demonstrating their safety, GMOs are among the
most studied subject in science.
- More than 275 organizations and scientific institutions support the safety of
GM crops. These include the World Health Organization, the United Nations
Development Programme, the Organization for Economic Co-operation and
Development.
- In 2016, a group of 107 Nobel laureates signed a letter endorsing GMOs.
- GMO‟s are widely used in medicine. One of the most important earliest
medical successes of GM-technologies was the production of human insulin.
One striking example of the possible great use of GMO is the new culture of
rice – Golden rice. It is a sort of rice produced through genetic engineering to
biosynthesize beta-carotene, a precursor of vitamin A, in the edible parts of rice.
Usual rice does not contain it. Golden rice allows solving a grave medical problem
– to prevent Vitamin-A deficiency. Vitamin A deficiency is estimated each year to
kill 670,000 children under the age of 5 and cause an additional 500,000 cases of

65
irreversible childhood blindness. The replacement of usual rice with Golden rice
would allow solving the greatest part of this problem, because for over half of the
world's population, rice is a staple food crop; it provides 30–72% of the energy
intake for people in Asian countries.

Human health and healthy lifestyle

In order to be healthy, our own constant and significant
efforts are required. Nothing can replace them.
M. Amosov
Health is the set of physical, spiritual and social qualities of a person that is the
foundation of his/her longevity and a necessary condition for the realization of
creative plans, high working capacity, creation of a strong family, birth and raising
children. Researches show that human health depends 20% on heredity, 10% on
the level of development of medicine, 20% on the state of the environment and
50% on the lifestyle.
Lifestyle is a set of sustainable forms of human activity that determine
his/her life path. It is a set of his/her habits. Healthy lifestyle implies adherence to
certain rules that ensure harmonious development, high performance, spiritual
equilibrium and health of a person. Healthy lifestyle involves practical actions
aimed at preventing diseases, strengthening all systems of the body and improving
the general well-being of a person. Healthy lifestyle principles include
• rational nutrition;
• optimum motor mode;
• tempering the body;
• personal hygienic care;
• absence of bad habits;
• positive emotions;
• intellectual development;
• moral and spiritual development;
• formation and development of volitional qualities.

66
2. Medical Psychology. Applied aspects of medical psychology in various fields of
biomedical ethics and deontology
Medical psychology is an applied field of psychology that studies the regularities
of functioning of the mind in the conditions of emergence and course of diseases,
as well as the restoration of health. The focus of medical psychology is the
relationship of the patient with the environment of the hospital (the relationship
between physician and patient; nurse and patient; physician, nurse and patient).
The founder of medical psychology is R.G. Lotze (German psychologist and
philosopher of the nineteenth century). Medical psychology includes clinical
psychology; clinical neuropsychology; psychopharmacology; pathopsychology,
etc.
Subject matter of medical psychology includes:
• the personality of the patient;
• the personality of the medician;
• the relationship between the patient and the medical professional in different
conditions (such as home visit, an outpatient clinic);
• the psychology of relations of medical workers in the course of their
professional activity, in everyday life, etc.
The tasks of medical psychology are:
• the study of the specifics of mental changes in the conditions of somatic and
mental illness;
• the study of mentally pathogenic life conditions and kinds of activity;
• the study of personal features that prevent or contribute to the disease.
Medical Psychology is divided into
– general medical psychology, which studies the personality of the patient,
physician, middle and junior health care professionals and their relationship
and
– special medical psychology, which studies the same issues in each specific
medical discipline: surgery, therapy, pediatrics, psychiatry, neuropathology and
others.

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 The most important methods of psychological research are observation and
experiment. Observation is a purposeful, conditioned task of deliberate perception
of mental phenomena and elucidation of their meaning. Experiment is an
interaction between a subject (or a group of subjects) and an experimental situation
organized by the researcher in order to establish the patterns of this interaction.
The auxiliary methods of psychological research are clinical interview, testing,
studying the products of mental activity of patients.
The main applied aspects of medical psychology in various fields of
biomedical ethics and deontology are:
• psychological characteristics of patients with various diseases and in
obstetrics;
• psychological aspects of dependent and suicidal behavior;
• psychological aspects of thanatology and euthanasia.

Glossary
Biosafety is the prevention of large-scale loss of biological integrity, focusing both
on ecology and human health. These prevention mechanisms include conduction of
regular reviews of the biosafety in laboratory settings, as well as strict guidelines to
follow.
Biosecurity, as originally conceptualized, was a set of preventive measures
designed to reduce the risk of transmission of infectious diseases in crops and
livestock, quarantined pests, invasive alien species, and living modified organisms.
From the 1990s, with in response to the threat of biological terrorism, biosecurity
started including the prevention of the theft of biological materials from research
laboratories. The emerging nature of second biosecurity threats means that small
scale risks blow up rapidly, thus an effective policy becomes a challenge for there
are limitations on time and resources available for analysing threats and estimating
the likelihood of their occurrence.
Bioterrorism is terrorism involving the intentional release or dissemination
of biological agents. These agents are bacteria, viruses, insects, fungi, or toxins,

68
and may be in a naturally occurring or a human-modified form, in much the same
way in biological warfare. Further, modern agribusiness is vulnerable to anti-
agricultural attacks by terrorists, and such attacks can seriously damage economy
as well as consumer confidence. The later destructive activity is called
agrobioterrorism and is subtype of agro-terrorism.
Agroterrorism, also known as agriterrorism and agricultural terrorism, is a
malicious attempt to disrupt or destroy the agricultural industry and/or food supply
system of a population through "the malicious use of plant or animal pathogens to
cause devastating disease in the agricultural sectors". It is closely related to the
concepts of biological warfare, chemical warfare and entomological warfare,
except carried out by non-state parties.
Biological warfare (BW) – also known as germ warfare – is the use of
biological toxins or infectious agents such as bacteria, viruses, insects, and fungi
with the intent to kill or incapacitate humans, animals or plants as an act of war.
Biological weapons (often termed "bio-weapons", "biological threat agents", or
"bio-agents") are living organisms or replicating entities (viruses, which are not
universally considered "alive"). Entomological (insect) warfare is a subtype of
BW.
A biological agent (also called bio-agent, biological threat agent,
biological warfare agent, biological weapon, or bioweapon) is a bacterium, virus,
protozoan, parasite, or fungus that can be used purposefully as a weapon in
bioterrorism or biological warfare (BW).[1] In addition to these living or
replicating pathogens, toxins and biotoxins are also included among the bio-agents.
More than 1,200 different kinds of potentially weaponizable bio-agents have been
described and studied to date.
A genetically modified organism (GMO) is any organism whose genetic
material has been altered using genetic engineering techniques. The exact
definition of a genetically modified organism and what constitutes genetic
engineering varies, with the most common being an organism altered in a way that
"does not occur naturally by mating and/or natural recombination".

69
 Lifestyle is the interests, opinions, behaviours, and behavioural orientations
of an individual, group, or culture.
A healthy lifestyle is a way of living that lowers the risk of being seriously
ill or dying early. Not all diseases are preventable, but a large proportion of deaths,
particularly those from coronary heart disease and lung cancer, can be avoided.
A bad habit is a habitual behavior considered to be detrimental to one's
physical or mental health and often linked to a lack of self-control. Habits that are
typically seen as "bad" include smoking, nail-biting, procrastinating and swearing.
Hypodynamia – slow or diminished movement of body musculature.
In a medical or biological context stress is a physical, mental, or emotional
factor that causes bodily or mental tension. Stresses can be external (from the
environment, psychological, or social situations) or internal (illness, or from a
medical procedure). Stress can initiate the "fight or flight" response, a complex
reaction of neurologic and endocrinologic systems.
Medical psychology has historically been defined as the branch of
psychology concerned with the application of psychological principles to the
practice of medicine. Medical psychology shares with the fields of health
psychology and behavioral medicine an interest in the ways in which biological,
psychological, and social factors interact to influence health.
Psychosomatics – a branch of medical science dealing with
interrelationships between the mind or emotions and the body and especially with
the relation of psychic conflict to somatic symptomatology.

70
 THEMES FOR REPORTS

1. Bioethical problems of the coexistence of "tradition" and "non-traditional"

medicine.
2. Bioethical, legal, social problems of advertisement in medicine and pharmacy.
3. Moral, psychological, social aspects of desocialization and resocialization of
patients.
4. Alcoholism, drug addiction, smoking: prevention, rehabilitation, re-
socialization.
5. Palliative treatment as an alternative to euthanasia.
6. Bioethical problems of resuscitation.
7. Moral problems of suicide.
8. Euthanasia: the problem, judgments, searches for an alternative.
9. The vital meaning of choosing death.
10. The main problems of modern transplantology.
11. Transplantation and the identity of the human person.
12. Ethical/deontological dominants of dentistry, pharmacy, and surgery.
13. Bioethical and personal dimensions of medical practice.
14. Bioethics as a factor of the prevention of medical errors in medicine.
15. The principles of evidence-based medicine and their ethical significance.
16. Medical-ethical problems of human and animal cloning.
17. Bioethical criteria for biomedical manipulation and genetic engineering.
18. Biosafety issues in the context of bioethics.
19. Specific responsibilities of the geneticist for the family and the community.
20. Biomedical ethics of genetic research, medical genetic counselling, and
population screening studies.
21. Man and illness. Illness as the experience and behavior of the human
personality.
22. Medical-ethical and legal evaluation of error and iatrogeny in clinical practice.

71
23. National and international documents regulating the ethical, professional and
legal activity of medical personnel.
24. Bioethical Aspects of medical paternalism in the doctor-patient relationship.
25. The content and meaning of the 1997 Council of Europe Convention “On the
Protection of Human Rights and Dignity with Respect to the Use of
Achievements in Biology and Medicine.
26. The content and meaning of the 1997 "Universal Declaration of the Genome of
Human and Human Rights"
27. Euthanasia: pro and contra.
28. Ethical problems of reproductive medicine.
29. The problem of the right for abortion and other
30. Child rights and medicine.

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 TEST TASKS FOR THE FINAL CONTROL

1. Bioethics studies
a) ethical problems that arise in medical practice and biomedical research
b) ethical problems that arise in the process of biological evolution
c) ethical views of biologists
d) the development of ethics in biological systems

2. As translated from Greek, "bioethics" means

a) ethics of life
b) ethics of death
c|) meaning of life
d) behaviour of living things

3. Academic bioethics studies

a) moral standards of relationships in academic institutions
b) general theoretical foundation for solving ethical problems in the biomedical
field
c) specific ethical issues encountered in medical practice
d) relationship between biological systems

4. Clinical ethics studies

a) relationship in medical teams
b) ethical problems arising in medical practice
c) moral standards of clinical research
d) clinical manifestations of moral abnormalities

5. The foundations of the traditional medical ethics were formed in the school of
a) Socrates
b) Hippocrates

73
c) Galen
d) Paracelsus

6. In the teachings of Hippocrates, the understanding of the nature of disease and

of the means of its treatment has ……………. character.
a) religious
b) magic
c) naturalistic
d) scientifically provable

7. The main principle of the medical ethics of Hippocrates:

a) effective treatment
b) love of humanity
c) non-harming
d) professionalism

8. The concept of deontology as a science of morality was introduced by

a) Bentham
b) Socrates
c) Hippocrates
d) Galen

9. The criterion of morality in the ethics of Bentham is

a) humanity
b) utility
c) professionalism
d) reciprocity

10. The concept of bioethics was introduced by

a) Kant

74
b) Bentham
c) van Potter
d) Aristotle

11. The Belmont report contains the formulation of three fundamental ethical
principles of biomedical research. These are:
a) respect for persons, beneficence, justice
b) respect for persons, beneficence, humanism
c) respect for persons, beneficence, utility calculation
d) respect for persons, informed consent, justice

12. In biomedical research, the principle of respect for persons serves as a guide
for
a) informed consent
b) risk/utility estimation
c) fair selection of participants
d) humanism

13. In biomedical research, the principle of beneficence serves as a guide for

a) informed consent
b) risk/utility estimation
c) fair selection of participants
d) humanism

14. In biomedical research, the principle of justice serves as a guide for

a) informed consent
b) risk/utility estimation
c) fair selection of participants
d) humanism

75
15. The main reason for the emergence of bioethics as the latest stage in the
development of medical ethics is
a) secularization of society
b) deprofessionalization of medicine
c) bureaucratization of medicine
d) the development of biomedical knowledge and technology

16. By “the deprofessionalization of medicine” researchers understand

a) the decrease in the effectiveness of medical care
b) the loss by medicine of the character of a self-regulatory corporation
c) incompetence of medical workers
d) the replacement of medical workers with modern medical equipment

17. “Secularization of society” means

a) the increased influence of religion
b) the recognition of the sacredness of human life
c) the weakening of the influence of religion
d) the denial of the sacredness of human life

18. The term “moral pluralism” means that

a) people differ in morality
b) there are different ideas about morally permissible and impermissible among
different nations
c) people have different views on ethical issues and proceed from different moral
systems
d) there is no objective difference between good and evil

19. The main principle of the Nuremberg Code:

a) Biomedical research should benefit society.

76
b) A necessary requirement for biomedical experiments is the voluntary consent of
the participants.
c) Biomedical research should contribute to the development of science.
d) In biomedical experiments on people suffering is impermissible.

20. The ethical principles of the Belmont Report were formulated for
a) clinical practice
b) regulation of the relationship between medical staff
c) biomedical research on people
d) biomedical animal research

21. The Hippocratic Oath DOES NOT contain the principle of

a) non-harming
b) sacredness of life
c) social justice
d) beneficence

22. The principle of respect for the autonomy of a patient means that
a) a physician should not act to the detriment of the patient
b) a physician must act for the good of the patient
c) the patient gives informed consent
d) health benefits should be distributed fairly

23. The development of medical ethics in the second half of the twentieth century
proceeded in the direction to
a) paternalism
b) autonomy of the patient
c) autonomy of the physician
d) feminism

77
24. The principle of respect for the autonomy of a patient does NOT imply
a) the patient being informed about his disease and ways of its treatment
b) thе patient‟s knowledge about the physician‟s values
c) the patient's right for free medical care
d) the patient‟s right to refuse the proposed treatment

25. The principle of patient autonomy can NOT be restricted on considerations of

a) immaturity
b) doctor's knowledge of the correct method of treatment
c) mental disorders
d) danger to other people
e) conflict with the autonomy of the doctor

26. A patient's informed consent does NOT imply obtaining complete information
about
a) goals of the planned intervention
b) expected positive consequences for the patient
c) possible discomfort and risks
d) mechanisms of action of the drugs
e) existing alternative treatments

27. The principle of confidentiality means that information about the patient
communicated to a physician or obtained as a result of medical research
a) cannot be used to harm the patient
b) should be used for medical purposes
c) cannot be communicated to a third party without the permission of the patient
d) can only be communicated to close relatives of the patient

78
28. The paternalistic model of physician-patient relationship implies that
a) a physician takes care of a patient, makes decisions, and the patient accepts this
care and follows the physician‟s instructions
b) a physician and a patient have equal rights and make joint decisions on
treatment methods
c) a physician and a patient act according to a contract that defines their rights and
obligations
d) a physician acts as a friend of a patient
e) a physician acts as a technician that provides services to a client-patient

29. The collegial model of physician-patient relationship implies that

a) a physician takes care of a patient, makes decisions, and the patient accepts this
care and follows the physician‟s instructions
b) a physician and a patient have equal rights and make joint decisions on
treatment methods
c) a physician and a patient act according to a contract that defines their rights and
obligations
d) a physician acts as a friend of a patient
e) a physician acts as a technician that provides services to a client-patient

30. The engineering model of physician-patient relationship implies that

a) a physician takes care of a patient, makes decisions, and the patient accepts this
care and follows the physician‟s instructions
b) a physician and a patient have equal rights and make joint decisions on
treatment methods
c) a physician and a patient act according to a contract that defines their rights and
obligations
d) a physician acts as a friend of a patient
e) a physician acts as a technician that provides services to a client-patient

79
31. Ethics of a nurse are formulated in
a) the Hippocratic Oath
b) the Florence Nightingale Pledge
c) the Oath of a physician of Ukraine
d) the Belmont report

32. The Florence Nightingale Pledge does not contain the principle of
a) confidentiality
b) non-harming
c) patient autonomy
d) professionalism
e) beneficence

33. The basis of the ethical issue of abortion is

a) woman's right to control her body
b) the moment when the human body becomes a person who has the right to life
c) the existence of the human soul
d) the importance of procreation

34. The pro life attitude on abortion gives priority to

a) woman's right to choose her way of life
b) the right of the human embryo (fetus) to life
c) woman's right to dispose of her body
d) creation of the conditions for the preservation and development of life of all
living beings

35. The pro choice attitude on abortion gives priority to

a) woman's right to choose her way of life
b) the right of the human embryo (fetus) to life
c) woman's right to dispose of her body

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d) creation of the conditions for the preservation and development of life of all
living beings

36. The attitude of the largest world religions (Christianity, Islam) toward abortion:
a) inadmissibility of abortion;
b) admissibility of abortion only at an early stage, before the first heartbeat
c) admissibility of abortion up to the birth of the child

37. Assisted reproductive technologies are

a) medical technologies that contribute to the normal development of an embryo
and the birth of a child for a woman in poor health
b) medical technologies aimed at the birth of a child, with some or all stages of
conception and development of the embryo carried out outside the body of the
future mother
c) technologies of operating a patient aimed at the birth of a child (cesarean
section)

38. Extracorporeal (in vitro) fertilization is

a) assisted reproductive technology in which donor‟s sperm is used for artificial
insemination
b) assisted reproductive technology in which donor‟s eggs are used for artificial
insemination
c) assisted reproductive technology in which an egg is removed from the body of a
woman and fertilized artificially
d) assisted reproductive technology in which the fetus is carried by a woman who
is not a genetic mother

39. Surrogacy is
a) assisted reproductive technology in which donor‟s sperm is used for artificial
insemination

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b) assisted reproductive technology in which donor‟s eggs are used for artificial
insemination
c) assisted reproductive technology in which an egg is removed from the body of a
woman and fertilized artificially
d) assisted reproductive technology in which the fetus is carried by a woman who
is not a genetic mother

40. The ethical issue of getting the status of mother by an elderly woman arises in
connection with the technology of
a) in vitro fertilization
b) egg donation
c) surrogacy
d) sperm donation

41. Ethical issues associated with assisted reproductive technologies (ART) do

NOT include:
a) the problem of the high cost of ART, their inaccessibility for the poor
b) the problem of the right of embryos to life
c) the problem of the permissibility of extramarital sexual intercourse
d) the problem of determining who should make decisions
e) the problem of the right of single and homosexual women to parenthood through
ART
f) the danger of slipping into eugenics

42. Preimplantation genetic diagnostics is used

a) to determine the genetic predisposition of parents to serious illnesses
b) to determine the genetic predisposition of the embryo for the development of
severe diseases and to screen out the embryos with the positive result
c) to determine the chemical structure of the genes of the embryo

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d) to select embryos with genetics that indicates a high probability of the desired
physical and intellectual qualities of the person who will be born

43. The main problem associated with the use of genetic therapy:
a) the risk of discrimination due to the violation of confidentiality
b) the probability of harmful side effects due to the use of viruses for the
transmission of genetic information
c) the danger of eugenic use

44. Artificial creation of an exact genetic copy of an organism, organ or tissue

a) proliferation
b) duplication
c) animation
d) cloning
e) generation

45. Ethical issue that is NOT related to human cloning

a) the death of many underdeveloped human organisms in the process of
experimentation and development of the technology
b) the issue of the admissibility for a person to "play God"
c) the problem of the ethical status of creatures with "artificial intelligence"
d) the risk of creating human beings with significant physiological and
psychological defects

46. The attitude of authoritative international medical and legal organizations, as

well as national legislation, to human cloning:
a) human cloning is unacceptable
b) human cloning is acceptable
c) human cloning is acceptable under certain conditions
d) different attitudes of different organizations and states

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47. The possibilities of the therapeutic use of stem cells include:
a) antibacterial effect, strengthening immunity
b) use in genetic therapy
c) the restoration of individual tissues of the body and, in the future, the production
of organs for transplantation
d) use in assisted reproductive technologies

48. The therapeutic benefits of embryonic stem cells are due to the property:
a) the ability to produce cells of the same kind
b) the ability to produce cells many cells of many kinds
c) the technology does not involve the destruction of embryos
d) cells of the patient are used

49. The advantage of using adult stem cells, as compared to the use of embryonic
ones:
a) the ability to produce cells of the same kind
b) the ability to produce cells many cells of many kinds
c) the technology does not involve the destruction of embryos

50. The disadvantage of using induced pluripotent stem cells, as compared to

conventional adult stem cells, is
a) the ability to produce cells of the same kind
b) the technology does not involve the destruction of embryos
c) cells of the patient are used
d) the use of viruses with the risk of dangerous side effects

51. A philosopher who taught that death should not be feared, because we do not
know what death is and whether it is bad or good for us:
a) Socrates
b) Epicurus

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c) Seneca
d) Unamuno
e) Schopenhauer

52. A philosopher who taught that death should not be feared, because we never
meet with it:
a) Plato
b) Aristotle
c) Epicurus
d) Unamuno
e) Schopenhauer

53. A philosopher who defended the right to suicide as a condition for a decent
life:
a) Plato
b) Aristotle
c) Seneca
d) Unamuno
e) Schopenhauer

54. What does the term “euthanasia” mean in Greek?

a) stem cell therapy
b) easy death
c) the acceleration of death with medication
d) the doctor‟s actions aimed at the resuscitation of the patient

55. Medical considerations against the euthanasia include:

a) chance for recovery
b) the possibility that the patient can change his/her mind
c) the violation of the main prescription for a physician - saving people

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d) all the factors in this list

56. Active euthanasia differs from passive in:

a) active intervention by a physician in the process of the termination of a patient‟s
life on his/her request
b) requiring no consent of the patient's guardians
c) the priority of the physician‟s decision over the patient‟s decision
d) active intervention of society in medical processes

57. What does the term “passive euthanasia” mean?

a) a physician's activity aimed at the continuation of human life
b) a physician's activity aimed at the termination of a patient's life
c) a physician's refusal from activities aimed at the support and prolongation of the
patient's life
d) intentional termination of the patient's life on his/her request

58. Permanent vegetative state is

a) the constant non-consumption of the food of animal origin
b) brain damage, in which the patient cannot express his/her states of
consciousness
c) brain damage, in which the patient has no consciousness (sensations, thinking,
awareness) for more than 3 months
d) brain damage in which the patient cannot move

59. The inadmissibility of euthanasia from the viewpoint of Christian ethics is

connected with
a) violation of the commandment "do not kill"
b) the need for suffering
c) opportunity to participate in the resurrection experience
d) all the factors in this list

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60. Kinds of euthanasia do not include:
a) active
b) physical
c) passive

61. Who was called "the Doctor Death"?

a) Jack Avonesyan
b) Jack Kevorkyan
c) Jack Tivoryan
d) Jack Black

62. Active euthanasia is legalized in the following group of countries:

a) Netherlands, Belgium, France
b) Netherlands, Belgium, Switzerland
c) Ukraine, Moldova, Belarus, USA
d) Russia, Moldova, USA

63. The patient's right to refuse treatment is based on:

a) the awareness of the insufficiency of funding
b) the awareness of the limitations of medical facilities
c) the acceptance of God's will
d) the patient's will

64. Iatrotanasia is
a) causing the death of a patient by a doctor in order to rid the patient of suffering
on his/her request
b) failure to provide medical care that leads to the death of the patient
c) causing the death of the patient by the doctor without the explicit will of the
patient
d) the patient causing his own death in a state of affect

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65. Palliative care is
a) a complex medical measures for the treatment of especially severe cases
b) complex care aimed at ensuring the best quality of life for a patient with a
terminal disease
c) financial assistance for poor patients for the purchase of medicines
d) psychological assistance to patients with mental disorders, complementary to
medication psychiatric treatment

66. Hospice is
a) specialized medical institution for the treatment of seriously ill patients
b) institution for palliative care
c) specialized medical institution for the treatment of patients posing a threat to
others
d) institution for euthanasia

67. Which of the factors should not affect the doctor‟s decision with regard to
difficult ethical problems in his/her professional sphere:
a) deontological
b) legislative
c) traditional moral
d) personal gain

68. The use of resuscitation equipment for a patient who is in critical condition is
a) an application of the principle of struggle for human life to the end
b) an abuse of therapeutic means
c) a sign of the low qualification of a specialist
d) an advantage of the availability of an appropriate insurance policy

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69. An actor with a significant percentage of skin lesions gets into the burn
compartment. He is conscious and asks the doctor to help him die, because he will
no longer be able to engage in his profession. Doctor's actions should be:
a) give the patient a sedative and invite a psychotherapist
b) conduct resuscitation
c) fulfill the request of the patient
d) consult with the head doctor

70. What is active euthanasia?

a) a physician‟s refusal from measures aimed at the prolongation of the patient's
life
b) a physician‟s actions aimed at the prolongation of the patient‟s life
c) deliberate termination of the patient‟s life at the request of his/her relatives
d) deliberate termination of the patient‟s life at his/her personal request

71. Bioterrorism is the use, as a means of the extermination and intimidation of

people, of
a) chemical agents
b) biological agents
c) physico-chemical agents
d) all kinds of agents in this list

72. International and national systems of the management of biological risk

include:
a) informing population
b) the system of control of bio-agents
c) normative documents
d) all the items in this list

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73. How many levels of biosafety there are?
a) one
b) two
c) three
d) four

74. Biological danger is:

a) the use of alternative treatments
b) bacterial contamination of products
c) non-compliance with the rules of personal hygiene
d) inflicting harm to the health of a large number of people by means of biological
agents

75. What belongs to GMOs?

a) dietary supplements
b) biological weapons
c) genetically modified microorganisms
d) all the items in this list

76. GMO can be defined as:

a) an organism whose genotype was artificially modified in a way that is
impossible in natural conditions
b) a plant with artificially modified genotype
c) an animal with artificially modified genotype

77. Which of the following factors does NOT serve as an ethical motivation for
donation?
a) love for people
b) financial gain
c) happiness of loved ones

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78. What criterion is not taken into account in the selection of a donor?
a) financial condition of the recipient
b) compatibility
c) the severity of the condition of the recipient
d) time of being in the "waiting list"

79. When selecting patients for transplantation, the following criteria should be
considered:
a) therapeutic
b) legal
c) utilitarian
d) all criteria in this list

80. In animal research, the replacement principle requires:

a) not to use animals if there is a threat to their life
b) if possible, to use other means or animals with a lower organization
c) to reduce the number of animals on which the experiment is held
d) to minimize suffering and improve the conditions of animals under experiment

81. In animal research, the principle of reduction requires:

a) not to use animals if there is a threat to their life
b) if possible, to use other means or animals with a lower organization
c) to reduce the number of animals on which the experiment is held
d) to minimize suffering and improve the conditions of animals under experiment

82. In animal research, the refinememt principle requires:

a) not to use animals if there is a threat to their life
b) if possible, to use other means or animals with a lower organization
c) to reduce the number of animals on which the experiment is held
d) to minimize suffering and improve the conditions of animals under experiment

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83. In biomedical experiments, the division into the experimental and control
groups is necessary for
a) objective assessment of the medical effectiveness of the drug by statistical
comparison of the results of those who take it and those who do not
b) objective assessment of the medical effectiveness of the drug by eliminating the
placebo effect
c) objective assessment of the medical efficacy of the drug due to the random
selection of the organisms to which it is applied
d) confidentiality

84. In biomedical experiments, randomization means that

a) the selection in the experimental and control groups is carried out randomly
b) the participants in the control group take an inactive substance, while believing
that they are taking the medicine
c) the patients and the medical staff who work with them do not know if the patient
is taking the test drug or placebo

85. Placebo control means that

a) the selection in the experimental and control groups is carried out randomly
b) the participants in the control group take an inactive substance, while believing
that they are taking the medicine
c) the patients and the medical staff who work with them do not know if the patient
is taking the test drug or placebo

86. A medical experiment is doubly blind if

a) the selection in the experimental and control groups is carried out randomly
b) the participants in the control group take an inactive substance, while believing
that they are taking the medicine
c) the patients and the medical staff who work with them do not know if the patient
is taking the test drug or placebo

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87. In biomedical experiments, randomization is needed in order to
a) prevent the influence of human subjectivity in the process of selection into the
experimental and control groups
b) distinguish distinction between the medical effect of the test drug and the
placebo effect
c) ensure that participants in the control group cannot find out that they were
taking a placebo rather than a medicine

88. In clinical trials, placebo control is needed to

a) prevent the influence of human subjectivity in the process of selection into the
experimental and control groups
b) distinguish between the medical effect of the test drug and the effect of the
change of the patient's mood due to the expectation of positive treatment results
c) ensure that participants in the control group cannot find out that they were
taking a placebo rather than a medicine

89. In clinical trials, “double blindness” is needed in order to

a) prevent the influence of human subjectivity in the process of selection into the
experimental and control groups
b) distinguish distinction between the medical effect of the test drug and the
placebo effect
c) ensure that participants in the control group cannot find out that they were
taking a placebo rather than a medicine

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Recommended Sources
Basic
1. Beauchamp T. L., Childress J. F. Principles of Biomedical Ethics / 8th ed. –
New York: Oxford University Press, 2019. – 512 p.
2. Bryant J., Velle L. Introduction to Bioethics. 2nd ed. – Wiley-Blackwell, 2018. –
360 p.
3. Veatch R., Guidry-Grimes L. The basics of bioethics. 4-th ed. – London, New
York: Routledge, 2019. – 205 p.

Auxiliary
1. Bioethics. An Anthology / ed. by H. Kuhze, P. Singer. – Oxford: Blackwell
Publ. Ltd, 2015. – 600 p.
2. Boylan M. Medical Ethics / 2nd ed. – Malden, MA and Oxford: Wiley-
Blackwell, 2013. – 403 p.
3. Bunge M. Medical Philosophy. Conceptual Issues in Medicine. – World
Scientific, 2013. – 287 p.
4. Campbell A. Bioethics: The Basics / 2nd ed. – Routledge, 2017. – 216 p.
5. Childress J. Who should decide? Paternalism in health care. – Oxford
University Press, 1982. – 264 p.
6. Holland S. The Virtue Ethics Approach to Bioethics // Bioethics. – 2011. –
Vol. 25(4). – pp. 192-201.
7. Jonsen A. R. A Short History of Medical Ethics. – New York: Oxford
University Press, 2008. – 168 p.
8. Kuhse H., Singer, P. A Companion to Bioethics / 2nd ed. – Oxford: Wiley-
Blackwell, 2012. – 636 p.
9. Mooney K. Bioethics. – Lucent Books, 2009. – 112 p.
10. Rawls J.D. Justice as Fairness: A. Restatement. – Harvard University Press.
2003. – 2014 p.

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11. Rendtorf J.P. Basic ethical principles in Europpean bioethics and biolaw.
Autonomy, dignity, integrity and vulnerability. – Guissona: Impremta Barlona,
2001. – 428 p.
12. Talbot M. Bioethics. An Introduction. – Cambridge University Press, 2012. –
478 p.
13. The Oxford Handbook of Animal Ethics / ed. T.L. Beauchamp & R.G. Frey. –
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14. Thomas A. Mappes Biomedical Ethics. – Mc Graw Hill. – 2001. – 707p.
15. Vaughn L. Bioethics: Principles, Issues, and Cases / 4th ed. – Oxford
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16. Veatch R. The basics of bioethics. – Kennedy Institute of Ethics Georgetown
University: Prentice Hall, Upper Saddle River, New Jersey. – 2003. – 205 p.
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Internet Information Resources

1. Bioethics entry in the Internet Encyclopedia of Philosophy. –
https://www.iep.utm.edu/bioethic/
2. Bioethics. Columbia University. – http://www.bioethics.net
3. Bioethics, from Wikipedia. – https://en.wikipedia.org/wiki/Bioethics
4. Canadian Bioethics Society. – http://www.bioethics.ca
5. Global Ethics Network. – http://www.globalethicsnetwork.org/
6. World medical association (declarations, conventions). – https://www.wma.net/

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– 360 p.
3. Bunge M. Medical Philosophy. – New Jersey, London: World Scientific,
2013. – 287 p.
4. Childress J. Who should decide? Paternalism in health care. – Oxford
University Press, 1982. – 264 p.
5. Engelhardt H. T. The Foundations of Bioethics. – New York, Oxford: Oxford
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Toward a Philosophy and Ethic of the Healing Professions. – New York:
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